article 14 of directive (eu) 2016/798 and commission
TRANSCRIPT
Guide for the application of Article 14 of Directive (EU) 2016/798 and Commission Implementing Regulation (EU) No 2019/779 on a system of certification of entities in charge of maintenance for vehicles
In accordance with Article 19(3) of Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016
Guidance on ECM certification process
Released by European Union Agency for Railways
This guide does not contain any legally binding advice. It may serve as a clarification tool without however dictating in any manner compulsory procedures to be followed and without establishing any legally binding practice. The guide provides explanations on the provisions contained in the TSIs and should be helpful for understanding the approaches and rules described therein. However, it does not substitute for them.
The guide is publicly available and it will be regularly updated to reflect progress with European standards and changes to the TSIs.
The reader should refer to the website of the European Union Agency for Railways for information about its latest available edition.
Manuscript completed in June 2021
Neither the European Union Agency for Railways nor any person acting on behalf of the European Union Agency for Railways is responsible for the use that might be made of the following information.
Luxembourg: Publications Office of the European Union, 2021
© European Union Agency for Railways, 2021
Reproduction is authorised provided the source is acknowledged.For any use or reproduction of photos or other material that is not under the ERA copyright, permission must be sought directly from the copyright holders.
Print ISBN 978-92-9477-302-9 doi:10.2821/423550 TR-04-20-455-EN-CPDF ISBN 978-92-9477-303-6 doi:10.2821/731954 TR-04-20-455-EN-N
Document History
Version Date Comments
Version 1.0 20/08/2013 New structure – new presentation
Version 2.0 08/07/2015 New § 9.7 supervision NSA – article 9 regulation 445/2011
Version 3.0 18/06/2020 Draft Revision for enter of application regulation 779/20219
Version 4.0 01/07/2020 Draft Revision of the guide after meeting on 30/06/2020
Version 5.0 29/07/2020 Draft Revision of the guide after meeting on 03/07/2020
Version 6.0 24/8/2020 Draft Revision of the guide after meeting on 11/08/2020
Version 7.0 20/10/2020 Draft Revision of the guide after meeting on 09/10/2020
Version 8.0 17/11/2020 Draft Revision of the guide after meeting on 26/10/2020
Version 9.0 01/03/2021 Final version of the guide after comments received on 01/12/2020
Guide for the application of Article 14 of Directive (EU) 2016/798 and Commission Implementing Regulation (EU) No 2019/779 on a system of certification of entities in charge of maintenance for vehicles
In accordance with Article 19(3) of Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016
Guidance on ECM certification process
Contents
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
1.1. Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.2. Principle for this guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3. Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2. DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
2.1. What legislative documents are related to ECM certification? . . . . . . . . . . . . . . . . . . . . . 8
2.2. What documents do you need to have in mind? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.3. Do you know the Wagon and LOC&PAS TSIs? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3. DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.1. Common acronyms in the day – to – day life in the ECM certification. . . . . . . . . . . . . 13
4. VEHICLE AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.1. What vehicles fall under regulation 2019/779? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.2. What are the exclusion of vehicles from the application of Commission Implementing Regulation 2019/779 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4.3. What is an ECM? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4.4. Who can be an ECM? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4.5. How many ECMs can a vehicle have? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4.6. What is a maintenance workshop? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.7. What does “maintenance” mean? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.8. What is a maintenance system? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.9. What is the ECM-F1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.10. What is the ECM-F2? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.11. What is the ECM-F3? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
4.12. What is the ECM-F4? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.13. What is release to service and return to operation? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284.13.1. Proposal of a minimum set of information to be exchanged during the
“Release to Service” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304.13.2. Proposal of a minimum set of information to be exchanged during the
“Return to operation” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5. CERTIFICATION OF ECM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.1. What does Certification mean? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.2. What is an ECM certificate? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.3. Which ECMs have to be certified . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.4. What are the steps to follow to obtain an ECM certificate? . . . . . . . . . . . . . . . . . . . . . . 37
5.5. What does the schema “Schema chosen to award ECM certificates in each member state” in ERADIS mean? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.6. Can a NSA of a Member State A give an ECM certificate in a Member State B? . . . . 38
6. RESERVED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
7. RESERVED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
8. IMPLEMENTATION OF THE REGULATION 2019/779 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
8.1. What does the transitional period mean? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
8.2. What are the deadlines you need to have in mind? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 418.2.1. Deadlines for certification bodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 418.2.2. Deadlines for ECM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
9. ORGANISATION OF THE RAILWAY SECTOR IN EUROPE AND RESPONSABILITIES OF ACTORS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
9.1. Who are the different “Stakeholders” participating in the maintenance of vehicles? . . . 43
9.2. You are a Keeper, what are your responsibilities? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
9.3. You are a RU/IM, what are your responsibilities? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
9.4. You are a manufacturer, what are your responsibilities? . . . . . . . . . . . . . . . . . . . . . . . . . 48
9.5. Is there a harmonised framework for the pre departure inspection? . . . . . . . . . . . . . 49
9.6. You are an ECM, what are your responsibilities? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
9.7. Application of Article 4(6) - Use of Safe Alert IT tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
9.8. You are an accredited or recognized ECM certification body or a NSA designated as ECM certification body. What are your responsibilities? . . . . . . . . . . . . . . . . . . . . . . . . . 51
9.9. You are an NSA supervising RUs and IMs. When supervision shows a non compliance of an ECM with the requirements, what are your responsibilities in connection with Article 11 of the ECM regulation? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
9.10. What other legal information do you need to have in mind when managing contracts? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
9.11. When a new authorisation for placing on the market is necessary? . . . . . . . . . . . . . . 54
9.12. How to understand the article 3(2)b (Assessment of RUs and IMs maintaining vehicles, other freight wagons, exclusively for their own operation)? . . . . . . . . . . . . 55
9.13. What are the steps for the assessment of the ECM requirements during the process of safety certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
10. WHAT IS THE MAINTENANCE FILE? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
11. EXCHANGE OF INFORMATION BETWEEN RAILWAY ACTORS . . . . . . . . . . . . . . . . . . . . . 65
11.1. What is the information that stakeholders have to exchange according to the maintenance of vehicles? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
11.2. How to find an ECM certification body, how to publish your ECM certificate, how to find an ECM certified? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
12. MANAGEMENT OF CHANGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
12.1. I would like to change the ECM of my fleet, how to proceed? . . . . . . . . . . . . . . . . . . . . 68
13. HOW TO MANAGE SAFETY CRITICAL COMPONENTS? . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
13.1. What is a safety critical component. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
13.2. For which type of vehicle? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
13.3. What is the SCC management process? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
13.4. What are the possible methods for the identification of SCC? . . . . . . . . . . . . . . . . . . . . 74
14. COMPETENCES OF MAINTENANCE STAFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
14.1. Develop a matrix of the qualifications according to the ECM functions and relevant key functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
14.2. Competences of maintenance workers (ECM-F4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
15. WAGONS FOR DANGEROUS GOODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
16. ECM ANNUAL REPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Annex I Mapping Table IM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Annex II Mapping Table RU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Annex III REGULATION 2019/779 Art.15 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
GUIDANCE ON ECM CERTIFICATION PROCESS
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1. INTRODUCTION
1.1. Scope
This guide provides information on the application of the “Commission Implementing Regulation (EU) 2019/779 of 16 May 2019 laying down detailed provisions on a system of certification of entities in charge of maintenance of vehicles1 pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 445/2011 [1]” as referred to in Article 14(6) and (8) of the Safety Directive. That regulation will be referred to in the present document as the “ECM Regulation”.
This guide aims at a correct and common understanding of the concepts of ECM developed in the ECM Regulation but does not contain any legally binding advice. It contains explanatory information of potential use to all actors2 whose activities may have an impact on the safety of railway systems and who directly or indirectly need to apply the ECM Regulation. It may serve as a clarification tool without however dictating in any manner compulsory procedures to be followed and without establishing any legally binding practice. The guide provides explanations on the provisions contained in the ECM Regulation and should aid understanding of the approaches and rules described therein.
This guide has been prepared by the European Union Agency for Railways (ERA) with the support of Recognised Bodies and National Safety Authority experts. It represents a developed collection of information gathered by the Agency during internal meetings and meetings with ACBs (Accredited Certification Bodies), RCBs (Recognised Certification Bodies) and NSAs.
ERA will organise other workshops during 2021/2022, and when necessary, ERA will review and update the guide to reflect the progress with the return on experience on the implementation of the ECM Regulation received during these workshops. As it is not possible to give a timetable for this revision process at the time of writing, the reader should refer to the Agency for information about the latest available edition of the guide or consult the Agency website (http://www.era.europa.eu).
The ECM Regulation provides a framework for the harmonisation of requirements and methods to assess the ability of entities in charge of maintenance for vehicles.
1.2. Principle for this guide
Although the guide may appear to be a stand-alone document for reading purposes, it is not a substitute for the ECM Regulation. For ease of reference, when relevant, the related article of the ECM Regulation or the safety directive is copied or referred to in the guide. Guidance
1 OJ L139/360 27/05/20192 The concerned actors are the contracting entities as defined in Article 5 of ECM Regulation including their suppliers
and service providers, or the certification bodies as defined in Article 6 of ECM Regulation.
1. INTRODUCTION
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is then provided in the following paragraphs to help provide understanding where this is considered necessary.
A first main structure of the present guide was proposed, discussed and approved during the “Task Force on the ECM Guidelines”.
1.3. Structure
The guide is divided into the following parts:
▶ Part 1 “Introduction” contains the scope and explains the structure of the guide;
▶ Part 2 “Documents” defines the documents useful for the guide;
▶ Part 3 “Definitions” contains a list of questions/answers relative to definitions, terms and abbreviations used throughout the guide;
▶ Part 4 “Vehicle and maintenance” explains the maintenance process;
▶ Part 5 “Certification of ECM” describes the different steps of the ECM certification;
▶ Part 6 “Where does the ECM certification apply ?” explains the geographical scope of ECM certificate;
▶ Part 7 “Accreditation – Recognition of certification bodies” contains a list of questions/answers relevant to better understand the environment of accreditation and recognition;
▶ Part 8 “Implementation of article 3 of the regulation 2019/779” System of certification.
▶ Part 9 “Organisation of the railway transport in Europe and responsibilities of actors”
▶ Part 10 “Maintenance file and technical file” contains a list of questions/answers to explain how to follow the requirements of the regulation 2019/779 to build the essential documents relative to the maintenance functions.
▶ Part 11 “Exchange of information between railway actors”
▶ Part 12 “Management of changes” It explains how to meet the different changes inherent to ECMs.
▶ Part 13 “Safety-critical components”
▶ Part 14 “Competences of maintenance workers”
▶ Part 15 “Wagons for Dangerous goods”
▶ Part 16 “ECM annual report”
▶ Part 17 “Annexes”
GUIDANCE ON ECM CERTIFICATION PROCESS
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2. DOCUMENTS
2.1. What legislative documents are related to ECM certification?
[Ref. N°] Title Reference Version
[1] Commission Implementing Regulation (EU) 2019/779 of 16 May 2019 laying down detailed provisions on a system of certification of entities in charge of maintenance of vehicles pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 445/2011Current consolidated version:(Hereafter called “ECM Regulation”)
(EU) 2019/779 27/05/201916/06/2020
[2] Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety (Railway Safety Directive)(Hereafter called “Safety Directive”)
(EU) 2016/798 11/05/2016
[3] Directive (EU) 2016/797 of the European Parliament and of the Council of 17 June 2008 on the Interoperability of the rail system within the Community(Hereafter called “Interoperability Directive”)
(EU) 2016/797 11/05/2016
[4] Commission Implementing Regulation (EU) N°402/2013 of 30 April 2013 on the common safety method on risk evaluation and assessment and repealing Regulation (EC) n° 352/2009 amended by Commission Implementing Regulation (EU) 2015/1136 of 13 July 2015.(Hereafter called “CSM-RA Regulation”)
402/2013/EC(EU) 2015/1136
30/04/201313/07/2015
[5] COMMISSION REGULATION (EU) No 1302/2014 of 18 November 2014 concerning a technical specification for interoperability relating to the ‘rolling stock — locomotives and passenger rolling stock’ subsystem of the rail system in the European Union.(Hereafter called “Loc&Pas TSI”)Amended by:Commission Regulation (EU) 2016/919 of 27 May 2016Commission Implementing Regulation (EU) 2018/868 of 13 June 2018Commission Implementing Regulation (EU) 2019/776 of 16 May 2019Commission Implementing Regulation (EU) 2020/387 of 9 March 2020
(EU) 1302/2014 18/11/2014
2. DOCUMENTS
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[Ref. N°] Title Reference Version
[6] COMMISSION REGULATION (EU) No 321/2013 of 13 March 2013 concerning the technical specification for interoperability relating to the subsystem ‘rolling stock — freight wagons’ of the rail system in the European Union and repealing Decision 2006/861/EC.(Hereafter called “Wagon TSI”)Amended by:Commission Regulation (EU) No 1236/2013 of 2 December 2013Commission Regulation (EU) 2015/924 of 8 June 2015Commission Implementing Regulation (EU) 2019/776 of 16 May 2019Commission Implementing Regulation (EU) 2020/387 of 9 March 2020
(EU) 321/2013 09/03/2020
[7] COMMISSION REGULATION (EU) 2016/919 of 27 May 2016on the technical specification for interoperability relating to the ‘control-command and signalling’ subsystems of the rail system in the European Union(Hereafter called “CCS TSI”)Amended by:Commission Implementing Regulation (EU) 2019/776 of 16 May 2019Commission Implementing Regulation (EU) 2020/387 of 9 March 2020
(EU) 2016/919 09/03/2020
[8] COMMISSION IMPLEMENTING REGULATION (EU) 2019/773 of 16 May 2019 on the technical specification for interoperability relating to the operation and traffic management subsystem of the rail system within the European Union and repealing Decision 2012/757/E(Hereafter called “OPE TSI”)
(EU) 2019/773 16/05/2019
[9] COMMISSION REGULATION (EU) No 1304/2014 of 26 November 2014 on the technical specification for interoperability relating to the subsystem ‘rolling stock — noise’ amending Decision 2008/232/EC and repealing Decision 2011/229/EU(Hereafter called “NOISE TSI”)Amended by:Commission Implementing Regulation (EU) 2019/774 of 16 May 2019
(EU) 1304/2014 16/05/2019
[10] Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.
765/2008/EC 09/07/2008
[11] COMMISSION IMPLEMENTING REGULATION (EU) 2018/545 of 4 April 2018 establishing practical arrangements for the railway vehicle authorisation and railway vehicle type authorisation process pursuant to Directive (EU) 2016/797 of the European Parliament and of the Council
(EU) 2018/545 04/04/2018
[12] COMMISSION IMPLEMENTING DECISION (EU) 2018/1614 of 25 October 2018 laying down specifications for the vehicle registers referred to in Article 47 of Directive (EU) 2016/797 of the European Parliament and of the Council and amending and repealing Commission Decision 2007/756/EC
(EU) 2018/1614 25/10/2018
[13] Commission Regulation (EU) No 1078/2012 of 16 November 2012 on a common safety method for monitoring to be applied by railway undertakings, infrastructure managers after receiving a safety certificate or safety authorisation and by entities in charge of maintenance(Hereafter called “CSM Monitoring”)
1078/2012/EC 16/11/2012
[14] Commission Delegated Regulation (EU) 2018/761 of 16 February 2018 establishing common safety methods for supervision by national safety authorities after the issue of a single safety certificate or a safety authorisation pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulation (EU) No 1077/2012(Hereafter called “CSM Supervision”)
(EU) 2018/761 16/02/2018
[15] RID – 2019 The Regulation concerning the International Carriage of Dangerous Goods by Rail (RID) forms Appendix C to COTIF, and has an annex. This Regulation applies to international traffic.
RID 2019 01/01/2019
GUIDANCE ON ECM CERTIFICATION PROCESS
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[Ref. N°] Title Reference Version
[16] DIRECTIVE 2008/68/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 24 September 2008 on the inland transport of dangerous goods
2008/68/EC 30/09/2008
[17] ECM certification scheme ERA-1172-003 V1.1
15/06/2020
[18] ECM accreditation scheme ERA -1172-002 V3.1
15/06/2020
[19] EN 17095 Railway applications – Rolling stock maintenance- Maintenance records
DS/EN 17095/2019
03/2019
[20] EN 17023 Railway applications-Railway vehicle maintenance- Creation and modification of maintenance plan
DS/EN 17023: 2018
12/2018
[21] ISO 9712 “Non-destructive testing — Qualification and certification of NDT personnel” ISO 9712 Edition 4
2012/06
[22] Series of standards EN 15085 “Railway applications — Welding of railway vehicles and components” Series EN 15085 Last versions
[23] EN ISO/IEC 17021 “Conformity assessment — Requirements for bodies providing audit and certification of management systems”
EN ISO/IEC 17021 2015/08
[24] EN ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”
EN ISO/IEC 17025 2018/01
[25] EN ISO/IEC 17065 Conformity assessment- Requirements for bodies certifying products, processes or services
EN ISO/IEC 17065 2012/09
[26] EN ISO/IEC 17000 Conformity assessment – Vocabulary and general principles
EN ISO/IEC 17000 2020/05
2. DOCUMENTS
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2.2. What documents do you need to have in mind?
Here you can find the diagram describing the different regulations and the schemes associated:
The different standards supporting the accreditation and recognition process of ECM certification bodies and ECM certification are:
▶ EN ISO/IEC 17065:2012 Conformity assessment- Requirements for bodies certifying products, processes or services
▶ EN ISO/IEC 17021-1:2015 Conformity assessment- Requirements for bodies providing audit and certification of management systems -- Part 1: Requirements
▶ EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
▶ EN 17095 Railway applications – Rolling stock maintenance- Maintenance records
▶ EN 17023 Railway applications-Railway vehicle maintenance- Creation and modification of maintenance plan
▶ EN ISO/IEC 17000:2020 Conformity assessment – Vocabulary and general principles
▶ IAF MD 1:2018 Audit and certification of a Management System Operated by a Multiple-Site Organization
Guidance for vehicle authorisation
ISBN 978‐92‐9205‐437‐3
Vehicle authorisation (EU) 2018/545
InteroperabilityDirective
(EU) 2016/797
TSI OPE (EU) 2019/773
TSI NOISE(EU) 1304/2014
TSI CCS(EU) 2016/919
TSI WAGON(EU) 321/2013
TSI LOC & PAS(EU) 1302/2014
ECM guidelinesERA – VERSION 09
ISBN 978‐92‐9477‐302‐9
ECM Regulation (EU) 2019/779
CSM on monitoring (EU) 1078/2012
CSM guide on monitoring ERA/GUI/05‐2012/SAF
Safety Directive(EU) 2016/798
Safety Certificate(EU) 2018/763
Guidance for safety certificateand supervision
ISBN 978‐92‐9205‐427‐4
ECM ACCREDITATION SCHEME
ECM‐1172‐002‐V3.1
ECM CERTIFICATION SCHEME
ECM‐1172‐003‐V1.1
CSM on risk (EU) 402/2013
NVRSpecifications for
vehicle register (EU) 2018/1614
CSM guide on risk ERA/GUI/01‐2008/SAF
ERADIS – ECMRECORDS
ERADISECM RFU
Active Regulation
Guidance material
Register
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▶ IAF MD 2:2017 Transfer of Accredited Certification of Management Systems
▶ IAF MD 5:2015 Determination of Audit Time of Quality and Environmental Management Systems.
The accreditation and recognition scheme [18] precises in the part 3.1.3 c the knowledge and skills addressing assessment principles, practices and techniques and knowledge of the specific standards related to them.
The above documents should be understood as the latest valid version of each document – in case of modifications, the latest version applies.
2.3. Do you know the Wagon and LOC&PAS TSIs?
The Technical Specifications for Interoperability (TSIs) define the technical and operational standards which must be met by each subsystem or part of subsystem in order to meet the essential requirements and ensure the interoperability of the railway system of the European Union.
The LOC&PAS TSI concerns the rolling stock subsystem and applies to the following types of rolling stock:
▶ Self-propelling thermal or electric trains;
▶ Thermal or electric traction units;
▶ Passenger carriages;
▶ Mobile railway infrastructure construction and maintenance equipment.
The Wagon TSI concerns the rolling stock subsystem and applies to freight wagons including vehicles designed to carry lorries.
More information on these TSIs can be found at
https://www.era.europa.eu/activities/technical-specifications-interoperability_en
3. DEFINITIONS
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3. DEFINITIONS
3.1. Common acronyms in the day – to – day life in the ECM certification.
Acronym Meaning
AB Accreditation Body
ACB Accredited Certification Body
APOM/APIS Authorisation for the Placing on the Market / Placing in Service (of structural subsystems and vehicles)
CA Conformity Assessment
CAB Conformity Assessment Body
CSM Common Safety Methods
CUV
EA European co-operation for Accreditation (http://www.european-accreditation.org)
EA (MLA) EA Multi-Lateral Agreement
EC European Commission (http://ec.europa.eu/index_en)
ECCM European Common Criteria for Maintenance
ECM Entity in Charge of Maintenance
ECM - F1 Management function
ECM - F2 Maintenance Development function
ECM - F3 Fleet Maintenance Management function
ECM - F4 Maintenance Delivery function
EEA European Economic Area
EFTA European Free Trade Association (http://www.efta.int)
EN European Norm
ERA European Railway Agency (http://www.era.europa.eu)
ERATV European register of authorised types of vehicles referred to in Article 34 of Interoperability Directive (Commission Implementing Decision 2011/665/EU)
ERADIS European Railway Agency Database of Interoperability and Safety
EVN European vehicle Number
EU European Union
ERA European Union Agency for Railways
EVIC European Visual Inspection Catalogue
EWT European Wheelset traceability catalogue
GCU General Contract of Use (http://www.gcubureau.org)
IAF International Accreditation Forum (http://www.iaf.nu/)
(IAF) MD Mandatory document of IAF
IM Infrastructure Manager
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ISA Independent Safety Assessment Body
ISO International Organization for standardization
IT Information Technology
LNG Liquefied Natural Gas
MLA Multilateral Agreements
MoU Memorandum of Understanding
MRA Mutual Recognition Agreements
MS Member State
NAB National Accreditation Body
NDT Non-Destructive Test
NoBo Notified Body
NSA National Safety Authority
NVR National Vehicle Register
OTIF Organisation intergouvernementale pour les Transports Internationaux Ferroviaires - Intergovernmental Organisation for International Carriage by Rail (http://www.otif.org)
OTM On–Track Machine
RID Regulations concerning the International Carriage of DangerousGoods by Rail, as adopted under Directive 2008/68/EC.
RFU Recommendations for use (https://eradis.era.europa.eu/safety_docs/ecm/recommendationsForUse/default.aspx)
RS Rolling Stock
RSD Railway Safety Directive
RU Railway Undertaking
SAIT Safety Alert IT-Tool
SCC Safety-critical components
SMS Safety Management System
VTA Vehicle Type Authorisation
RTS Release to Service
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4. VEHICLE AND MAINTENANCE
4. VEHICLE AND MAINTENANCE
4.1. What vehicles fall under regulation 2019/779?
▶ Freight wagon
A non-self-propelled vehicle designed for the purpose of transporting freight or other materials to be used for activities such as construction or infrastructure maintenance.
Each freight wagon must have been assigned a unique EVN and one ECM in charge for this wagon in the NVR. As it is permissible in certain circumstances to assign a single EVN to a fixed formation of two or more wagon units (defined as multiple wagons in [6] and [12]), it is in turn possible that a “wagon” from the perspective of the ECM can consist of more than one element. In each case the EVN and the associated entry in the NVR will be the binding definition on what constitutes an individual “wagon”.
Picture 1: Example of a unit consisting of a (freight) wagon that can be operated separately, featuring
an individual frame mounted on its own set of wheels
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Picture 2: Example of a unit consisting of a rake of permanently connected two elements (blue and
orange), those elements cannot be operated separately (articulated wagon)
Picture 3: Example of a unit consisting of a rake of permanently connected two elements, those
elements cannot be operated separately
▶ Locomotives (thermal or electric traction units)
Locomotives (mentioned in TSI Loc§Pas 2.3.1) consists in the engine of a train designed for pulling or, sometimes, pushing a train or individual railway cars or freight wagons. These traction vehicles are not capable of carrying a payload. They are intended for freight and/ or passenger transport. Power sources can be one, or a combination, of the following: diesel engine, steam, electricity, LNG, battery or hydrogen (non-exhaustive list).
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4. VEHICLE AND MAINTENANCE
Picture 4: Example of a French freight locomotive that is powered by electricity.
▶ Multiple units/Trainset
Multiple units or trainset (mentioned in TSI Loc§Pas 2.3.1) consist of several vehicles formed into a fixed formation or set, with their own means of propulsion and do not require a locomotive. Depending on the power source these multiple units are sometimes known as Electric Multiple Units (EMUs), Diesel Multiple Units (DMUs) and Battery Electric Multiple Unit (BEMU). Other power sources and hybrids also exist e.g. battery and Hydrogen or LNG.
Picture 5 : Example of an Electric Multiple unit in Germany.
▶ Passenger coaches
Passenger coaches (mentioned in TSI Loc§Pas 2.3.1) are vehicles that contain no traction power and thus rely on locomotives to push or pull them. Their primary purpose is for the transportation of passengers.
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Picture 6: Example of passenger coaches being pulled by an electric locomotive in Switzerland.
▶ On Track Machines (OTM)
An OTM (mentioned in TSI Loc§Pas 2.3.1) is a vehicle used for performing works on or around the tracks, running on its own rail wheels, designed and intended to be detected by a track-based train detection system for traffic management. When in transport (running) mode they are self-propelled or hauled.
Picture 8: Example of an On-Track Machine, often painted bright yellow.
4.2. What are the exclusion of vehicles from the application of Commission Implementing Regulation 2019/779
It must be noted that some vehicles are excluded from the application of Commission Implementing Regulation 2019/779:
▶ The vehicles corresponding to cases stated in the article 2(2) of Directive 2016/798. Example: Metros. The reason is that the art 2(2) states the cases for which the Directive 2016/798 does not apply.
▶ Upon decision of the MS when transposing the Directive 2016/798, the vehicles corresponding to cases stated in the article 2(3) of Directive 2016/798. Example: Vehicles reserved for strictly local, historical or tourist use. This reflects a choice by MS when transposing the Directive 2016/798.
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4. VEHICLE AND MAINTENANCE
▶ Upon derogation identified and justified in NSA annual report according to article 19 of directive 2016/798, the vehicles corresponding to the cases stated in the art 15(1) of Directive 2016/798. Examples: Freight wagons operated under international agreement with third countries on 1520 mm system. This reflects a choice by MS.
As these vehicles are excluded from the scope of the ECM regulation and these categories are not foreseen on the certificate forms of annex IV of the regulation, no certificates may be granted to Entities in Charge of Maintenance of these vehicles only, nor should there be any reference to them on certificates covering other vehicles well on the scope.
Nevertheless, the services of voluntary assessment of Maintenance Management Systems according to the requirements of annex II of the regulation may be provided by certification bodies under the same conditions as foreseen in the certification scheme.
In this case however, the attestations possibly granted after the assessments shall not be called “certificates” and will not be registered in the ERADIS database.
4.3. What is an ECM?
After a vehicle is placed in service, an Entity in Charge of its Maintenance has to be designated and to be identified in the National Vehicle Register.
The ECM shall ensure the vehicles for the maintenance of which it is in charge are in a safe state of running by means of the establishment of a maintenance system.
The maintenance system shall be composed of four functions (see section 4.8).
In accordance with article 3(1) of the regulation 2019/779 any ECM shall satisfy the requirements of Annex II, in respect of all vehicles subject to Directive (EU) 2016/798.
4.4. Who can be an ECM?
The ECM is the body registered as such in the NVRs. There are no conditions of nationality to become an ECM. An ECM established outside the EU or outside the contracting countries of OTIF can provide maintenance to vehicles used on the railway system of the EU or of the contracting countries of OTIF. In that case the ECM has to be certified against the ECM Regulation or its equivalent in OTIF rules ATMF annex A.
4.5. How many ECMs can a vehicle have?
Article 47 of Directive (EU) 2016/797 provides that the NVR is to contain, among other compulsory information, the identification of the owner, the keeper and the entity in charge of maintenance of the vehicle.
Commission Implementing Decision (EU) 2018/1614 establishes the requirements for the information to be contained in the NVR and, for each vehicle, the data relative to the ECM (and not several ECM) has to be compulsorily fulfilled. Therefore a vehicle can only have one ECM assigned in the NVR at any given time.
GUIDANCE ON ECM CERTIFICATION PROCESS
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4.6. What is a maintenance workshop?
A Maintenance workshop is a mobile or fixed entity composed of staff, including those with management responsibility, tools and facilities organised to deliver maintenance on vehicles, parts, components or sub-assemblies of vehicles.
A Maintenance workshop is an entity having a management, staff, tools and facilities necessary to carry out maintenance operations on the vehicle itself or on parts and components of the vehicle. Mobile teams, depending on a fixed structure where maintenance works are performed or being self-supporting, and fulfilling the requirements of the definition of a maintenance workshop as defined hereinbefore, are assimilated to maintenance workshops.
A maintenance Workshop may be in charge, of the whole maintenance delivery function (ECM-F4) or parts of it as described in the Art. 14(3)d of the Directive (EU) 2016/798.
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4. VEHICLE AND MAINTENANCE
4.7. What does “maintenance” mean?
The design operating state:
(Definition in the TSI wagon [7] )The ‘design operating state’ covers all conditions under which the unit is intended to operate and its technical boundaries. This design operating state may go beyond the specifications of the TSI in order that units may be used together in a train on the network under the safety management system of a railway undertaking.
It means a state when a vehicle, subsystem or part of subsystem is performing a required function for which it has been designed, manufactured and tested. It includes at least the nominal operating mode, it may include degraded operating modes, provided theses modes have been designed, implemented and tested so that the essential requirements are met.
When the vehicle is used, it will be subject to wear and tear or may get damaged more or less and therefore will not remain fully conform to its design operating state. The goal of maintenance is to restore this vehicle in its design operating state.
4.8. What is a maintenance system?
MAINTENANCE Restore the vehicle in its conditions of use (design operating state)
DESIGN OPERATING STATE
Described in the technical file
USE
The vehicle is operated
DEGRADATION OF PERFORMANCE
Vehicle no more in a design operating state
Establish the maintenance file
ECM‐F2
MANAGEMENT
Remove from operation and
return to operation ECM‐F3
MANAGEMENT
Deliver the technical
maintenance tasks ECM‐F4
MANAGEMENT
MANAGEMENT PROCESS‐
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According to article 1(1) of the regulation 2019/779, the maintenance system shall be composed of the following functions:
(a) the ECM-F1, which supervises and coordinates the maintenance functions referred to in points (b) to (d) and ensures the safe state of the vehicle in the railway system;
(b) the ECM-F2, which is responsible for the management of the maintenance documentation, including the configuration management, based on design and operational data as well as on performance and return on experience;
(c) the ECM-F3, which manages the vehicle’s removal for maintenance and its return to operation after maintenance; and
(d) the ECM-F4, which delivers the required technical maintenance of a vehicle or parts of it, including the release to service documentation
These 3 last functions are coordinated in the maintenance system through a MANAGEMENT PROCESS
It should not be understood as a strictly mandatory organisational structure for ECMs. Nevertheless the structure put in place by the ECM has to reflect on this functional maintenance breakdown. The ECM has to attach all elements (internal services, subdivisions and contractors) of its organisational structure to one or more maintenance functions.
MAINTENANCE DEVELOPMENT
FLEET MAINTENANCEMANAGEMENT
MAINTENANCE DELIVERY
Performancetargets
Initial technicaldocumentation
Technological survey Legislation
Information on operationsfrom RUs, IMs, keepers Records on
maintenance performed
Return on experience
Information on SCC
Maintenance file
Return to operationto RUs, IMs, keepers
Records on maintenance performed
Release to service Return on
experience
Maintenance orders
Vehicle to maintain
Vehicle maintained
ECM
MAN
AGEM
ENT
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4. VEHICLE AND MAINTENANCE
4.9. What is the ECM-F1
The Management Function ECM-F1 shall supervise and coordinate the functions ECM-F2, ECM-F3 and ECM-F4 of the ECM and ensure the safe state of vehicle.
The ECM-F1 has two main tasks:
▶ Coordination of the functions ECM-F2, ECM-F3 and ECM-F4, as defined in the article 14(3) of Directive (EU) 2016/798, allowing the organization to achieve the maintenance targets defined in the Maintenance System (e.g. in the Maintenance Policy);
▶ Monitoring of the functions ECM-F2, ECM-F3 and ECM-F4 as defined in the article 14(3) of Directive (EU) 2016/798, granting the conformity against legislation and standards and allowing the organization to improve its Maintenance System.
The safe state of vehicles can be ensured through the design, the implementation and the improvement of the Maintenance System.
The coordination activities shall be performed according to processes and procedures defined within the Maintenance System, those provisions shall take into account the use of contractors to implement the functions, the allocation of responsibilities, the management and exchange of information, the management of documents and their traceability, the management of competence of the staff, the definition of strategies and plans to define and to achieve the maintenance targets, etc..
The ECM-F1 checks the implementation of the Maintenance System defining a systematic monitoring process, based on the CSM for Monitoring (Commission Regulation 1078/2012) to check the performances of the ECM in the field of maintenance (and safety, as consequence). When needed, the ECM-F1 creates the conditions to correct or to improve the Maintenance performances, defining and implementing changes in the Maintenance System. The impact of those changes on the maintenance processes shall be evaluated according to the CSM for Risk Assessment[4]. Monitoring can be performed through checks of results of processes if a maintenance function is certified (point 9.5)
A decision making process should be managed by the ECM-F1 on the basis of the results of the assessments of shared and owned risks. An initial process-based risk assessment, or equivalent, shall be used to identify such risks, whereas the CSM-RA regulation [4] shall be used for all changes and the CSM monitoring [13] shall be used for monitoring during the O&M phase.
4.10. What is the ECM-F2?
The maintenance development function (ECM-F2) covers the management of the maintenance documentation, including the configuration management, based on design and operational data as well as on required performance and return on experience.
It also covers the compliance with interoperability rules and the establishment and continuous update of the maintenance file.
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The maintenance development process can be described as follows:
At the moment when operation starts
The initial development of the maintenance file depends on the initial technical documentation (see chapter 10) and the pattern of operations planned.
The process may be described as following:
When operation starts it is necessary to check if the initial technical documentation supplied by the manufacturer is relevant in comparison with the operations performed or planned to be performed and the performance targets of the users of the vehicles (keepers, RUs, IMs).
During the lifecycle of the vehicle
INPUT
Initial technical documentation (in particular interoperability limit values)
Information on operation planned to be performed
Performance targets Information on Safety critical
components
OUTPUT
(First) Maintenance file
Maintenance development
INPUT
Maintenance file Interoperability limit values Information on operation Records on maintenance
performed and return on experience
Technological survey Legislation (changes) Performance targets Information on Safety critical
components
OUTPUT
Maintenance file updated
Maintenance development
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4. VEHICLE AND MAINTENANCE
In accordance with the Annex II(II)(5) of the ECM Regulation, the update of the maintenance file depends on:
▶ The limit values that have to be maintained to assure the interoperability of the vehicle according to its authorisation of placing on the market/placing in service. They are stated in the initial technical documentation and every update of this documentation justified by a change in the design of the vehicle.
▶ Information on operation such as but not limited to:
⚬ Behaviour of the vehicle during operation;
⚬ type and extent of operations (passenger or freight, high speed or conventional, long straight lines or lots of curves, direct trains or lots of stop-start,…);
⚬ empty or loaded journeys;
⚬ mileage / journey time;
⚬ detected failures on components
⚬ incidents, accidents or defects occurred during operation;
⚬ content of daily inspection performed by the RUs (maintenance level 1);
⚬ environmental conditions (mountains, climatic, dust conditions, sand along ,coast,…)
⚬ behaviour and skills of drivers.
▶ Records on maintenance already performed, on inspections performed by RUs/IMs, keepers, ECM, owners and on studies related to return of experience. The ECM-F4 are often requested to take part to return on experience studies.
▶ Technological survey. The lifecycle of rolling stock extends to 40-50 years. Technology evolves a lot during this long lifecycle. The technological survey may include:
⚬ Condition based monitoring. This monitoring considers the behaviour of the different components.
⚬ Technological progress that includes the continuous progress of:
• materials,
• equipment,
• spare parts,
• tools and industrial equipment,
• IT systems,
• working and management methods.
⚬ Availability of materials, equipment and spare parts. Spare parts or materials may become obsolete or be unavailable. Generally the manufacturers give 10 years assurance regarding availability of electrical / electronic devices. So at certain time equivalent spare parts or materials have to be found.
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▶ Evolution of applicable legislation:
⚬ Railway,
⚬ Environment,
⚬ Health and safety,
⚬ Safety of components,
⚬ Etc.
▶ Performance targets imposed by users (RU, IM, keeper):
⚬ reliability and availability of vehicles,
⚬ safety.
After taking into account all information, the ECM-F2 covers the update or not of the maintenance file and the dissemination of the updates of documentation to interested parties.
4.11. What is the ECM-F3?
The Fleet Maintenance Management (ECM-F3) covers the removal from/return to operation before/after maintenance and the management of relations with ECM internal/external entities delivering maintenance (ECMs-F4).
Return to operation is only possible when maintenance operations are completed and the vehicles are back in a safe state of running. With regard to the exchange of information, the information on the completeness of maintenance activities performed on the vehicle must be received from ECM-F4, this is done through the releases to service that are the confirmation of the maintenance delivery that the maintenance activities ordered have been completed.
ECM-F3 may be defined as the management of a company’s vehicle fleet. The fleet maintenance management is then the part of the fleet management dedicated to maintenance of vehicles.
This function means in particular the responsibility for:
▶ applying the maintenance file to the vehicles through maintenance orders addressed to maintenance delivery.
▶ collecting and transferring, to maintenance development, information on maintenance performed and operations performed, including at least defects, incidents, accidents, mileage.
The inputs for the ECM-F3 are:
▶ the maintenance file;
▶ the performance targets imposed by users (RU, IM, keeper), such as the reliability and availability of vehicles.
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4. VEHICLE AND MAINTENANCE
The ECM-F3 must check the availability of the maintenance delivery.
The ECM-F3 will have the duty to ensure that maintenance orders are addressed only to duly qualified entities performing maintenance delivery.
The outputs of the ECM-F3 processes are:
▶ The maintenance orders addressed to the maintenance delivery. The maintenance orders are addressed by applying internal procedures when ECM-F3 and ECM-F4 are both internal to the ECM and by contracts in other cases. The maintenance orders contain the complete information issued from the maintenance file that is necessary to perform the maintenance tasks required from the maintenance delivery.
▶ The organisation for the return to operation of the vehicle in due time (including any delays occurred in the maintenance work resulting in the implementation of additional provisions for ensuring a safe state of running to the vehicle.
The ECM-F3 is responsible for declaring the vehicle fit for purpose and fit for its return to operation after the maintenance work has been completed by the ECM-F4. This return to operation is finally addressed to RUs generally through the keeper.
Further the ECM-F3 has to give to RUs, directly or through the keepers, all the information obtained from the ECM-F4 about maintenance limitations due to maintenance activities affecting the operating state of the vehicle, in order to able the RUs in stating operation limitations/restrictions for use to ensure a safe operation.
4.12. What is the ECM-F4?
The Maintenance Delivery (ECM–F4) is the technical execution of the ordered technical maintenance tasks. The ECM-F4 task may be done in Maintenance Workshops. The ECM-F4 covers the management of maintenance orders issued by the ECM-F3, the management of the supply chain, the management of facilities, industrial equipment and tools and the management of maintenance technical works.
This function means the technical execution of tasks/works defined in the maintenance file and ordered by the fleet maintenance management. The ECM-F4 must be competent to perform the maintenance works/tasks requested in the orders.
Generally after completion of a maintenance order coming from the ECM-F4, the ECM-F3 addresses a report including a summary of the activities performed, information about limitation affecting the operating state of the vehicle and release to service. This report may also be addressed directly to the ECM-F2.
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There is a huge need to request not only delivery but also information on return of experience between the ECM-F1 and the ECM-F4. The requirements addressing the return on experience are based on the requests from the ECM-F2 and should be part of the maintenance orders
4.13. What is release to service and return to operation?
Release to service
The “Release to Service” (RTS) is the confirmation by the ECM-F4 to the ECM-F3, that all maintenance work ordered has been performed according to the maintenance documentation. This confirmation can be noticed as documented information in paper or a defined electronic information channel. It must be traceable.
The ECM-F3 defines what maintenance records are needed for the completion of the task. It delivers these documents together with its maintenance order as a basis for establishing an “RTS notice”. The ECM-F4 executes the ordered work, completes the maintenance records and reports discovered but unresolved safety related deficiencies.
In addition to the formal RTS notice, the following information may possibly be needed by the ECM-F3:
▶ Records on work performed incl. any findings, (extra-)time for execution, etc.
▶ Records of unplanned work performed due to findings and incl. the release by the ECM-F3
▶ Records on final vehicle testing
▶ Records on main component testing (incl. used testing devices)
▶ Lists of exchanged parts (incl. their exact identification)
▶ List of deficiencies related to safety
▶ List of deficiencies related to reliability, if requested
▶ Any information on vehicle or component condition, as requested by the ECM-F3 (in case of condition-based maintenance)
INPUT
Maintenance orders Rolling stock that has to be
maintained
OUTPUT Records on maintenance
performed including the release to service
Return on experience if requested
Rolling stock maintained
SCC: exceptional maintenance findings beyond wear and tear if necessary
Maintenance delivery
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4. VEHICLE AND MAINTENANCE
The ECM-F4 delivers the document set via the agreed channel to the ECM-F3.
The report shall include all the information related to maintenance limitations due to maintenance activities affecting the operating state of the vehicle, in order to able the RUs in deciding stating operation limitations/restrictions for use to ensure a safe operation.
When this is completed, the vehicle is ready to leave the workshop and physically go back to commercial operation, however for this the “notice of return to operation” is requested by the ECM-F3 (see next chapter).
Return to operation
The “Return to Operation” is considered as a sensitive topic. It is formally the confirmation of the ECM that the vehicle is in a safe state for operation. The RU may operate the vehicle on the network only with a valid “Return to Operation Notice”.
A formal approach would suggest that the vehicle is transferred by the ECM to the Keeper. Further the vehicle is transferred from the keeper to the RU, which is responsible to use correctly the vehicle. In reality, the vehicle is brought to an agreed transfer point, where from it is taken into commercial use after establishing the “return to operation notice”.
The ECM-F 3 establishes the Return to Operation Notice based on the Release to Service documentation from the ECM-F4. The duty is to check the documentation for completeness and to clarify whether safety-relevant defects are listed which might cause a restriction of use. The Return to Operation Notice can be noticed as documented information in paper or a defined electronic information channel. It must be traceable.
The definition of the return to operation (article 2(d) of the regulation 2019/779) states that it possible to send the return to operation to the RU or to the keeper. Especially when a restriction of use be necessary it is the duty of the ECM-F3 to make this available to the responsible RU or via keeper upon contractual agreement.
It is a duty of RUs to consider the information included in the Return to Operation in order to establish and ensure the operation of the vehicle in a safe state.
ECM – F4Release to Service
documentation
According to the Maintenance System
ECM – F3
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In the reality the keeper is not practically involved in this process, so there is a functional direct contact between the ECMs and RUs. To avoid confusion in the distribution of responsibilities, normally no information other than that reported about the vehicle should be given to the RU.
The minimum information that the keeper should receive is reported in 4.12.2.
4.13.1. Proposal of a minimum set of information to be exchanged during the “Release to Service”
Minimum set of information to be addressed to the Fleet Management function:
Workshop (Name of the workshop)
12 Digits vehicle N. (EVN)
Check in date (Date of the check in of the vehicle in the workshop)
Check out date (Date of the check out of the vehicle (workshop))
Maintenance File (Reference to the adopted maintenance file)
Derogation against the technical instructions?: YES / NO
Description of the derogation
list of safety related deficiencies as base for ECM-F3 for restrictions
This field contains the Safety related deficiencies that the ECM-F4 shall report to the ECM-F3 for restrictions.
ECM – F3 Return to operations
According to the Maintenance system and contractual arrangements
Keeper
RU/IM
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4. VEHICLE AND MAINTENANCE
4.13.2. Proposal of a minimum set of information to be exchanged during the “Return to operation”
Minimum set of information to be addressed to the keeper:
The keeper (and the RU) needs the information that the vehicle is in a safe state for operation. No need to transfer all the details to the keeper (or to the RU). The traceability of maintenance record is the ECM’s responsibility. ECM is releasing a vehicle to operation with or without restriction for use. This is the information the keeper (RU) needs for operation.
Note concerning the use of the vehicle
Notes concerning the use of the vehicle, this field contains the limitations that the keeper shall report to the RU. These limitations shall be related to the parameters used by the staff to compose trains.
Formal transmission of information between the ECM and RU may be possible. The Return to Operation document accompanying the vehicle contains all the necessary information for the RU, in case of technical restrictions affecting operations, the keeper has the responsibility to inform the RU.
RU sets the restriction for use and communicates them on the agreed channel to keeper. (Normally it is the responsibility RU to take the operation restriction to ensure the safe state based on its Safety Management System)
It is a duty of RUs to consider the information included in the Return to Operation in order to establish and ensure the operation of the vehicle in a safe state.
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5. CERTIFICATION OF ECM
5.1. What does Certification mean?
It means: “Third party attestation related to products, processes, systems or persons (ISO/IEC 17000:2004).”
In the application of the ECM Regulation, the certification is the process to be applied by the tandem:
▶ The accredited or recognised certification body or the NSA (acting as certification body) and
▶ The applicant for the certificate: the ECM or the outsourced maintenance function
The requirements to be fulfilled by the applicant during the certification process are described in the Annex II of the ECM Regulation and the certification scheme ERA-1172/003 V1.1
5.2. What is an ECM certificate?
The certificate provided by the accredited or recognised certification body or by the NSA (acting as certification body) according to the ECM Regulation, provides the assurance that the applicant fulfills the requirements established in Annex II of the ECM Regulation and the certification scheme.
The format of this certificate is defined in the Annex IV of the ECM Regulation and available in the ERA database ERADIS. This database is accessible in the following link:
http://eradis.era.europa.eu/safety_docs/ecm/default.aspx
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5.3. Which ECMs have to be certified
As mentioned in the diagram below, for case (1) and case (2), the certificate is mandatory.
Case 3 is an exemption for RU’s and IM’s who maintain vehicles exclusively for their own operation (the RU exclusively operates the vehicles, no other RU operates the vehicles) from mandatory ECM certification. When the RU/IM operate vehicles in partnership with others RUs, the article 3(4) cannot be applied. If an RU or IM maintains vehicles exclusively for its own operations, the RU or IM has to be the registered ECM of the vehicles it operates, and keeper too, in the relevant NVR.
The operation of a vehicle does not only cover the transport of freight or passengers. Operation covers any authorized use of the vehicle like the transport of freight or passengers, pulling/pushing other vehicles, movements for disposition, running of locomotives without a train, movement of empty wagons, running of an OTM from one construction site to the next (self-propelled or pulled by other traction / in a train).
Article 3.1All ECMs shall satisfy the requirements of Annex II, in respect of all vehicles subject to Safety Directive
2016/798
Case(1)
Entity applies for becoming ECM for freight wagons
Case(2)
All the other cases/scenarios not covered nor in Case (1)
neither in Case (3)
Case(3)
Entity applies for becoming ECM for vehicles (xx):
Vehicles (xx) are not freight wagons
Entity has the role of RU/IM too
Entity maintains vehicles exclusively for their own operation
Art. 3.2 (a)Mandatory certificate
Art. 3.2 (b)Mandatory certificate
Art. 3.3 or 3.4Entity may choose 2 possibilities for Annex II
requirements checks
Art. 3.4Compliance with Annex II to be checked via ECM certification process Art. 3.4
Compliance with Annex II to be checked via ECM certification process
Art. 3.3Voluntary certificate Art. 3.4
Compliance with Annex II to be checked via safety certification/authorisation
process
Regulation (EU) 2019/779 and system of ECM certification
ECM Certificate by CertBody
Art. 3.5If ECM is RU/IM too, the ECM certificate is deemed evidence for compilance with CSM SMS 5.2.4, 5.2.5
Compliance registered by NSA/ERA in the Safety Certification/
Authorisation
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RU’s/IMs cannot apply for an article 3(4) assessment for vehicles that they operate in partnership with other RU’s/IMs.
RUs/IMs cannot use compliance with the Annex II of ECM Regulation assessed during safety certification/authorization process to operate nor be the ECM for other vehicles not included in art. 3(2)b of ECM Regulation nor operate as an outsourced maintenance function.
This RU/IM cannot use compliance with Annex II to act as ECM for freight wagons. To do so, it needs a valid ECM certificate for freight wagons (ECM Regulation see article 3(2) a).
Possible exceptions are:
▶ Movements following an accident or incident to clean the track or as part of technical assistance if the vehicle used aren’t registered in the NVR and they don’t run as a train to arrive in the area affected by the accident or incident;
▶ Activities or shunting operations carried out by contractors (i.e. entities other than the railway undertaking or the infrastructure manager being ECM of the concerned vehicles) excluding any other railway undertakings or infrastructure managers operating these vehicles for their own railway activities.
When the RU/IM wants to become, or continue as, an ECM maintaining vehicles exclusively for its own operations according to Article 3(2)b of Regulation 2019/779, they must notify their NSA or Safety Certification Body (NSA/ERA) thereof. The RU/IM must analyse the risks related to the changes according to their SMS and take proper risk mitigation measures. The requirements in Annex II of the ECM Regulation 2019/779 must be fulfilled from 16th of June 2022, at the latest.
If the changes to the SMS are deemed as substantial changes by the RU/IM, they have to apply for an update of their SSC or SA. An NSA/ERA can also initiate the need for an updated SSC, or NSA in cases of an updated SA, if the changes to the SMS for a specific RU/IM are considered as substantial changes.
a) NSAs will assess fulfilment of the obligations of the ECM Regulation during NSAs supervision activities.
b) The mapping table in Annex I for the IM and Annex II for the RU to this guide presents a cross-reference between SMS (2018/762) and Annex II (2019/779) requirements, the template can be used by the RU/IM to easily understand the link between SMS and Annex II and provide necessary evidence where the corresponding requirement of Regulation EU 2019/779 is allocated and accomplished by means of the company´s SMS documentation.
c) The RU/IM need to at least fulfil requirements for the management function ECM-F1, in their own SMS and their own operation. Remaining functions as the maintenance development function ECM-F2, the fleet maintenance management function ECM-F3, and the maintenance delivery function ECM-F4 may be outsourced under the responsibility and monitoring of the management function ECM-F1.
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If an RU/IM wants to demonstrate compliance with Annex II of Regulation 2019/779 during the process of safety certification/authorisation, it has to apply for the assessment to the safety certification body (ERA or NSA) /safety authorisation (NSA) in the case of an application for the granting or renewal or update of a safety certificate/authorisation. The request for a safety certificate from the RU is made in the One Stop Shop, the request for the safety authorisation is made by the IM directly to the NSA involved following the national rules. It is necessary, when the RUs submit the application through the OSS for a new safety certificate or renewal/change update of safety certificate or IMs submit the application to the NSAs of new safety authorisation or renewal/update of safety authorisation, to make explicit if they intend to be checked as an ECM in the safety certification process/safety authorisation process. If not they should attach the ECM certificate issued by a certification body in the part 5.2.4 and 5.2.5 of the mapping table. According to article 3(5) of the ECM Regulation, the ECM certificate granted to a railway undertaking or an infrastructure manager shall be deemed evidence of compliance with points 5.2.4 and 5.2.5 both of Annex I and Annex II to Commission Delegated Regulation (EU) 2018/762 as regards vehicle maintenance of vehicles.
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The following diagram describes the different options.
Note 1: Based on the knowledge of the safety performance of the RU/IM that the NSA has got from previous supervision activities, the NSA identifies the requirements of annex II of Regulation 2019/779 that it judges pertinent to be assessed. However it is not required to the NSA to assess the conformity to all the requirements of the annex II of Regulation 2019/779 during supervision’
To be ECM certified by certification body< 16/06/2022
maintaining vehicles exclusively for its own
operations ?
Notified as ECM in NVR?
Change to comply with Annex IIconsidered significant
when applying CSM RA?
Existing Safety Certificate valid > 16/06/2022 ?
RU/IM (not freight)
performing ECM functions
Compliance with Annex II to be demonstrated
through safety certification/
authorisation process by using the mapping table provided in ECM
guideline (Art. 3.4) < 16/06/
2022‐ and notification in NVR
Update NVR
SSC issued, including ECM activities
SSC is issued and a Certified ECM is
needed for maintenace activities > 16/06/2022
Application checked against ECM Annex II
Intermediate check against ECM Annex II (NSA supervision)
*see note 1
NO
YES
YES
NO
YES
NO
YES
NO
YES
NO
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5.4. What are the steps to follow to obtain an ECM certificate?
For further information see also the Certification scheme ERA-1172/003 V1.1
5.5. What does the schema “Schema chosen to award ECM certificates in each member state” in ERADIS mean?
According to the Article 6(1) of the ECM regulation, the Member States shall provide the Agency information concerning the ECM certification bodies.
Therefore there are different schemas to be chosen by each Member State:
▶ “Accreditation”: it means accredited certification bodies will be able to perform the ECM certification.
▶ “Recognition”: certification bodies recognised by the member state will be able to perform the ECM certification.
▶ NSA as certification body: the NSA designated by the member state as certification body will be able to perform the ECM certification
The sectoral scheme for accreditation and recognition ERA1172/002 V3.1 contains requirements to be used by National Accreditation Bodies or by recognition bodies when assessing certification bodies performing ECM certification. It shall be also used by Members States when designating the NSAs to act as ECM certification body (according to article 14 of Directive (EU) 2016/798).
Review of the application collected to ensure that: Information is
sufficient Certification
activities can be prepared
Initial application review
Assessment of maintenance documentation
Evaluate presence of necessary processes (requirements)
Document review
Evaluate implementation of maintenance system
Interview of ECM personnel
On‐site audits
Evaluate appropriateness of competences in place
Coherence in application of processes(b,c,d) and sampling
Activities affecting safety annex II
On‐site inspections
Regular monitoring of representative areas and functions covered by the scope of maintenance system
Minimum one audit every 12 months
Surveillance activities
Stage 1 Stage 2
Starting of certification process
Granting of ECM Certificate
DECISION4 months
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The applicant ECM is free to choose its certification body (Article 7(1) of ECM Regulation). The ECM can contract body:
▶ with a certification accredited or recognised in any Member state;
▶ With the NSA of the Member State where the ECM is established only if the NSA has been designated by its Member state to perform ECM certification.
5.6. Can a NSA of a Member State A give an ECM certificate in a Member State B?
An accredited or recognized ECM certification body can certify any ECM on the whole territory of the EU.
But if those ECM certification bodies are NATIONAL (public) authorities/agencies, they are limited to the national territory for matters associated to national sovereignty.
When an NSA acts as ECM certification body, as an NSA is a national (public) authority, it is also limited to its national territory.
NSA of a member state A may certify ECMs with legal address in the member state A only. Nevertheless, the certificate granted by a NSA is valid on the whole territory of EU.
European cooperation accreditation
National Accreditation Body
Certification body
Designation by Member State
Cooperation of
Certification bodies (ERA)
ISO 17011 Regulation 765/2008/EC
Accreditation scheme (13)
Certification scheme (14)
Recognition by Member State
NSA as Certification body
Supervises, monitors (cross auditing)
ECM Certificate
6. RESERVED
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6. RESERVED
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7. RESERVED
8. IMPLEMENTATION OF THE REGULATION 2019/779
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8. IMPLEMENTATION OF THE REGULATION 2019/779
8.1. What does the transitional period mean?
Starting from 16.06.2020, any ECM certificate shall be issued in accordance with the ECM Regulation to entities in charge of maintenance, without prejudice to Article 15(1) of Directive 2016/798/EU.
Nevertheless, as defined in the Article 15 of the ECM Regulation 2019/779/EU, there are different transitional periods related to special cases in the implementation of the ECM Regulation.
8.2. What are the deadlines you need to have in mind?
8.2.1. Deadlines for certification bodies
Between 16 June 2020 and 15 June 2021, under Article 6(3) of Commission Implementing Regulation (EU) 2019/779, certification bodies may comply with either the previous or the new accreditation scheme, details can be found in the ERA clarification note ERA1172/001 .
That means that the certification bodies accredited or recognised or NSAs acting as ECM certification bodies in accordance with the sectoral accreditation scheme for Regulation (EU) No 445/2011, should be deemed accredited or recognised to perform the activity of certification also for the scope of other categories of vehicles until 16 June 2021.
The scope of activities of ECM certification bodies compliant with the sectoral accreditation scheme for Regulation (EU) No 445/2011 should be automatically extended to all vehicle categories but with a time limited validity (until 15 June 2021).
As of 16 June 2021, certification bodies shall be accredited or recognised in accordance with the new sectoral accreditation scheme in order to be able to perform the activity of certification also for the scope of other categories of vehicles.
In accordance with Article 15(1), certification bodies remain accredited or recognised under the conditions for which those certification bodies have been accredited or recognised. They are not affected by the 16 June 2021 deadline as regards performing the activity of certification for freight wagons.
For more information see the clarification ERA 1172/001 V2.0
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8.2.2. Deadlines for ECM
The following figures show the details of the transitional period as foreseen by ECM Regulation EU 2019/779 and Regulation 2020/780.
For new RUs/IMs that intend to cover the role of ECM for vehicles other than wagons in accordance of application of article 3(4) of Regulation 2019/779 from 16 June 2020 they can do so by demonstrating compliance with the requirements of Annex II of Reg. 2019/779 during the SSC process from the 16th June 2020 on.
When you are an RU/IM and declared as an ECM in the NVR and maintaining vehicles exclusively for your own operations, you have a safety certificate or a safety authorisation, you can continue to be ECM and maintaining vehicles exclusively for your own operations until the end of validity of the existing safety certificate and at the moment of the renewal of certificate, the assessment done by the authorizing entity will cover all the requirements of annex II of Regulation 2019/779.
“When you are an RU/IM and not declared as an ECM in the NVR and you would like to become an ECM and maintaining vehicles exclusively for its own operations, either you need to have an ECM certificate (voluntary) or it will be done via notification to NSA/ERA as the Safety Certification Body for Safety Certificate or NSA for Safety Authorisation, and be “assessed” according point 5.3. It shall be done at latest 16 June 2022.
ECM certificates for freight wagons delivered before 16 June 2020 under the regulation 445/2011 keep the date of end validity (maximum until 06/2025). All the surveillance activities and amendments made during this time will be under the regulation 445/2011. It is recommended to the ECM certification bodies to prepare the ECM to the new requirements of the regulation 2019/779 during this phase of transition. (See different scenarios in Annex III)
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9. ORGANISATION OF THE RAILWAY SECTOR IN EUROPE AND RESPONSABILITIES OF ACTORS
9.1. Who are the different “Stakeholders” participating in the maintenance of vehicles?
The different roles (ECM, RU/IM, keeper, maintenance workshop) can be encompassed by one or several entities provided that they fulfil their intended responsibilities.
The responsibilities of railway parties are stated in the Safety Directive 2016/798, in Articles 4(14)a and 16 (for NSAs) and the RID, chapter 1.4 (for the transport of dangerous goods). Regarding the maintenance of vehicles, responsibilities are also stated in the ECM regulation.
For example, a railway undertaking encompassing the role of ECM of vehicles shall comply in addition to its duties and responsibilities of railway undertaking with the requirements of Annex II of the ECM Regulation 2019/779.It is not regulated who should appoint the ECM. This is left to decisions of the stakeholders. Article 33 of the Interoperability Directive indicates that the registration holder is responsible for providing the information for registration of vehicles to the registering entity. This information includes among others the denomination of the ECM.
Nevertheless it is important to consider that, in practice, the tasks and obligations of RUs and ECMs have to be described in contractual arrangements. These contractual arrangements may also concern intermediaries such as keepers.
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9.2. You are a Keeper, what are your responsibilities?
The keeper is defined in the article 3(19) of the Safety Directive and in the article 3(21) of the interoperability directive.
Apart from the obligations of registration holder, the Safety or Interoperability Directive does not define any additional explicit responsibility for the keeper. In practical terms, unless otherwise specified in the registration documents, the keeper of the vehicle is considered to be the “registration holder” in the meaning of Article 47(6) of the Interoperability Directive (See Annex 3.2.3 of the NVR Decision [12]). Based on Article 4(4) of the Safety Directive it can be understood that the responsibilities of the keeper are basically to implement the necessary risk control measures, where appropriate in cooperation with other actors, to assure in contractual way to RUs/IMs that vehicles (and when requested additional services) provided meet consistently safety requirements.
The contract of use established between a keeper and a RU/IM should cover all the relevant requirements, including at least: Obligations and tasks related to safety issues including the obligations related to the exchange of relevant information or the traceability of safety related documents.
Also based on article 4(4) of the Safety Directive it can be understood that responsibilities of the keeper are to assure to RUs/IMs that vehicles provided meet consistently the appropriate legal requirements.
In particular the keeper should assure to RUs/IMs that the vehicles provided have:
▶ a valid authorization for placing on the market;
▶ an ECM registered in the NVR;
▶ all initial documentation of maintenance of vehicles involved was consigned to ECM uncharged.
For freight wagons and for vehicles other than freight wagons, in the case of Art. 3(2)b of the ECM Regulation, the keeper should assure also to RUs/IMs that the ECM certificate is valid.
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A keeper may be an ECM but it is not mandatory.
To avoid its vehicles being put out of operation, the keeper should pay attention to the following responsibilities:
▶ The keeper may select an ECM and contracts with it
▶ The keeper may make contractual arrangements with subcontractors (e.g. maintenance workshops), but nevertheless the ECM is responsible to take the decision if the subcontractor is sufficiently competent to be authorised to perform maintenance tasks. To this end an agreement should be achieved between the keeper and the ECM.
▶ The keeper acting as registration holder has to ensure that the data it addresses to the registration entity is correct and has to get assurance that the ECM holds a valid certificate for freight wagons and for vehicles other than freight wagons, in the case of Art. 3(2)b of the ECM Regulation. Nevertheless when the keeper is not the registration holder, as it is the main interlocutor for the RUs, it should assure that the vehicle is compliant with the legislation in force and thus that data stated in the NVR is correct and that the ECM holds a valid certificate (only for freight wagons and for vehicles other than freight wagons, in the case of Art. 3(2)b of the ECM Regulation).
▶ As main interlocutor of the RUs/IMs, the keeper should assure that a vehicle is put, in due time, at disposal of the ECM to perform maintenance tasks in consistency with the decisions of the Fleet Maintenance Management (ECM-F3).
▶ For freight wagons and for vehicles other than freight wagons, in the case of Art. 3(2)b of ECM Regulation: the keeper should take specific actions if ECM certificate is suspended or revoked (e.g. assign another ECM, inform its customers including RUs).
▶ Suspension and revocation of ECM certificates imply that the ECM registered in NVRs is not compliant anymore to the legislation in force and therefore that the registration of the vehicle should be suspended forbidding this latter to be operated.
▶ The keeper should specify to the RUs/IMs the conditions of use of the wagons, especially if there are specific conditions (e.g. type of goods transportable, specific operational limitations).
▶ In any case the keeper should participate actively to the exchange of information between ECMs and RUs/IMs when there is no direct contractual arrangement on exchange of information between ECMs and RUs/IMs.
▶ The keeper has to implement the necessary risk control measures and has to cooperate with other actors.
For international transport the provisions of the OTIF CUV and GCU (General Contract of Use) apply to keepers and RUs as users of freight wagons. The obligations and rights of the keepers of freight wagons are described in chapter II of the GCU.
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9.3. You are a RU/IM, what are your responsibilities?
The Railway Safety Directive states in Article 4(3) that RUs shall be made responsible for safe operation and to fulfill this responsibility, it requires that they establish a SMS.
According to the Art 9(2) of the Safety Directive, the RU is responsible to control all the risks related to the supply of maintenance and therefore has to implement control measures to get assurance that vehicles are maintained in such a way that they can be used safely when put in trains.
Controlling the risks associated to the supply of maintenance is not equivalent to being responsible for the maintenance. Controlling the risks means that the RUs has identified hazards to its operations caused by maintenance, evaluated the risks associated with those hazards and define control measures to ensure the safe operation of its trains.
This means in particular that:
▶ The RU must get assurance, that the maintenance provided by the ECM leads to a safe state of running of the vehicles. This may be achieved by getting assurance that the maintenance system put in place by the ECM ensures the safe state of running. In other words the RU must get assurance that the maintenance system makes the ECM capable of providing maintenance keeping the vehicles in a safe state of running. Nevertheless ensuring this safe state of running through a maintenance system remains the unique responsibility of ECMs.
The ECM is responsible for the maintenance and the RU, within its risk control, must get assurance that the ECM is capable to comply with its responsibility and that maintenance is sufficiently effective to make the vehicles in a safe state of running.
▶ The ECM certification is the effective and efficient way to bring this assurance to the RUs. Therefore the RUs should not be required to re-evaluate the maintenance system of ECM already being granted with ECM certificate.
USE
The vehicle is operated
RU/IM
MAINTENANCE Restore the vehicle in its conditions of use (design operating state)
DESIGN OPERATING STATE
Described in the technical file
DEGRADATION OF PERFORMANCE
Vehicle no more in a design operating state
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▶ By virtue of point 5.1.3. c) of annex I of Regulation (EU) 2018/762, the RU shall ensure the freight wagons and other vehicles in the case of Art. 3(2)b of the ECM Regulation it operates, before their departure, have a certified ECM. The Certificate has to be delivered by a duly accredited or recognised certification body or by an NSA entitled by its MS as certification body. The certificate has also to be within its validity period. The ERADIS database provide data on certificates.
In addition the RUs check that the scope of the certificate corresponds to the three kinds of wagons (tank wagons for dangerous goods, other wagons for dangerous goods, or other wagons). Those checks could also be facilitated by contractual arrangements with the keeper or through sectorial arrangements in place, e.g. GCU.
▶ The ECM certification, like any certification, doesn’t guarantee to RU that there will never be non-conformities on the wagons due to improper maintenance. In addition, between maintenance interventions a vehicle may also be damaged by users such as loaders.
The RU is therefore responsible for taking additional control measures described here below. The RU should undertake inspections before the departure of a train or on route. Those inspections have to comply with the processes described in its SMS. The RU must assure that each vehicle in its train will be in such a state that doesn’t compromise the safe operations. It does not aim to control that maintenance was appropriate and done correctly but that vehicles are in a sufficient state for safe use.
Some of those inspections are carried out by the RU itself (e.g. drivers and/or operational staff), for some the RU may subcontract to other entities like loaders or maintenance workshops. But even by subcontracting some of the measures to other players the RU keeps the responsibility according to Article 4(3) of the Safety Directive. The RU must decide how to fulfil its obligations and, if necessary, agree with the other players on rules for procedures that the other players take over for the RU.
▶ The pre-departure and on-route inspections can be seen by the ECM as information on the minimum performance level required by the RUs or on the limitations the RUs meet in operating wagons. Therefore this information should be considered as an input by the ECM for updating the maintenance file.
On the other hand, there could be specific information included in the maintenance file that could be seen as an input by the RU to update the content of pre-departure or on- route inspections/monitoring measures.
Consequently exchange of technical information should be developed by railway parties.
▶ By virtue of Article 5(4) of the ECM Regulation, if a contracting party, in particular a RU/IM, has a justified reason to believe that a particular ECM does not comply with the requirements of Article 14 of Directive (EU) 2016/798 or with the certification requirements of this Regulation, it shall without delay inform the certification body and the relevant NSA thereof. The certification body or, where the ECM is not certified (see Art. 3(2)b), the relevant NSA shall take appropriate action to check if the claim of non- compliance is justified and shall inform the parties involved. As a consequence, the certification body has to consider this claim within its surveillance activities (or, where the ECM is not certified (see Art. 3(2)b, the relevant NSA has to consider this claim within its supervision activity) and may take actions such as imposing an improvement plan, limiting the scope of application of the
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certificate, suspending the certificate, or revoking the certificate depending on the degree of non–compliance (See Article 8 of ECM Regulation).
▶ By virtue of Article 5(2) of the ECM Regulation, the RU/IM shall provide information on the real operations performed. In particular the mileage and specific operational conditions are requested by the ECM to update the maintenance file. This provision of information should be organised between the RU/IM and the ECM or between the RU/IM and the keeper (the keeper plays the role of intermediate).
▶ By virtue of Article 5(3) of the ECM Regulation, all contracting parties shall exchange information on maintenance of vehicles in accordance with the criteria listed in section I.7 and I.8 of Annex II of ECM Regulation.
▶ The RU shall fulfil its duties about transmission of information with its commercial partners – i.e. other RUs/IMs, keepers and ECMs since there could be direct relations between RU and ECM (e.g. RU assuming also the role of keeper or requesting for direct exchange of information).
▶ The RU/IM shall implement any other additional control measures that it considers necessary to keep the identified risks related to the supply of maintenance under control. Those risks could be highlighted through a structured approach to risks assessment and a systematic analysis of findings related to the routine monitoring put in place by the RU/IM as part of its SMS arrangements.
9.4. You are a manufacturer, what are your responsibilities?
Apart from the obligations in the role of “applicant”, the Interoperability Directive do not define any additional explicit responsibility for the manufacturer.
In the role of “applicant” as is defined in the article 2(22) of the Interoperability Directive, the manufacturer shall provide to the keeper of vehicle:
▶ initial identification of safety-critical components;
▶ the complete technical file with specific maintenance instructions recorded in the technical files of subsystems referred to in Article 15(4) of Directive (EU) 2016/797;
▶ recommendations for maintenance as part of the initial documentation ;
▶ information on safety critical components and appropriate maintenance instructions related to them through reference in the technical file of subsystems referred to in Article 15(4) of Directive (EU) 2016/797 ;
▶ technical and engineering support on SCCs and their safe integration when an ECM/Keeper addresses a request; this can be done by agreement or contractual arrangements.
As previewed in the Article 5 of the ECM Regulation the manufacturer shall exchange of information with the ECM and other actors when they address a request.
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9.5. Is there a harmonised framework for the pre departure inspection?
The ECM Regulation doesn’t regulate the pre-departure inspections. They are not part of the maintenance activities of the ECM but they are set up by the Railway Undertaking, as part of their SMS, to verify the vehicle is fit for the journey and the operation: the ECM Certification does not liberate the RU/IM from its responsibilities to manage the risks in operations and maintenance.
The pre-departure inspections are regulated in particular by the TSI OPE [8] and must be managed by Railway Undertakings within their SMS. There are some harmonising tools already in place. The GCU (General Contract of Use) is a harmonised contract between Railway Undertakings and keepers regarding the provision of wagons.
The harmonisation of the pre-departure inspections should be developed by the stakeholders themselves.
It is important for the ECM to know the content of those inspections and their possible differences when establishing and updating the maintenance file. For that purpose, cooperation between RU/IMs and ECMs is crucial.
9.6. You are an ECM, what are your responsibilities?
All ECMs shall satisfy the requirements of Annex II, even if they are not certified.
ECM must set up and keep updated the maintenance file (maintenance development part II.4 b and II.5 annex II)
ECM must ensure that the implementation of the first maintenance file is done correctly (maintenance development part II.4 c annex II)
ECM must coordinate all those activities and supervise its subcontractors
Exchange of information - Article 5(1) of ECM regulation
ECM
USE
The vehicle is operated
RU/IM KEEPER
MAINTENANCE Restore the vehicle in its conditions of use (design operating state)
DESIGN OPERATING STATE
Described in the technical file
DEGRADATION OF PERFORMANCE
Vehicle no more in a design operating state
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The ECM has to address return to operation issues to RUs/IMs and keepers.
Regarding the vehicles, responsibilities are also stated in the ECM regulation. The ECM should ensure that it continuously meets the relevant requirements set out in Article 14(3) of the safety directive and in article 4, 5(1), 5(3), 5(5) and Annex II of the ECM Regulation and applies them consistently. This assurance may be provided to other railway parties by means of the ECM certification, when it is mandatory, or by means of the compliance related to the application of Art. 3(4) of ECM Regulation.
The ECM has the responsibility for setting out the maintenance file for each vehicle and to ensure that this maintenance file is correctly applied.
As part of the maintenance management function (ECM-F1), the ECM has to perform itself the necessary coordination and monitoring of all its maintenance activities. These tasks may be partially outsourced but coordination and monitoring as a whole remain one of the main and crucial task of the management function of the ECM in accordance with Article 14(3) of the safety directive. The other maintenance functions may be performed (totally or partially) internally or (totally or partially) outsourced. This includes the call for technical expertise when not available internally, for instance from manufacturers of vehicles or components, and the use of contracted maintenance workshops.
Regardless of the outsourcing arrangements in place, the ECM shall be responsible for the outcome of maintenance activities it manages and shall establish a system to monitor performance of those activities (See Article 9(3) of ECM Regulation). In addition the ECM has to apply the CSM on monitoring.
The ECM has to inform its clients about any change in the status of its certificate (amended, renewed or revoked) that may cause contractual liability issue.
9.7. Application of Article 4(6) - Use of Safe Alert IT tool
Safety Alerts IT tool is a platform, developed by Agency in the frame of Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety. It facilitates the exchange of information among the relevant actors who identify or are informed of a safety risk relating to defects and construction non-conformities or malfunctions of technical equipment, including those of structural subsystems.
SAIT is a secure website which grants registered users the ability to share information quickly about safety risks relating to defects of technical equipment between the European railway actors.
▶ Who shall report?
SAIT is for railway undertakings, infrastructure managers, entities in charge of maintenance and all other actors (not including national or state bodies and authorities), including manufacturers, maintenance suppliers, keepers, service providers, contracting entities, carriers, consignors, consignees, loaders, unloaders, fillers and unfillers.
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Only employees or agents of one of the above mentioned categories of organisations, will be granted access to the SAIT (Safety Alerts IT tool). Organisations may request as many user accounts as they require. Organisations should make their own internal arrangements for authorizing staff to publish, comment and receive safety alerts.
▶ What to report?
Users should report information about hazards that, in their own judgement and in accordance with the policies of their own organisation:
Relate to defects and construction non-conformities or malfunctions of technical equipment, including those of structural subsystems
The hazard, event or information is novel or unexpected and therefore the related risk is likely to be poorly controlled
The related risk, if not controlled, has the potential to lead to an accident or incident involving serious injury or 1 or more fatalities
The related risk is relevant for more than 1 actor
▶ Where to report?
When you for the first time use SAIT, you must create an EU Login account for your company. SAIT can be found at the following web address: https://safetyalerts.era.europa.eu/safetyalerts
SAIT is overseen by Agency. SAIT was developed, is hosted and day to day support is provided by Directorate-General for Informatics of the European Commission (DIGIT).
▶ When to report?
As soon as possible after detection of the defect, including out of business hours.
▶ Why to report?
The entity in charge of maintenance shall use the SAIT to inform the rail sector and the rail supply industry about new or unexpected safety relevant findings including exceptional maintenance findings beyond wear and tear (article 4(6) of [1])
9.8. You are an accredited or recognized ECM certification body or a NSA designated as ECM certification body. What are your responsibilities?
The applicant ECM is free to choose its certification body (Article 6(1) of ECM Regulation). The ECM can contract body:
▶ With a certification accredited or recognised in any Member state;
▶ With the NSA of the Member State where the ECM is established only if the NSA has been designated by its Member state to perform ECM certification
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The Member State shall be responsible for ensuring the competency of the NSA acting as ECM certification body when it is not accredited or recognised. To this end the Member State should base its control measures on the annex II of the ECM regulation and the ECM accreditation scheme. The Member State should also communicate on those control measures and their results with all interested parties to avoid creating doubts on the competence of NSAs.
For recognition, when applying the article 5(2) of the Regulation 765/2008, the Member State shall provide evidences to the Commission and the other Member States on equivalence between the scheme put in place with the Annex II of the ECM Regulation and the ECM accreditation scheme.
The certification bodies have to examine and treat claims from the NSA (Article 11 of ECM Regulation), RU or any other contracting party (Article 5(7) of ECM Regulation) and take appropriate action to check if the claim of non-compliance is justified and shall inform the parties involved (including the relevant national safety authority) of the results of its investigation (Article 5(4) of ECM Regulation).
The certification body is solely empowered to decide whether to amend, renew, limit the scope of application, suspend or revoke the ECM certificate based upon significant changes in the circumstances applying at the time the original certificate was awarded (Cf. Article 7(8) of ECM Regulation) or if the ECM no longer complies with the certification requirements or any improvement plan (Cf. Article 8(2) of ECM Regulation).
9.9. You are an NSA supervising RUs and IMs. When supervision shows a non compliance of an ECM with the requirements, what are your responsibilities in connection with Article 11 of the ECM regulation?
According to Article 11 of the ECM Regulation, an NSA that has a justified reason to believe that an ECM does not meet the requirements of the ECM Regulation shall at first “take the necessary decision” and then afterwards “inform the national bodies or authorities responsible for the accreditation or recognition, the Agency, the certification body and other interested parties as appropriate. As a general rule, an NSA shall not supervise certified ECMs as this would lead to a duplication of the surveillance regime of the ECM certification bodies, except when the NSA acts as ECM certification body. But, during its regular supervision activities directed towards IMs and RUs, an NSA can detect problems and defects that may put in question the compliance of the ECM’s with the requirements of ECM Regulation.
Which decision shall be taken?
After requesting justification about the supposed lack of compliance with the requirements of ECM Regulation and based on the information received from the RU/IM/keeper (and possibly ECM and ECM certification body), the NSA may take further action or a decision is necessary.
The NSA, in a proportionate way, may take the following action:
▶ NSA decision against RU/IM if measures from RU/IM are not satisfactory as regards technical aspects and timing;
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▶ If measures from RU/IM are not satisfactory and the NSA has legal duty regarding ECMs: NSA decision against ECM if measures from ECM are not satisfactory as regards technical aspects and timing.
Who shall be informed?
For informing the sector, it shall be sufficient that an NSA informs the RU/IM/keeper where the lack of compliance with requirements of ECM Regulation occured. According to Article 5(5) of the ECM Regulation, it is the responsibility of the sector to take the necessary activities and spread this information to all parties involved. The NSA asks the RU/IM for confirmation that the RU/IM has fulfilled its duties according to Article 5(3). The RU/IM shall report back to the NSA.
Further information according to Article 11 shall follow a graduated approach depending on the safety criticality of lack of compliance with requirements of ECM Regulation and the corresponding actions of the RU/IM/ECM in response to the defect. To accommodate this, the following matrix shall be applied:
(re)action of the ECM / frequency of occurrence of the defect
ECM acts efficient and competent / isolated case
ECM actions show deficiencies / repeated cases
No or inadequate ECM actions / numerous cases
safety risk of the defect
high 2 3 3
medium 1 2 3
low 1 1 2
▶ “1” means mild case, not safety critical (No further information by NSA necessary)
▶ “2” means medium case, safety critical (NSA informs ECM certification body, NSA checks necessity of recording in ERA Safety Information System)
▶ “3” means severe case, safety critical (NSA informs ECM certification body, NSA records case in ERA Safety Information System (= information to ERA), NSA informs ERA and national bodies or authorities responsible for the accreditation or recognition)
The examples provided here are specific only for wagons and focused only on the maintenance activities performed from ECM-F4:
▶ Low: Wrong/incomplete marking on wagons/vehicles, deadline for overhaul elapsed;
▶ Medium: Wrong tare/load spring installed (Y25 bogies), brake rigging wrongly plugged;
▶ High: Defect on axle or solid wheel repaired by welding, visibly different buffer types in wagon/vehicle ending, bogie frame rubbing against axle, axle box destroyed by loose screws.
9.10. What other legal information do you need to have in mind when managing contracts?
The contractual and non-contractual liability issues, as private law in general, remain within the competence of the Member States, although the EU has intervened in such field where
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it appeared necessary to ensure the proper functioning of the internal market. In particular, the EU has adopted two regulations, one dealing with the law applicable to contractual obligations and the other one dealing with the law applicable to non-contractual obligations (See respectively Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) and Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II)). These two regulations establish a set of binding rules of private international law which determine which (national) law is applicable.
So EU Regulations applicable to ECM are “Without prejudice to civil liability in accordance with the legal requirements of the Member States” (See Article 4(3) of the Safety Directive) or “without prejudice to existing national and international liability rules” (See Article 7(4) of the Safety Directive).
An ECM is liable to its contract partners (RU, IM, keepers, etc.) for breaches of contract (as provided in the contract and in the law governing the contract) whereas it is liable for damages caused to others than its contract partners (or to its contract partners but outside the scope of the contract) under the national laws governing the damage and the resulting liability.
Court jurisdiction
Article 6(4) of the ECM Regulation provides that “Member States shall take the measures necessary to ensure that decisions taken by the certification bodies are subject to judicial review”. Article 7(6) of the same Regulation provides that “The certification body shall set out in detail the reasons on which each of its decisions is based. The certification body shall notify its decision and the reasons to the entity in charge of maintenance, together with an indication of the process, time limit for appeal and the contact details of the appeal body”.
The “appeal body” referred to in the ECM Regulation is not a new body to be established by the Member States but rather an existing judicial (or administrative) body within the Member State where the certification body is established competent to hear appeal cases by applicants ECM against decisions of such certification body.
9.11. When a new authorisation for placing on the market is necessary?
New authorisation for placing on the market of vehicle is not required when substituted parts are compliant with references or specifications in the technical file.
The “new authorisation” is defined in the Art. 14, paragraph 1, letter d) of Regulation (UE) 2018/545 [12] as the vehicle type authorisation and/or vehicle authorisation for placing on the market issued by the authorising entity after a change of an already authorised vehicle and/or vehicle type, pursuant to Articles 21(12) or 24(3) of Directive (EU) 2016/797.
The criteria to apply for the decision when a “new authorisation” for placing on the market is necessary are set out in the Art. 15 of Regulation (UE) 2018/545 [12].
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Concerning the change in the framework of maintenance of the vehicle, “new authorisation”
For instance, in the case of the substitution of a wheel by another one complying with the specification of the technical file, it would not be necessary to proceed to a new authorisation for placing on the market/placing in service neither a communication to the NSA. According to the Interoperability Directive this substitution is a “substitution in the framework of maintenance” means any replacement of components by parts of identical function and performance in the framework of preventive or corrective maintenance. It should only be necessary to have this substitution recorded in the configuration file of the vehicle. This information is, of course, available to NSAs upon request.
If the specification of the new parts impairs the design operating state, it is considered as a major change of the technical design and possibly leads to a new authorisation for placing on the market/placing in service according to the Interoperability Directive.
The Interoperability Directive distinguishes between
a) ‘upgrading’ means any major modification work on a subsystem or part of it which results in a change in the technical file accompanying the ‘EC’ declaration of verification, if that technical file exists, and which improves the overall performance of the subsystem and
b) ‘renewal’ means any major substitution work on a subsystem or part of it which does not change the overall performance of the subsystem;
In case of upgrading or renewal, the ECM could be the applicant for this new authorisation. In any case, the ECM should manage it through contractual arrangements with the RU/keeper and taking in consideration:
▶ The existing authorisation for placing in service;
▶ The guarantee of the vehicle by the manufacturer.
Other different question is if the fact, that the specification of the new parts impairs the design operating state, could be considered as a significant change affecting safety. In this case it is necessary to evaluate by the proposer (ECM) of the change if the change is safety relevant and, in this case, to apply the Common safety Method on Risk Assessment and Evaluation[4].
Activities in context of substitution in the framework of maintenance are covered by the ECM Regulation and by ECM-certification. Upgrading and renewal are not covered by the ECM-Regulation.
9.12. How to understand the article 3(2)b (Assessment of RUs and IMs maintaining vehicles, other freight wagons, exclusively for their own operation)?
According to Article 3(2)b an ECM certification is not mandatory for an ECM which is RU or IM maintaining vehicles, other than freight wagons, exclusively for its own operations. However,
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these entities have to satisfy the Requirements of Annex II (ECM requirements) according to the methods and times described in paragraph 8.2.2.
They shall demonstrate compliance with Annex II:
a) By a voluntary ECM certification by the relevant certification body. The relevant certification body issues an ECM certificate. The certificate is included in the ECM Certificates Database of ERADIS. The RU/IM is a regular ECM and treated as such. By a voluntary ECM certification by a competent certification body. The competent certification body issues an ECM certificate. The certificate is included in the ECM Certificates Database of ERADIS and it shall be deemed evidence of compliance with points 5.2.4 and 5.2.5 both of Annex I and Annex II to Commission Delegated Regulation (EU) 2018/762 as regards maintenance of vehicles. The RU/IM is a regular ECM and treated as such. The RU/IM in this case shall communicate to the authorising entity the possession of the ECM Certificate as this could lead to the need for an update of the Safety Certificate/Authorisation.
b) Through the process of safety certification/safety authorisation. In this case, the safety certification body will not issue an ECM certificate nor an entry in the ECM Certificates Database of ERADIS. The maintenance activities are limited to vehicles exclusively operated by the applicant for its own operations.
Although it is possible to strictly apply the ECM Certification scheme, while assessing the compliance of the maintenance activities of a RU/IM with the ECM requirements together with the application for a safety certificate (or safety authorisation), the safety certification body may follow a more flexible approach adapted to the safety certification (or authorisation) process.”
If the safety certification body follows the adapted approach, it brings its assessment process for the maintenance activities of the applicant in consistency with its existing processes for safety certification/authorisation (in compliance with the practical arrangements for issuing single safety certificates to railway undertakings, the CSM on safety management system requirements and the CSM for supervision by national safety authorities after the issue of a single safety certificate or a safety authorisation).
The safety certification body will incorporate all maintenance activities described in the ECM certification scheme and in particular will take into account its knowledge of the applicant and those risks related to:
▶ the management system of the RU/IM;
▶ the existing competences;
▶ the assurance that the RU/IM address seriously the establishment and the updates of the maintenance files.
The principles underpinning this flexibility lie on the wide and detailed view the Agency and NSAs have, among stakeholders and interested parties, on the safety of the (European) railway system and in particular, on safety risks. The Agency and NSAs have then sufficient safety maturity and knowledge of the applicants to target the assessment of the maintenance system of the RU/IMs by using a risk based approach.
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This picture shows the possible adaptation of the ECM Certification Scheme by safety certification/authorisation bodies assessing together the application for a safety certificate (or safety authorisation) and the ECM requirements.
The Assessment of RU or IM during the process of safety certification
Initial Assessment
CSM SMS / PA SSC CSM Supervision
Supervision activities
Granting of safety certificate or safety authorisation
ECM Certification Scheme‐
Initial Assessment Surveillance activities
Initial audit
On‐site audit
On‐site inspections
On‐site audit
On‐site inspections
Granting of ECM certificate
Initial Assessment Supervision activities
CSM SMS CSM
Granting of safety certificate (or safety
autorisation)Targeting of surveillance
activities based on safety risks
ECM certification process adapted to existing processes for safety certification (CSM SMS) and supervision activities (CSM Supervision)
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The picture shows, that the process of safety certification is different from the process of ECM certification.
A RU/IM who demonstrates compliance with Annex II during the process of safety certification will not receive an ECM-Certificate.
The ECM activities of this RU/IM are mandatory limited to the vehicles exclusively for its own operations.
This RU/IM cannot act as ECM for freight wagons.
NSAs and the ERA have been established as safety certification bodies. The CSM on SMS requirements and the CSM on supervision consider the implementation of processes for safety certification, which is different from the process of ECM certification.
The management system of an RU/IM that maintains vehicles exclusively for its own operations has to include methods and instruments for complying with both, the safety management system requirements and the requirements of Annex II of ECM Regulation. Although the two management systems are designed for different actors there are overlaps.
The assessment of the ECM requirements should take the overlaps into account. It should be seen as an “add on” to the SMS assessment according to Regulation (EU) 2018/763.
According Safety directive, for RUs/IMs there are 2 different phases:
▶ safety assessment for the issuing the safety certification / safety authorization; in this phase audits / inspections are possible but not mandatory; the assessment is made by the certification body / NSA for the safety authorization;
Compliance with Annex II
RU maintaining vehicles exclusively for its own operation
Voluntary ECM certification Process of safety certification
+initial certification audit ‐stage 1: documents ‐stage 2: on side‐ 2019/779 inc. Annex II‐ SZS
+Issuing the ECM certificate
+ surveillance‐ 2019/779, Art. 8‐ every 12 M‐ geographical and functional balance‐ audit time for surveillance audits should be proportional to the audit time spent on the initial audit ensuring overall continuing compilance
ECM‐Certification Bo
dy
Internal excha
nge
or
ERA NSA + Safety assessment‐ 2018/763 practical arrangements‐ 2018/762 SMS requirements ‐ Annex II of 2019/779+ Issuing the safety certificate
+ Supervision‐ 2018/761, article 3 supervision process‐ identify risk areas‐ develop the supervision strategy ‐ coordination with other NSA if necessary‐ supervision plan(s)‐ allocated resources affect priorities
Internal excha
nge
Information gathered during
assessment
Information gathered during
supervision
Safety certification bo
dyNSA
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▶ supervision process after the issuing the safety certification / safety authorization, made by NSAs; in this phase audits and inspections are suitable techniques for assessing that RU / IM continues to duly apply their SMS.”
During supervision activities, after issuing a safety certification / authorization NSAs monitor the SMS effectiveness and the application of CSMs.
Before issuing a safety certificate, the safety certification body has to check,
▶ if the RU is aware of the requirements of annex II of the ECM Regulation
▶ if the RU established procedures to supervise and coordinate its maintenance activities (management function)
▶ If the RU has procedures to identify safety critical components.
Before issuing the safety authorization, the national safety authority has to check.
▶ if the IM is aware of the requirements of annex II of the ECM Regulation
▶ if the IM established procedures to supervise and coordinate its maintenance activities (management function)
▶ If the IM has procedures to identify safety critical components.
9.13. What are the steps for the assessment of the ECM requirements during the process of safety certification
1) Initial screen
The safety certification body checks an add-on to the SMS requirements if
a) the provided basic information covers the maintenance of vehicles exclusively for RU/IM operations
b) the application file contains sufficient evidence and is structured and internally cross-referenced so that it can be properly assessed against the requirements of annex II of ECM regulation
c the maintenance report is available
2) Detailed assessment before issuing the safety certificate :
After the completion of the initial screen stage, the safety certification body shall proceed with the detailed assessment of the application file, using the safety management system requirements and as “add on” for maintenance and checking the compliance with ECM Regulation through the Safety Certification/Authorisation mapping table (see Annex I and Annex II).
If the RU/IM is a newcomer ECM, the company presents during Safety Certification/Authorisation process (first issue/renewal by Agency/NSA) the mapping table with the
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requirements of Regulation EU 2018/762 (Annex I for RU or Annex II for IM) by adding a column where the corresponding requirement of Regulation EU 2019/779 is allocated and accomplished by means of the company SMS documentation.
If the RU/IM is already registered as ECM, the company presents during Safety Certification/Authorisation process (renewal by Agency/NSA or supervision activity by NSA) the mapping table already presented at the moment of the first issue/renewal of the Safety Certificate/Authorisation by adding a column where the corresponding requirement of Regulation EU 2019/779 is allocated and accomplished by means of the company SMS documentation.
Where correspondence is not found, the RU/IM can present an adjunctive mapping table where the remaining ECM requirements are allocated and accomplished by means of the company specific maintenance system documentation.
The ECM Regulation guide contains appendix 1 and appendix 2 with an example of a complete mapping table for RU/IM where corresponding ECM Regulation requirements are indicated.
Agency/NSA can also use the ECM Certification Scheme (doc. ERA 1172/003) to check in detail the compliance with ECM Regulation requirements and are enabled to arrange on-site visits, where appropriate, to gain evidence of the implementation of such requirements.
3) Supervision after issuing the safety certificate
During the period of validity of the safety certificate, the NSA(s) shall supervise the continued fulfilment of the safety management system requirements and the “add on” for all 4 maintenance functions as shown in the annex II.
The NSA has develop a supervision strategy according to the specifications of the CSM Supervision.
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10. WHAT IS THE MAINTENANCE FILE?
Article 14(2) of the Safety Directive introduces the maintenance file as follow:
“…the entity in charge of maintenance shall:
(a) ensure that vehicles are maintained in accordance with the maintenance file of each vehicle;”
According to the sections II.4. and II.5. of annex II of the ECM Regulation [1], the ECM has the duty to develop and maintain (continuously update) the maintenance file. For building this document, the ECM needs to have:
Initial technical documentation
For vehicles compliant with TSIs, the initial development of the maintenance file is based on the technical file (Refer to section 2.4 of annex IV of the Interoperability Directive [3]) and on the APOM. The content of the technical file is described in detail in the relevant TSIs.
As interoperability doesn’t cover all the technical characteristics of a vehicle but only the ones making the vehicle compliant with the essential requirements through the applicable TSIs, there may be additional technical information that has to be provided to the ECM. This additional technical information is requested contractually between the applicant and the manufacturer of the vehicle.
Therefore the initial technical documentation on which the maintenance file will be built is composed of:
Initial technical documentation including initial maintenance documentation
Technical fileAdditional technical documentation
requested contractually including the relevant maintenance documentation
In case the complete technical file has not been provided to the ECM, access should be arranged contractually between the keeper and the ECM. The keeper himself should be aware of its responsibility to provide the appropriate and correct technical information on the vehicle.
For vehicles compliant with TSIs, the documentation described in the relevant TSIs as part of the technical file should be necessarily provided to the ECM, for instance:
▶ Freight vehicles under the revised TSI wagon: There is the chapter 4.5 of annex to TSI Vehicle [6];
▶ Vehicles other than freight wagons under revised TSI Loc&pas: There is the chapters 4.2.12 and 4.5 of annex to TSI Loc&Pas [5];
▶ CCS on board subsystem of vehicles other than freight wagons under revised TSI CCS: There is the chapter 4.5 of annex to TSI CCS [7].
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For vehicles not complaint with TSIs (like the majority of existing vehicles) or partially compliant with TSIs, the technical file is replaced by all technical and existing maintenance information that accompany the vehicle.
Initial technical documentation including initial maintenance documentation
Technical and existing maintenance information that accompany the wagon
Additional technical documentation requested contractually including
the relevant maintenance documentation
The initial development of the maintenance file shall take also into account the pattern of operations planned. It includes also the performance targets required by the users: RUs/IMs and keepers.
Content of the maintenance file
The maintenance file has to be created for each vehicle and contains all the information that is necessary to carry out maintenance.
The maintenance file is composed of the following four elements:
1 General Documentation ( extract of chapter 4.5.1 of annex to TSI Wagons [6], chapter 4.2.12.2. of annex to TSI Loc&Pas [5] and chapter 4.5.1 of annex to TSI CCS [7])composed of:
▶ Drawings and description of the vehicle and its components;
▶ Any legal requirement concerning the maintenance of the unit;
▶ Drawing of systems (electrical, pneumatic, hydraulic and control-circuit diagrams);
▶ Additional on-board systems (description of the systems including description of functionality, specification of interfaces and data processing and protocols);
▶ Configuration files for each vehicle (parts list and bill of material) to enable (in particular but not only) traceability during maintenance activities;
▶ the conditions for first line maintenance, i.e. the definition of Line Replaceable Units (LRUs), the definition of approved compatible versions of hardware and software, the procedures for replacing failed LRUs, the conditions for storing LRUs and for repairing failed LRUs.
This documentation may be updated by the ECM.
2 Maintenance Design Justification File (extract of chapter 4.5.2 of annex to TSI Wagons [6], chapter 4.2.12.3.1. of annex to TSI Loc&Pas [5] and chapter 4.5.1 of annex to TSI CCS [7]) explains how maintenance activities are defined, designed and updated in order to ensure that the vehicle characteristics will be kept within permissible limits of use during its lifetime and to ensure that the vehicle is in a safe state of running compliant with the planned pattern of operations. It shall give input data to determine the criteria for maintenance activities. It consists of :
▶ Precedents, principles and methods used to design the maintenance of the unit;
▶ Limits of the normal use of the unit (e.g. km/month, climatic limits, foreseen types of loads etc.) according to the planned pattern of operations;
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▶ Relevant data used to design the maintenance and origin of these data (e.g. return of experience);
▶ Tests, investigations and calculations carried out to design the maintenance;
▶ (first/initial) maintenance file (mostly created by the manufacturer): all safety verifications and risk analysis done for defining maintenance activities, intervals etc. shall be covered in the file, because it shall be transparent for the ECM. This is necessary for optimizations of the file by the ECM later on. This is also relevant in case of changing ECM;
▶ all maintenance requirements and procedures (including health monitoring, diagnosis of events, test methods and tools and also the required professional competence) necessary for achieving essential requirements and values quoted in the mandatory requirements of TSI CCS throughout the equipment life-cycle (transport and storage before installation, normal operation, failures, repair work, checking and maintenance, decommissioning, etc.).
This file must be updated by the ECM to enable traceability of changes in maintenance.
3 Maintenance Description File (extract of chapter 4.5.3 of annex to TSI Wagons [6], chapter 4.2.12.3.2. of annex to TSI Loc&Pas [5] and chapter 4.5.1 of annex to TSI CCS [7]) describing how maintenance activities have to be conducted. Maintenance activities include, among others: inspections, monitoring, tests, measurements, replacements, adjustments and repairs. These activities are split into :
▶ Preventive maintenance; scheduled and controlled;
▶ Corrective maintenance;
▶ Light and heavy maintenance
Basically the maintenance description file should contain at least:
▶ Component hierarchy and functional description. The hierarchy sets up the boundaries of the vehicle by listing all the items belonging to the product structure of that vehicle and using an appropriate number of discrete levels. The lowest item of the hierarchy shall be a replaceable component;
▶ Parts list: the parts list shall contain the technical and functional descriptions of the spare parts (replaceable units) and the references from the spare part provider and manufacturer, in order to allow identification and procurement of the correct spare parts. The list shall include all parts specified for changing on condition, or which may require replacement following electrical or mechanical malfunction, or which will foreseeable require replacement after accidental damage. The spare parts list shall also cover component and software modification levels. Interoperability constituent shall be indicated and referenced to their corresponding declaration of conformity;
▶ The limit values for components which are not to be exceeded in service are to be stated; the possibility of specifying operational restrictions in degraded mode (limit value reached) is permitted;
▶ The checks to be carried out when maintaining equipment other than Control-Command and Signaling equipment and which influences the Control-Command and Signaling Subsystems (e.g. changing the wheel diameter);
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▶ The checks to be carried out if CCS equipment is subject to exceptional stress (e.g. adverse environmental conditions or abnormal shocks);
▶ List of reference to the European legal obligations to which components or subsystems are subject.
▶ A maintenance plan i.e. the structured set of tasks to perform the maintenance including the activities, procedures and means. The description of this set of tasks includes:
⚬ Disassembly/assembly instructions drawings necessary for correct assembly/disassembly of replaceable parts;
⚬ Maintenance criteria;
⚬ Checks and inspections in particular of safety relevant parts; these include visual inspection and non-destructive tests (where appropriate e.g. to detect deficiencies that may impair safety);
⚬ Welding procedures;
⚬ Tools and materials required to undertake the task;
⚬ Consumables required to undertake the task;
⚬ Personal protective safety provision and equipment;
⚬ Necessary tests and procedures to be undertaken before release to service and return to operation.
4 Configuration File for each vehicle (parts list and bill of material) to enable (in particular but not only) traceability during maintenance activities all along the lifecycle. The configuration files contain the records on maintenance performed. Traceability of maintenance records depends on their impact on safety and has to be compliant with applicable legislation.
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11. EXCHANGE OF INFORMATION BETWEEN RAILWAY ACTORS
11.1. What is the information that stakeholders have to exchange according to the maintenance of vehicles?
The exchange of information is critical. Therefore, this is an important requirement in the ECM Regulation obliging RUs, IMs, manufacturers, keepers, ECMs, certification bodies and the relevant national safety authorities to exchange information. As established in the Article 5 of the ECM Regulation:
▶ The entity in charge of the maintenance of the vehicle shall deliver information on the maintenance of a vehicle, and, where applicable on aspects relevant for the operation to the railway undertakings or infrastructure managers at request, either directly or via the keeper;
▶ The railway undertaking or the infrastructure manager shall deliver information on the operation of a vehicle to the entity in charge of maintenance at request, either directly or via the keeper of the vehicle;
▶ All parties involved in the maintenance process such as railway undertakings, infrastructure managers, keepers, entities in charge of maintenance, as well as manufacturers of vehicles, subsystems or components, shall exchange relevant information about maintenance in accordance with the criteria listed in Sections I.7 and I.8 of Annex II;
▶ Where any involved party, in particular a railway undertaking or an infrastructure manager, has evidence that an entity in charge of maintenance does not comply with Article 14 of Directive (EU) 2016/798 or with the requirements of this Regulation, it shall without delay inform the certification body and the relevant national safety authority thereof. The certification body or, where the entity in charge of maintenance is not certified, the relevant national safety authority shall take appropriate action to check whether the claim of non-compliance is justified;
▶ Where there is a change of entity in charge of maintenance, the keeper, in accordance with Article 47(6) of Directive (EU) 2016/797, shall inform without delay the registration entity referred to in Article 4(1) of Commission Decision 2007/756/EC (9) and request the update of the vehicle register. In that situation:
(i) the former entity in charge of maintenance shall without delay deliver the maintenance documentation to the keeper;
(ii) the former entity in charge of maintenance shall be relieved of its obligations when it is removed from the vehicle register;
(iii) in the absence of a new entity in charge of maintenance the registration of the vehicle shall be suspended.
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The exchange of information covers specifically Safety Critical Components too. As established in the Article 4(2), 4(3) and 4(6) of the ECM Regulation:
▶ The entity in charge of maintenance shall, either directly or via the keeper provide information to the railway undertakings and infrastructure managers operating the vehicles, keepers, manufacturers, holders of vehicles authorisations and holders of the type authorisation of vehicles, subsystems or components, as most appropriate and shall in particular, inform them of exceptional maintenance findings beyond wear and tear;
▶ Where during the maintenance of a vehicle an entity in charge of maintenance becomes aware of evidence suggesting a component not previously identified as safety critical should be considered as such, it shall inform the manufacturer, the holder of the vehicle type authorisation and the holder of the vehicle authorisation without delay;
▶ The entity in charge of maintenance shall inform the rail sector and the rail supply industry about new or unexpected safety relevant findings including exceptional maintenance findings beyond wear and tear, in relation to vehicles, subsystems or other components, when the related risks are relevant for more actors and are likely to be poorly controlled. The entity in charge of maintenance shall use the Safety Alert IT or another informatics tool provided by the Agency for this purpose.
The exchange of information covers also information between certification body, Member States and authorities as in article 6(1), 6(2), 6(8), 11 and 13:
▶ Member States shall provide the Agency with the following information concerning the certification bodies:
⚬ name
⚬ address
⚬ contact details
⚬ the nature of their empowerment in accordance with Article 14 of Directive (EU) 2016/798 (accreditation, recognition or if they have taken on the task as the national safety authority);
▶ Member States shall inform the Agency about any change in the situation within one month of the occurrence of that change;
▶ A national safety authority, a national investigation body or the Agency may request information from any certification body on the situation concerning an individual ECM certification. The certification body shall reply within 2 weeks at the latest;
▶ If a national safety authority has knowledge that an entity in charge of maintenance does not comply with the requirements of Annex III of Directive (EU) 2016/798 or with the certification requirements of this Regulation, it shall inform the national bodies or authorities responsible for the accreditation or recognition, the Agency, the certification body and other interested parties as appropriate;
▶ The Agency shall collect, record and publish basic information on certification bodies and certified entities in charge of maintenance. The Agency shall create an IT tool for delivering this task.
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The exchange of information on changes related to ECM certificate is ruled in Article 7(8):
▶ An ECM certification shall be valid for a maximum period of 5 years. The certified entity in charge of maintenance shall inform the certification body of any changes that might have an impact on the validity of its certification without delay.
The exchange of information between the ECM and other actors may be done in various ways using various methods of communication. The traditional method is paper-based forms (e.g. defined proformas, train books, engineering documents e.g. change request documents, modifications, special checks, safety bulletins etc.). Digital data exchange is now increasingly the norm, this can be a commercial industrial software solution (e.g. SAP, Maximo), or ECM in-house system linked to the Maintenance Management Information System (MMIS) or customer’s system (e.g. Railfleet). Day-to-day information exchange also uses common methods such as E-mail (normal and certified), phone, Text SMS and even verbal. What is important, whichever mixture of methods is chosen, is that the information is correct, complete, comprehensible by both parties and a record is generated to provide traceability.
11.2. How to find an ECM certification body, how to publish your ECM certificate, how to find an ECM certified?
See the ERADIS guide, part 5
http://eradis.era.europa.eu/help/docs/User%20Manual%20-%20ERADIS%20Safety%20Documents.pdf
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12. MANAGEMENT OF CHANGES
12.1. I would like to change the ECM of my fleet, how to proceed?
The critical aspect when changing of ECM is the proper transfer of information between the former ECM and the new ECM.
▶ (sufficient) information on the maintenance file including records on maintenance performed and safety verifications and risk analysis done for defining maintenance activities, intervals etc.
▶ The technical documentation (technical file is not the property of ECM)
▶ The configuration files of each vehicle
▶ All additional information required by contract between keeper and ‘former’ ECM
Consequently, ERA recommends strongly taking in account these details and issues when negotiating and setting up contractual arrangements between all the involved parts, above all with contracts between the ECM and the client.
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13. HOW TO MANAGE SAFETY CRITICAL COMPONENTS?
To deal with Safety Critical Components, a guidance has been prepared by WG48 of CEN/TC256.
The objective of the “guide for identification and management of Safety Critical Component for railway vehicle” (SSCs guide) drafted by the above WG48 is to provide an overview of the requirements captured from the legislation and the actors involved in their fulfilment.
In addition, the document SCCs guide aims to promote a common understanding of those requirements together with practical arrangements to fulfil them in a proper way and giving guidance for the SCC identification and management.
The objective of the SCCs guide is neither to produce an applicable list of SCC components nor to provide for examples of SCC.
This SCCs guide is applicable to vehicles only. The definition of “vehicle” is as in Art. 3(21) Directive 2016/798 (Safety Directive).
13.1. What is a safety critical component
Safety critical components are components for which a single failure has a credible potential to lead directly to a serious accident such as:
▶ any train collision or derailment of trains resulting in the death of at least one person or serious injuries to five or more persons or extensive damage to rolling stock, the infrastructure or the environment, and
▶ any other accident with the same consequences which has an obvious impact on railway safety regulation or the management of safety;
▶ ‘extensive damage’ means damage that can be immediately assessed by the investigating body to cost at least EUR 2 million in total
The SCCs guide collects in a table a list of accidents related to the definition of SCCs applicable for vehicle’s components.
13.2. For which type of vehicle?
To make it clear the applicability of SCC requirements in the field of railway vehicles, it is necessary to distinguish between two categories of vehicles:
▶ new vehicle;
▶ existing vehicle.
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For convenience, a new vehicle is intended as a vehicle for which an applicant has requested to the authorizing entity a vehicle authorisation for placing on the market following the new legislation (complying with Regulation 2018/545)
The SCCs requirements for new vehicles also apply to existing vehicles that have a vehicle authorisation for placing in service following engineering change/renewal/upgrading/refurbishment of existing vehicles, which already have a vehicle authorisation for placing on the market, only for the parts of the vehicle related to engineering change/renewal/upgrading/refurbishment.
In that cases, the entity managing the change (holder of the vehicle type authorisation) plays the same role as the Manufacturer.
In addition, the applicant for the vehicle type authorisation is responsible for compiling the technical file that is to accompany the ‘EC’ declaration of verification to be submitted for the application.
Usually, the detailed content of the different documents of the technical file is prepared by the Manufacturer of the vehicle, where the Manufacturer may play the role of “applicant” itself.
The maintenance documentation is a part of the technical file and it is given by the applicant (directly or via the Keeper) to the ECM to make it able to manage and implement the maintenance of the vehicle.
The ECM is responsible for managing the first “maintenance file” by adapting the maintenance documentation to the real operating conditions, performances required and return on experience and to keep updated the maintenance file throughout the lifecycle of the vehicle.
In the case of existing vehicle too, the ECM is responsible for managing the maintenance documentation (see Art. 14(3)b of safety directive) and keeping it updated throughout the lifecycle of the vehicle.
The technical file and the maintenance file play a fundamental role in the accomplishment of the SCC requirements.
13.3. What is the SCC management process?
The identification and management of SCCs starts as part of the design phase under the responsibility of the vehicle Designer/Manufacturer from the concept phase and, when the vehicle is in operation/maintenance phases, through the collaboration and exchange of information with ECM/RU/Keeper (references on the life-cycle phases applicable to a vehicle can be found in EN50126-1-2017).
Generally, to guarantee the safety level in normal and degraded situations, as requested by the relevant TSIs, Designers/Manufacturers are requested to carry out design, construction or assembly for satisfying at least safety requirements.
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As regards SCCs, it is expected that Designers/Manufacturers will seek to minimise or eliminate SCCs by means of architectural and functional design choices (see also 5.9 of EN50126-1:2017). However, where it is not practicable to ‘design out’ a SCC, it is crucial that the component is clearly identified, managed and notified. To do so for new vehicles, the Manufacturer is required to:
▶ identify SCCs during the concept/design phase by means of risk-based analysis;
▶ insert a SCCs list in the technical file/maintenance description file/operation documentation together with their specific requirements for:
⚬ operation, servicing, maintenance,
⚬ operational, servicing and maintenance traceability;
▶ specify precedents, principles and methods used to identify SCCs and their specific requirements inside the Maintenance Design Justification File.
These SCCs deliverables, being part of the technical documentation of the vehicle, need to be notified to ECMs/RUs/Keepers to support them during operation/maintenance phases and to update, where necessary, the technical file of the vehicle.
The same process is also valid in the case of engineering change/renewal/upgrading/refurbishment of the vehicle, where in this case the designer/Manufacturer/Entity managing the engineering change/renewal/upgrading/refurbishment is called to provide for the SCCs deliverables.
Neither Manufacturers/Entities managing the change nor ECMs are obliged to identify retrospectively SCCs for existing vehicles except in the case of engineering change/renewal/upgrading/refurbishment, only for the parts of the vehicle related to engineering change/renewal/upgrading/refurbishment.
However, for existing and new vehicles, if during its routine maintenance activities (see Table for details) an ECM becomes aware of evidence suggesting a component not previously identified as safety critical should be considered as such, it must notify the:
▶ Manufacturer,
▶ the holder of the vehicle type authorisation and
▶ the holder of the vehicle authorisation.
After receiving this notification, the Manufacturer, when it can be identified, is required to confirm if the component is safety-critical through risk assessment taking into account use and environment of the component in the context of the vehicle’s operation and maintenance.
In the case of confirmed SCC, the Manufacturer is required to collaborate with the ECM/RU/Keeper to develop specific operational, servicing, maintenance and traceability requirements.
If the Manufacturer cannot be identified, the ECM may confirm the identification of the SCC through a risk assessment procedure as part of its maintenance system and develop specific operational, servicing, maintenance and traceability requirements in collaboration with RU/Keeper.
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As a consequence, the outcomes and deliverables of the confirmed SCC need to be notified to, at least:
▶ Keepers/RUs
▶ ECMs
▶ the entity managing the technical file and recorded in the relevant part of the technical file.
In addition, for existing and new vehicles, the Manufacturer is required to provide technical and engineering support on SCCs and their safe integration, when an ECM or a Keeper makes a request.
As detailed above, the ECM is involved to identify new potential SCC during its routine maintenance (reference to in Article 4(3) of ECM Regulation) and, in addition, it may have need, based on REX or other ECM’s activities, to change the SCCs list or their specific requirements (see Annex III.10 of Safety Directive).
In these cases, the ECM is required to use the appropriate “SCCs identification procedure” of its maintenance system through the application of risk-based analysis as required in Annex II of the ECM Regulation.
The following table summarises the high-level activities during which the ECM could:
▶ become aware of evidence that a new SCC is identified as such and notifies it to the Manufacturer for confirmation
▶ change the SCCs list provided by the Manufacturer or their specific requirements
▶ make a request to the Manufacturer for technical and engineering support on SCCs and their safe integration:
ID. ECM Regulation – Annex II, referenced activities Detail of activities
1
Ref. to in: ▶ 2.2, 2.3 part. I, ▶ 2, 4, 5, 6 part II:
when managing changes to the maintenance file of the vehicle as a consequence of:
Non-exhaustive list of examples: ▶ technical/operational change ▶ renewal/upgrading/refurbishment ▶ change of:
⚬ mission profile ⚬ Maintenance plan ⚬ authorization of the vehicle ⚬ vehicle’s configuration ⚬ competence of personnel
▶ legislation’s requirement
2
Ref. to in: ▶ 3, part I:
as an output of monitoring activities on:
▶ collection and analysis of safety relevant data comprising unexpected or exceptional safety and maintenance findings
▶ reporting from accidents, incidents, near misses and other dangerous occurrences
▶ internal audit reporting
3
Ref. to in: ▶ 4, part I:
as an output of continuous improvement on:
▶ collection and analysis of data from: ⚬ regular monitoring ⚬ auditing ⚬ recommendation from national safety authority, national
investigation body, industry, internal investigation, ⚬ report or information from railway undertakings or other sources
to determine measures to be adopted
Table x – ECM activities related to the SCCs list (new component or changes), changes to SCCs requirements and requests for support from Manufacturer
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The following flow diagrams show the Manufacturer’s and the ECM’s perspective of the SCCs management process above described.
Vehicleoperation/maintenance
ECM is operating:
Changes to the maintenance file
Monitoring activities
Continuous improvement and finds out:
Need for Manufacturer
support about SCC and its safe integration
Evidence of new potential SCC
Need for changing on SCC list or SCC requirements
Send notification about potential SCC to:
Manufacturer
Holder of the vehicle type
Holder of the vehicle authorisation
Address a request of support, directly or via the Keeper, to
Manufacturer
Is Manufacturer identified?
ECM to Perform Risk‐based analysis
NOManufacturer identified?
Risk‐based analysis
Manufacturer is asked to:
Confirm new SCC
Respond to the request of support
Manufacturer to perform Risk‐based analysis
Manufacturer to consider use and environment of component and
vehicle
SCC Deliverables: Confirmation (Y/N) Requirements Precedents,
principles, methods
Collaboration with RU/Keeper for operational requirements
SCC Deliverables: Confirmation (Y/N) Requirements Precedents,
principles, methods
Collaboration with ECM for servicing/maintenance
requirements
Provide for updating:Technical File Maintenance File Maintenance Design
Justification File Operation documentation
YES
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13.4. What are the possible methods for the identification of SCC?
A way to identify safety critical components is to use a bottom-up method which has the characteristic to start from the point of view of the component and, by analysis, going through different levels up to the main effect of the component failure.
Using a bottom-up method implies 2 steps to be carried out:
▶ Step 1 – Identification of vehicle’s components
▶ Step 2 - Analysis and identification of component’s criticality
One of the most common used bottom-up method is FMECA process
Another way to identify critical components is to use a top-down method.
The top-down method does not start from the component’s view as in the bottom-up method, but it starts from the main “top” effect and, by analysis, going through different levels down to the elementary event causing the main one.
One of the most common used top-down method is the Fault Tree Analysis
More explanations on these methods are in the “Railway Applications - Vehicle Maintenance - Guide for identification and management of Safety Critical Components for railway vehicles” drafted by the WG48 of CEN/CENELEC. The document is referenced as FprCEN/TR 17696, and the publication is forecasted for the end of 2021.
(The link when it will be available could be add in this part)
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14. COMPETENCES OF MAINTENANCE STAFF
This part is focused on the competence management of maintenance staff as previewed in the Annex II, Section I, Point 6 of Regulation (EU) n. 2019/779.
When designing the competency management system, the ECM and/or maintenance workshop should ensure that there is an alignment between safety responsibility and competency for staff at all levels of the ECM and/or maintenance functions The qualifications and certifications must be aligned with the tasks a person may undertake and the safety responsibilities that person may be designated.
§ 6. Competence management — a structured approach to ensure that employees have the competences required in order to achieve the organisation’s objectives safely, effectively and efficiently in all circumstances
6.1. The organisation must set up a competence management system providing for:
(a) the identification of posts with responsibility…
(b) the identification of posts involving safety tasks;
(c) the allocation of staff with the appropriate competence to relevant tasks.
6.2. Within the organisation’s competence management system, there must be procedures to manage the competence of staff, including at least:
(a) identification of the knowledge, skills and experience required for safety-related tasks as appropriate for the responsibilities;
(b) selection principles, including basic educational level, mental aptitude and physical fitness;
(c) initial training and qualification or certification of acquired competence and skills;
(d) assurance that all staff are aware of the relevance and importance of their activities and how they contribute to the achievement of safety objectives;
(e) ongoing training and periodical updating of existing knowledge and skills;
(f ) periodic checks of competence, mental aptitude and physical fitness where appropriate;
(g) special measures in the case of accidents/incidents or long absences from work, as required.
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The organisation to set up a competence management system must to take into account:
▶ Requirements of TSIs about professional competences required for the maintenance (information designer/manufacturer of vehicles or part of vehicles shall to include in the maintenance file).
For example see the extract of chapter 4.5 (5) of annex to TSI Loc&Pas [6] and chapter 4.6 of annex to TSI CCS [8]):
▶ For on-board software, the designer/manufacturer shall specify, for any on-board software modification, all maintenance requirements and procedures (including health monitoring, diagnosis of events, test methods and tools and also the required professional competence) necessary for achieving essential requirements and values quoted in the mandatory requirements of this TSI throughout the life-cycle (Installation, normal operation, failures, repair work, checking and maintenance, decommissioning, etc.);
▶ The manufacturers of the equipment and of the subsystem shall provide information sufficient to define the professional competences required for the installation, final inspection and maintenance of the Control-Command and Signalling Subsystems.
▶ National rules if existing about professional competences required for the maintenance issued exclusively in the national territory.
▶ The risks manufacturers has indicated in the technical file for health and safety that arise from using and maintaining their equipment and subsystems.
14.1. Develop a matrix of the qualifications according to the ECM functions and relevant key functions.
Below some recommendations and examples as evidences for building an efficient competence management system and to respect the above requirements of ECM Regulation.
The following rules could be included in the maintenance system as they are considered as good practice.
If the ECM or Maintenance workshop can demonstrate through experience and risk assessment that it has more effective maintenance rules than the here-below recommended good practices, it should better introduce these in its maintenance system.
The objective of this part is to provide a guideline to define, within the ECM’s competence management system, the procedures to manage the competence of maintenance staff of four functions of ECM with a specific focus concerning the procedures to manage the competence of maintenance staff of ECM-F4.”
Qualification of acquired competence and skills is a mixture of:
▶ Work experience
▶ Basic education (elementary school, university, ...)
▶ Additional training (activity-related)
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The matrix below could be used as a guide by ECM to be a part of their competence management system and to monitor and control the qualification of the staff.
Activities work experience rail sector
basic education additional training
1 YE
AR
3 YE
AR
5 YE
AR
x YE
AR
unsk
illed
wor
ker,
tem
pora
ry e
mpl
oyee
(E
QF
leve
l 1 a
nd 2
)
skill
ed w
orke
rs
(EQ
F le
vel 3
and
4)
colle
ge w
ith
mat
urity
exa
m
(E
QF
leve
l 5 a
nd 6
)
Uni
vers
ity
(E
QF
leve
l 7 a
nd 8
)
wel
ding
or a
dhes
ive
engi
neer
Basi
c tr
aini
ng fl
eet "
xy"
ND
T
ETCS
com
pone
nts
xxx
ECM-F1 manager
ECM-F2 manager
ECM-F3 manager
ECM-F4 manager
Fleet engineer
Component engineer
Workers / inspectors of safety-critical components
14.2. Competences of maintenance workers (ECM-F4)
The staff deployed in maintenance delivery function (ECM-F4) needs to have personal skills (physical fitness, mental aptitude, basic educational level and, where requested in the member state, a minimum age) and be generally trained to work in railway vehicle maintenance field (competence on maintenance).
The basic educational level also ensures the competence on the language of the country (general knowledge, speaking, speech comprehension, reading, writing), where this competence is required.
In addition, high skill and competence may be required for people working on specific safety components/activities (ref. to in Annex II, IV.8).
The competence on maintenance can be recognized through the CMS of the ECM (internal process of training to issue a qualification) or through external resources (training centre).
The basic requirements of a general training program covering railway vehicle maintenance sector should be at least:
▶ basic knowledge of vehicle’s operation and maintenance,
▶ basic knowledge on vehicle’s main functions/systems,
▶ basic rules to carry out maintenance (repair, inspection, cleaning, lubrication, calibration, measuring, diagnosis, assembly and disassembly activities, testing),
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▶ basic knowledge of the most common tools and equipment used in vehicle’s maintenance
▶ general health and safety instructions, ergonomics and health protection, generic earthing provisions, provisions against electric shock, hot surface and other,
▶ organisation of vehicle’s maintenance (maintenance plan, maintenance manuals and reference documents, use/handling of tools and equipment, maintenance orders, spare parts list),
▶ interfaces between the various processes within ECM-F4 and between function ECM-F4 and ECM-F3 (for the creation of the Maintenance orders / for the release to service) and between ECM-F4 and ECM-F2 (for the proposed changes / for applying changes).
Based on the organisation of the ECM, the general training program may be characterized in professional areas and structured/grouped with a technical view as the following non-exhaustive examples:
Group A – ‘Release to service’ skill with the following competence on:
▶ final vehicle testing procedure, methods and results,
▶ specific vehicle’s operation and maintenance profile (scheduled operation profile, scheduled maintenance intervals),
▶ checking maintenance orders performed and restrictions applicable for safe running,
▶ current vehicle documentation applicable (legal requirements, technical specifications),
▶ preparing document accompanying vehicle for its release to service.
Group B – ‘Brake and pneumatic system’ skill with the following competence on:
▶ knowledge on vehicle’s different brake systems, their functioning principles, interfaces, typical malfunctions and fault-finding procedure,
▶ comprehension of technical drawings and functional schemes related to brake and pneumatic system and knowledge on physical location of its components on the vehicle,
▶ knowledge on use, handling and storage of specific tools and equipment for calibration, measuring, testing, diagnostics and IT system devices.
Group C – ‘Electric/electronic main power supply system’ skill with the following competence on:
▶ knowledge on vehicle’s power supply systems, their functioning principles, interfaces, typical malfunctions and fault-finding procedure,
▶ specific health protection measures for a safe maintenance (i.e. earthing provisions),
▶ comprehension of technical drawings and functional schemes related to vehicle’s power supply system and knowledge on physical location of its components on the vehicle,
▶ knowledge on use, handling and storage of specific tools and equipment for calibration, measuring, testing, diagnostics and IT system devices.
Group D – ‘Mechanical parts related to movement and traction coupling’ (bogie, wheel, axle, axle-boxes, running-gear, suspensions, shock-absorbers, buffing and draw gear, coupling system…) skills with the following competence on:
14. COMPETENCES OF MAINTENANCE STAFF
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▶ knowledge on vehicle’s mechanical components related to movement and traction coupling, their functioning, interfaces, typical malfunctions and fault-finding procedure,
▶ specific health protection measures for a safe maintenance,
▶ comprehension of technical drawings and functional schemes related to vehicle’s movement and traction coupling and knowledge on physical location of its components on the vehicle,
▶ knowledge on use, handling and storage of specific tools and equipment for calibration, measuring, testing, diagnostics and IT system devices.
Additional specific training program may be required for particular maintenance activities related to safety (see Annex II, IV.8), where required by law or NSA or established by ECM itself:
(a) joining techniques (including welding and bonding);
(b) non-destructive testing;
(c) final vehicle testing and release to service;
(d) maintenance activities on brake systems, wheel sets and draw gear;
(e) Maintenance activities on firefighting system (such as portable fire extinguishers, fire detection systems, fire containment and control systems for passenger rolling stock, etc.)
(f ) maintenance activities on specific components of freight wagons for the transport of dangerous goods, such as tanks, valves, etc.;
(g) maintenance activities on specific components of OTMs (such as elevating platforms and other work equipment typical of OTMs)
(h) maintenance activities on safety-critical components;
(i) maintenance activities on control-command and signalisation systems;
(l) maintenance activities on door control systems;
(m) other identified specialist areas affecting safety.
ECM should consider existing standards, where appropriate, and indications provided by Manufacturer to identify qualification requirements and issue specific qualification based on defined training process, for instance:
NON-DESTRUCTIVE TESTING
Concerning the activities “non-destructive testing” on all safety-critical components and in general on all components listed above, at least evidence of compliance of maintenance workers competences with the relevant standard should be required:
GUIDANCE ON ECM CERTIFICATION PROCESS
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* “non-destructive testing”: qualification of NDT staff regarding the application of the tests in the industrial sector “railway maintenance”.
In particular, should be necessary to give evidence of the competences in the industrial sector “railway maintenance” in compliance with standard ISO 9712. The criteria for the qualification of NDT staff regarding the application of the tests in “railway maintenance” is in addition to standard ISO 9712.
If there are national rules concerning this field each ECM or Maintenance workshop shall respect them for its staff involved in the application of the NDTs in “railway maintenance”.
In absence of national rules, each ECM or Maintenance workshop should define a specific procedure for the qualification of NDT staff regarding the application of the tests in the industrial sector “railway maintenance” issued by the relevant third part Certification Body.
JOINING TECHNIQUES (INCLUDING WELDING AND BONDING)
Concerning the activities joining techniques in the case of “welding processes”, at least evidence of compliance with the relevant standard is required:
* joining techniques in the case of “welding processes”: certification of staff and maintenance workshop.
In particular, in the case of “welding processes” are applied, at least for staff and maintenance workshop the certification in conformity to the series of standards EN 15085 and EN ISO 14731 is required.
The certification body shall fulfil the requirements of the standard EN 15085-1.
If there are national rules concerning this field each ECM or Maintenance workshop should respect them for its staff and the organisation of workshop.
In absence of national rules, each ECM or Maintenance workshop should define a specific procedure for the certification of staff and maintenance workshop issued by the relevant third part Certification Body.
It is recommended that the above rules are included in the maintenance system as they are considered as good practice.
If the ECM or Maintenance workshop can demonstrate through experience and risk assessment that it has more effective maintenance rules than the here-below recommended good practices, it should better introduce these in its maintenance system.
15. WAGONS FOR DANGEROUS GOODS
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15. WAGONS FOR DANGEROUS GOODS
You are an ECM dealing with wagons transporting dangerous goods; some requirements shall be taken into account during the certification process.
Additional requirements for ECM, dealing with wagons transporting dangerous goods
▶ Competence management in Dangerous Goods as required in RID Chapter 1.3
▶ Maintenance system for tanks based on legal requirements (RID, Type approval) and return of experience
▶ Information management with RU and others e.g. customer/operator regarding checks between mandatory RID-inspections as defined in GCU Annex 9 or suggested in RID 1.4.3.3 a
▶ Documentation system regarding tank file as required in RID 4.3.2.1.7
Only for ECM-F4 (Maintenance Delivery)
▶ Competence management system in Dangerous goods (RID Chapter 1.3)
▶ Qualification for welding of tanks acc. RID 6.8.2.1.23
▶ Particular proceedings/equipment related to this substances
▶ Occupational health and safety processes with regard to Dangerous Goods
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16. ECM ANNUAL REPORT
Each entity in charge of maintenance shall submit an annual report of its activities.
The requirements for this report are set out in Annex V of the ECM-Regulation.
If compliance with Annex II is demonstrated through an ECM certification, the report shall be submitted to the certification body and to the relevant customers (including keepers). The ECM shall make it available to the national safety authority and to the Agency upon request.
If compliance with Annex II is demonstrated through the process of safety certification or authorisation, the report shall be submitted to the safety certification body in case of application for granting or renewal of a safety certificate and to the NSA that does the surveillance.
The entity in charge of maintenance shall issue a report, which covers usually a period of 12 months, starting 2 months before the last surveillance and ending 2 months before the next planned surveillance. In case of article 3(4) of the ECM-Regulation the NSA can define other periods.
The entity in charge of maintenance shall address the report to the NSA 1 month before the next planned surveillance audit.
In case of a requested renewal or amendment of an issued certificate the application should cover a current maintenance report.
period of report
2 months 1 month2 months
last surveillance send report planed surveillance
83Ve
rsio
n 9.
0 (0
1/03
/202
1). U
ncon
trol
led
whe
n pr
inte
d. D
ownl
oad
the
late
st v
ersi
on a
t era
.eur
opa.
eu.
© 2
021
EU A
genc
y fo
r Rai
lway
s. A
ll rig
hts
rese
rved
.
AN
NEX
Ann
ex I
Map
ping
Tab
le IM
Defi
nitio
n1.
2.
For t
he p
urpo
se o
f thi
s A
nnex
the
follo
win
g de
finiti
ons
are
appl
ied:
(a) ‘c
hara
cter
’ in re
latio
n to
railw
ay o
pera
tions
car
ried
out b
y in
fras
truc
ture
man
ager
s m
eans
the
char
acte
risat
ion
of o
pera
tion
by it
s sc
ope,
incl
udin
g in
fras
truc
ture
des
ign
and
cons
truc
tion,
infr
astr
uctu
re m
aint
enan
ce, t
raffi
c pl
anni
ng, t
raffi
c m
anag
emen
t and
con
trol
, an
d by
the
use
of th
e ra
ilway
infr
astr
uctu
re, i
nclu
ding
con
vent
iona
l and
/or h
igh
spee
d lin
es,
tran
spor
t of p
asse
nger
s an
d/or
goo
ds;
Defi
nitio
n1.
2.
For t
he p
urpo
se o
f thi
s A
nnex
the
follo
win
g de
finiti
ons
are
appl
ied:
(b) ‘e
xten
t’ in
rela
tion
to ra
ilway
ope
ratio
ns c
arrie
d ou
t by
infr
astr
uctu
re m
anag
ers
mea
ns
the
exte
nt c
hara
cter
ised
by
the
leng
th o
f rai
lway
trac
k an
d th
e es
timat
ed s
ize
of th
e in
fras
truc
ture
man
ager
in te
rms
of n
umbe
r of e
mpl
oyee
s w
orki
ng in
the
railw
ay s
ecto
r.
NO
TE(1
)(1
) Poi
nt 2
.1. o
f the
App
endi
x to
Ann
ex I
to D
irect
ive
(EU
) 201
6/79
8.
NO
TE(2
)(2
) Poi
nt 2
.2. o
f the
App
endi
x to
Ann
ex I
to D
irect
ive
(EU
) 201
6/79
8.
Regu
lati
on E
U 2
018/
762
(CSM
on
SMS)
- A
nnex
II -
SMS
requ
irem
ents
rela
ted
to In
fras
truc
ture
Man
ager
sRe
g EU
201
9/77
9 -
ECM
Reg
ulat
ion
IM S
MS
docu
men
tati
on
refe
renc
es
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
11.
CO
NTE
XT
OF
THE
ORG
AN
ISAT
ION
Non
e1.
1. T
he o
rgan
isat
ion
shal
l:(a
) des
crib
e th
e ch
arac
ter a
nd
exte
nt o
f its
ope
ratio
ns;
I.1.(a
) (pa
rtia
lly
cove
red)
21.
CO
NTE
XT
OF
THE
ORG
AN
ISAT
ION
Non
e1.
1. T
he o
rgan
isat
ion
shal
l:(b
) ide
ntify
the
serio
us ri
sks
for s
afet
y po
sed
by it
s ra
ilway
op
erat
ions
whe
ther
they
are
ca
rrie
d ou
t by
the
orga
nisa
tion
itsel
f, or
by
cont
ract
ors,
part
ners
or
sup
plie
rs u
nder
its
cont
rol;
I.2 (i
n ge
nera
l)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
84
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
31.
CO
NTE
XT
OF
THE
ORG
AN
ISAT
ION
Non
e1.
1. T
he o
rgan
isat
ion
shal
l:(c
) ide
ntify
inte
rest
ed p
artie
s (e
.g. r
egul
ator
y bo
dies
, au
thor
ities
, rai
lway
und
erta
king
s, in
fras
truc
ture
man
ager
s, co
ntra
ctor
s, su
pplie
rs, p
artn
ers)
, in
clud
ing
thos
e pa
rtie
s ex
tern
al
to th
e ra
ilway
sys
tem
, tha
t ar
e re
leva
nt to
the
safe
ty
man
agem
ent s
yste
m;
I.2.1
(par
tially
co
vere
d), I
.9.1
(p
artia
lly c
over
ed)
41.
CO
NTE
XT
OF
THE
ORG
AN
ISAT
ION
Non
e1.
1. T
he o
rgan
isat
ion
shal
l:(d
) ide
ntify
and
mai
ntai
n le
gal
and
othe
r req
uire
men
ts re
late
d to
saf
ety
from
the
inte
rest
ed
part
ies
refe
rred
to in
poi
nt (c
);
I.1.(b
) and
(f),
I.9.3
51.
CO
NTE
XT
OF
THE
ORG
AN
ISAT
ION
Non
e1.
1. T
he o
rgan
isat
ion
shal
l:(e
) ens
ure
that
the
requ
irem
ents
re
ferr
ed to
in p
oint
(d) a
re ta
ken
into
acc
ount
in d
evel
opin
g,
impl
emen
ting
and
mai
ntai
ning
th
e sa
fety
man
agem
ent s
yste
m;
I.1.(d
)
61.
CO
NTE
XT
OF
THE
ORG
AN
ISAT
ION
Non
e1.
1. T
he o
rgan
isat
ion
shal
l:(f
) des
crib
e th
e sc
ope
of th
e sa
fety
man
agem
ent s
yste
m,
indi
catin
g w
hich
par
t of t
he
busi
ness
is in
clud
ed o
r not
in it
s sc
ope
and
taki
ng in
to a
ccou
nt
the
requ
irem
ents
refe
rred
to in
po
int (
d).
I.1.(a
) (pa
rtia
lly
cove
red)
, I.9
.1
(par
tially
cov
ered
)
72.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip
and
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te
lead
ersh
ip a
nd
com
mitm
ent t
o th
e de
velo
pmen
t, im
plem
enta
tion,
m
aint
enan
ce a
nd c
ontin
ual
impr
ovem
ent o
f the
saf
ety
man
agem
ent s
yste
m b
y:
(a) t
akin
g ov
eral
l acc
ount
abili
ty
and
resp
onsi
bilit
y fo
r saf
ety;
I.5.5
and
I.5
(in
gene
ral)
85Ve
rsio
n 9.
0 (0
1/03
/202
1). U
ncon
trol
led
whe
n pr
inte
d. D
ownl
oad
the
late
st v
ersi
on a
t era
.eur
opa.
eu.
© 2
021
EU A
genc
y fo
r Rai
lway
s. A
ll rig
hts
rese
rved
.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
82.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip
and
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te
lead
ersh
ip a
nd
com
mitm
ent t
o th
e de
velo
pmen
t, im
plem
enta
tion,
m
aint
enan
ce a
nd c
ontin
ual
impr
ovem
ent o
f the
saf
ety
man
agem
ent s
yste
m b
y:
(b) e
nsur
ing
com
mitm
ent
to s
afet
y by
man
agem
ent
at d
iffer
ent l
evel
s w
ithin
th
e or
gani
satio
n th
roug
h th
eir a
ctiv
ities
and
in th
eir
rela
tions
hips
with
sta
ff an
d co
ntra
ctor
s;
I.1.(g
) and
(h)
(par
tially
cov
ered
), I.9
.3
92.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip
and
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te
lead
ersh
ip a
nd
com
mitm
ent t
o th
e de
velo
pmen
t, im
plem
enta
tion,
m
aint
enan
ce a
nd c
ontin
ual
impr
ovem
ent o
f the
saf
ety
man
agem
ent s
yste
m b
y:
(c) e
nsur
ing
that
the
safe
ty
polic
y an
d sa
fety
obj
ectiv
es a
re
esta
blis
hed,
und
erst
ood
and
are
com
patib
le w
ith th
e st
rate
gic
dire
ctio
n of
the
orga
nisa
tion;
I.1(a
) and
(b),
I.9.3
102.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip
and
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te
lead
ersh
ip a
nd
com
mitm
ent t
o th
e de
velo
pmen
t, im
plem
enta
tion,
m
aint
enan
ce a
nd c
ontin
ual
impr
ovem
ent o
f the
saf
ety
man
agem
ent s
yste
m b
y:
(d) e
nsur
ing
the
inte
grat
ion
of th
e sa
fety
man
agem
ent
syst
em re
quire
men
ts in
to
the
orga
nisa
tion’
s bu
sine
ss
proc
esse
s;
I.1(d
)
112.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip
and
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te
lead
ersh
ip a
nd
com
mitm
ent t
o th
e de
velo
pmen
t, im
plem
enta
tion,
m
aint
enan
ce a
nd c
ontin
ual
impr
ovem
ent o
f the
saf
ety
man
agem
ent s
yste
m b
y:
(e) e
nsur
ing
that
the
reso
urce
s ne
eded
for t
he s
afet
y m
anag
emen
t sys
tem
are
av
aila
ble;
I.1(e
)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
86
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
122.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip
and
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te
lead
ersh
ip a
nd
com
mitm
ent t
o th
e de
velo
pmen
t, im
plem
enta
tion,
m
aint
enan
ce a
nd c
ontin
ual
impr
ovem
ent o
f the
saf
ety
man
agem
ent s
yste
m b
y:
(f) e
nsur
ing
that
the
safe
ty
man
agem
ent s
yste
m is
effe
ctiv
e in
con
trol
ling
the
safe
ty ri
sks
pose
d by
the
orga
nisa
tion;
I.1.(c
) (pa
rtia
lly
cove
red)
132.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip
and
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te
lead
ersh
ip a
nd
com
mitm
ent t
o th
e de
velo
pmen
t, im
plem
enta
tion,
m
aint
enan
ce a
nd c
ontin
ual
impr
ovem
ent o
f the
saf
ety
man
agem
ent s
yste
m b
y:
(g) e
ncou
ragi
ng s
taff
to
supp
ort c
ompl
ianc
e w
ith th
e sa
fety
man
agem
ent s
yste
m
requ
irem
ents
;
I.1.(g
) and
(h)
(par
tially
cov
ered
)
142.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip
and
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te
lead
ersh
ip a
nd
com
mitm
ent t
o th
e de
velo
pmen
t, im
plem
enta
tion,
m
aint
enan
ce a
nd c
ontin
ual
impr
ovem
ent o
f the
saf
ety
man
agem
ent s
yste
m b
y:
(h) p
rom
otin
g co
ntin
ual
impr
ovem
ent o
f the
saf
ety
man
agem
ent s
yste
m;
I.4 (p
artia
lly c
over
ed)
152.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip
and
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te
lead
ersh
ip a
nd
com
mitm
ent t
o th
e de
velo
pmen
t, im
plem
enta
tion,
m
aint
enan
ce a
nd c
ontin
ual
impr
ovem
ent o
f the
saf
ety
man
agem
ent s
yste
m b
y:
(i) e
nsur
ing
that
saf
ety
is
cons
ider
ed w
hen
iden
tifyi
ng
and
man
agin
g th
e or
gani
satio
n’s
busi
ness
risk
s an
d ex
plai
ning
ho
w c
onfli
ct b
etw
een
safe
ty
and
othe
r bus
ines
s go
als
will
be
reco
gnis
ed a
nd re
solv
ed;
I.2.2
and
I.2.
3 (p
artia
lly c
over
ed),
I.1.(f
), I.9
.1
87Ve
rsio
n 9.
0 (0
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/202
1). U
ncon
trol
led
whe
n pr
inte
d. D
ownl
oad
the
late
st v
ersi
on a
t era
.eur
opa.
eu.
© 2
021
EU A
genc
y fo
r Rai
lway
s. A
ll rig
hts
rese
rved
.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
162.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip
and
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te
lead
ersh
ip a
nd
com
mitm
ent t
o th
e de
velo
pmen
t, im
plem
enta
tion,
m
aint
enan
ce a
nd c
ontin
ual
impr
ovem
ent o
f the
saf
ety
man
agem
ent s
yste
m b
y:
(j) p
rom
otin
g a
posi
tive
safe
ty
cultu
re.
172.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.1.
A
doc
umen
t de
scrib
ing
the
orga
nisa
tion’
s sa
fety
pol
icy
is e
stab
lishe
d by
the
top
man
agem
ent a
nd is
:
(a) a
ppro
pria
te to
the
orga
nisa
tion’
s ch
arac
ter a
nd
exte
nt o
f rai
lway
ope
ratio
ns;
I.1.(a
)
182.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.1.
A
doc
umen
t de
scrib
ing
the
orga
nisa
tion’
s sa
fety
pol
icy
is e
stab
lishe
d by
the
top
man
agem
ent a
nd is
:
(b) a
ppro
ved
by th
e or
gani
satio
n’s
chie
f exe
cutiv
e (o
r a
repr
esen
tativ
e(s)
of t
he to
p-m
anag
emen
t);
I.1.(a
)
192.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.1.
A
doc
umen
t de
scrib
ing
the
orga
nisa
tion’
s sa
fety
pol
icy
is e
stab
lishe
d by
the
top
man
agem
ent a
nd is
:
(c) a
ctiv
ely
impl
emen
ted,
co
mm
unic
ated
and
mad
e av
aila
ble
to a
ll st
aff.
I.1.(a
)
202.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.2.
The
saf
ety
polic
y sh
all:
(a) i
nclu
de a
com
mitm
ent t
o co
nfor
m w
ith a
ll le
gal a
nd o
ther
re
quire
men
ts re
late
d to
saf
ety;
I.1.(b
) (pa
rtia
lly
cove
red)
and
I.1.
(a)
(in g
ener
al)
212.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.2.
The
saf
ety
polic
y sh
all:
(b) p
rovi
de a
fram
ewor
k fo
r se
ttin
g sa
fety
obj
ectiv
es a
nd
eval
uatin
g th
e or
gani
satio
n’s
safe
ty p
erfo
rman
ce a
gain
st th
ese
obje
ctiv
es;
I.1.(b
) and
(c ),
and
I.1
.(a) (
in g
ener
al),
I.9.3
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
88
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
222.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.2.
The
saf
ety
polic
y sh
all:
(c) i
nclu
de a
com
mitm
ent t
o co
ntro
l saf
ety
risks
whi
ch a
rise
both
from
its
own
activ
ities
and
th
ose
caus
ed b
y ot
hers
;
I.1.(f
), an
d I.1
.(a) (
in
gene
ral),
I.9.
4 (in
ge
nera
l), I.
9.5
(in
gene
ral)
232.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.2.
The
saf
ety
polic
y sh
all:
(d) i
nclu
de a
com
mitm
ent t
o co
ntin
ual i
mpr
ovem
ent o
f the
sa
fety
man
agem
ent s
yste
m;
I.4 a
nd I.
1.(a
) (in
ge
nera
l)
242.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.2.
The
saf
ety
polic
y sh
all:
(e) b
e m
aint
aine
d in
acc
orda
nce
with
the
busi
ness
str
ateg
y an
d th
e ev
alua
tion
of th
e sa
fety
pe
rfor
man
ce o
f the
org
anis
atio
n.
I.1.(c
) and
I.1.
(a) (
in
gene
ral)
252.
LE
AD
ERSH
IP2.
3.
Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
2.3.
1. T
he re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
of s
taff
havi
ng
a ro
le th
at a
ffect
s sa
fety
(in
clud
ing
man
agem
ent
and
othe
r sta
ff in
volv
ed in
sa
fety
-rel
ated
task
s) s
hall
be d
efine
d at
all
leve
ls
with
in th
e or
gani
satio
n,
docu
men
ted,
ass
igne
d an
d co
mm
unic
ated
to th
em.
I.5 (i
n ge
nera
l)
262.
LE
AD
ERSH
IP2.
3.
Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
2.3.
2. T
he o
rgan
isat
ion
shal
l ens
ure
that
sta
ff w
ith
dele
gate
d re
spon
sibi
litie
s fo
r saf
ety-
rela
ted
task
s sh
all h
ave
the
auth
ority
, co
mpe
tenc
e an
d ap
prop
riate
reso
urce
s to
pe
rfor
m th
eir t
asks
with
out
bein
g ad
vers
ely
affec
ted
by th
e ac
tiviti
es o
f oth
er
busi
ness
func
tions
.
I.5 (i
n ge
nera
l), I.
6 (in
gen
eral
), II.
6 (in
ge
nera
l), II
I.1, I
II.7,
IV.8
89Ve
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n 9.
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1). U
ncon
trol
led
whe
n pr
inte
d. D
ownl
oad
the
late
st v
ersi
on a
t era
.eur
opa.
eu.
© 2
021
EU A
genc
y fo
r Rai
lway
s. A
ll rig
hts
rese
rved
.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
272.
LE
AD
ERSH
IP2.
3.
Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
2.3.
3.
Del
egat
ion
of
resp
onsi
bilit
y fo
r saf
ety-
rela
ted
task
s sh
all
be d
ocum
ente
d an
d co
mm
unic
ated
to th
e re
leva
nt s
taff,
acc
epte
d an
d un
ders
tood
.
I.5 (i
n ge
nera
l)
282.
LE
AD
ERSH
IP2.
3.
Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
2.3.
4. T
he o
rgan
isat
ion
shal
l des
crib
e th
e al
loca
tion
of ro
les
refe
rred
to
in p
arag
raph
2.3
.1. t
o bu
sine
ss fu
nctio
ns w
ithin
an
d w
here
rele
vant
, out
side
th
e or
gani
satio
n (s
ee 5
.3.
Cont
ract
ors,
part
ners
and
su
pplie
rs).
I.5 (i
n ge
nera
l), I.
9.4
and
I.9.6
(in
gene
ral)
292.
LE
AD
ERSH
IP2.
4.
Cons
ulta
tion
of s
taff
and
othe
r pa
rtie
s
2.4.
1.
Staff
, the
ir re
pres
enta
tives
and
ex
tern
al in
tere
sted
par
ties,
as a
ppro
pria
te a
nd w
here
re
leva
nt, s
hall
be c
onsu
lted
in d
evel
opin
g, m
aint
aini
ng
and
impr
ovin
g th
e sa
fety
m
anag
emen
t sys
tem
in
the
rele
vant
par
ts th
ey a
re
resp
onsi
ble
for,
incl
udin
g th
e sa
fety
asp
ects
of
oper
atio
nal p
roce
dure
s.
I.1.(h
)
302.
LE
AD
ERSH
IP2.
4.
Cons
ulta
tion
of s
taff
and
othe
r pa
rtie
s
2.4.
2. T
he o
rgan
isat
ion
shal
l fac
ilita
te th
e co
nsul
tatio
n of
sta
ff by
pr
ovid
ing
the
met
hods
and
m
eans
for i
nvol
ving
sta
ff,
reco
rdin
g st
aff’s
opin
ion
and
prov
idin
g fe
edba
ck o
n st
aff’s
opin
ion.
I.5.4
and
I.1.
(h)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
90
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
313.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
1. T
he o
rgan
isat
ion
shal
l:(a
) ide
ntify
and
ana
lyse
all
oper
atio
nal,
orga
nisa
tiona
l an
d te
chni
cal r
isks
rele
vant
to
the
char
acte
r and
ext
ent o
f op
erat
ions
car
ried
out b
y th
e or
gani
satio
n. S
uch
risks
sha
ll in
clud
e th
ose
aris
ing
from
hum
an
and
orga
nisa
tiona
l fac
tors
suc
h as
wor
kloa
d, jo
b de
sign
, fat
igue
or
sui
tabi
lity
of p
roce
dure
s, an
d th
e ac
tiviti
es o
f oth
er in
tere
sted
pa
rtie
s (s
ee 1
. Con
text
of t
he
orga
nisa
tion)
;
I.2.2
, I.2
.3, I
.9.1
(in
gene
ral)
323.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
1. T
he o
rgan
isat
ion
shal
l:(b
) eva
luat
e th
e ris
ks re
ferr
ed to
in
poin
t (a)
by
appl
ying
app
ropr
iate
ris
k as
sess
men
t met
hods
;
I.2.2
333.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
1. T
he o
rgan
isat
ion
shal
l:(c
) dev
elop
and
put
in p
lace
safe
ty
mea
sure
s, w
ith id
entifi
catio
n of
ass
ocia
ted
resp
onsi
bilit
ies
(see
2.3
. Org
anis
atio
nal r
oles
, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
);
I.3 (i
n ge
nera
l)
343.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
1. T
he o
rgan
isat
ion
shal
l:(d
) dev
elop
a s
yste
m to
mon
itor
the
effec
tiven
ess
of s
afet
y m
easu
res
(see
6.1
. Mon
itorin
g);
I.3 (i
n ge
nera
l)
91Ve
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n 9.
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/202
1). U
ncon
trol
led
whe
n pr
inte
d. D
ownl
oad
the
late
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ersi
on a
t era
.eur
opa.
eu.
© 2
021
EU A
genc
y fo
r Rai
lway
s. A
ll rig
hts
rese
rved
.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
353.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
1. T
he o
rgan
isat
ion
shal
l:(e
) rec
ogni
se th
e ne
ed to
co
llabo
rate
with
oth
er in
tere
sted
pa
rtie
s (s
uch
as ra
ilway
un
dert
akin
gs, i
nfra
stru
ctur
e m
anag
ers,
man
ufac
ture
r, m
aint
enan
ce s
uppl
ier,
entit
y in
ch
arge
of m
aint
enan
ce, r
ailw
ay
vehi
cle
keep
er, s
ervi
ce p
rovi
der
and
proc
urem
ent e
ntity
), w
here
ap
prop
riate
, on
shar
ed ri
sks
and
the
putt
ing
in p
lace
of a
dequ
ate
safe
ty m
easu
res;
I.2.1
, I.7
(in
gene
ral)
363.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
1. T
he o
rgan
isat
ion
shal
l:(f
) com
mun
icat
e ris
ks to
sta
ff an
d in
volv
ed e
xter
nal p
artie
s (s
ee 4
.4.
Info
rmat
ion
and
com
mun
icat
ion)
.
I.1.(h
) par
tially
co
vere
d), I
.9.4
(p
artia
lly c
over
ed)
373.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
2. W
hen
asse
ssin
g ris
k,
an o
rgan
isat
ion
shal
l tak
e in
to a
ccou
nt th
e ne
ed to
de
term
ine,
pro
vide
and
sus
tain
a
safe
wor
king
env
ironm
ent
whi
ch c
onfo
rms
to a
pplic
able
le
gisl
atio
n, in
par
ticul
ar D
irect
ive
89/3
91/E
EC.
I.2.3
383.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.2.
Pl
anni
ng fo
r cha
nge
3.1.
2.1.
The
org
anis
atio
n sh
all
iden
tify
pote
ntia
l saf
ety
risks
and
ap
prop
riate
saf
ety
mea
sure
s (s
ee
3.1.
1. R
isk
asse
ssm
ent)
bef
ore
the
impl
emen
tatio
n of
a c
hang
e (s
ee 5
.4. M
anag
emen
t of c
hang
e)
in a
ccor
danc
e w
ith th
e ris
k m
anag
emen
t pro
cess
set
out
in
Regu
latio
n (E
U) N
o 40
2/20
13,
incl
udin
g co
nsid
erat
ion
of th
e sa
fety
risk
s fr
om th
e ch
ange
pr
oces
s its
elf.
I.2.2
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
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ncy
for R
ailw
ays.
All
right
s re
serv
ed.
92
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
393.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
1. T
he o
rgan
isat
ion
shal
l est
ablis
h sa
fety
ob
ject
ives
for r
elev
ant
func
tions
at r
elev
ant l
evel
s to
mai
ntai
n an
d, w
here
re
ason
ably
pra
ctic
able
, im
prov
e its
saf
ety
perf
orm
ance
.
I.1.(b
) and
(c )
403.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
2. T
he s
afet
y ob
ject
ives
sh
all:
(a) b
e co
nsis
tent
with
the
safe
ty
polic
y an
d th
e or
gani
satio
n’s
stra
tegi
c ob
ject
ives
(whe
re
appl
icab
le);
I.1.(b
)
413.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
2. T
he s
afet
y ob
ject
ives
sh
all:
(b) b
e lin
ked
to th
e pr
iorit
y ris
ks th
at in
fluen
ce th
e sa
fety
pe
rfor
man
ce o
f the
org
anis
atio
n;
I.1.(b
) and
(c )
423.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
2. T
he s
afet
y ob
ject
ives
sh
all:
(c) b
e m
easu
rabl
e;
433.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
2. T
he s
afet
y ob
ject
ives
sh
all:
(d) t
ake
into
acc
ount
app
licab
le
lega
l and
oth
er re
quire
men
ts;
I.1.(b
)
443.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
2. T
he s
afet
y ob
ject
ives
sh
all:
(e) b
e re
view
ed a
s re
gard
s th
eir
achi
evem
ents
and
revi
sed
as
appr
opria
te;
453.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
2. T
he s
afet
y ob
ject
ives
sh
all:
(f) b
e co
mm
unic
ated
.
463.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
3. T
he o
rgan
isat
ion
shal
l hav
e pl
an(s
) to
desc
ribe
how
it w
ill a
chie
ve
its s
afet
y ob
ject
ives
.
I.1.(d
)
93Ve
rsio
n 9.
0 (0
1/03
/202
1). U
ncon
trol
led
whe
n pr
inte
d. D
ownl
oad
the
late
st v
ersi
on a
t era
.eur
opa.
eu.
© 2
021
EU A
genc
y fo
r Rai
lway
s. A
ll rig
hts
rese
rved
.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
473.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
4. T
he o
rgan
isat
ion
shal
l des
crib
e th
e st
rate
gy
and
plan
(s) u
sed
to m
onito
r th
e ac
hiev
emen
t of t
he
safe
ty o
bjec
tives
(see
6.1
. M
onito
ring)
.
I.3 (i
n ge
nera
l)
484.
SU
PPO
RT4.
1.
Reso
urce
s4.
1.1.
The
org
anis
atio
n sh
all p
rovi
de th
e re
sour
ces,
incl
udin
g co
mpe
tent
sta
ff an
d eff
ectiv
e an
d us
eabl
e eq
uipm
ent,
need
ed
for t
he e
stab
lishm
ent,
impl
emen
tatio
n,
mai
nten
ance
and
con
tinua
l im
prov
emen
t of t
he s
afet
y m
anag
emen
t sys
tem
.
I.1.(e
), II.
3, IV
.3, I
V.4,
IV
.5
494.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
1. T
he o
rgan
isat
ion’
s co
mpe
tenc
e m
anag
emen
t sy
stem
sha
ll en
sure
th
at s
taff
havi
ng a
role
th
at a
ffect
s sa
fety
are
co
mpe
tent
in th
e sa
fety
-re
late
d ta
sks
for w
hich
th
ey a
re re
spon
sibl
e (s
ee 2
.3. O
rgan
isat
iona
l ro
les,
resp
onsi
bilit
ies,
acco
unta
bilit
ies
and
auth
oriti
es),
incl
udin
g at
le
ast:
(a) i
dent
ifica
tion
of th
e co
mpe
tenc
ies
(incl
udin
g kn
owle
dge,
ski
lls, n
on-t
echn
ical
be
havi
ours
and
att
itude
s)
requ
ired
for s
afet
y-re
late
d ta
sks;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
504.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
1. T
he o
rgan
isat
ion’
s co
mpe
tenc
e m
anag
emen
t sy
stem
sha
ll en
sure
th
at s
taff
havi
ng a
role
th
at a
ffect
s sa
fety
are
co
mpe
tent
in th
e sa
fety
-re
late
d ta
sks
for w
hich
th
ey a
re re
spon
sibl
e (s
ee 2
.3. O
rgan
isat
iona
l ro
les,
resp
onsi
bilit
ies,
acco
unta
bilit
ies
and
auth
oriti
es),
incl
udin
g at
le
ast:
(b) s
elec
tion
prin
cipl
es (b
asic
ed
ucat
iona
l lev
el, p
sych
olog
ical
an
d ph
ysic
al fi
tnes
s re
quire
d);
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
94
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
514.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
1. T
he o
rgan
isat
ion’
s co
mpe
tenc
e m
anag
emen
t sy
stem
sha
ll en
sure
th
at s
taff
havi
ng a
role
th
at a
ffect
s sa
fety
are
co
mpe
tent
in th
e sa
fety
-re
late
d ta
sks
for w
hich
th
ey a
re re
spon
sibl
e (s
ee 2
.3. O
rgan
isat
iona
l ro
les,
resp
onsi
bilit
ies,
acco
unta
bilit
ies
and
auth
oriti
es),
incl
udin
g at
le
ast:
(c) i
nitia
l tra
inin
g, e
xper
ienc
e an
d qu
alifi
catio
n;I.6
(in
gene
ral),
II.6
(in
gene
ral),
III.1
, III.
7, IV
.8
524.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
1. T
he o
rgan
isat
ion’
s co
mpe
tenc
e m
anag
emen
t sy
stem
sha
ll en
sure
th
at s
taff
havi
ng a
role
th
at a
ffect
s sa
fety
are
co
mpe
tent
in th
e sa
fety
-re
late
d ta
sks
for w
hich
th
ey a
re re
spon
sibl
e (s
ee 2
.3. O
rgan
isat
iona
l ro
les,
resp
onsi
bilit
ies,
acco
unta
bilit
ies
and
auth
oriti
es),
incl
udin
g at
le
ast:
(d) o
ngoi
ng tr
aini
ng a
nd p
erio
dic
upda
te o
f exi
stin
g co
mpe
tenc
ies;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
95Ve
rsio
n 9.
0 (0
1/03
/202
1). U
ncon
trol
led
whe
n pr
inte
d. D
ownl
oad
the
late
st v
ersi
on a
t era
.eur
opa.
eu.
© 2
021
EU A
genc
y fo
r Rai
lway
s. A
ll rig
hts
rese
rved
.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
534.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
1. T
he o
rgan
isat
ion’
s co
mpe
tenc
e m
anag
emen
t sy
stem
sha
ll en
sure
th
at s
taff
havi
ng a
role
th
at a
ffect
s sa
fety
are
co
mpe
tent
in th
e sa
fety
-re
late
d ta
sks
for w
hich
th
ey a
re re
spon
sibl
e (s
ee 2
.3. O
rgan
isat
iona
l ro
les,
resp
onsi
bilit
ies,
acco
unta
bilit
ies
and
auth
oriti
es),
incl
udin
g at
le
ast:
(e) p
erio
dic
asse
ssm
ent o
f co
mpe
tenc
e an
d ch
ecks
of
psyc
holo
gica
l and
phy
sica
l fit
ness
to e
nsur
e th
at
qual
ifica
tions
and
ski
lls a
re
mai
ntai
ned
over
tim
e;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
544.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
1. T
he o
rgan
isat
ion’
s co
mpe
tenc
e m
anag
emen
t sy
stem
sha
ll en
sure
th
at s
taff
havi
ng a
role
th
at a
ffect
s sa
fety
are
co
mpe
tent
in th
e sa
fety
-re
late
d ta
sks
for w
hich
th
ey a
re re
spon
sibl
e (s
ee 2
.3. O
rgan
isat
iona
l ro
les,
resp
onsi
bilit
ies,
acco
unta
bilit
ies
and
auth
oriti
es),
incl
udin
g at
le
ast:
(f) s
peci
fic tr
aini
ng in
rele
vant
pa
rts
of th
e sa
fety
man
agem
ent
syst
em in
ord
er to
del
iver
thei
r sa
fety
-rel
ated
task
s.
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
554.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
2. T
he o
rgan
isat
ion
shal
l pro
vide
a tr
aini
ng
prog
ram
me,
as
refe
rred
to
in p
oint
s (c
), (d
) and
(f) o
f pa
ragr
aph
4.2.
1, fo
r sta
ff pe
rfor
min
g sa
fety
-rel
ated
ta
sks
whi
ch e
nsur
es th
at:
(a) t
he tr
aini
ng p
rogr
amm
e is
del
iver
ed a
ccor
ding
to
the
iden
tified
com
pete
ncy
requ
irem
ents
and
indi
vidu
al
need
s of
the
staff
;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
564.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
2. T
he o
rgan
isat
ion
shal
l pro
vide
a tr
aini
ng
prog
ram
me,
as
refe
rred
to
in p
oint
s (c
), (d
) and
(f) o
f pa
ragr
aph
4.2.
1, fo
r sta
ff pe
rfor
min
g sa
fety
-rel
ated
ta
sks
whi
ch e
nsur
es th
at:
(b) w
here
app
licab
le, t
he tr
aini
ng
ensu
res
that
sta
ff ca
n op
erat
e un
der a
ll op
erat
ing
cond
ition
s (n
orm
al, d
egra
ded
and
emer
genc
y);
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
96
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
574.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
2. T
he o
rgan
isat
ion
shal
l pro
vide
a tr
aini
ng
prog
ram
me,
as
refe
rred
to
in p
oint
s (c
), (d
) and
(f) o
f pa
ragr
aph
4.2.
1, fo
r sta
ff pe
rfor
min
g sa
fety
-rel
ated
ta
sks
whi
ch e
nsur
es th
at:
(c) t
he d
urat
ion
of th
e tr
aini
ng
and
the
freq
uenc
y of
the
refr
eshe
r tra
inin
g ar
e ap
prop
riate
fo
r the
trai
ning
obj
ectiv
es;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
584.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
2. T
he o
rgan
isat
ion
shal
l pro
vide
a tr
aini
ng
prog
ram
me,
as
refe
rred
to
in p
oint
s (c
), (d
) and
(f) o
f pa
ragr
aph
4.2.
1, fo
r sta
ff pe
rfor
min
g sa
fety
-rel
ated
ta
sks
whi
ch e
nsur
es th
at:
(d) r
ecor
ds a
re k
ept f
or a
ll st
aff (s
ee 4
.5.3
. Con
trol
of
docu
men
ted
info
rmat
ion)
;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
594.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
2. T
he o
rgan
isat
ion
shal
l pro
vide
a tr
aini
ng
prog
ram
me,
as
refe
rred
to
in p
oint
s (c
), (d
) and
(f) o
f pa
ragr
aph
4.2.
1, fo
r sta
ff pe
rfor
min
g sa
fety
-rel
ated
ta
sks
whi
ch e
nsur
es th
at:
(e) t
he tr
aini
ng p
rogr
amm
e is
re
gula
rly re
view
ed a
nd a
udite
d (s
ee 6
.2. I
nter
nal a
uditi
ng) a
nd
chan
ges
mad
e w
hen
nece
ssar
y (s
ee 5
.4. M
anag
emen
t of
chan
ge).
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
604.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
3.
Back
to w
ork
arra
ngem
ents
sha
ll be
in
plac
e fo
r sta
ff fo
llow
ing
acci
dent
s/in
cide
nts
or
long
abs
ence
s fr
om w
ork,
in
clud
ing
prov
idin
g ad
ditio
nal t
rain
ing
whe
re
such
a n
eed
is id
entifi
ed.
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
97Ve
rsio
n 9.
0 (0
1/03
/202
1). U
ncon
trol
led
whe
n pr
inte
d. D
ownl
oad
the
late
st v
ersi
on a
t era
.eur
opa.
eu.
© 2
021
EU A
genc
y fo
r Rai
lway
s. A
ll rig
hts
rese
rved
.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
614.
SU
PPO
RT4.
3.
Awar
enes
s4.
3.1.
Top
man
agem
ent
shal
l ens
ure
that
they
and
th
eir s
taff
havi
ng a
role
that
aff
ects
saf
ety
are
awar
e of
th
e re
leva
nce,
impo
rtan
ce
and
cons
eque
nces
of
thei
r act
iviti
es a
nd h
ow
they
con
trib
ute
to th
e co
rrec
t app
licat
ion
and
the
effec
tiven
ess
of th
e sa
fety
m
anag
emen
t sys
tem
, in
clud
ing
the
achi
evem
ent
of s
afet
y ob
ject
ives
(see
3.
2. S
afet
y ob
ject
ives
and
pl
anni
ng).
I.1.(g
) (pa
rtia
lly
cove
red)
624.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
1. T
he o
rgan
isat
ion
shal
l defi
ne a
dequ
ate
com
mun
icat
ion
chan
nels
to
ens
ure
that
saf
ety-
rela
ted
info
rmat
ion
is
exch
ange
d am
ong
the
diffe
rent
leve
ls o
f the
or
gani
satio
n an
d w
ith
exte
rnal
inte
rest
ed p
artie
s in
clud
ing
cont
ract
ors,
part
ners
and
sup
plie
rs.
I.7 (i
n ge
nera
l), I.
9.6
(par
tially
cov
ered
), II.
5 (in
gen
eral
), III
.9, I
V.9,
A
rt. 5
(1),
Art
. 5(3
)
634.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
2. T
o en
sure
that
sa
fety
-rel
ated
info
rmat
ion
reac
hes
thos
e m
akin
g ju
dgem
ents
and
dec
isio
ns,
the
orga
nisa
tion
shal
l m
anag
e th
e id
entifi
catio
n,
rece
ipt,
proc
essi
ng,
gene
ratio
n an
d di
ssem
inat
ion
of s
afet
y-re
late
d in
form
atio
n.
I.7 (i
n ge
nera
l), I.
9.6
(par
tially
cov
ered
), II.
5 (in
gen
eral
), III
.9,
IV.9
, Art
. 4(2
), A
rt. 4
(3),
Art
. 4(6
)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
98
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
644.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l ens
ure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(a) r
elev
ant,
com
plet
e an
d un
ders
tand
able
for t
he in
tend
ed
user
s;
I.7 (i
n ge
nera
l)
654.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l ens
ure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(b) v
alid
;I.7
(in
gene
ral)
664.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l ens
ure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(c) a
ccur
ate;
I.7 (i
n ge
nera
l)
674.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l ens
ure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(d) c
onsi
sten
t;I.7
(in
gene
ral)
684.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l ens
ure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(e) c
ontr
olle
d (s
ee 4
.5.3
. Con
trol
of
doc
umen
ted
info
rmat
ion)
;I.7
(in
gene
ral)
694.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l ens
ure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(f) c
omm
unic
ated
bef
ore
it ta
kes
effec
t;I.7
(in
gene
ral)
704.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l ens
ure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(g) r
ecei
ved
and
unde
rsto
od.
I.7 (i
n ge
nera
l)
714.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
1. T
here
is a
des
crip
tion
of
the
safe
ty m
anag
emen
t sys
tem
in
clud
ing:
(a) t
he id
entifi
catio
n an
d de
scrip
tion
of th
e pr
oces
ses
and
activ
ities
rela
ted
to s
afet
y of
rail
oper
atio
ns, i
nclu
ding
sa
fety
-rel
ated
task
s an
d as
soci
ated
resp
onsi
bilit
ies
(see
2.3
. Org
anis
atio
nal r
oles
, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
);
I.8 (i
n ge
nera
l)
99Ve
rsio
n 9.
0 (0
1/03
/202
1). U
ncon
trol
led
whe
n pr
inte
d. D
ownl
oad
the
late
st v
ersi
on a
t era
.eur
opa.
eu.
© 2
021
EU A
genc
y fo
r Rai
lway
s. A
ll rig
hts
rese
rved
.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
724.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
1. T
here
is a
des
crip
tion
of
the
safe
ty m
anag
emen
t sys
tem
in
clud
ing:
(b) t
he in
tera
ctio
n of
thes
e pr
oces
ses;
I.8 (i
n ge
nera
l)
734.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
1. T
here
is a
des
crip
tion
of
the
safe
ty m
anag
emen
t sys
tem
in
clud
ing:
(c) t
he p
roce
dure
s or
oth
er
docu
men
ts d
escr
ibin
g ho
w th
ese
proc
esse
s ar
e im
plem
ente
d;
I.8 (i
n ge
nera
l)
744.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
1. T
here
is a
des
crip
tion
of
the
safe
ty m
anag
emen
t sys
tem
in
clud
ing:
(d) t
he id
entifi
catio
n of
co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
with
a d
escr
iptio
n of
th
e ty
pe a
nd e
xten
t of s
ervi
ces
deliv
ered
;
I.8 (i
n ge
nera
l), I.
9 (in
ge
nera
l)
754.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
1. T
here
is a
des
crip
tion
of
the
safe
ty m
anag
emen
t sys
tem
in
clud
ing:
(e) t
he id
entifi
catio
n of
co
ntra
ctua
l arr
ange
men
ts a
nd
othe
r bus
ines
s ag
reem
ents
, co
nclu
ded
betw
een
the
orga
nisa
tion
and
othe
r par
ties
iden
tified
und
er (d
), ne
cess
ary
to c
ontr
ol th
e sa
fety
risk
s of
the
orga
nisa
tion
and
thos
e re
late
d to
th
e us
e of
con
trac
tors
;
I.8 (i
n ge
nera
l), I.
9 (in
ge
nera
l)
764.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
1. T
here
is a
des
crip
tion
of
the
safe
ty m
anag
emen
t sys
tem
in
clud
ing:
(f) r
efer
ence
to d
ocum
ente
d in
form
atio
n re
quire
d by
this
Re
gula
tion.
I.8 (i
n ge
nera
l)
774.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
an
annu
al s
afet
y re
port
is s
ubm
itted
to th
e re
leva
nt n
atio
nal s
afet
y au
thor
ity
(or a
utho
ritie
s) in
acc
orda
nce
with
Art
icle
9(6
) of D
irect
ive
(EU
) 20
16/7
98, i
nclu
ding
:
(a) a
syn
thes
is o
f the
dec
isio
ns
on th
e le
vel o
f sig
nific
ance
of t
he
safe
ty-r
elat
ed c
hang
es, i
nclu
ding
an
ove
rvie
w o
f sig
nific
ant
chan
ges,
in a
ccor
danc
e w
ith
Art
icle
18(
1) o
f Reg
ulat
ion
(EU
) No
402/
2013
;
Ann
ex V
(ECM
M
aint
enan
ce R
epor
t)
(in g
ener
al),
Art
. 8(5
)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
100
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
784.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
an
annu
al s
afet
y re
port
is s
ubm
itted
to th
e re
leva
nt n
atio
nal s
afet
y au
thor
ity
(or a
utho
ritie
s) in
acc
orda
nce
with
Art
icle
9(6
) of D
irect
ive
(EU
) 20
16/7
98, i
nclu
ding
:
(b) t
he o
rgan
isat
ion’
s sa
fety
ob
ject
ives
for t
he fo
llow
ing
year
(s) a
nd h
ow s
erio
us ri
sks
for
safe
ty in
fluen
ce th
e se
ttin
g of
th
ese
safe
ty o
bjec
tives
;
Ann
ex V
(ECM
M
aint
enan
ce R
epor
t)
(in g
ener
al),
Art
. 8(5
)
794.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
an
annu
al s
afet
y re
port
is s
ubm
itted
to th
e re
leva
nt n
atio
nal s
afet
y au
thor
ity
(or a
utho
ritie
s) in
acc
orda
nce
with
Art
icle
9(6
) of D
irect
ive
(EU
) 20
16/7
98, i
nclu
ding
:
(c) t
he re
sults
of i
nter
nal a
ccid
ent/
inci
dent
inve
stig
atio
n (s
ee 7
.1.
Lear
ning
from
acc
iden
ts a
nd
inci
dent
s) a
nd o
ther
mon
itorin
g ac
tiviti
es (s
ee 6
.1. M
onito
ring,
6.
2. In
tern
al a
uditi
ng a
nd
6.3.
Man
agem
ent r
evie
w),
in
acco
rdan
ce w
ith A
rtic
le 5
(1) o
f Re
gula
tion
(EU
) No
1078
/201
2;
Ann
ex V
(ECM
M
aint
enan
ce R
epor
t)
(in g
ener
al),
Art
. 8(5
)
804.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
an
annu
al s
afet
y re
port
is s
ubm
itted
to th
e re
leva
nt n
atio
nal s
afet
y au
thor
ity
(or a
utho
ritie
s) in
acc
orda
nce
with
Art
icle
9(6
) of D
irect
ive
(EU
) 20
16/7
98, i
nclu
ding
:
(d) d
etai
ls o
f pro
gres
s on
ad
dres
sing
out
stan
ding
re
com
men
datio
ns fr
om th
e na
tiona
l inv
estig
atio
n bo
dies
(s
ee 7
.1. L
earn
ing
from
acc
iden
ts
and
inci
dent
s);
Ann
ex V
(ECM
M
aint
enan
ce R
epor
t)
(in g
ener
al),
Art
. 8(5
)
814.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
an
annu
al s
afet
y re
port
is s
ubm
itted
to th
e re
leva
nt n
atio
nal s
afet
y au
thor
ity
(or a
utho
ritie
s) in
acc
orda
nce
with
Art
icle
9(6
) of D
irect
ive
(EU
) 20
16/7
98, i
nclu
ding
:
(e) t
he o
rgan
isat
ion’
s sa
fety
in
dica
tors
set
out
to e
valu
ate
the
orga
nisa
tion’
s sa
fety
per
form
ance
(s
ee 6
.1. M
onito
ring)
;
Ann
ex V
(ECM
M
aint
enan
ce R
epor
t)
(in g
ener
al),
Art
. 8(5
)
101
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
824.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
an
annu
al s
afet
y re
port
is s
ubm
itted
to th
e re
leva
nt n
atio
nal s
afet
y au
thor
ity
(or a
utho
ritie
s) in
acc
orda
nce
with
Art
icle
9(6
) of D
irect
ive
(EU
) 20
16/7
98, i
nclu
ding
:
(f) w
here
app
licab
le, t
he
conc
lusi
ons
of th
e an
nual
repo
rt
of th
e sa
fety
adv
isor
, as
refe
rred
to
in R
ID (1
), on
the
activ
ities
of
the
orga
nisa
tion
rela
ting
to th
e tr
ansp
ort o
f dan
gero
us g
oods
(2).
Ann
ex V
(ECM
M
aint
enan
ce R
epor
t)
(in g
ener
al),
Art
. 8(5
)
834.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
2.
Crea
ting
and
upda
ting
4.5.
2.1.
The
org
anis
atio
n sh
all
ensu
re th
at w
hen
crea
ting
and
upda
ting
docu
men
ted
info
rmat
ion
rela
ted
to th
e sa
fety
m
anag
emen
t sys
tem
ade
quat
e fo
rmat
s an
d m
edia
are
use
d.
I.8 (i
n ge
nera
l)
844.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
3.
Cont
rol o
f do
cum
ente
d in
form
atio
n4.
5.3.
1. T
he o
rgan
isat
ion
shal
l con
trol
doc
umen
ted
info
rmat
ion
rela
ted
to th
e sa
fety
man
agem
ent s
yste
m, i
n pa
rtic
ular
its
stor
age,
dis
trib
utio
n an
d th
e co
ntro
l of c
hang
es,
to e
nsur
e its
ava
ilabi
lity,
su
itabi
lity
and
prot
ectio
n w
here
ap
prop
riate
.
I.8 (i
n ge
nera
l), I.
9 (in
ge
nera
l), II
.7, I
II.10
, IV
.10
854.
SU
PPO
RT4.
6.
Inte
grat
ion
of h
uman
and
or
gani
satio
nal
fact
ors
4.6.
1. T
he o
rgan
isat
ion
shal
l dem
onst
rate
a
syst
emat
ic a
ppro
ach
to in
tegr
atin
g hu
man
an
d or
gani
satio
nal
fact
ors
with
in th
e sa
fety
m
anag
emen
t sys
tem
. Thi
s ap
proa
ch s
hall:
(a) i
nclu
de th
e de
velo
pmen
t of
a s
trat
egy
and
the
use
of
expe
rtis
e an
d re
cogn
ised
m
etho
ds fr
om th
e fie
ld o
f hum
an
and
orga
nisa
tiona
l fac
tors
;
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
102
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
864.
SU
PPO
RT4.
6.
Inte
grat
ion
of h
uman
and
or
gani
satio
nal
fact
ors
4.6.
1. T
he o
rgan
isat
ion
shal
l dem
onst
rate
a
syst
emat
ic a
ppro
ach
to in
tegr
atin
g hu
man
an
d or
gani
satio
nal
fact
ors
with
in th
e sa
fety
m
anag
emen
t sys
tem
. Thi
s ap
proa
ch s
hall:
(b) a
ddre
ss ri
sks
asso
ciat
ed w
ith
the
desi
gn a
nd u
se o
f equ
ipm
ent,
task
s, w
orki
ng c
ondi
tions
and
or
gani
satio
nal a
rran
gem
ents
, ta
king
into
acc
ount
hum
an
capa
bilit
ies
as w
ell a
s lim
itatio
ns,
and
the
influ
ence
s on
hum
an
perf
orm
ance
.
I.2.3
(in
gene
ral),
II.3
(in
gen
eral
), IV
.3, I
V.4,
IV
.5
875.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
1. W
hen
plan
ning
, de
velo
ping
, im
plem
entin
g an
d re
view
ing
its
oper
atio
nal p
roce
sses
, the
or
gani
satio
n sh
all e
nsur
e th
at d
urin
g op
erat
ion:
(a) r
isk
acce
ptan
ce c
riter
ia a
nd
safe
ty m
easu
res
are
appl
ied
(see
3.
1.1.
Ris
k as
sess
men
t);
I.3 a
nd I.
9.6
(in
gene
ral)
885.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
1. W
hen
plan
ning
, de
velo
ping
, im
plem
entin
g an
d re
view
ing
its
oper
atio
nal p
roce
sses
, the
or
gani
satio
n sh
all e
nsur
e th
at d
urin
g op
erat
ion:
(b) p
lan(
s) to
ach
ieve
the
safe
ty
obje
ctiv
es a
re d
eliv
ered
(see
3.2
. Sa
fety
obj
ectiv
es a
nd p
lann
ing)
;
I.1.(d
), I.3
, I.9
.3
895.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
1. W
hen
plan
ning
, de
velo
ping
, im
plem
entin
g an
d re
view
ing
its
oper
atio
nal p
roce
sses
, the
or
gani
satio
n sh
all e
nsur
e th
at d
urin
g op
erat
ion:
(c) i
nfor
mat
ion
is c
olle
cted
to
mea
sure
the
corr
ect a
pplic
atio
n an
d eff
ectiv
enes
s of
the
oper
atio
nal a
rran
gem
ents
(see
6.
1. M
onito
ring)
.
I.3 (i
n ge
nera
l), I.
9.6
(in g
ener
al),
I.9.5
(in
gen
eral
), I.7
(in
gene
ral)
103
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
905.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
2. T
he o
rgan
isat
ion
shal
l ens
ure
that
its
oper
atio
nal a
rran
gem
ents
co
nfor
m to
the
safe
ty-
rela
ted
requ
irem
ents
of
app
licab
le Te
chni
cal
Spec
ifica
tions
for
Inte
rope
rabi
lity
and
rele
vant
nat
iona
l ru
les
and
any
othe
r re
leva
nt re
quire
men
ts
(see
1. C
onte
xt o
f the
or
gani
satio
n).
II.2,
Art
. 4(1
)
915.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
3. T
o co
ntro
l ris
ks
whe
re re
leva
nt fo
r the
sa
fety
of o
pera
tiona
l ac
tiviti
es (s
ee 3
.1.1
. Ris
k as
sess
men
t), a
t lea
st th
e fo
llow
ing
shal
l be
take
n in
to a
ccou
nt:
(a) i
dent
ifica
tion
of th
e sa
fe
boun
darie
s of
tran
spor
t for
traffi
c pl
anni
ng a
nd c
ontr
ol b
ased
on
the
desi
gn c
hara
cter
istic
s of
the
infr
astr
uctu
re;
925.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
3. T
o co
ntro
l ris
ks
whe
re re
leva
nt fo
r the
sa
fety
of o
pera
tiona
l ac
tiviti
es (s
ee 3
.1.1
. Ris
k as
sess
men
t), a
t lea
st th
e fo
llow
ing
shal
l be
take
n in
to a
ccou
nt:
(b) t
raffi
c pl
anni
ng, i
nclu
ding
tim
etab
le a
nd tr
ain
path
al
loca
tion;
935.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
3. T
o co
ntro
l ris
ks
whe
re re
leva
nt fo
r the
sa
fety
of o
pera
tiona
l ac
tiviti
es (s
ee 3
.1.1
. Ris
k as
sess
men
t), a
t lea
st th
e fo
llow
ing
shal
l be
take
n in
to a
ccou
nt:
(c) r
eal-t
ime
traffi
c m
anag
emen
t in
nor
mal
mod
e an
d in
deg
rade
d m
odes
with
the
appl
icat
ion
of
traffi
c re
stric
tions
of u
se a
nd
the
man
agem
ent o
f tra
ffic
disr
uptio
ns;
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
104
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
945.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
3. T
o co
ntro
l ris
ks
whe
re re
leva
nt fo
r the
sa
fety
of o
pera
tiona
l ac
tiviti
es (s
ee 3
.1.1
. Ris
k as
sess
men
t), a
t lea
st th
e fo
llow
ing
shal
l be
take
n in
to a
ccou
nt:
(d) s
ettin
g of
con
ditio
ns
for r
unni
ng e
xcep
tiona
l co
nsig
nmen
ts.
955.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
4. T
o co
ntro
l th
e al
loca
tion
of
resp
onsi
bilit
ies
whe
re
rele
vant
for t
he s
afet
y of
ope
ratio
nal a
ctiv
ities
, th
e or
gani
satio
n sh
all
iden
tify
resp
onsi
bilit
ies
for
plan
ning
and
ope
ratin
g th
e ra
il ne
twor
k an
d de
fine
how
rele
vant
task
s aff
ectin
g th
e sa
fe d
eliv
ery
of a
ll se
rvic
es a
re a
lloca
ted
to c
ompe
tent
sta
ff w
ithin
the
orga
nisa
tion
(see
2.3
. Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
) and
to o
ther
ex
tern
al q
ualifi
ed p
artie
s w
hen
appr
opria
te (s
ee 5
.3.
Cont
ract
ors,
part
ners
and
su
pplie
rs).
I.9.1
and
I.9.
2 (in
ge
nera
l)
105
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
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nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
965.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
5. T
o co
ntro
l in
form
atio
n an
d co
mm
unic
atio
n w
here
re
leva
nt fo
r the
saf
ety
of o
pera
tiona
l act
iviti
es
(see
4.4
. Inf
orm
atio
n an
d co
mm
unic
atio
n), r
elev
ant
staff
(e.g
. sig
nalle
rs) s
hall
be in
form
ed a
bout
spe
cific
ro
utin
g re
quire
men
ts fo
r tr
ains
and
mov
emen
ts o
f ve
hicl
es in
clud
ing
rele
vant
ch
ange
s w
hich
may
resu
lt in
a h
azar
d, te
mpo
rary
or
perm
anen
t ope
ratio
nal
rest
rictio
ns (e
.g. d
ue to
tr
ack
mai
nten
ance
) and
co
nditi
ons
for e
xcep
tiona
l co
nsig
nmen
ts w
here
ap
plic
able
.
I.7, I
I.5, I
II.6,
III.9
, III.
10,
IV.9
, Art
. 4(2
), A
rt. 4
(6)
975.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
6. T
o co
ntro
l co
mpe
tenc
e w
here
re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
4.
2. C
ompe
tenc
e), t
he
orga
nisa
tion
shal
l ens
ure,
in
acco
rdan
ce w
ith a
pplic
able
le
gisl
atio
n (s
ee 1
. Con
text
of
the
orga
nisa
tion)
, for
its
staff
:
(a) c
ompl
ianc
e w
ith th
eir t
rain
ing
and
wor
k in
stru
ctio
ns, a
nd
corr
ectiv
e ac
tions
are
take
n w
here
requ
ired;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
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sion
at e
ra.e
urop
a.eu
.©
202
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Age
ncy
for R
ailw
ays.
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right
s re
serv
ed.
106
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
985.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
6. T
o co
ntro
l co
mpe
tenc
e w
here
re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
4.
2. C
ompe
tenc
e), t
he
orga
nisa
tion
shal
l ens
ure,
in
acco
rdan
ce w
ith a
pplic
able
le
gisl
atio
n (s
ee 1
. Con
text
of
the
orga
nisa
tion)
, for
its
staff
:
(b) s
peci
fic tr
aini
ng in
cas
e of
an
ticip
ated
cha
nges
affe
ctin
g th
e ru
nnin
g of
ope
ratio
ns o
r the
ir ta
sk a
ssig
nmen
t;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
995.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
6. T
o co
ntro
l co
mpe
tenc
e w
here
re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
4.
2. C
ompe
tenc
e), t
he
orga
nisa
tion
shal
l ens
ure,
in
acco
rdan
ce w
ith a
pplic
able
le
gisl
atio
n (s
ee 1
. Con
text
of
the
orga
nisa
tion)
, for
its
staff
:
(c) a
dopt
ion
of a
dequ
ate
mea
sure
s fo
llow
ing
acci
dent
s an
d in
cide
nts.
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
100
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.1.
The
org
anis
atio
n sh
all m
anag
e th
e sa
fety
ris
ks a
ssoc
iate
d w
ith
phys
ical
ass
ets
thro
ugho
ut
thei
r life
cycl
e (s
ee 3
.1.1
. Ri
sk a
sses
smen
t), f
rom
de
sign
to d
ispo
sal,
and
fulfi
l the
hum
an fa
ctor
s re
quire
men
ts in
all
phas
es
of th
e lif
e cy
cle.
I.2 (i
n ge
nera
l)
107
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ion
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ailw
ays.
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right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
101
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.2.
The
org
anis
atio
n sh
all:
(a) e
nsur
e th
at th
e as
sets
are
us
ed fo
r the
pur
pose
inte
nded
w
hile
mai
ntai
ning
thei
r saf
e op
erat
iona
l sta
te a
nd th
eir
expe
cted
leve
l of p
erfo
rman
ce;
102
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.2.
The
org
anis
atio
n sh
all:
(b) m
anag
e th
e as
sets
in n
orm
al
and
degr
aded
ope
ratio
ns;
103
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.2.
The
org
anis
atio
n sh
all:
(c) d
etec
t as
soon
as
reas
onab
ly
prac
ticab
le in
stan
ces
of n
on-
com
plia
nce
with
ope
ratin
g re
quire
men
ts b
efor
e or
dur
ing
the
oper
atio
n of
the
asse
t, in
clud
ing
the
appl
icat
ion
of
rest
rictio
ns o
f use
as
appr
opria
te
to e
nsur
e a
safe
ope
ratio
nal s
tate
of
the
asse
t (se
e 6.
1. M
onito
ring)
.
III.6
, III.
9, II
I.10
104
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.3.
The
org
anis
atio
n sh
all e
nsur
e th
at it
s as
set m
anag
emen
t ar
rang
emen
ts, w
here
ap
plic
able
, con
form
to a
ll es
sent
ial r
equi
rem
ents
as
set
out
in th
e re
leva
nt
Tech
nica
l Spe
cific
atio
ns
for I
nter
oper
abili
ty
and
any
othe
r rel
evan
t re
quire
men
ts (s
ee
1. C
onte
xt o
f the
or
gani
satio
n).
II. 2
(in
gene
ral),
Art
. 4(
1)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
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olle
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hen
prin
ted.
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nloa
d th
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ailw
ays.
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right
s re
serv
ed.
108
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
105
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.4.
To
cont
rol r
isks
w
here
rele
vant
for t
he
supp
ly o
f mai
nten
ance
(see
3.
1.1.
Ris
k as
sess
men
t), a
t le
ast t
he fo
llow
ing
shal
l be
take
n in
to a
ccou
nt:
(a) t
he id
entifi
catio
n of
the
need
for m
aint
enan
ce to
kee
p th
e in
fras
truc
ture
in a
saf
e op
erat
iona
l sta
te, b
ased
on
the
plan
ned
and
real
use
of t
he
infr
astr
uctu
re a
nd it
s de
sign
ch
arac
teris
tics;
III.4
106
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.4.
To
cont
rol r
isks
w
here
rele
vant
for t
he
supp
ly o
f mai
nten
ance
(see
3.
1.1.
Ris
k as
sess
men
t), a
t le
ast t
he fo
llow
ing
shal
l be
take
n in
to a
ccou
nt:
(b) t
he m
anag
emen
t of t
he
rem
oval
of t
he a
sset
from
op
erat
ion
for m
aint
enan
ce, w
hen
defe
cts
have
bee
n id
entifi
ed o
r w
hen
asse
t con
ditio
n de
grad
es
outs
ide
the
limits
of a
saf
e op
erat
iona
l sta
te a
s re
ferr
ed to
in
poin
t (a)
;
III.4
, Art
. 4(2
), A
rt. 4
(4)
107
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.4.
To
cont
rol r
isks
w
here
rele
vant
for t
he
supp
ly o
f mai
nten
ance
(see
3.
1.1.
Ris
k as
sess
men
t), a
t le
ast t
he fo
llow
ing
shal
l be
take
n in
to a
ccou
nt:
(c) t
he m
anag
emen
t of t
he
retu
rn to
ope
ratio
n of
the
asse
t w
ith e
vent
ual r
estr
ictio
ns o
f use
af
ter m
aint
enan
ce h
as b
een
deliv
ered
to e
nsur
e it
is in
a s
afe
oper
atio
nal s
tate
;
III.4
108
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.4.
To
cont
rol r
isks
w
here
rele
vant
for t
he
supp
ly o
f mai
nten
ance
(see
3.
1.1.
Ris
k as
sess
men
t), a
t le
ast t
he fo
llow
ing
shal
l be
take
n in
to a
ccou
nt:
(d) t
he m
anag
emen
t of
mon
itorin
g an
d m
easu
rem
ent
equi
pmen
t to
ensu
re th
at it
is fi
t fo
r its
inte
nded
pur
pose
.
II.3
(in g
ener
al),
III.6
, III
.9, I
II.10
, IV.
3, IV
.4,
IV.5
109
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ion
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at e
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urop
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202
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ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
109
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.5.
To
cont
rol
info
rmat
ion
and
com
mun
icat
ion
whe
re
rele
vant
for t
he s
afe
man
agem
ent o
f ass
ets
(see
4.4
. Inf
orm
atio
n an
d co
mm
unic
atio
n), t
he
orga
nisa
tion
shal
l tak
e in
to
acco
unt:
(a) t
he e
xcha
nge
of re
leva
nt
info
rmat
ion
with
in th
e or
gani
satio
n or
with
ext
erna
l en
titie
s re
spon
sibl
e fo
r m
aint
enan
ce (s
ee 5
.3.
Cont
ract
ors,
part
ners
and
su
pplie
rs),
in p
artic
ular
on
safe
ty-
rela
ted
mal
func
tions
, acc
iden
ts,
inci
dent
s as
wel
l as
on e
vent
ual
rest
rictio
ns o
f use
of t
he a
sset
;
I.7 (i
n ge
nera
l), I.
9.6,
II.
5, II
I.6, I
II.9,
III.1
0,
IV.9
, Art
. 4(2
), A
rt. 4
(6),
Art
. 5(1
), A
rt. 5
(2),
Art
. 5(3
)
110
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.5.
To
cont
rol
info
rmat
ion
and
com
mun
icat
ion
whe
re
rele
vant
for t
he s
afe
man
agem
ent o
f ass
ets
(see
4.4
. Inf
orm
atio
n an
d co
mm
unic
atio
n), t
he
orga
nisa
tion
shal
l tak
e in
to
acco
unt:
(b) t
he tr
acea
bilit
y of
all
nece
ssar
y in
form
atio
n in
clud
ing
the
info
rmat
ion
rela
ted
to
poin
t (a)
(see
4.4
. Inf
orm
atio
n an
d co
mm
unic
atio
n an
d 4.
5.3.
Con
trol
of d
ocum
ente
d in
form
atio
n);
I.7 (i
n ge
nera
l), I.
8,
I.9.6
, II.5
(in
gene
ral),
II.
7, II
I.4 (i
n ge
nera
l),
III.9
, IV.
9, A
rt. 4
(5)b
111
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.5.
To
cont
rol
info
rmat
ion
and
com
mun
icat
ion
whe
re
rele
vant
for t
he s
afe
man
agem
ent o
f ass
ets
(see
4.4
. Inf
orm
atio
n an
d co
mm
unic
atio
n), t
he
orga
nisa
tion
shal
l tak
e in
to
acco
unt:
(c) t
he e
stab
lishm
ent a
nd
mai
nten
ance
of r
ecor
ds in
clud
ing
the
man
agem
ent o
f cha
nges
aff
ectin
g th
e sa
fety
of a
sset
s (s
ee
5.4.
Man
agem
ent o
f cha
nge)
.
I.7, I
.8, I
I.2 (i
n ge
nera
l),
II.5
(in g
ener
al),
II.7,
III
.10,
IV.1
0, A
rt. 4
(5)b
112
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
1. T
he o
rgan
isat
ion
shal
l ide
ntify
and
con
trol
sa
fety
risk
s ar
isin
g fr
om
outs
ourc
ed a
ctiv
ities
, in
clud
ing
oper
atio
ns
or c
oope
ratio
n w
ith
cont
ract
ors,
part
ners
and
su
pplie
rs.
I.9.1
, Art
. 9(2
)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
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olle
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ailw
ays.
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right
s re
serv
ed.
110
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
113
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
2. T
o co
ntro
l the
sa
fety
risk
s re
ferr
ed to
in
par
agra
ph 5
.3.1
, the
or
gani
satio
n sh
all d
efine
th
e cr
iteria
for t
he s
elec
tion
of th
e co
ntra
ctor
s, pa
rtne
rs
and
supp
liers
and
the
cont
ract
requ
irem
ents
they
ha
ve to
mee
t, in
clud
ing:
(a) t
he le
gal a
nd o
ther
re
quire
men
ts re
late
d to
sa
fety
(see
1. C
onte
xt o
f the
or
gani
satio
n);
I.9 (i
n ge
nera
l)
114
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
2. T
o co
ntro
l the
sa
fety
risk
s re
ferr
ed to
in
par
agra
ph 5
.3.1
, the
or
gani
satio
n sh
all d
efine
th
e cr
iteria
for t
he s
elec
tion
of th
e co
ntra
ctor
s, pa
rtne
rs
and
supp
liers
and
the
cont
ract
requ
irem
ents
they
ha
ve to
mee
t, in
clud
ing:
(b) t
he le
vel o
f com
pete
nce
requ
ired
to d
eliv
er th
e ta
sks
set o
ut in
the
cont
ract
(see
4.2
. Co
mpe
tenc
e);
I.9.2
115
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
2. T
o co
ntro
l the
sa
fety
risk
s re
ferr
ed to
in
par
agra
ph 5
.3.1
, the
or
gani
satio
n sh
all d
efine
th
e cr
iteria
for t
he s
elec
tion
of th
e co
ntra
ctor
s, pa
rtne
rs
and
supp
liers
and
the
cont
ract
requ
irem
ents
they
ha
ve to
mee
t, in
clud
ing:
(c) t
he re
spon
sibi
litie
s fo
r the
ta
sks
to b
e pe
rfor
med
;I.9
.6
111
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ion
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urop
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202
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ncy
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ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
116
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
2. T
o co
ntro
l the
sa
fety
risk
s re
ferr
ed to
in
par
agra
ph 5
.3.1
, the
or
gani
satio
n sh
all d
efine
th
e cr
iteria
for t
he s
elec
tion
of th
e co
ntra
ctor
s, pa
rtne
rs
and
supp
liers
and
the
cont
ract
requ
irem
ents
they
ha
ve to
mee
t, in
clud
ing:
(d) t
he e
xpec
ted
safe
ty
perf
orm
ance
to b
e m
aint
aine
d du
ring
the
cont
ract
;
I.9.3
, Art
. 9(3
)
117
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
2. T
o co
ntro
l the
sa
fety
risk
s re
ferr
ed to
in
par
agra
ph 5
.3.1
, the
or
gani
satio
n sh
all d
efine
th
e cr
iteria
for t
he s
elec
tion
of th
e co
ntra
ctor
s, pa
rtne
rs
and
supp
liers
and
the
cont
ract
requ
irem
ents
they
ha
ve to
mee
t, in
clud
ing:
(e) t
he o
blig
atio
ns re
latin
g to
th
e ex
chan
ge o
f saf
ety-
rela
ted
info
rmat
ion
(see
4.4
. Inf
orm
atio
n an
d co
mm
unic
atio
n);
I.9.6
118
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
2. T
o co
ntro
l the
sa
fety
risk
s re
ferr
ed to
in
par
agra
ph 5
.3.1
, the
or
gani
satio
n sh
all d
efine
th
e cr
iteria
for t
he s
elec
tion
of th
e co
ntra
ctor
s, pa
rtne
rs
and
supp
liers
and
the
cont
ract
requ
irem
ents
they
ha
ve to
mee
t, in
clud
ing:
(f) t
he tr
acea
bilit
y of
saf
ety-
rela
ted
docu
men
ts (s
ee 4
.5.
Doc
umen
ted
info
rmat
ion)
.
I.9.6
119
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
3.
In a
ccor
danc
e w
ith th
e pr
oces
s se
t out
in
Art
icle
3 o
f Reg
ulat
ion
(EU
) No
1078
/201
2, th
e or
gani
satio
n sh
all m
onito
r:
(a) t
he s
afet
y pe
rfor
man
ce o
f al
l act
iviti
es a
nd o
pera
tions
of
con
trac
tors
, par
tner
s an
d su
pplie
rs to
ens
ure
that
they
co
mpl
y w
ith th
e re
quire
men
ts
set o
ut in
the
cont
ract
;
I.9.5
, Art
. 4(4
), A
rt. 9
(3)
120
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
3.
In a
ccor
danc
e w
ith th
e pr
oces
s se
t out
in
Art
icle
3 o
f Reg
ulat
ion
(EU
) No
1078
/201
2, th
e or
gani
satio
n sh
all m
onito
r:
(b) t
he a
war
enes
s of
con
trac
tors
, pa
rtne
rs a
nd s
uppl
iers
of
safe
ty ri
sks
they
ent
ail t
o th
e or
gani
satio
n’s
oper
atio
ns.
I.9.2
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
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nloa
d th
e la
test
ver
sion
at e
ra.e
urop
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.©
202
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Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
112
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
121
5.
OPE
RATI
ON
5.4.
M
anag
emen
t of
cha
nge
5.4.
1. T
he o
rgan
isat
ion
shal
l im
plem
ent a
nd
cont
rol c
hang
es to
the
safe
ty m
anag
emen
t sys
tem
to
mai
ntai
n or
impr
ove
the
safe
ty p
erfo
rman
ce. T
his
shal
l inc
lude
dec
isio
ns a
t th
e di
ffere
nt s
tage
s of
the
chan
ge m
anag
emen
t and
th
e su
bseq
uent
revi
ew o
f sa
fety
risk
s (s
ee 3
.1.1
. Ris
k as
sess
men
t).
122
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
1. T
he o
rgan
isat
ion
shal
l ide
ntify
the
emer
genc
y si
tuat
ions
an
d as
soci
ated
tim
ely
mea
sure
s to
be
take
n to
m
anag
e th
em (s
ee 3
.1.1
. Ri
sk a
sses
smen
t) a
nd to
re-
esta
blis
h no
rmal
ope
ratin
g co
nditi
ons
in a
ccor
danc
e w
ith R
egul
atio
n (E
U)
2015
/995
.
123
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
2. T
he o
rgan
isat
ion
shal
l ens
ure
that
, for
ea
ch id
entifi
ed ty
pe o
f em
erge
ncy:
(a) t
he e
mer
genc
y se
rvic
es c
an
be p
rom
ptly
con
tact
ed;
124
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
2. T
he o
rgan
isat
ion
shal
l ens
ure
that
, for
ea
ch id
entifi
ed ty
pe o
f em
erge
ncy:
(b) t
he e
mer
genc
y se
rvic
es
are
prov
ided
with
all
rele
vant
in
form
atio
n bo
th in
adv
ance
, to
pre
pare
thei
r em
erge
ncy
resp
onse
, and
at t
he ti
me
of a
n em
erge
ncy;
I.7.(j
)
113
Vers
ion
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(01/
03/2
021)
. Unc
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e la
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urop
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202
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ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
125
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
2. T
he o
rgan
isat
ion
shal
l ens
ure
that
, for
ea
ch id
entifi
ed ty
pe o
f em
erge
ncy:
(c) fi
rst a
id is
pro
vide
d in
tern
ally
.
126
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
3. T
he o
rgan
isat
ion
shal
l ide
ntify
and
do
cum
ent t
he ro
les
and
resp
onsi
bilit
ies
of a
ll pa
rtie
s in
acc
orda
nce
with
Re
gula
tion
(EU
) 201
5/99
5.
127
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
4. T
he o
rgan
isat
ion
shal
l hav
e pl
ans
for a
ctio
n,
aler
ts a
nd in
form
atio
n in
cas
e of
em
erge
ncy,
in
clud
ing
arra
ngem
ents
to:
(a) a
lert
all
staff
with
re
spon
sibi
lity
for e
mer
genc
y m
anag
emen
t;
128
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
4. T
he o
rgan
isat
ion
shal
l hav
e pl
ans
for a
ctio
n,
aler
ts a
nd in
form
atio
n in
cas
e of
em
erge
ncy,
in
clud
ing
arra
ngem
ents
to:
(b) c
omm
unic
ate
info
rmat
ion
to a
ll pa
rtie
s (e
.g. r
ailw
ay
unde
rtak
ings
, con
trac
tors
, au
thor
ities
, em
erge
ncy
serv
ices
), in
clud
ing
emer
genc
y in
stru
ctio
ns fo
r pas
seng
ers;
I.7 (i
n ge
nera
l)
129
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
4. T
he o
rgan
isat
ion
shal
l hav
e pl
ans
for a
ctio
n,
aler
ts a
nd in
form
atio
n in
cas
e of
em
erge
ncy,
in
clud
ing
arra
ngem
ents
to:
(c) t
ake
any
deci
sion
s re
quire
d in
acc
orda
nce
with
the
type
of
emer
genc
y.
130
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
5. T
he o
rgan
isat
ion
shal
l des
crib
e ho
w
reso
urce
s an
d m
eans
for
emer
genc
y m
anag
emen
t ha
ve b
een
allo
cate
d (s
ee 4
.1. R
esou
rces
) and
ho
w tr
aini
ng re
quire
men
ts
have
bee
n id
entifi
ed (s
ee
4.2.
Com
pete
nce)
.
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
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Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
114
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
131
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
6. T
he e
mer
genc
y ar
rang
emen
ts a
re re
gula
rly
test
ed in
coo
pera
tion
with
ot
her i
nter
este
d pa
rtie
s and
up
date
d w
hen
appr
opria
te.
132
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
7. T
he o
rgan
isat
ion
shal
l coo
rdin
ate
emer
genc
y pl
ans
with
all
railw
ay
unde
rtak
ings
that
ope
rate
on
the
orga
nisa
tion’
s in
fras
truc
ture
, with
the
emer
genc
y se
rvic
es, s
o as
to fa
cilit
ate
thei
r rap
id
inte
rven
tion,
and
with
any
ot
her p
arty
that
cou
ld b
e in
volv
ed in
an
emer
genc
y si
tuat
ion.
133
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
8. T
he o
rgan
isat
ion
shal
l hav
e ar
rang
emen
ts
to h
alt o
pera
tions
and
ra
ilway
traffi
c pr
ompt
ly, i
f ne
cess
ary,
and
to in
form
al
l int
eres
ted
part
ies
of th
e ac
tion
take
n.
I.7 (i
n ge
nera
l)
134
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
9.
For c
ross
-bor
der
infr
astr
uctu
re, t
he
coop
erat
ion
betw
een
the
rele
vant
infr
astr
uctu
re
man
ager
s sh
all f
acili
tate
th
e ne
cess
ary
coor
dina
tion
and
prep
ared
ness
of t
he
com
pete
nt e
mer
genc
y se
rvic
es o
n bo
th s
ides
of
the
bord
er.
115
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
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ted.
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nloa
d th
e la
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ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
135
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.1.
M
onito
ring
6.1.
1. T
he o
rgan
isat
ion
shal
l per
form
mon
itorin
g in
ac
cord
ance
with
Reg
ulat
ion
(EU
) No
1078
/201
2:
(a) t
o ch
eck
the
corr
ect
appl
icat
ion
and
the
effec
tiven
ess
of a
ll th
e pr
oces
ses
and
proc
edur
es in
the
safe
ty
man
agem
ent s
yste
m, i
nclu
ding
th
e op
erat
iona
l, or
gani
satio
nal
and
tech
nica
l saf
ety
mea
sure
s;
I.3 (i
n ge
nera
l), A
rt.
4(4)
, Art
. 7(1
), A
rt. 9
(3)
136
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.1.
M
onito
ring
6.1.
1. T
he o
rgan
isat
ion
shal
l per
form
mon
itorin
g in
ac
cord
ance
with
Reg
ulat
ion
(EU
) No
1078
/201
2:
(b) t
o ch
eck
the
corr
ect
appl
icat
ion
of th
e sa
fety
m
anag
emen
t sys
tem
as
a w
hole
, an
d if
it ac
hiev
es th
e ex
pect
ed
outc
omes
;
I.3 (i
n ge
nera
l), A
rt.
4(4)
, Art
. 7(1
), A
rt. 9
(3)
137
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.1.
M
onito
ring
6.1.
1. T
he o
rgan
isat
ion
shal
l per
form
mon
itorin
g in
ac
cord
ance
with
Reg
ulat
ion
(EU
) No
1078
/201
2:
(c) t
o in
vest
igat
e w
heth
er th
e sa
fety
man
agem
ent s
yste
m
conf
orm
s to
the
requ
irem
ents
in
this
Reg
ulat
ion;
I.3 (i
n ge
nera
l), A
rt.
4(4)
, Art
. 7(1
), A
rt. 9
(3)
138
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.1.
M
onito
ring
6.1.
1. T
he o
rgan
isat
ion
shal
l per
form
mon
itorin
g in
ac
cord
ance
with
Reg
ulat
ion
(EU
) No
1078
/201
2:
(d) t
o id
entif
y, im
plem
ent a
nd
eval
uate
the
effec
tiven
ess
of
the
corr
ectiv
e m
easu
res
(see
7.
2. C
ontin
ual i
mpr
ovem
ent)
, as
app
ropr
iate
, if a
ny re
leva
nt
inst
ance
of n
on-c
ompl
ianc
e to
po
ints
(a),
(b) a
nd (c
) is
dete
cted
.
I.3 a
nd I.
4 (in
gen
eral
), A
rt. 4
(4),
Art
. 7(1
), A
rt. 9
(3)
139
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.1.
M
onito
ring
6.1.
2. T
he o
rgan
isat
ion
shal
l reg
ular
ly m
onito
r at
all
leve
ls w
ithin
th
e or
gani
satio
n th
e pe
rfor
man
ce o
f saf
ety-
rela
ted
task
s an
d in
terv
ene
if th
ese
task
s ar
e no
t bei
ng
prop
erly
per
form
ed.
I.3 a
nd I.
4 (in
gen
eral
), A
rt. 4
(4),
Art
. 7(1
), A
rt. 9
(3)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
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(01/
03/2
021)
. Unc
ontr
olle
d w
hen
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ted.
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nloa
d th
e la
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sion
at e
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urop
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202
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Age
ncy
for R
ailw
ays.
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right
s re
serv
ed.
116
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
140
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l con
duct
inte
rnal
au
dits
in a
n in
depe
nden
t, im
part
ial a
nd tr
ansp
aren
t w
ay to
col
lect
and
ana
lyse
in
form
atio
n fo
r the
pu
rpos
es o
f its
mon
itorin
g ac
tiviti
es (s
ee 6
.1.
Mon
itorin
g), i
nclu
ding
:
(a) A
sch
edul
e of
pla
nned
in
tern
al a
udits
whi
ch c
an b
e re
vise
d de
pend
ing
on th
e re
sults
of p
revi
ous
audi
ts a
nd
mon
itorin
g of
per
form
ance
;
I.3 (i
n ge
nera
l)
141
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l con
duct
inte
rnal
au
dits
in a
n in
depe
nden
t, im
part
ial a
nd tr
ansp
aren
t w
ay to
col
lect
and
ana
lyse
in
form
atio
n fo
r the
pu
rpos
es o
f its
mon
itorin
g ac
tiviti
es (s
ee 6
.1.
Mon
itorin
g), i
nclu
ding
:
(b) T
he id
entifi
catio
n an
d se
lect
ion
of c
ompe
tent
aud
itors
(s
ee 4
.2. C
ompe
tenc
e);
142
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l con
duct
inte
rnal
au
dits
in a
n in
depe
nden
t, im
part
ial a
nd tr
ansp
aren
t w
ay to
col
lect
and
ana
lyse
in
form
atio
n fo
r the
pu
rpos
es o
f its
mon
itorin
g ac
tiviti
es (s
ee 6
.1.
Mon
itorin
g), i
nclu
ding
:
(c) T
he a
naly
sis
and
eval
uatio
n of
th
e re
sults
of t
he a
udits
;I.3
(in
gene
ral)
117
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ion
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sion
at e
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urop
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.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
143
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l con
duct
inte
rnal
au
dits
in a
n in
depe
nden
t, im
part
ial a
nd tr
ansp
aren
t w
ay to
col
lect
and
ana
lyse
in
form
atio
n fo
r the
pu
rpos
es o
f its
mon
itorin
g ac
tiviti
es (s
ee 6
.1.
Mon
itorin
g), i
nclu
ding
:
(d) T
he id
entifi
catio
n of
the
need
fo
r cor
rect
ive
or im
prov
emen
t m
easu
res;
I.3 (i
n ge
nera
l)
144
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l con
duct
inte
rnal
au
dits
in a
n in
depe
nden
t, im
part
ial a
nd tr
ansp
aren
t w
ay to
col
lect
and
ana
lyse
in
form
atio
n fo
r the
pu
rpos
es o
f its
mon
itorin
g ac
tiviti
es (s
ee 6
.1.
Mon
itorin
g), i
nclu
ding
:
(e) T
he v
erifi
catio
n of
the
com
plet
ion
and
effec
tiven
ess
of
thes
e m
easu
res;
I.3 (i
n ge
nera
l)
145
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l con
duct
inte
rnal
au
dits
in a
n in
depe
nden
t, im
part
ial a
nd tr
ansp
aren
t w
ay to
col
lect
and
ana
lyse
in
form
atio
n fo
r the
pu
rpos
es o
f its
mon
itorin
g ac
tiviti
es (s
ee 6
.1.
Mon
itorin
g), i
nclu
ding
:
(f) T
he d
ocum
enta
tion
pert
aini
ng
to th
e ex
ecut
ion
and
resu
lts o
f au
dits
;
I.3 (i
n ge
nera
l)
146
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l con
duct
inte
rnal
au
dits
in a
n in
depe
nden
t, im
part
ial a
nd tr
ansp
aren
t w
ay to
col
lect
and
ana
lyse
in
form
atio
n fo
r the
pu
rpos
es o
f its
mon
itorin
g ac
tiviti
es (s
ee 6
.1.
Mon
itorin
g), i
nclu
ding
:
(g) T
he c
omm
unic
atio
n of
the
resu
lts o
f aud
its to
the
top
man
agem
ent.
I.1.(g
)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
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(01/
03/2
021)
. Unc
ontr
olle
d w
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ted.
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e la
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urop
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202
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Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
118
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
147
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
1. T
op m
anag
emen
t sh
all r
egul
arly
revi
ew th
e co
ntin
uing
ade
quac
y an
d eff
ectiv
enes
s of
the
safe
ty m
anag
emen
t sy
stem
incl
udin
g at
leas
t co
nsid
erat
ion
of:
(a) d
etai
ls o
f pro
gres
s on
ad
dres
sing
out
stan
ding
act
ions
fr
om p
revi
ous
man
agem
ent
revi
ews;
I.1 a
nd I.
3 (in
gen
eral
)
148
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
1. T
op m
anag
emen
t sh
all r
egul
arly
revi
ew th
e co
ntin
uing
ade
quac
y an
d eff
ectiv
enes
s of
the
safe
ty m
anag
emen
t sy
stem
incl
udin
g at
leas
t co
nsid
erat
ion
of:
(b) c
hang
ing
inte
rnal
and
ex
tern
al c
ircum
stan
ces
(see
1.
Cont
ext o
f the
org
anis
atio
n);
I.1 a
nd I.
3 (in
gen
eral
)
149
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
1. T
op m
anag
emen
t sh
all r
egul
arly
revi
ew th
e co
ntin
uing
ade
quac
y an
d eff
ectiv
enes
s of
the
safe
ty m
anag
emen
t sy
stem
incl
udin
g at
leas
t co
nsid
erat
ion
of:
(c) t
he o
rgan
isat
ion’
s sa
fety
pe
rfor
man
ce re
late
d to
:(i)
the
achi
evem
ent o
f its
saf
ety
obje
ctiv
es;
I.1 a
nd I.
3 (in
gen
eral
)
150
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
1. T
op m
anag
emen
t sh
all r
egul
arly
revi
ew th
e co
ntin
uing
ade
quac
y an
d eff
ectiv
enes
s of
the
safe
ty m
anag
emen
t sy
stem
incl
udin
g at
leas
t co
nsid
erat
ion
of:
(c) t
he o
rgan
isat
ion’
s sa
fety
pe
rfor
man
ce re
late
d to
:(ii
) the
resu
lts fr
om it
s m
onito
ring
activ
ities
, inc
ludi
ng th
e in
tern
al
audi
t find
ings
, and
inte
rnal
ac
cide
nt/in
cide
nt in
vest
igat
ions
an
d st
atus
of t
heir
resp
ectiv
e ac
tions
;
I.1 a
nd I.
3 (in
gen
eral
)
119
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ion
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at e
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urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
151
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
1. T
op m
anag
emen
t sh
all r
egul
arly
revi
ew th
e co
ntin
uing
ade
quac
y an
d eff
ectiv
enes
s of
the
safe
ty m
anag
emen
t sy
stem
incl
udin
g at
leas
t co
nsid
erat
ion
of:
(c) t
he o
rgan
isat
ion’
s sa
fety
pe
rfor
man
ce re
late
d to
:(ii
i) th
e re
leva
nt o
utpu
ts fr
om
supe
rvis
ory
activ
ities
con
duct
ed
by th
e na
tiona
l saf
ety
auth
ority
;
I.1 a
nd I.
3 (in
gen
eral
)
152
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
1. T
op m
anag
emen
t sh
all r
egul
arly
revi
ew th
e co
ntin
uing
ade
quac
y an
d eff
ectiv
enes
s of
the
safe
ty m
anag
emen
t sy
stem
incl
udin
g at
leas
t co
nsid
erat
ion
of:
(d) r
ecom
men
datio
ns fo
r im
prov
emen
t.I.1
and
I.3
(in g
ener
al)
153
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
2.
Base
d on
th
e ou
tput
s of
its
man
agem
ent r
evie
w, t
he
top
man
agem
ent s
hall
take
ove
rall
resp
onsi
bilit
y fo
r the
pla
nnin
g an
d im
plem
enta
tion
of n
eede
d ch
ange
s to
the
safe
ty
man
agem
ent s
yste
m.
I.1.(g
)
154
7.
IMPR
OVE
MEN
T7.
1.
Lear
ning
from
ac
cide
nts
and
inci
dent
s
7.1.
1.
Acci
dent
s an
d in
cide
nts
rela
ted
to th
e or
gani
satio
n’s
railw
ay
oper
atio
ns s
hall
be:
(a) r
epor
ted,
logg
ed, i
nves
tigat
ed
and
anal
ysed
to d
eter
min
e th
eir
caus
es;
I.3 (i
n ge
nera
l)
155
7.
IMPR
OVE
MEN
T7.
1.
Lear
ning
from
ac
cide
nts
and
inci
dent
s
7.1.
1.
Acci
dent
s an
d in
cide
nts
rela
ted
to th
e or
gani
satio
n’s
railw
ay
oper
atio
ns s
hall
be:
(b) r
epor
ted
to n
atio
nal b
odie
s as
ap
prop
riate
.I.3
(in
gene
ral)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
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ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
120
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
156
7.
IMPR
OVE
MEN
T7.
1.
Lear
ning
from
ac
cide
nts
and
inci
dent
s
7.1.
2. T
he o
rgan
isat
ion
shal
l ens
ure
that
:(a
) rec
omm
enda
tions
from
the
natio
nal s
afet
y au
thor
ity, t
he
natio
nal i
nves
tigat
ing
body
and
in
dust
ry/in
tern
al in
vest
igat
ions
ar
e ev
alua
ted
and
impl
emen
ted
if ap
prop
riate
or m
anda
ted;
I.3 (i
n ge
nera
l), A
rt.
4(4)
157
7.
IMPR
OVE
MEN
T7.
1.
Lear
ning
from
ac
cide
nts
and
inci
dent
s
7.1.
2. T
he o
rgan
isat
ion
shal
l ens
ure
that
:(b
) rel
evan
t rep
orts
/info
rmat
ion
from
oth
er in
tere
sted
par
ties
such
as
railw
ay u
nder
taki
ngs,
infr
astr
uctu
re m
anag
ers,
entit
ies
in c
harg
e of
mai
nten
ance
and
ra
ilway
veh
icle
kee
pers
are
co
nsid
ered
and
take
n in
to
acco
unt.
I.3 (i
n ge
nera
l), I.
7 (in
ge
nera
l), II
I.9, I
V.9,
Art
. 4(
4), A
rt. 5
(2),
Art
. 5(3
)
158
7.
IMPR
OVE
MEN
T7.
1.
Lear
ning
from
ac
cide
nts
and
inci
dent
s
7.1.
3. T
he o
rgan
isat
ion
shal
l use
info
rmat
ion
rela
ting
to th
e in
vest
igat
ion
to re
view
the
risk
asse
ssm
ent (
see
3.1.
1. R
isk
asse
ssm
ent)
, to
lear
n w
ith
the
aim
of i
mpr
ovin
g sa
fety
an
d, w
here
app
licab
le, t
o ad
opt c
orre
ctiv
e an
d/or
im
prov
emen
t mea
sure
s (s
ee 5
.4. M
anag
emen
t of
chan
ge).
I.3 a
nd I.
4 (in
gen
eral
), A
rt. 4
(4)
121
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ion
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urop
a.eu
.©
202
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Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
159
7.
IMPR
OVE
MEN
T7.
2.
Cont
inua
l im
prov
emen
t7.
2.1.
The
org
anis
atio
n sh
all c
ontin
ually
impr
ove
the
adeq
uacy
and
eff
ectiv
enes
s of
its
safe
ty
man
agem
ent s
yste
m,
taki
ng in
to a
ccou
nt
the
fram
ewor
k se
t out
in
Reg
ulat
ion
(EU
) No
1078
/201
2 an
d at
leas
t the
ou
tput
s of
the
follo
win
g ac
tiviti
es:
(a) m
onito
ring
(see
6.1
. M
onito
ring)
;I.4
(in
gene
ral),
Art
. 4(
4), A
rt. 7
(1),
Art
. 9(3
)
160
7.
IMPR
OVE
MEN
T7.
2.
Cont
inua
l im
prov
emen
t7.
2.1.
The
org
anis
atio
n sh
all c
ontin
ually
impr
ove
the
adeq
uacy
and
eff
ectiv
enes
s of
its
safe
ty
man
agem
ent s
yste
m,
taki
ng in
to a
ccou
nt
the
fram
ewor
k se
t out
in
Reg
ulat
ion
(EU
) No
1078
/201
2 an
d at
leas
t the
ou
tput
s of
the
follo
win
g ac
tiviti
es:
(b) i
nter
nal a
uditi
ng (s
ee 6
.2.
Inte
rnal
aud
iting
);I.4
(in
gene
ral)
161
7.
IMPR
OVE
MEN
T7.
2.
Cont
inua
l im
prov
emen
t7.
2.1.
The
org
anis
atio
n sh
all c
ontin
ually
impr
ove
the
adeq
uacy
and
eff
ectiv
enes
s of
its
safe
ty
man
agem
ent s
yste
m,
taki
ng in
to a
ccou
nt
the
fram
ewor
k se
t out
in
Reg
ulat
ion
(EU
) No
1078
/201
2 an
d at
leas
t the
ou
tput
s of
the
follo
win
g ac
tiviti
es:
(c) m
anag
emen
t rev
iew
(see
6.3
. M
anag
emen
t rev
iew
);I.4
(in
gene
ral)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
122
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
162
7.
IMPR
OVE
MEN
T7.
2.
Cont
inua
l im
prov
emen
t7.
2.1.
The
org
anis
atio
n sh
all c
ontin
ually
impr
ove
the
adeq
uacy
and
eff
ectiv
enes
s of
its
safe
ty
man
agem
ent s
yste
m,
taki
ng in
to a
ccou
nt
the
fram
ewor
k se
t out
in
Reg
ulat
ion
(EU
) No
1078
/201
2 an
d at
leas
t the
ou
tput
s of
the
follo
win
g ac
tiviti
es:
(d) l
earn
ing
from
acc
iden
ts a
nd
inci
dent
s (s
ee 7
.1. L
earn
ing
from
ac
cide
nts
and
inci
dent
s).
I.4 (i
n ge
nera
l)
163
7.
IMPR
OVE
MEN
T7.
2.
Cont
inua
l im
prov
emen
t7.
2.2.
The
org
anis
atio
n sh
all p
rovi
de m
eans
to
mot
ivat
ing
staff
and
oth
er
inte
rest
ed p
artie
s to
be
activ
e in
impr
ovin
g sa
fety
as
par
t of i
ts o
rgan
isat
iona
l le
arni
ng.
164
7.
IMPR
OVE
MEN
T7.
2.
Cont
inua
l im
prov
emen
t7.
2.3.
The
org
anis
atio
n sh
all p
rovi
de a
str
ateg
y to
con
tinua
lly im
prov
e its
sa
fety
cul
ture
, rel
ying
on
the
use
of e
xper
tise
and
reco
gnis
ed m
etho
ds to
id
entif
y be
havi
oura
l iss
ues
affec
ting
the
diffe
rent
par
ts
of th
e sa
fety
man
agem
ent
syst
em a
nd to
put
in p
lace
m
easu
res
to a
ddre
ss th
ese.
123
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
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nloa
d th
e la
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ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
Ann
ex II
Map
ping
Tab
le R
U
NO
TE (1
)(1
) Com
mis
sion
Impl
emen
ting
Regu
latio
n (E
U) N
o 40
2/20
13 o
f 30
Apr
il 20
13 o
n th
e co
mm
on s
afet
y m
etho
d fo
r ris
k ev
alua
tion
and
asse
ssm
ent a
nd re
peal
ing
Regu
latio
n (E
C) N
o 35
2/20
09 (O
J L 1
21, 3
.5.2
013,
p. 8
).
NO
TE (2
)
(2)
Com
mis
sion
Reg
ulat
ion
(EU
) No
1078
/201
2 of
16
Nov
embe
r 201
2 on
a c
omm
on s
afet
y m
etho
d fo
r mon
itorin
g to
be
appl
ied
by ra
ilway
und
erta
king
s, in
fras
truc
ture
man
ager
s af
ter r
ecei
ving
a s
afet
y ce
rtifi
cate
or s
afet
y au
thor
isat
ion
and
by e
ntiti
es in
cha
rge
of m
aint
enan
ce (O
J L 3
20, 1
7.11
.201
2, p
. 8).
NO
TE (3
)(3
) Po
int 2
.1. o
f the
App
endi
x to
Ann
ex I
to D
irect
ive
(EU
) 201
6/79
8.
NO
TE (4
)(4
) Po
int 2
.2. o
f the
App
endi
x to
Ann
ex I
to D
irect
ive
(EU
) 201
6/79
8.
NO
TE (5
)
(5)
Com
mis
sion
Reg
ulat
ion
(EU
) 201
5/99
5 of
8 Ju
ne 2
015
amen
ding
Dec
isio
n 20
12/7
57/E
U c
once
rnin
g th
e te
chni
cal s
peci
ficat
ion
for i
nter
oper
abili
ty re
latin
g to
th
e ‘o
pera
tion
and
traffi
c m
anag
emen
t’ su
bsys
tem
of t
he ra
il sy
stem
in th
e Eu
rope
an U
nion
(OJ L
165
, 30.
6.20
15, p
. 1).
Regu
lati
on E
U 2
018/
762
(CSM
on
SMS)
- A
nnex
I - S
MS
requ
irem
ents
rela
ted
to R
ailw
ay U
nder
taki
ngs
Reg
EU 2
019/
779
- EC
M R
egul
atio
n
RU S
MS
docu
men
tati
on
refe
renc
es
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
11.
CO
NTE
XT
OF
THE
ORG
AN
ISAT
ION
Non
e1.
1. T
he o
rgan
isat
ion
shal
l:(a
) des
crib
e th
e ty
pe, e
xten
t and
ar
ea o
f its
ope
ratio
ns;
I.1.(a
) (pa
rtia
lly
cove
red)
21.
CO
NTE
XT
OF
THE
ORG
AN
ISAT
ION
Non
e1.
1. T
he o
rgan
isat
ion
shal
l:(b
) ide
ntify
the
serio
us ri
sks
for s
afet
y po
sed
by it
s ra
ilway
op
erat
ions
whe
ther
they
are
ca
rrie
d ou
t by
the
orga
nisa
tion
itsel
f, or
by
cont
ract
ors,
part
ners
or
supp
liers
und
er it
s co
ntro
l;
I.2 (i
n ge
nera
l)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
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ver
sion
at e
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urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
124
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
31.
CO
NTE
XT
OF
THE
ORG
AN
ISAT
ION
Non
e1.
1. T
he o
rgan
isat
ion
shal
l:(c
) ide
ntify
inte
rest
ed p
artie
s (e
.g.
regu
lato
ry b
odie
s, au
thor
ities
, in
fras
truc
ture
man
ager
s, co
ntra
ctor
s, su
pplie
rs, p
artn
ers)
, in
clud
ing
thos
e pa
rtie
s ex
tern
al
to th
e ra
ilway
sys
tem
, tha
t are
re
leva
nt to
the
safe
ty m
anag
emen
t sy
stem
;
I.2.1
(par
tially
co
vere
d), I
.9.1
(p
artia
lly c
over
ed)
41.
CO
NTE
XT
OF
THE
ORG
AN
ISAT
ION
Non
e1.
1. T
he o
rgan
isat
ion
shal
l:(d
) ide
ntify
and
mai
ntai
n le
gal
and
othe
r req
uire
men
ts re
late
d to
sa
fety
from
the
inte
rest
ed p
artie
s re
ferr
ed to
in p
oint
(c);
I.1.(b
) and
(f),
I.9.3
51.
CO
NTE
XT
OF
THE
ORG
AN
ISAT
ION
Non
e1.
1. T
he o
rgan
isat
ion
shal
l:(e
) ens
ure
that
the
requ
irem
ents
re
ferr
ed to
in p
oint
(d) a
re ta
ken
into
acc
ount
in d
evel
opin
g,
impl
emen
ting
and
mai
ntai
ning
the
safe
ty m
anag
emen
t sys
tem
;
I.1.(d
)
61.
CO
NTE
XT
OF
THE
ORG
AN
ISAT
ION
Non
e1.
1. T
he o
rgan
isat
ion
shal
l:(f
) des
crib
e th
e sc
ope
of th
e sa
fety
man
agem
ent s
yste
m,
indi
catin
g w
hich
par
t of t
he
busi
ness
is in
clud
ed o
r not
in it
s sc
ope
and
taki
ng in
to a
ccou
nt th
e re
quire
men
ts re
ferr
ed to
in p
oint
(d
).
I.1.(a
) (pa
rtia
lly
cove
red)
, I.9
.1
(par
tially
cov
ered
)
72.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip a
nd
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te le
ader
ship
an
d co
mm
itmen
t to
the
deve
lopm
ent,
impl
emen
tatio
n,
mai
nten
ance
and
con
tinua
l im
prov
emen
t of t
he s
afet
y m
anag
emen
t sys
tem
by:
(a) t
akin
g ov
eral
l acc
ount
abili
ty
and
resp
onsi
bilit
y fo
r saf
ety;
I.5.5
and
I.5
(in
gene
ral)
125
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
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ted.
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nloa
d th
e la
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ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
82.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip a
nd
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te le
ader
ship
an
d co
mm
itmen
t to
the
deve
lopm
ent,
impl
emen
tatio
n,
mai
nten
ance
and
con
tinua
l im
prov
emen
t of t
he s
afet
y m
anag
emen
t sys
tem
by:
(b) e
nsur
ing
com
mitm
ent t
o sa
fety
by
man
agem
ent a
t diff
eren
t le
vels
with
in th
e or
gani
satio
n th
roug
h th
eir a
ctiv
ities
and
in
thei
r rel
atio
nshi
ps w
ith s
taff
and
cont
ract
ors;
I.1.(g
) and
(h) (
part
ially
co
vere
d), I
.9.3
92.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip a
nd
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te le
ader
ship
an
d co
mm
itmen
t to
the
deve
lopm
ent,
impl
emen
tatio
n,
mai
nten
ance
and
con
tinua
l im
prov
emen
t of t
he s
afet
y m
anag
emen
t sys
tem
by:
(c) e
nsur
ing
that
the
safe
ty
polic
y an
d sa
fety
obj
ectiv
es a
re
esta
blis
hed,
und
erst
ood
and
are
com
patib
le w
ith th
e st
rate
gic
dire
ctio
n of
the
orga
nisa
tion;
I.1(a
) and
(b),
I.9.3
102.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip a
nd
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te le
ader
ship
an
d co
mm
itmen
t to
the
deve
lopm
ent,
impl
emen
tatio
n,
mai
nten
ance
and
con
tinua
l im
prov
emen
t of t
he s
afet
y m
anag
emen
t sys
tem
by:
(d) e
nsur
ing
the
inte
grat
ion
of th
e sa
fety
man
agem
ent
syst
em re
quire
men
ts in
to th
e or
gani
satio
n’s
busi
ness
pro
cess
es;
I.1(d
)
112.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip a
nd
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te le
ader
ship
an
d co
mm
itmen
t to
the
deve
lopm
ent,
impl
emen
tatio
n,
mai
nten
ance
and
con
tinua
l im
prov
emen
t of t
he s
afet
y m
anag
emen
t sys
tem
by:
(e) e
nsur
ing
that
the
reso
urce
s ne
eded
for t
he sa
fety
man
agem
ent
syst
em a
re a
vaila
ble;
I.1(e
)
122.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip a
nd
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te le
ader
ship
an
d co
mm
itmen
t to
the
deve
lopm
ent,
impl
emen
tatio
n,
mai
nten
ance
and
con
tinua
l im
prov
emen
t of t
he s
afet
y m
anag
emen
t sys
tem
by:
(f) e
nsur
ing
that
the
safe
ty
man
agem
ent s
yste
m is
effe
ctiv
e in
co
ntro
lling
the
safe
ty ri
sks
pose
d by
the
orga
nisa
tion;
I.1.(c
) (pa
rtia
lly
cove
red)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
126
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
132.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip a
nd
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te le
ader
ship
an
d co
mm
itmen
t to
the
deve
lopm
ent,
impl
emen
tatio
n,
mai
nten
ance
and
con
tinua
l im
prov
emen
t of t
he s
afet
y m
anag
emen
t sys
tem
by:
(g) e
ncou
ragi
ng s
taff
to
supp
ort c
ompl
ianc
e w
ith th
e sa
fety
man
agem
ent s
yste
m
requ
irem
ents
;
I.1.(g
) and
(h) (
part
ially
co
vere
d)
142.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip a
nd
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te le
ader
ship
an
d co
mm
itmen
t to
the
deve
lopm
ent,
impl
emen
tatio
n,
mai
nten
ance
and
con
tinua
l im
prov
emen
t of t
he s
afet
y m
anag
emen
t sys
tem
by:
(h) p
rom
otin
g co
ntin
ual
impr
ovem
ent o
f the
saf
ety
man
agem
ent s
yste
m;
I.4 (p
artia
lly c
over
ed)
152.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip a
nd
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te le
ader
ship
an
d co
mm
itmen
t to
the
deve
lopm
ent,
impl
emen
tatio
n,
mai
nten
ance
and
con
tinua
l im
prov
emen
t of t
he s
afet
y m
anag
emen
t sys
tem
by:
(i) e
nsur
ing
that
saf
ety
is
cons
ider
ed w
hen
iden
tifyi
ng
and
man
agin
g th
e or
gani
satio
n’s
busi
ness
risk
s an
d ex
plai
ning
how
co
nflic
t bet
wee
n sa
fety
and
oth
er
busi
ness
goa
ls w
ill b
e re
cogn
ised
an
d re
solv
ed;
I.2.2
and
I.2.
3 (p
artia
lly
cove
red)
, I.1
.(f),
I.9.1
162.
LE
AD
ERSH
IP2.
1.
Lead
ersh
ip a
nd
com
mitm
ent
2.1.
1. T
op m
anag
emen
t sh
all d
emon
stra
te le
ader
ship
an
d co
mm
itmen
t to
the
deve
lopm
ent,
impl
emen
tatio
n,
mai
nten
ance
and
con
tinua
l im
prov
emen
t of t
he s
afet
y m
anag
emen
t sys
tem
by:
(j) p
rom
otin
g a
posi
tive
safe
ty
cultu
re.
172.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.1.
A
doc
umen
t des
crib
ing
the
orga
nisa
tion’
s sa
fety
pol
icy
is e
stab
lishe
d by
the
top
man
agem
ent a
nd is
:
(a) a
ppro
pria
te to
the
orga
nisa
tion’
s ty
pe a
nd e
xten
t of
railw
ay o
pera
tions
;
I.1.(a
)
127
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ion
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ailw
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right
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serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
182.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.1.
A
doc
umen
t des
crib
ing
the
orga
nisa
tion’
s sa
fety
pol
icy
is e
stab
lishe
d by
the
top
man
agem
ent a
nd is
:
(b) a
ppro
ved
by th
e or
gani
satio
n’s
chie
f exe
cutiv
e (o
r a
repr
esen
tativ
e(s)
of t
he to
p-m
anag
emen
t);
I.1.(a
)
192.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.1.
A
doc
umen
t des
crib
ing
the
orga
nisa
tion’
s sa
fety
pol
icy
is e
stab
lishe
d by
the
top
man
agem
ent a
nd is
:
(c) a
ctiv
ely
impl
emen
ted,
co
mm
unic
ated
and
mad
e av
aila
ble
to a
ll st
aff.
I.1.(a
)
202.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.2.
The
saf
ety
polic
y sh
all:
(a) i
nclu
de a
com
mitm
ent t
o co
nfor
m w
ith a
ll le
gal a
nd o
ther
re
quire
men
ts re
late
d to
saf
ety;
I.1.(b
) (pa
rtia
lly
cove
red)
and
I.1.
(a) (
in
gene
ral)
212.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.2.
The
saf
ety
polic
y sh
all:
(b) p
rovi
de a
fram
ewor
k fo
r se
ttin
g sa
fety
obj
ectiv
es a
nd
eval
uatin
g th
e or
gani
satio
n’s
safe
ty p
erfo
rman
ce a
gain
st th
ese
obje
ctiv
es;
I.1.(b
) and
(c ),
and
I.1
.(a) (
in g
ener
al),
I.9.3
222.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.2.
The
saf
ety
polic
y sh
all:
(c) i
nclu
de a
com
mitm
ent t
o co
ntro
l saf
ety
risks
whi
ch a
rise
both
from
its
own
activ
ities
and
th
ose
caus
ed b
y ot
hers
;
I.1.(f
), an
d I.1
.(a) (
in
gene
ral),
I.9.
4 (in
ge
nera
l), I.
9.5
(in
gene
ral)
232.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.2.
The
saf
ety
polic
y sh
all:
(d) i
nclu
de a
com
mitm
ent t
o co
ntin
ual i
mpr
ovem
ent o
f the
sa
fety
man
agem
ent s
yste
m;
I.4 a
nd I.
1.(a
) (in
ge
nera
l)
242.
LE
AD
ERSH
IP2.
2.
Safe
ty p
olic
y2.
2.2.
The
saf
ety
polic
y sh
all:
(e) b
e m
aint
aine
d in
acc
orda
nce
with
the
busi
ness
str
ateg
y an
d th
e ev
alua
tion
of th
e sa
fety
pe
rfor
man
ce o
f the
org
anis
atio
n.
I.1.(c
) and
I.1.
(a) (
in
gene
ral)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
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ion
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(01/
03/2
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olle
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ncy
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ailw
ays.
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right
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serv
ed.
128
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
252.
LE
AD
ERSH
IP2.
3.
Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
2.3.
1. T
he re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
of s
taff
havi
ng
a ro
le th
at a
ffect
s sa
fety
(in
clud
ing
man
agem
ent
and
othe
r sta
ff in
volv
ed in
sa
fety
-rel
ated
task
s) s
hall
be
defin
ed a
t all
leve
ls w
ithin
the
orga
nisa
tion,
doc
umen
ted,
as
sign
ed a
nd c
omm
unic
ated
to
them
.
I.5 (i
n ge
nera
l)
262.
LE
AD
ERSH
IP2.
3.
Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
2.3.
2. T
he o
rgan
isat
ion
shal
l ens
ure
that
sta
ff w
ith
dele
gate
d re
spon
sibi
litie
s fo
r sa
fety
-rel
ated
task
s sh
all h
ave
the
auth
ority
, com
pete
nce
and
appr
opria
te re
sour
ces
to
perf
orm
thei
r tas
ks w
ithou
t be
ing
adve
rsel
y aff
ecte
d by
th
e ac
tiviti
es o
f oth
er b
usin
ess
func
tions
.
I.5 (i
n ge
nera
l), I.
6 (in
gen
eral
), II.
6 (in
ge
nera
l), II
I.1, I
II.7,
IV.8
272.
LE
AD
ERSH
IP2.
3.
Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
2.3.
3.
Del
egat
ion
of
resp
onsi
bilit
y fo
r saf
ety-
rela
ted
task
s sh
all b
e do
cum
ente
d an
d co
mm
unic
ated
to th
e re
leva
nt s
taff,
acc
epte
d an
d un
ders
tood
.
I.5 (i
n ge
nera
l)
129
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ailw
ays.
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right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
282.
LE
AD
ERSH
IP2.
3.
Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
2.3.
4. T
he o
rgan
isat
ion
shal
l de
scrib
e th
e al
loca
tion
of
role
s re
ferr
ed to
in p
arag
raph
2.
3.1.
to b
usin
ess
func
tions
w
ithin
and
whe
re re
leva
nt,
outs
ide
the
orga
nisa
tion
(see
5.
3. C
ontr
acto
rs, p
artn
ers
and
supp
liers
).
I.5 (i
n ge
nera
l), I.
9.4
and
I.9.6
(in
gene
ral)
292.
LE
AD
ERSH
IP2.
4.
Cons
ulta
tion
of s
taff
and
othe
r pa
rtie
s
2.4.
1.
Staff
, the
ir re
pres
enta
tives
and
ex
tern
al in
tere
sted
par
ties,
as a
ppro
pria
te a
nd w
here
re
leva
nt, s
hall
be c
onsu
lted
in d
evel
opin
g, m
aint
aini
ng
and
impr
ovin
g th
e sa
fety
m
anag
emen
t sys
tem
in
the
rele
vant
par
ts th
ey a
re
resp
onsi
ble
for,
incl
udin
g th
e sa
fety
asp
ects
of o
pera
tiona
l pr
oced
ures
.
I.1.(h
)
302.
LE
AD
ERSH
IP2.
4.
Cons
ulta
tion
of s
taff
and
othe
r pa
rtie
s
2.4.
2. T
he o
rgan
isat
ion
shal
l fa
cilit
ate
the
cons
ulta
tion
of
staff
by
prov
idin
g th
e m
etho
ds
and
mea
ns fo
r inv
olvi
ng s
taff,
re
cord
ing
staff
’s op
inio
n an
d pr
ovid
ing
feed
back
on
staff
’s op
inio
n.
I.5.4
and
I.1.
(h)
313.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
1. T
he o
rgan
isat
ion
shal
l:(a
) ide
ntify
and
ana
lyse
all
oper
atio
nal,
orga
nisa
tiona
l an
d te
chni
cal r
isks
rele
vant
to
the
type
, ext
ent a
nd a
rea
of
oper
atio
ns c
arrie
d ou
t by
the
orga
nisa
tion.
Suc
h ris
ks s
hall
incl
ude
thos
e ar
isin
g fr
om h
uman
an
d or
gani
satio
nal f
acto
rs s
uch
as w
orkl
oad,
job
desi
gn, f
atig
ue
or s
uita
bilit
y of
pro
cedu
res,
and
the
activ
ities
of o
ther
inte
rest
ed
part
ies
(see
1. C
onte
xt o
f the
or
gani
satio
n);
I.2.2
, I.2
.3, I
.9.1
(in
gene
ral)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
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ion
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olle
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ailw
ays.
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ed.
130
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
323.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
1. T
he o
rgan
isat
ion
shal
l:(b
) eva
luat
e th
e ris
ks re
ferr
ed
to in
poi
nt (a
) by
appl
ying
ap
prop
riate
risk
ass
essm
ent
met
hods
;
I.2.2
333.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
1. T
he o
rgan
isat
ion
shal
l:(c
) dev
elop
and
put
in
plac
e sa
fety
mea
sure
s, w
ith
iden
tifica
tion
of a
ssoc
iate
d re
spon
sibi
litie
s (s
ee 2
.3.
Org
anis
atio
nal r
oles
, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
);
I.3 (i
n ge
nera
l)
343.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
1. T
he o
rgan
isat
ion
shal
l:(d
) dev
elop
a s
yste
m to
mon
itor
the
effec
tiven
ess
of s
afet
y m
easu
res
(see
6.1
. Mon
itorin
g);
I.3 (i
n ge
nera
l)
353.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
1. T
he o
rgan
isat
ion
shal
l:(e
) rec
ogni
se th
e ne
ed to
co
llabo
rate
with
oth
er in
tere
sted
pa
rtie
s (s
uch
as ra
ilway
un
dert
akin
gs, i
nfra
stru
ctur
e m
anag
ers,
man
ufac
ture
r, m
aint
enan
ce s
uppl
ier,
entit
y in
ch
arge
of m
aint
enan
ce, r
ailw
ay
vehi
cle
keep
er, s
ervi
ce p
rovi
der
and
proc
urem
ent e
ntity
), w
here
ap
prop
riate
, on
shar
ed ri
sks
and
the
putt
ing
in p
lace
of a
dequ
ate
safe
ty m
easu
res;
I.2.1
, I.7
(in
gene
ral)
363.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
1. T
he o
rgan
isat
ion
shal
l:(f
) com
mun
icat
e ris
ks to
sta
ff an
d in
volv
ed e
xter
nal p
artie
s (s
ee 4
.4.
Info
rmat
ion
and
com
mun
icat
ion)
.
I.1.(h
) par
tially
co
vere
d), I
.9.4
(p
artia
lly c
over
ed)
131
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ion
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ailw
ays.
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right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
373.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.1.
Ri
sk a
sses
smen
t3.
1.1.
2. W
hen
asse
ssin
g ris
k,
an o
rgan
isat
ion
shal
l tak
e in
to
acco
unt t
he n
eed
to d
eter
min
e,
prov
ide
and
sust
ain
a sa
fe w
orki
ng
envi
ronm
ent w
hich
con
form
s to
ap
plic
able
legi
slat
ion,
in p
artic
ular
D
irect
ive
89/3
91/E
EC.
I.2.3
383.
PL
AN
NIN
G3.
1.
Actio
ns to
ad
dres
s ris
ks3.
1.2.
Pl
anni
ng fo
r cha
nge
3.1.
2.1.
The
org
anis
atio
n sh
all
iden
tify
pote
ntia
l saf
ety
risks
an
d ap
prop
riate
saf
ety
mea
sure
s (s
ee 3
.1.1
. Ris
k as
sess
men
t)
befo
re th
e im
plem
enta
tion
of
a ch
ange
(see
5.4
. Man
agem
ent
of c
hang
e) in
acc
orda
nce
with
th
e ris
k m
anag
emen
t pro
cess
se
t out
in th
e Re
gula
tion
(EU
) N
o 40
2/20
13 (1
), in
clud
ing
cons
ider
atio
n of
the
safe
ty ri
sks
from
the
chan
ge p
roce
ss it
self.
I.2.2
393.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
1. T
he o
rgan
isat
ion
shal
l es
tabl
ish
safe
ty o
bjec
tives
fo
r rel
evan
t fun
ctio
ns a
t re
leva
nt le
vels
to m
aint
ain
and,
whe
re re
ason
ably
pr
actic
able
, im
prov
e its
saf
ety
perf
orm
ance
.
I.1.(b
) and
(c )
403.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
2. T
he s
afet
y ob
ject
ives
sh
all:
(a) b
e co
nsis
tent
with
the
safe
ty
polic
y an
d th
e or
gani
satio
n’s
stra
tegi
c ob
ject
ives
(whe
re
appl
icab
le);
I.1.(b
)
413.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
2. T
he s
afet
y ob
ject
ives
sh
all:
(b) b
e lin
ked
to th
e pr
iorit
y ris
ks th
at in
fluen
ce th
e sa
fety
pe
rfor
man
ce o
f the
org
anis
atio
n;
I.1.(b
) and
(c )
423.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
2. T
he s
afet
y ob
ject
ives
sh
all:
(c) b
e m
easu
rabl
e;
GU
IDA
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E O
N E
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CER
TIFI
CA
TIO
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RO
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ion
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ed.
132
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
433.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
2. T
he s
afet
y ob
ject
ives
sh
all:
(d) t
ake
into
acc
ount
app
licab
le
lega
l and
oth
er re
quire
men
ts;
I.1.(b
)
443.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
2. T
he s
afet
y ob
ject
ives
sh
all:
(e) b
e re
view
ed a
s re
gard
s th
eir
achi
evem
ents
and
revi
sed
as
appr
opria
te;
453.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
2. T
he s
afet
y ob
ject
ives
sh
all:
(f) b
e co
mm
unic
ated
.
463.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
3. T
he o
rgan
isat
ion
shal
l ha
ve p
lan(
s) to
des
crib
e ho
w it
will
ach
ieve
its
safe
ty
obje
ctiv
es.
I.1.(d
)
473.
PL
AN
NIN
G3.
2.
Safe
ty
obje
ctiv
es a
nd
plan
ning
3.2.
4. T
he o
rgan
isat
ion
shal
l des
crib
e th
e st
rate
gy
and
plan
(s) u
sed
to m
onito
r th
e ac
hiev
emen
t of t
he
safe
ty o
bjec
tives
(see
6.1
. M
onito
ring)
.
I.3 (i
n ge
nera
l)
484.
SU
PPO
RT4.
1.
Reso
urce
s4.
1.1.
The
org
anis
atio
n sh
all p
rovi
de th
e re
sour
ces,
incl
udin
g co
mpe
tent
sta
ff an
d eff
ectiv
e an
d us
eabl
e eq
uipm
ent,
need
ed
for t
he e
stab
lishm
ent,
impl
emen
tatio
n, m
aint
enan
ce
and
cont
inua
l im
prov
emen
t of
the
safe
ty m
anag
emen
t sy
stem
.
I.1.(e
), II.
3, IV
.3, I
V.4,
IV.5
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ion
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ailw
ays.
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right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
494.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
1. T
he o
rgan
isat
ion’
s co
mpe
tenc
e m
anag
emen
t sy
stem
sha
ll en
sure
that
sta
ff ha
ving
a ro
le th
at a
ffect
s sa
fety
are
com
pete
nt in
th
e sa
fety
-rel
ated
task
s fo
r w
hich
they
are
resp
onsi
ble
(see
2.3
. Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
), in
clud
ing
at le
ast:
(a) i
dent
ifica
tion
of th
e co
mpe
tenc
ies
(incl
udin
g kn
owle
dge,
ski
lls, n
on-t
echn
ical
be
havi
ours
and
att
itude
s) re
quire
d fo
r saf
ety-
rela
ted
task
s;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
504.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
1. T
he o
rgan
isat
ion’
s co
mpe
tenc
e m
anag
emen
t sy
stem
sha
ll en
sure
that
sta
ff ha
ving
a ro
le th
at a
ffect
s sa
fety
are
com
pete
nt in
th
e sa
fety
-rel
ated
task
s fo
r w
hich
they
are
resp
onsi
ble
(see
2.3
. Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
), in
clud
ing
at le
ast:
(b) s
elec
tion
prin
cipl
es (b
asic
ed
ucat
iona
l lev
el, p
sych
olog
ical
an
d ph
ysic
al fi
tnes
s re
quire
d);
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
514.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
1. T
he o
rgan
isat
ion’
s co
mpe
tenc
e m
anag
emen
t sy
stem
sha
ll en
sure
that
sta
ff ha
ving
a ro
le th
at a
ffect
s sa
fety
are
com
pete
nt in
th
e sa
fety
-rel
ated
task
s fo
r w
hich
they
are
resp
onsi
ble
(see
2.3
. Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
), in
clud
ing
at le
ast:
(c) i
nitia
l tra
inin
g, e
xper
ienc
e an
d qu
alifi
catio
n;I.6
(in
gene
ral),
II.6
(in
gene
ral),
III.1
, III.
7, IV
.8
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
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ion
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ontr
olle
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urop
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ncy
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ailw
ays.
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right
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serv
ed.
134
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
524.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
1. T
he o
rgan
isat
ion’
s co
mpe
tenc
e m
anag
emen
t sy
stem
sha
ll en
sure
that
sta
ff ha
ving
a ro
le th
at a
ffect
s sa
fety
are
com
pete
nt in
th
e sa
fety
-rel
ated
task
s fo
r w
hich
they
are
resp
onsi
ble
(see
2.3
. Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
), in
clud
ing
at le
ast:
(d) o
ngoi
ng tr
aini
ng a
nd p
erio
dic
upda
te o
f exi
stin
g co
mpe
tenc
ies;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
534.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
1. T
he o
rgan
isat
ion’
s co
mpe
tenc
e m
anag
emen
t sy
stem
sha
ll en
sure
that
sta
ff ha
ving
a ro
le th
at a
ffect
s sa
fety
are
com
pete
nt in
th
e sa
fety
-rel
ated
task
s fo
r w
hich
they
are
resp
onsi
ble
(see
2.3
. Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
), in
clud
ing
at le
ast:
(e) p
erio
dic
asse
ssm
ent o
f co
mpe
tenc
e an
d ch
ecks
of
psyc
holo
gica
l and
phy
sica
l fitn
ess
to e
nsur
e th
at q
ualifi
catio
ns a
nd
skill
s ar
e m
aint
aine
d ov
er ti
me;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
544.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
1. T
he o
rgan
isat
ion’
s co
mpe
tenc
e m
anag
emen
t sy
stem
sha
ll en
sure
that
sta
ff ha
ving
a ro
le th
at a
ffect
s sa
fety
are
com
pete
nt in
th
e sa
fety
-rel
ated
task
s fo
r w
hich
they
are
resp
onsi
ble
(see
2.3
. Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
), in
clud
ing
at le
ast:
(f) s
peci
fic tr
aini
ng in
rele
vant
pa
rts
of th
e sa
fety
man
agem
ent
syst
em in
ord
er to
del
iver
thei
r sa
fety
-rel
ated
task
s.
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
135
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ailw
ays.
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right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
554.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
2. T
he o
rgan
isat
ion
shal
l pr
ovid
e a
trai
ning
pro
gram
me,
as
refe
rred
to in
poi
nts
(c),
(d)
and
(f) o
f par
agra
ph 4
.2.1
, for
st
aff p
erfo
rmin
g sa
fety
-rel
ated
ta
sks
whi
ch e
nsur
es th
at:
(a) t
he tr
aini
ng p
rogr
amm
e is
del
iver
ed a
ccor
ding
to
the
iden
tified
com
pete
ncy
requ
irem
ents
and
indi
vidu
al n
eeds
of
the
staff
;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
564.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
2. T
he o
rgan
isat
ion
shal
l pr
ovid
e a
trai
ning
pro
gram
me,
as
refe
rred
to in
poi
nts
(c),
(d)
and
(f) o
f par
agra
ph 4
.2.1
, for
st
aff p
erfo
rmin
g sa
fety
-rel
ated
ta
sks
whi
ch e
nsur
es th
at:
(b) w
here
app
licab
le, t
he
trai
ning
ens
ures
that
sta
ff ca
n op
erat
e un
der a
ll op
erat
ing
cond
ition
s (n
orm
al, d
egra
ded
and
emer
genc
y);
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
574.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
2. T
he o
rgan
isat
ion
shal
l pr
ovid
e a
trai
ning
pro
gram
me,
as
refe
rred
to in
poi
nts
(c),
(d)
and
(f) o
f par
agra
ph 4
.2.1
, for
st
aff p
erfo
rmin
g sa
fety
-rel
ated
ta
sks
whi
ch e
nsur
es th
at:
(c) t
he d
urat
ion
of th
e tr
aini
ng
and
the
freq
uenc
y of
the
refr
eshe
r tr
aini
ng a
re a
ppro
pria
te fo
r the
tr
aini
ng o
bjec
tives
;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
584.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
2. T
he o
rgan
isat
ion
shal
l pr
ovid
e a
trai
ning
pro
gram
me,
as
refe
rred
to in
poi
nts
(c),
(d)
and
(f) o
f par
agra
ph 4
.2.1
, for
st
aff p
erfo
rmin
g sa
fety
-rel
ated
ta
sks
whi
ch e
nsur
es th
at:
(d) r
ecor
ds a
re k
ept f
or a
ll st
aff
(see
4.5
.3. C
ontr
ol o
f doc
umen
ted
info
rmat
ion)
;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
594.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
2. T
he o
rgan
isat
ion
shal
l pr
ovid
e a
trai
ning
pro
gram
me,
as
refe
rred
to in
poi
nts
(c),
(d)
and
(f) o
f par
agra
ph 4
.2.1
, for
st
aff p
erfo
rmin
g sa
fety
-rel
ated
ta
sks
whi
ch e
nsur
es th
at:
(e) t
he tr
aini
ng p
rogr
amm
e is
re
gula
rly re
view
ed a
nd a
udite
d (s
ee 6
.2. I
nter
nal a
uditi
ng) a
nd
chan
ges
mad
e w
hen
nece
ssar
y (s
ee 5
.4. M
anag
emen
t of c
hang
e).
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
604.
SU
PPO
RT4.
2.
Com
pete
nce
4.2.
3.
Back
to w
ork
arra
ngem
ents
sha
ll be
in p
lace
fo
r sta
ff fo
llow
ing
acci
dent
s/in
cide
nts
or lo
ng a
bsen
ces
from
wor
k, in
clud
ing
prov
idin
g ad
ditio
nal t
rain
ing
whe
re s
uch
a ne
ed is
iden
tified
.
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
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CES
S
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ion
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at e
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urop
a.eu
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ncy
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ailw
ays.
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right
s re
serv
ed.
136
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
614.
SU
PPO
RT4.
3.
Awar
enes
s4.
3.1.
Top
man
agem
ent s
hall
ensu
re th
at th
ey a
nd th
eir s
taff
havi
ng a
role
that
affe
cts
safe
ty
are
awar
e of
the
rele
vanc
e,
impo
rtan
ce a
nd c
onse
quen
ces
of th
eir a
ctiv
ities
and
how
th
ey c
ontr
ibut
e to
the
corr
ect a
pplic
atio
n an
d th
e eff
ectiv
enes
s of
the
safe
ty m
anag
emen
t sys
tem
, in
clud
ing
the
achi
evem
ent
of s
afet
y ob
ject
ives
(see
3.
2. S
afet
y ob
ject
ives
and
pl
anni
ng).
I.1.(g
) (pa
rtia
lly
cove
red)
624.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
1. T
he o
rgan
isat
ion
shal
l defi
ne a
dequ
ate
com
mun
icat
ion
chan
nels
to
ensu
re th
at s
afet
y-re
late
d in
form
atio
n is
exc
hang
ed
amon
g th
e di
ffere
nt le
vels
of
the
orga
nisa
tion
and
with
ex
tern
al in
tere
sted
par
ties
incl
udin
g co
ntra
ctor
s, pa
rtne
rs
and
supp
liers
.
I.7 (i
n ge
nera
l), I.
9.6
(par
tially
cov
ered
), II.
5 (in
gen
eral
), III
.9, I
V.9,
A
rt. 5
(1),
Art
. 5(3
)
634.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
2. T
o en
sure
that
sa
fety
-rel
ated
info
rmat
ion
reac
hes
thos
e m
akin
g ju
dgem
ents
and
dec
isio
ns,
the
orga
nisa
tion
shal
l man
age
the
iden
tifica
tion,
rece
ipt,
proc
essi
ng, g
ener
atio
n an
d di
ssem
inat
ion
of s
afet
y-re
late
d in
form
atio
n.
I.7 (i
n ge
nera
l), I.
9.6
(par
tially
cov
ered
), II.
5 (in
gen
eral
), III
.9,
IV.9
, Art
. 4(2
), A
rt. 4
(3),
Art
. 4(6
)
137
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
644.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l en
sure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(a) r
elev
ant,
com
plet
e an
d un
ders
tand
able
for t
he in
tend
ed
user
s;
I.7 (i
n ge
nera
l)
654.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l en
sure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(b) v
alid
;I.7
(in
gene
ral)
664.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l en
sure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(c) a
ccur
ate;
I.7 (i
n ge
nera
l)
674.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l en
sure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(d) c
onsi
sten
t;I.7
(in
gene
ral)
684.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l en
sure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(e) c
ontr
olle
d (s
ee 4
.5.3
. Con
trol
of
docu
men
ted
info
rmat
ion)
;I.7
(in
gene
ral)
694.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l en
sure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(f) c
omm
unic
ated
bef
ore
it ta
kes
effec
t;I.7
(in
gene
ral)
704.
SU
PPO
RT4.
4.
Info
rmat
ion
and
com
mun
icat
ion
4.4.
3. T
he o
rgan
isat
ion
shal
l en
sure
that
saf
ety-
rela
ted
info
rmat
ion
is:
(g) r
ecei
ved
and
unde
rsto
od.
I.7 (i
n ge
nera
l)
714.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
1. T
here
is a
des
crip
tion
of
the
safe
ty m
anag
emen
t sys
tem
in
clud
ing:
(a) t
he id
entifi
catio
n an
d de
scrip
tion
of th
e pr
oces
ses
and
activ
ities
rela
ted
to s
afet
y of
rail
oper
atio
ns, i
nclu
ding
sa
fety
-rel
ated
task
s an
d as
soci
ated
resp
onsi
bilit
ies
(see
2.3
. Org
anis
atio
nal r
oles
, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
);
I.8 (i
n ge
nera
l)
724.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
1. T
here
is a
des
crip
tion
of
the
safe
ty m
anag
emen
t sys
tem
in
clud
ing:
(b) t
he in
tera
ctio
n of
thes
e pr
oces
ses;
I.8 (i
n ge
nera
l)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
138
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
734.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
1. T
here
is a
des
crip
tion
of
the
safe
ty m
anag
emen
t sys
tem
in
clud
ing:
(c) t
he p
roce
dure
s or
oth
er
docu
men
ts d
escr
ibin
g ho
w th
ese
proc
esse
s ar
e im
plem
ente
d;
I.8 (i
n ge
nera
l)
744.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
1. T
here
is a
des
crip
tion
of
the
safe
ty m
anag
emen
t sys
tem
in
clud
ing:
(d) t
he id
entifi
catio
n of
co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
with
a d
escr
iptio
n of
th
e ty
pe a
nd e
xten
t of s
ervi
ces
deliv
ered
;
I.8 (i
n ge
nera
l), I.
9 (in
ge
nera
l)
754.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
1. T
here
is a
des
crip
tion
of
the
safe
ty m
anag
emen
t sys
tem
in
clud
ing:
(e) t
he id
entifi
catio
n of
co
ntra
ctua
l arr
ange
men
ts a
nd
othe
r bus
ines
s ag
reem
ents
, co
nclu
ded
betw
een
the
orga
nisa
tion
and
othe
r par
ties
iden
tified
und
er (d
), ne
cess
ary
to c
ontr
ol th
e sa
fety
risk
s of
the
orga
nisa
tion
and
thos
e re
late
d to
th
e us
e of
con
trac
tors
;
I.8 (i
n ge
nera
l), I.
9 (in
ge
nera
l)
764.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
1. T
here
is a
des
crip
tion
of
the
safe
ty m
anag
emen
t sys
tem
in
clud
ing:
(f) r
efer
ence
to d
ocum
ente
d in
form
atio
n re
quire
d by
this
Re
gula
tion.
I.8 (i
n ge
nera
l)
774.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
an
annu
al s
afet
y re
port
is s
ubm
itted
to th
e re
leva
nt
natio
nal s
afet
y au
thor
ity (o
r au
thor
ities
) in
acco
rdan
ce w
ith
Art
icle
9(6
) of D
irect
ive
(EU
) 20
16/7
98, i
nclu
ding
:
(a) a
syn
thes
is o
f the
dec
isio
ns
on th
e le
vel o
f sig
nific
ance
of t
he
safe
ty-r
elat
ed c
hang
es, i
nclu
ding
an
ove
rvie
w o
f sig
nific
ant
chan
ges,
in a
ccor
danc
e w
ith
Art
icle
18(
1) o
f Reg
ulat
ion
(EU
) N
o 40
2/20
13;
Ann
ex V
(ECM
M
aint
enan
ce R
epor
t)
(in g
ener
al),
Art
. 8(5
)
139
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
784.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
an
annu
al s
afet
y re
port
is s
ubm
itted
to th
e re
leva
nt
natio
nal s
afet
y au
thor
ity (o
r au
thor
ities
) in
acco
rdan
ce w
ith
Art
icle
9(6
) of D
irect
ive
(EU
) 20
16/7
98, i
nclu
ding
:
(b) t
he o
rgan
isat
ion’
s sa
fety
ob
ject
ives
for t
he fo
llow
ing
year
(s) a
nd h
ow s
erio
us ri
sks
for
safe
ty in
fluen
ce th
e se
ttin
g of
th
ese
safe
ty o
bjec
tives
;
Ann
ex V
(ECM
M
aint
enan
ce R
epor
t)
(in g
ener
al),
Art
. 8(5
)
794.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
an
annu
al s
afet
y re
port
is s
ubm
itted
to th
e re
leva
nt
natio
nal s
afet
y au
thor
ity (o
r au
thor
ities
) in
acco
rdan
ce w
ith
Art
icle
9(6
) of D
irect
ive
(EU
) 20
16/7
98, i
nclu
ding
:
(c) t
he re
sults
of i
nter
nal
acci
dent
/inci
dent
inve
stig
atio
n (s
ee 7
.1. L
earn
ing
from
acc
iden
ts
and
inci
dent
s) a
nd o
ther
m
onito
ring
activ
ities
(see
6.1
. M
onito
ring,
6.2
. Int
erna
l aud
iting
an
d 6.
3. M
anag
emen
t rev
iew
), in
ac
cord
ance
with
Art
icle
5(1
) of
Regu
latio
n (E
U) N
o 10
78/2
012
(2);
Ann
ex V
(ECM
M
aint
enan
ce R
epor
t)
(in g
ener
al),
Art
. 8(5
)
804.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
an
annu
al s
afet
y re
port
is s
ubm
itted
to th
e re
leva
nt
natio
nal s
afet
y au
thor
ity (o
r au
thor
ities
) in
acco
rdan
ce w
ith
Art
icle
9(6
) of D
irect
ive
(EU
) 20
16/7
98, i
nclu
ding
:
(d) d
etai
ls o
f pro
gres
s on
ad
dres
sing
out
stan
ding
re
com
men
datio
ns fr
om th
e na
tiona
l inv
estig
atio
n bo
dies
(s
ee 7
.1. L
earn
ing
from
acc
iden
ts
and
inci
dent
s);
Ann
ex V
(ECM
M
aint
enan
ce R
epor
t)
(in g
ener
al),
Art
. 8(5
)
814.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
an
annu
al s
afet
y re
port
is s
ubm
itted
to th
e re
leva
nt
natio
nal s
afet
y au
thor
ity (o
r au
thor
ities
) in
acco
rdan
ce w
ith
Art
icle
9(6
) of D
irect
ive
(EU
) 20
16/7
98, i
nclu
ding
:
(e) t
he o
rgan
isat
ion’
s sa
fety
in
dica
tors
set
out
to e
valu
ate
the
orga
nisa
tion’
s sa
fety
per
form
ance
(s
ee 6
.1. M
onito
ring)
;
Ann
ex V
(ECM
M
aint
enan
ce R
epor
t)
(in g
ener
al),
Art
. 8(5
)
824.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
1.
Safe
ty m
anag
emen
t sy
stem
doc
umen
tatio
n4.
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
an
annu
al s
afet
y re
port
is s
ubm
itted
to th
e re
leva
nt
natio
nal s
afet
y au
thor
ity (o
r au
thor
ities
) in
acco
rdan
ce w
ith
Art
icle
9(6
) of D
irect
ive
(EU
) 20
16/7
98, i
nclu
ding
:
(f) w
here
app
licab
le, t
he
conc
lusi
ons
of th
e an
nual
repo
rt
of th
e sa
fety
adv
isor
, as
refe
rred
to
in R
ID (3
), on
the
activ
ities
of
the
orga
nisa
tion
rela
ting
to th
e tr
ansp
ort o
f dan
gero
us g
oods
(4).
Ann
ex V
(ECM
M
aint
enan
ce R
epor
t)
(in g
ener
al),
Art
. 8(5
)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
140
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
834.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
2.
Crea
ting
and
upda
ting
4.5.
2.1.
The
org
anis
atio
n sh
all
ensu
re th
at w
hen
crea
ting
and
upda
ting
docu
men
ted
info
rmat
ion
rela
ted
to th
e sa
fety
man
agem
ent
syst
em a
dequ
ate
form
ats
and
med
ia a
re u
sed.
I.8 (i
n ge
nera
l)
844.
SU
PPO
RT4.
5.
Doc
umen
ted
info
rmat
ion
4.5.
3.
Cont
rol o
f doc
umen
ted
info
rmat
ion
4.5.
3.1.
The
org
anis
atio
n sh
all
cont
rol d
ocum
ente
d in
form
atio
n re
late
d to
the
safe
ty m
anag
emen
t sy
stem
, in
part
icul
ar it
s st
orag
e,
dist
ribut
ion
and
the
cont
rol o
f ch
ange
s, to
ens
ure
its a
vaila
bilit
y,
suita
bilit
y an
d pr
otec
tion
whe
re
appr
opria
te.
I.8 (i
n ge
nera
l), I.
9 (in
ge
nera
l), II
.7, I
II.10
, IV
.10
854.
SU
PPO
RT4.
6.
Inte
grat
ion
of h
uman
and
or
gani
satio
nal
fact
ors
4.6.
1. T
he o
rgan
isat
ion
shal
l de
mon
stra
te a
sys
tem
atic
ap
proa
ch to
inte
grat
ing
hum
an a
nd o
rgan
isat
iona
l fa
ctor
s w
ithin
the
safe
ty
man
agem
ent s
yste
m. T
his
appr
oach
sha
ll:
(a) i
nclu
de th
e de
velo
pmen
t of
a st
rate
gy a
nd th
e us
e of
exp
ertis
e an
d re
cogn
ised
met
hods
from
the
field
of h
uman
and
org
anis
atio
nal
fact
ors;
864.
SU
PPO
RT4.
6.
Inte
grat
ion
of h
uman
and
or
gani
satio
nal
fact
ors
4.6.
1. T
he o
rgan
isat
ion
shal
l de
mon
stra
te a
sys
tem
atic
ap
proa
ch to
inte
grat
ing
hum
an a
nd o
rgan
isat
iona
l fa
ctor
s w
ithin
the
safe
ty
man
agem
ent s
yste
m. T
his
appr
oach
sha
ll:
(b) a
ddre
ss ri
sks
asso
ciat
ed w
ith
the
desi
gn a
nd u
se o
f equ
ipm
ent,
task
s, w
orki
ng c
ondi
tions
and
or
gani
satio
nal a
rran
gem
ents
, ta
king
into
acc
ount
hum
an
capa
bilit
ies
as w
ell a
s lim
itatio
ns,
and
the
influ
ence
s on
hum
an
perf
orm
ance
.
I.2.3
(in
gene
ral),
II.3
(in
gen
eral
), IV
.3, I
V.4,
IV
.5
141
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ailw
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right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
875.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
1. W
hen
plan
ning
, de
velo
ping
, im
plem
entin
g an
d re
view
ing
its o
pera
tiona
l pr
oces
ses,
the
orga
nisa
tion
shal
l ens
ure
that
dur
ing
oper
atio
n:
(a) r
isk
acce
ptan
ce c
riter
ia a
nd
safe
ty m
easu
res
are
appl
ied
(see
3.
1.1.
Ris
k as
sess
men
t);
I.3 a
nd I.
9.6
(in
gene
ral)
885.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
1. W
hen
plan
ning
, de
velo
ping
, im
plem
entin
g an
d re
view
ing
its o
pera
tiona
l pr
oces
ses,
the
orga
nisa
tion
shal
l ens
ure
that
dur
ing
oper
atio
n:
(b) p
lan(
s) to
ach
ieve
the
safe
ty
obje
ctiv
es a
re d
eliv
ered
(see
3.2
. Sa
fety
obj
ectiv
es a
nd p
lann
ing)
;
I.1.(d
), I.3
, I.9
.3
895.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
1. W
hen
plan
ning
, de
velo
ping
, im
plem
entin
g an
d re
view
ing
its o
pera
tiona
l pr
oces
ses,
the
orga
nisa
tion
shal
l ens
ure
that
dur
ing
oper
atio
n:
(c) i
nfor
mat
ion
is c
olle
cted
to
mea
sure
the
corr
ect a
pplic
atio
n an
d eff
ectiv
enes
s of
the
oper
atio
nal a
rran
gem
ents
(see
6.1
. M
onito
ring)
.
I.3 (i
n ge
nera
l), I.
9.6
(in g
ener
al),
I.9.5
(in
gen
eral
), I.7
(in
gene
ral)
905.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
its
oper
atio
nal
arra
ngem
ents
con
form
to
the
safe
ty-r
elat
ed
requ
irem
ents
of a
pplic
able
Te
chni
cal S
peci
ficat
ions
for
Inte
rope
rabi
lity
and
rele
vant
na
tiona
l rul
es a
nd a
ny o
ther
re
leva
nt re
quire
men
ts (s
ee 1
. Co
ntex
t of t
he o
rgan
isat
ion)
.
II.2,
Art
. 4(1
)
915.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
3. T
o co
ntro
l ris
ks w
here
re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
3.1
.1.
Risk
ass
essm
ent)
, at l
east
the
follo
win
g sh
all b
e ta
ken
into
ac
coun
t:
(a) p
lann
ing
of e
xist
ing
or n
ew
trai
n ro
utes
and
new
trai
n se
rvic
es,
incl
udin
g th
e in
trod
uctio
n of
new
ty
pes
of v
ehic
les,
the
need
to le
ase
vehi
cles
and
/or t
o hi
re s
taff
from
ex
tern
al p
artie
s an
d th
e ex
chan
ge
of in
form
atio
n on
the
mai
nten
ance
fo
r ope
ratio
nal p
urpo
ses
with
en
titie
s in
cha
rge
of m
aint
enan
ce;
I.7 (i
n ge
nera
l), A
rt.
5(1)
, Art
. 5(2
), A
rt. 5
(3)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
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ion
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ed.
142
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
925.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
3. T
o co
ntro
l ris
ks w
here
re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
3.1
.1.
Risk
ass
essm
ent)
, at l
east
the
follo
win
g sh
all b
e ta
ken
into
ac
coun
t:
(b) d
evel
opm
ent a
nd
impl
emen
tatio
n of
trai
n tim
etab
les;
935.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
3. T
o co
ntro
l ris
ks w
here
re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
3.1
.1.
Risk
ass
essm
ent)
, at l
east
the
follo
win
g sh
all b
e ta
ken
into
ac
coun
t:
(c) p
repa
ratio
n of
trai
ns o
r veh
icle
s be
fore
mov
emen
t, in
clud
ing
pre-
depa
rtur
e ch
ecks
and
trai
n co
mpo
sitio
n;
945.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
3. T
o co
ntro
l ris
ks w
here
re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
3.1
.1.
Risk
ass
essm
ent)
, at l
east
the
follo
win
g sh
all b
e ta
ken
into
ac
coun
t:
(d) r
unni
ng tr
ains
or m
ovem
ent o
f ve
hicl
es in
the
diffe
rent
ope
ratin
g co
nditi
ons
(nor
mal
, deg
rade
d an
d em
erge
ncy)
;
955.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
3. T
o co
ntro
l ris
ks w
here
re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
3.1
.1.
Risk
ass
essm
ent)
, at l
east
the
follo
win
g sh
all b
e ta
ken
into
ac
coun
t:
(e) a
dapt
atio
n of
the
oper
atio
n to
requ
ests
for r
emov
al fr
om
oper
atio
n an
d no
tifica
tion
of
retu
rn to
ope
ratio
n is
sued
by
entit
ies
in c
harg
e of
mai
nten
ance
;
III.4
, III.
6, II
I.9, I
II.10
965.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
3. T
o co
ntro
l ris
ks w
here
re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
3.1
.1.
Risk
ass
essm
ent)
, at l
east
the
follo
win
g sh
all b
e ta
ken
into
ac
coun
t:
(f) a
utho
risat
ions
for m
ovem
ents
of
veh
icle
s;
143
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ion
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ted.
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urop
a.eu
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ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
975.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
3. T
o co
ntro
l ris
ks w
here
re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
3.1
.1.
Risk
ass
essm
ent)
, at l
east
the
follo
win
g sh
all b
e ta
ken
into
ac
coun
t:
(g) u
sabi
lity
of in
terf
aces
in tr
ain
driv
ing
cabs
and
trai
n co
ntro
l ce
ntre
s an
d w
ith e
quip
men
t use
d by
mai
nten
ance
sta
ff.
II.3,
IV.3
, IV.
4, IV
.5
985.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
4. T
o co
ntro
l the
al
loca
tion
of re
spon
sibi
litie
s w
here
rele
vant
for t
he s
afet
y of
ope
ratio
nal a
ctiv
ities
, th
e or
gani
satio
n sh
all
iden
tify
resp
onsi
bilit
ies
for
coor
dina
ting
and
man
agin
g th
e sa
fe ru
nnin
g of
trai
ns
and
mov
emen
ts o
f veh
icle
s an
d de
fine
how
rele
vant
ta
sks
affec
ting
the
safe
de
liver
y of
all
serv
ices
are
al
loca
ted
to c
ompe
tent
st
aff w
ithin
the
orga
nisa
tion
(see
2.3
. Org
anis
atio
nal
role
s, re
spon
sibi
litie
s, ac
coun
tabi
litie
s an
d au
thor
ities
) and
to o
ther
ex
tern
al q
ualifi
ed p
artie
s w
hen
appr
opria
te (s
ee 5
.3.
Cont
ract
ors,
part
ners
and
su
pplie
rs).
I.9.1
and
I.9.
2 (in
ge
nera
l)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
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ion
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(01/
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olle
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ailw
ays.
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ed.
144
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
995.
O
PERA
TIO
N5.
1.
Ope
ratio
nal
plan
ning
and
co
ntro
l
5.1.
5. T
o co
ntro
l inf
orm
atio
n an
d co
mm
unic
atio
n w
here
re
leva
nt fo
r the
saf
ety
of o
pera
tiona
l act
iviti
es
(see
4.4
. Inf
orm
atio
n an
d co
mm
unic
atio
n), r
elev
ant
staff
(e.g
. tra
in c
rew
s) s
hall
be
advi
sed
of th
e de
tails
of a
ny
spec
ified
con
ditio
ns o
f tra
vel,
incl
udin
g re
leva
nt c
hang
es
whi
ch m
ay re
sult
in a
haz
ard,
te
mpo
rary
or p
erm
anen
t op
erat
iona
l res
tric
tions
(e.g
. du
e to
spe
cific
type
of v
ehic
les
or to
spe
cific
rout
es) a
nd
cond
ition
s fo
r exc
eptio
nal
cons
ignm
ents
, whe
re
appl
icab
le.
I.7, I
I.5, I
II.6,
III.9
, III.
10,
IV.9
, Art
. 4(2
), A
rt. 4
(6)
100
5.
OPE
RATI
ON
5.1.
O
pera
tiona
l pl
anni
ng a
nd
cont
rol
5.1.
6. T
o co
ntro
l com
pete
nce
whe
re re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
4.2
. Co
mpe
tenc
e), t
he o
rgan
isat
ion
shal
l ens
ure,
in a
ccor
danc
e w
ith a
pplic
able
legi
slat
ion
(see
1.
Con
text
of t
he o
rgan
isat
ion)
, fo
r its
sta
ff:
(a) c
ompl
ianc
e w
ith th
eir t
rain
ing
and
wor
k in
stru
ctio
ns, a
nd
corr
ectiv
e ac
tions
are
take
n w
here
re
quire
d;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
101
5.
OPE
RATI
ON
5.1.
O
pera
tiona
l pl
anni
ng a
nd
cont
rol
5.1.
6. T
o co
ntro
l com
pete
nce
whe
re re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
4.2
. Co
mpe
tenc
e), t
he o
rgan
isat
ion
shal
l ens
ure,
in a
ccor
danc
e w
ith a
pplic
able
legi
slat
ion
(see
1.
Con
text
of t
he o
rgan
isat
ion)
, fo
r its
sta
ff:
(b) s
peci
fic tr
aini
ng in
cas
e of
an
ticip
ated
cha
nges
affe
ctin
g th
e ru
nnin
g of
ope
ratio
ns o
r the
ir ta
sk
assi
gnm
ent;
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
145
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ailw
ays.
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right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
102
5.
OPE
RATI
ON
5.1.
O
pera
tiona
l pl
anni
ng a
nd
cont
rol
5.1.
6. T
o co
ntro
l com
pete
nce
whe
re re
leva
nt fo
r the
saf
ety
of
oper
atio
nal a
ctiv
ities
(see
4.2
. Co
mpe
tenc
e), t
he o
rgan
isat
ion
shal
l ens
ure,
in a
ccor
danc
e w
ith a
pplic
able
legi
slat
ion
(see
1.
Con
text
of t
he o
rgan
isat
ion)
, fo
r its
sta
ff:
(c) a
dopt
ion
of a
dequ
ate
mea
sure
s fo
llow
ing
acci
dent
s an
d in
cide
nts.
I.6 (i
n ge
nera
l), II
.6 (i
n ge
nera
l), II
I.1, I
II.7,
IV.8
103
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.1.
The
org
anis
atio
n sh
all m
anag
e th
e sa
fety
risk
s as
soci
ated
with
phy
sica
l ass
ets
thro
ugho
ut th
eir l
ife c
ycle
(s
ee 3
.1.1
. Ris
k as
sess
men
t),
from
des
ign
to d
ispo
sal,
and
fulfi
l the
hum
an fa
ctor
s re
quire
men
ts in
all
phas
es o
f th
e lif
e cy
cle.
I.2 (i
n ge
nera
l)
104
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.2.
The
org
anis
atio
n sh
all:
(a) e
nsur
e th
at th
e as
sets
are
use
d fo
r the
pur
pose
inte
nded
whi
le
mai
ntai
ning
thei
r saf
e op
erat
iona
l st
ate,
in a
ccor
danc
e w
ith A
rtic
le
14(2
) of D
irect
ive
(EU
) 201
6/79
8 w
here
rele
vant
, and
thei
r exp
ecte
d le
vel o
f per
form
ance
;
105
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.2.
The
org
anis
atio
n sh
all:
(b) m
anag
e th
e as
sets
in n
orm
al
and
degr
aded
ope
ratio
ns;
106
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.2.
The
org
anis
atio
n sh
all:
(c) d
etec
t as
soon
as
reas
onab
ly
prac
ticab
le in
stan
ces
of n
on-
com
plia
nce
with
ope
ratin
g re
quire
men
ts b
efor
e or
dur
ing
the
oper
atio
n of
the
asse
t, in
clud
ing
the
appl
icat
ion
of re
stric
tions
of
use
as a
ppro
pria
te to
ens
ure
a sa
fe
oper
atio
nal s
tate
of t
he a
sset
(see
6.
1. M
onito
ring)
.
III.6
, III.
9, II
I.10
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
146
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
107
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.3.
The
org
anis
atio
n sh
all e
nsur
e th
at it
s as
set
man
agem
ent a
rran
gem
ents
, w
here
app
licab
le, c
onfo
rm
to a
ll es
sent
ial r
equi
rem
ents
as
set
out
in th
e re
leva
nt
Tech
nica
l Spe
cific
atio
ns fo
r In
tero
pera
bilit
y an
d an
y ot
her
rele
vant
requ
irem
ents
(see
1.
Cont
ext o
f the
org
anis
atio
n).
II. 2
(in
gene
ral),
Art
. 4(
1)
108
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.4.
To
cont
rol r
isks
whe
re
rele
vant
for t
he s
uppl
y of
m
aint
enan
ce (s
ee 3
.1.1
. Ris
k as
sess
men
t), a
t lea
st th
e fo
llow
ing
shal
l be
take
n in
to
acco
unt:
(a) t
he id
entifi
catio
n of
the
need
fo
r mai
nten
ance
to k
eep
the
asse
t in
a s
afe
oper
atio
nal s
tate
, bas
ed
on th
e pl
anne
d an
d re
al u
se o
f the
as
set a
nd it
s de
sign
cha
ract
eris
tics;
III.4
109
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.4.
To
cont
rol r
isks
whe
re
rele
vant
for t
he s
uppl
y of
m
aint
enan
ce (s
ee 3
.1.1
. Ris
k as
sess
men
t), a
t lea
st th
e fo
llow
ing
shal
l be
take
n in
to
acco
unt:
(b) t
he m
anag
emen
t of t
he
rem
oval
of t
he a
sset
from
op
erat
ion
for m
aint
enan
ce, w
hen
defe
cts
have
bee
n id
entifi
ed o
r w
hen
asse
t con
ditio
n de
grad
es
outs
ide
the
limits
of a
saf
e op
erat
iona
l sta
te a
s re
ferr
ed to
in
poin
t (a)
;
III.4
, Art
. 4(2
), A
rt. 4
(4)
110
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.4.
To
cont
rol r
isks
whe
re
rele
vant
for t
he s
uppl
y of
m
aint
enan
ce (s
ee 3
.1.1
. Ris
k as
sess
men
t), a
t lea
st th
e fo
llow
ing
shal
l be
take
n in
to
acco
unt:
(c) t
he m
anag
emen
t of t
he re
turn
to
ope
ratio
n of
the
asse
t with
ev
entu
al re
stric
tions
of u
se a
fter
m
aint
enan
ce h
as b
een
deliv
ered
to
ens
ure
it is
in a
saf
e op
erat
iona
l st
ate;
III.4
147
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
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nloa
d th
e la
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ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
111
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.4.
To
cont
rol r
isks
whe
re
rele
vant
for t
he s
uppl
y of
m
aint
enan
ce (s
ee 3
.1.1
. Ris
k as
sess
men
t), a
t lea
st th
e fo
llow
ing
shal
l be
take
n in
to
acco
unt:
(d) t
he m
anag
emen
t of m
onito
ring
and
mea
sure
men
t equ
ipm
ent t
o en
sure
that
it is
fit f
or it
s in
tend
ed
purp
ose.
II.3
(in g
ener
al),
III.6
, III
.9, I
II.10
, IV.
3, IV
.4, I
V.5
112
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.5.
To
cont
rol i
nfor
mat
ion
and
com
mun
icat
ion
whe
re re
leva
nt fo
r the
saf
e m
anag
emen
t of a
sset
s (s
ee 4
.4. I
nfor
mat
ion
and
com
mun
icat
ion)
, the
or
gani
satio
n sh
all t
ake
into
ac
coun
t:
(a) t
he e
xcha
nge
of re
leva
nt
info
rmat
ion
with
in th
e or
gani
satio
n or
with
ext
erna
l en
titie
s re
spon
sibl
e fo
r m
aint
enan
ce (s
ee 5
.3. C
ontr
acto
rs,
part
ners
and
sup
plie
rs),
in
part
icul
ar o
n sa
fety
-rel
ated
m
alfu
nctio
ns, a
ccid
ents
, inc
iden
ts
as w
ell a
s on
eve
ntua
l res
tric
tions
of
use
of t
he a
sset
;
I.7 (i
n ge
nera
l), I.
9.6,
II.
5, II
I.6, I
II.9,
III.1
0, IV
.9,
Art
. 4(2
), A
rt. 4
(6),
Art
. 5(
1), A
rt. 5
(2),
Art
. 5(3
)
113
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.5.
To
cont
rol i
nfor
mat
ion
and
com
mun
icat
ion
whe
re re
leva
nt fo
r the
saf
e m
anag
emen
t of a
sset
s (s
ee 4
.4. I
nfor
mat
ion
and
com
mun
icat
ion)
, the
or
gani
satio
n sh
all t
ake
into
ac
coun
t:
(b) t
he tr
acea
bilit
y of
all
nece
ssar
y in
form
atio
n in
clud
ing
the
info
rmat
ion
rela
ted
to p
oint
(a
) (se
e 4.
4. In
form
atio
n an
d co
mm
unic
atio
n an
d 4.
5.3.
Con
trol
of
doc
umen
ted
info
rmat
ion)
;
I.7 (i
n ge
nera
l), I.
8,
I.9.6
, II.5
(in
gene
ral),
II.
7, II
I.4 (i
n ge
nera
l),
III.9
, IV.
9, A
rt. 4
(5)b
114
5.
OPE
RATI
ON
5.2.
A
sset
m
anag
emen
t5.
2.5.
To
cont
rol i
nfor
mat
ion
and
com
mun
icat
ion
whe
re re
leva
nt fo
r the
saf
e m
anag
emen
t of a
sset
s (s
ee 4
.4. I
nfor
mat
ion
and
com
mun
icat
ion)
, the
or
gani
satio
n sh
all t
ake
into
ac
coun
t:
(c) t
he e
stab
lishm
ent a
nd
mai
nten
ance
of r
ecor
ds in
clud
ing
the
man
agem
ent o
f cha
nges
aff
ectin
g th
e sa
fety
of a
sset
s (s
ee
5.4.
Man
agem
ent o
f cha
nge)
.
I.7, I
.8, I
I.2 (i
n ge
nera
l),
II.5
(in g
ener
al),
II.7,
III
.10,
IV.1
0, A
rt. 4
(5)b
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
148
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
115
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
1. T
he o
rgan
isat
ion
shal
l ide
ntify
and
con
trol
sa
fety
risk
s ar
isin
g fr
om
outs
ourc
ed a
ctiv
ities
, inc
ludi
ng
oper
atio
ns o
r coo
pera
tion
with
con
trac
tors
, par
tner
s an
d su
pplie
rs.
I.9.1
, Art
. 9(2
)
116
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
2. T
o co
ntro
l the
saf
ety
risks
refe
rred
to in
par
agra
ph
5.3.
1, th
e or
gani
satio
n sh
all
defin
e th
e cr
iteria
for t
he
sele
ctio
n of
the
cont
ract
ors,
part
ners
and
sup
plie
rs a
nd th
e co
ntra
ct re
quire
men
ts th
ey
have
to m
eet,
incl
udin
g:
(a) t
he le
gal a
nd o
ther
re
quire
men
ts re
late
d to
saf
ety
(see
1.
Con
text
of t
he o
rgan
isat
ion)
;
I.9 (i
n ge
nera
l)
117
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
2. T
o co
ntro
l the
saf
ety
risks
refe
rred
to in
par
agra
ph
5.3.
1, th
e or
gani
satio
n sh
all
defin
e th
e cr
iteria
for t
he
sele
ctio
n of
the
cont
ract
ors,
part
ners
and
sup
plie
rs a
nd th
e co
ntra
ct re
quire
men
ts th
ey
have
to m
eet,
incl
udin
g:
(b) t
he le
vel o
f com
pete
nce
requ
ired
to d
eliv
er th
e ta
sks
set o
ut in
the
cont
ract
(see
4.2
. Co
mpe
tenc
e);
I.9.2
118
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
2. T
o co
ntro
l the
saf
ety
risks
refe
rred
to in
par
agra
ph
5.3.
1, th
e or
gani
satio
n sh
all
defin
e th
e cr
iteria
for t
he
sele
ctio
n of
the
cont
ract
ors,
part
ners
and
sup
plie
rs a
nd th
e co
ntra
ct re
quire
men
ts th
ey
have
to m
eet,
incl
udin
g:
(c) t
he re
spon
sibi
litie
s fo
r the
task
s to
be
perf
orm
ed;
I.9.6
149
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
119
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
2. T
o co
ntro
l the
saf
ety
risks
refe
rred
to in
par
agra
ph
5.3.
1, th
e or
gani
satio
n sh
all
defin
e th
e cr
iteria
for t
he
sele
ctio
n of
the
cont
ract
ors,
part
ners
and
sup
plie
rs a
nd th
e co
ntra
ct re
quire
men
ts th
ey
have
to m
eet,
incl
udin
g:
(d) t
he e
xpec
ted
safe
ty
perf
orm
ance
to b
e m
aint
aine
d du
ring
the
cont
ract
;
I.9.3
, Art
. 9(3
)
120
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
2. T
o co
ntro
l the
saf
ety
risks
refe
rred
to in
par
agra
ph
5.3.
1, th
e or
gani
satio
n sh
all
defin
e th
e cr
iteria
for t
he
sele
ctio
n of
the
cont
ract
ors,
part
ners
and
sup
plie
rs a
nd th
e co
ntra
ct re
quire
men
ts th
ey
have
to m
eet,
incl
udin
g:
(e) t
he o
blig
atio
ns re
latin
g to
th
e ex
chan
ge o
f saf
ety-
rela
ted
info
rmat
ion
(see
4.4
. Inf
orm
atio
n an
d co
mm
unic
atio
n);
I.9.6
121
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
2. T
o co
ntro
l the
saf
ety
risks
refe
rred
to in
par
agra
ph
5.3.
1, th
e or
gani
satio
n sh
all
defin
e th
e cr
iteria
for t
he
sele
ctio
n of
the
cont
ract
ors,
part
ners
and
sup
plie
rs a
nd th
e co
ntra
ct re
quire
men
ts th
ey
have
to m
eet,
incl
udin
g:
(f) t
he tr
acea
bilit
y of
saf
ety-
rela
ted
docu
men
ts (s
ee 4
.5. D
ocum
ente
d in
form
atio
n).
I.9.6
122
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
3.
In a
ccor
danc
e w
ith th
e pr
oces
s se
t out
in A
rtic
le 3
of
Regu
latio
n (E
U) N
o 10
78/2
012,
th
e or
gani
satio
n sh
all m
onito
r:
(a) t
he s
afet
y pe
rfor
man
ce o
f al
l act
iviti
es a
nd o
pera
tions
of
cont
ract
ors,
part
ners
and
sup
plie
rs
to e
nsur
e th
at th
ey c
ompl
y w
ith
the
requ
irem
ents
set
out
in th
e co
ntra
ct;
I.9.5
, Art
. 4(4
), A
rt. 9
(3)
123
5.
OPE
RATI
ON
5.3.
Co
ntra
ctor
s, pa
rtne
rs a
nd
supp
liers
5.3.
3.
In a
ccor
danc
e w
ith th
e pr
oces
s se
t out
in A
rtic
le 3
of
Regu
latio
n (E
U) N
o 10
78/2
012,
th
e or
gani
satio
n sh
all m
onito
r:
(b) t
he a
war
enes
s of
con
trac
tors
, pa
rtne
rs a
nd s
uppl
iers
of
safe
ty ri
sks
they
ent
ail t
o th
e or
gani
satio
n’s
oper
atio
ns.
I.9.2
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
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ncy
for R
ailw
ays.
All
right
s re
serv
ed.
150
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
124
5.
OPE
RATI
ON
5.4.
M
anag
emen
t of
cha
nge
5.4.
1. T
he o
rgan
isat
ion
shal
l im
plem
ent a
nd c
ontr
ol
chan
ges
to th
e sa
fety
m
anag
emen
t sys
tem
to
mai
ntai
n or
impr
ove
the
safe
ty p
erfo
rman
ce. T
his
shal
l inc
lude
dec
isio
ns a
t th
e di
ffere
nt s
tage
s of
the
chan
ge m
anag
emen
t and
th
e su
bseq
uent
revi
ew o
f sa
fety
risk
s (s
ee 3
.1.1
. Ris
k as
sess
men
t).
125
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
1. T
he o
rgan
isat
ion
shal
l ide
ntify
the
emer
genc
y si
tuat
ions
and
ass
ocia
ted
timel
y m
easu
res
to b
e ta
ken
to m
anag
e th
em (s
ee 3
.1.1
. Ri
sk a
sses
smen
t) a
nd to
re-
esta
blis
h no
rmal
ope
ratin
g co
nditi
ons
in a
ccor
danc
e w
ith
Regu
latio
n (E
U) 2
015/
995
(5).
126
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
, for
eac
h id
entifi
ed
type
of e
mer
genc
y:
(a) t
he e
mer
genc
y se
rvic
es c
an b
e pr
ompt
ly c
onta
cted
;
127
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
, for
eac
h id
entifi
ed
type
of e
mer
genc
y:
(b) t
he e
mer
genc
y se
rvic
es
are
prov
ided
with
all
rele
vant
in
form
atio
n bo
th in
adv
ance
, to
prep
are
thei
r em
erge
ncy
resp
onse
, an
d at
the
time
of a
n em
erge
ncy;
I.7.(j
)
128
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
, for
eac
h id
entifi
ed
type
of e
mer
genc
y:
(c) fi
rst a
id is
pro
vide
d in
tern
ally
.
151
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
129
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
3. T
he o
rgan
isat
ion
shal
l id
entif
y an
d do
cum
ent t
he
role
s an
d re
spon
sibi
litie
s of
al
l par
ties
in a
ccor
danc
e w
ith
Regu
latio
n (E
U) 2
015/
995.
130
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
4. T
he o
rgan
isat
ion
shal
l hav
e pl
ans
for a
ctio
n,
aler
ts a
nd in
form
atio
n in
ca
se o
f em
erge
ncy
incl
udin
g ar
rang
emen
ts to
:
(a) a
lert
all
staff
with
resp
onsi
bilit
y fo
r em
erge
ncy
man
agem
ent;
131
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
4. T
he o
rgan
isat
ion
shal
l hav
e pl
ans
for a
ctio
n,
aler
ts a
nd in
form
atio
n in
ca
se o
f em
erge
ncy
incl
udin
g ar
rang
emen
ts to
:
(b) c
omm
unic
ate
info
rmat
ion
to a
ll pa
rtie
s (e
.g. i
nfra
stru
ctur
e m
anag
er, c
ontr
acto
rs, a
utho
ritie
s, em
erge
ncy
serv
ices
), in
clud
ing
emer
genc
y in
stru
ctio
ns fo
r pa
ssen
gers
;
I.7 (i
n ge
nera
l)
132
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
4. T
he o
rgan
isat
ion
shal
l hav
e pl
ans
for a
ctio
n,
aler
ts a
nd in
form
atio
n in
ca
se o
f em
erge
ncy
incl
udin
g ar
rang
emen
ts to
:
(c) t
ake
any
deci
sion
s re
quire
d in
acc
orda
nce
with
the
type
of
emer
genc
y.
133
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
5. T
he o
rgan
isat
ion
shal
l de
scrib
e ho
w re
sour
ces
and
mea
ns fo
r em
erge
ncy
man
agem
ent h
ave
been
al
loca
ted
(see
4.1
. Res
ourc
es)
and
how
trai
ning
requ
irem
ents
ha
ve b
een
iden
tified
(see
4.2
. Co
mpe
tenc
e).
134
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
6. T
he e
mer
genc
y ar
rang
emen
ts a
re re
gula
rly
test
ed in
coo
pera
tion
with
ot
her i
nter
este
d pa
rtie
s an
d up
date
d w
hen
appr
opria
te.
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
152
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
135
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
7. T
he o
rgan
isat
ion
shal
l en
sure
that
com
pete
nt s
taff
in c
harg
e, w
ith a
dequ
ate
lang
uage
ski
lls, c
an b
e co
ntac
ted
easi
ly a
nd w
ithou
t de
lay
by th
e in
fras
truc
ture
m
anag
er a
nd p
rovi
de th
e la
tter
with
the
right
leve
l of
info
rmat
ion.
136
5.
OPE
RATI
ON
5.5.
Em
erge
ncy
man
agem
ent
5.5.
8. T
he o
rgan
isat
ion
shal
l hav
e a
proc
edur
e to
co
ntac
t the
ent
ity in
cha
rge
of m
aint
enan
ce o
r the
railw
ay
vehi
cle
keep
er in
the
even
t of
an e
mer
genc
y.
I.7 (i
n ge
nera
l)
137
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.1.
M
onito
ring
6.1.
1. T
he o
rgan
isat
ion
shal
l per
form
mon
itorin
g in
ac
cord
ance
with
Reg
ulat
ion
(EU
) No
1078
/201
2:
(a) t
o ch
eck
the
corr
ect a
pplic
atio
n an
d th
e eff
ectiv
enes
s of
all
the
proc
esse
s an
d pr
oced
ures
in
the
safe
ty m
anag
emen
t sys
tem
, in
clud
ing
the
oper
atio
nal,
orga
nisa
tiona
l and
tech
nica
l saf
ety
mea
sure
s;
I.3 (i
n ge
nera
l), A
rt.
4(4)
, Art
. 7(1
), A
rt. 9
(3)
138
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.1.
M
onito
ring
6.1.
1. T
he o
rgan
isat
ion
shal
l per
form
mon
itorin
g in
ac
cord
ance
with
Reg
ulat
ion
(EU
) No
1078
/201
2:
(b) t
o ch
eck
the
corr
ect a
pplic
atio
n of
the
safe
ty m
anag
emen
t sys
tem
as
a w
hole
, and
if it
ach
ieve
s th
e ex
pect
ed o
utco
mes
;
I.3 (i
n ge
nera
l), A
rt.
4(4)
, Art
. 7(1
), A
rt. 9
(3)
139
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.1.
M
onito
ring
6.1.
1. T
he o
rgan
isat
ion
shal
l per
form
mon
itorin
g in
ac
cord
ance
with
Reg
ulat
ion
(EU
) No
1078
/201
2:
(c) t
o in
vest
igat
e w
heth
er th
e sa
fety
man
agem
ent s
yste
m
conf
orm
s to
the
requ
irem
ents
in
this
Reg
ulat
ion;
I.3 (i
n ge
nera
l), A
rt.
4(4)
, Art
. 7(1
), A
rt. 9
(3)
153
Vers
ion
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(01/
03/2
021)
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olle
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ted.
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nloa
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e la
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sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
140
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.1.
M
onito
ring
6.1.
1. T
he o
rgan
isat
ion
shal
l per
form
mon
itorin
g in
ac
cord
ance
with
Reg
ulat
ion
(EU
) No
1078
/201
2:
(d) t
o id
entif
y, im
plem
ent a
nd
eval
uate
the
effec
tiven
ess
of
the
corr
ectiv
e m
easu
res
(see
7.
2. C
ontin
ual i
mpr
ovem
ent)
, as
app
ropr
iate
, if a
ny re
leva
nt
inst
ance
of n
on-c
ompl
ianc
e to
po
ints
(a),
(b) a
nd (c
) is
dete
cted
.
I.3 a
nd I.
4 (in
gen
eral
), A
rt. 4
(4),
Art
. 7(1
), A
rt.
9(3)
141
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.1.
M
onito
ring
6.1.
2. T
he o
rgan
isat
ion
shal
l re
gula
rly m
onito
r at a
ll le
vels
w
ithin
the
orga
nisa
tion
the
perf
orm
ance
of s
afet
y-re
late
d ta
sks
and
inte
rven
e if
thes
e ta
sks
are
not b
eing
pro
perly
pe
rfor
med
.
I.3 a
nd I.
4 (in
gen
eral
), A
rt. 4
(4),
Art
. 7(1
), A
rt.
9(3)
142
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l co
nduc
t int
erna
l aud
its in
an
inde
pend
ent,
impa
rtia
l and
tr
ansp
aren
t way
to c
olle
ct a
nd
anal
yse
info
rmat
ion
for t
he
purp
oses
of i
ts m
onito
ring
activ
ities
(see
6.1
. Mon
itorin
g),
incl
udin
g:
(a) A
sch
edul
e of
pla
nned
inte
rnal
au
dits
whi
ch c
an b
e re
vise
d de
pend
ing
on th
e re
sults
of
prev
ious
aud
its a
nd m
onito
ring
of
perf
orm
ance
;
I.3 (i
n ge
nera
l)
143
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l co
nduc
t int
erna
l aud
its in
an
inde
pend
ent,
impa
rtia
l and
tr
ansp
aren
t way
to c
olle
ct a
nd
anal
yse
info
rmat
ion
for t
he
purp
oses
of i
ts m
onito
ring
activ
ities
(see
6.1
. Mon
itorin
g),
incl
udin
g:
(b) T
he id
entifi
catio
n an
d se
lect
ion
of c
ompe
tent
aud
itors
(see
4.2
. Co
mpe
tenc
e);
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
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ncy
for R
ailw
ays.
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right
s re
serv
ed.
154
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
144
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l co
nduc
t int
erna
l aud
its in
an
inde
pend
ent,
impa
rtia
l and
tr
ansp
aren
t way
to c
olle
ct a
nd
anal
yse
info
rmat
ion
for t
he
purp
oses
of i
ts m
onito
ring
activ
ities
(see
6.1
. Mon
itorin
g),
incl
udin
g:
(c) T
he a
naly
sis
and
eval
uatio
n of
th
e re
sults
of t
he a
udits
;I.3
(in
gene
ral)
145
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l co
nduc
t int
erna
l aud
its in
an
inde
pend
ent,
impa
rtia
l and
tr
ansp
aren
t way
to c
olle
ct a
nd
anal
yse
info
rmat
ion
for t
he
purp
oses
of i
ts m
onito
ring
activ
ities
(see
6.1
. Mon
itorin
g),
incl
udin
g:
(d) T
he id
entifi
catio
n of
the
need
fo
r cor
rect
ive
or im
prov
emen
t m
easu
res;
I.3 (i
n ge
nera
l)
146
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l co
nduc
t int
erna
l aud
its in
an
inde
pend
ent,
impa
rtia
l and
tr
ansp
aren
t way
to c
olle
ct a
nd
anal
yse
info
rmat
ion
for t
he
purp
oses
of i
ts m
onito
ring
activ
ities
(see
6.1
. Mon
itorin
g),
incl
udin
g:
(e) T
he v
erifi
catio
n of
the
com
plet
ion
and
effec
tiven
ess
of
thes
e m
easu
res;
I.3 (i
n ge
nera
l)
147
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l co
nduc
t int
erna
l aud
its in
an
inde
pend
ent,
impa
rtia
l and
tr
ansp
aren
t way
to c
olle
ct a
nd
anal
yse
info
rmat
ion
for t
he
purp
oses
of i
ts m
onito
ring
activ
ities
(see
6.1
. Mon
itorin
g),
incl
udin
g:
(f) T
he d
ocum
enta
tion
pert
aini
ng
to th
e ex
ecut
ion
and
resu
lts o
f au
dits
;
I.3 (i
n ge
nera
l)
155
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ion
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ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
148
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.2.
In
tern
al
audi
ting
6.2.
1. T
he o
rgan
isat
ion
shal
l co
nduc
t int
erna
l aud
its in
an
inde
pend
ent,
impa
rtia
l and
tr
ansp
aren
t way
to c
olle
ct a
nd
anal
yse
info
rmat
ion
for t
he
purp
oses
of i
ts m
onito
ring
activ
ities
(see
6.1
. Mon
itorin
g),
incl
udin
g:
(g) T
he c
omm
unic
atio
n of
the
resu
lts o
f aud
its to
the
top
man
agem
ent.
I.1.(g
)
149
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
1. T
op m
anag
emen
t sh
all r
egul
arly
revi
ew th
e co
ntin
uing
ade
quac
y an
d eff
ectiv
enes
s of
the
safe
ty
man
agem
ent s
yste
m in
clud
ing
at le
ast c
onsi
dera
tion
of:
(a) d
etai
ls o
f pro
gres
s on
ad
dres
sing
out
stan
ding
act
ions
fr
om p
revi
ous
man
agem
ent
revi
ews;
I.1 a
nd I.
3 (in
gen
eral
)
150
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
1. T
op m
anag
emen
t sh
all r
egul
arly
revi
ew th
e co
ntin
uing
ade
quac
y an
d eff
ectiv
enes
s of
the
safe
ty
man
agem
ent s
yste
m in
clud
ing
at le
ast c
onsi
dera
tion
of:
(b) c
hang
ing
inte
rnal
and
ext
erna
l ci
rcum
stan
ces
(see
1. C
onte
xt o
f th
e or
gani
satio
n);
I.1 a
nd I.
3 (in
gen
eral
)
151
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
1. T
op m
anag
emen
t sh
all r
egul
arly
revi
ew th
e co
ntin
uing
ade
quac
y an
d eff
ectiv
enes
s of
the
safe
ty
man
agem
ent s
yste
m in
clud
ing
at le
ast c
onsi
dera
tion
of:
(c) t
he o
rgan
isat
ion’
s sa
fety
pe
rfor
man
ce re
late
d to
:(i)
the
achi
evem
ent o
f its
saf
ety
obje
ctiv
es;
I.1 a
nd I.
3 (in
gen
eral
)
152
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
1. T
op m
anag
emen
t sh
all r
egul
arly
revi
ew th
e co
ntin
uing
ade
quac
y an
d eff
ectiv
enes
s of
the
safe
ty
man
agem
ent s
yste
m in
clud
ing
at le
ast c
onsi
dera
tion
of:
(c) t
he o
rgan
isat
ion’
s sa
fety
pe
rfor
man
ce re
late
d to
:(ii
) the
resu
lts fr
om it
s m
onito
ring
activ
ities
, inc
ludi
ng th
e in
tern
al
audi
t find
ings
, and
inte
rnal
ac
cide
nt/in
cide
nt in
vest
igat
ions
an
d st
atus
of t
heir
resp
ectiv
e ac
tions
;
I.1 a
nd I.
3 (in
gen
eral
)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
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03/2
021)
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olle
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ncy
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ailw
ays.
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right
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serv
ed.
156
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
153
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
1. T
op m
anag
emen
t sh
all r
egul
arly
revi
ew th
e co
ntin
uing
ade
quac
y an
d eff
ectiv
enes
s of
the
safe
ty
man
agem
ent s
yste
m in
clud
ing
at le
ast c
onsi
dera
tion
of:
(c) t
he o
rgan
isat
ion’
s sa
fety
pe
rfor
man
ce re
late
d to
:(ii
i) th
e re
leva
nt o
utpu
ts fr
om
supe
rvis
ory
activ
ities
con
duct
ed
by th
e na
tiona
l saf
ety
auth
ority
;
I.1 a
nd I.
3 (in
gen
eral
)
154
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
1. T
op m
anag
emen
t sh
all r
egul
arly
revi
ew th
e co
ntin
uing
ade
quac
y an
d eff
ectiv
enes
s of
the
safe
ty
man
agem
ent s
yste
m in
clud
ing
at le
ast c
onsi
dera
tion
of:
(d) r
ecom
men
datio
ns fo
r im
prov
emen
t.I.1
and
I.3
(in g
ener
al)
155
6.
PERF
ORM
AN
CE
EVA
LUAT
ION
6.3.
M
anag
emen
t re
view
6.3.
2.
Base
d on
the
outp
uts
of it
s m
anag
emen
t rev
iew
, the
to
p m
anag
emen
t sha
ll ta
ke
over
all r
espo
nsib
ility
for t
he
plan
ning
and
impl
emen
tatio
n of
nee
ded
chan
ges
to th
e sa
fety
man
agem
ent s
yste
m.
I.1.(g
)
156
7.
IMPR
OVE
MEN
T7.
1.
Lear
ning
from
ac
cide
nts
and
inci
dent
s
7.1.
1.
Acci
dent
s an
d in
cide
nts
rela
ted
to th
e or
gani
satio
n’s
railw
ay o
pera
tions
sha
ll be
:
(a) r
epor
ted,
logg
ed, i
nves
tigat
ed
and
anal
ysed
to d
eter
min
e th
eir
caus
es;
I.3 (i
n ge
nera
l)
157
7.
IMPR
OVE
MEN
T7.
1.
Lear
ning
from
ac
cide
nts
and
inci
dent
s
7.1.
1.
Acci
dent
s an
d in
cide
nts
rela
ted
to th
e or
gani
satio
n’s
railw
ay o
pera
tions
sha
ll be
:
(b) r
epor
ted
to n
atio
nal b
odie
s as
ap
prop
riate
.I.3
(in
gene
ral)
158
7.
IMPR
OVE
MEN
T7.
1.
Lear
ning
from
ac
cide
nts
and
inci
dent
s
7.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
:(a
) rec
omm
enda
tions
from
the
natio
nal s
afet
y au
thor
ity, t
he
natio
nal i
nves
tigat
ing
body
and
in
dust
ry/in
tern
al in
vest
igat
ions
ar
e ev
alua
ted
and
impl
emen
ted
if ap
prop
riate
or m
anda
ted;
I.3 (i
n ge
nera
l), A
rt.
4(4)
157
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ion
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urop
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202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
159
7.
IMPR
OVE
MEN
T7.
1.
Lear
ning
from
ac
cide
nts
and
inci
dent
s
7.1.
2. T
he o
rgan
isat
ion
shal
l en
sure
that
:(b
) rel
evan
t rep
orts
/info
rmat
ion
from
oth
er in
tere
sted
par
ties
such
as
railw
ay u
nder
taki
ngs,
infr
astr
uctu
re m
anag
ers,
entit
ies
in
char
ge o
f mai
nten
ance
and
railw
ay
vehi
cle
keep
ers
are
cons
ider
ed a
nd
take
n in
to a
ccou
nt.
I.3 (i
n ge
nera
l), I.
7 (in
ge
nera
l), II
I.9, I
V.9,
Art
. 4(
4), A
rt. 5
(2),
Art
. 5(3
)
160
7.
IMPR
OVE
MEN
T7.
1.
Lear
ning
from
ac
cide
nts
and
inci
dent
s
7.1.
3. T
he o
rgan
isat
ion
shal
l us
e in
form
atio
n re
latin
g to
th
e in
vest
igat
ion
to re
view
th
e ris
k as
sess
men
t (se
e 3.
1.1.
Ri
sk a
sses
smen
t), t
o le
arn
with
the
aim
of i
mpr
ovin
g sa
fety
and
, whe
re a
pplic
able
, to
ado
pt c
orre
ctiv
e an
d/or
im
prov
emen
t mea
sure
s (s
ee
5.4.
Man
agem
ent o
f cha
nge)
.
I.3 a
nd I.
4 (in
gen
eral
), A
rt. 4
(4)
161
7.
IMPR
OVE
MEN
T7.
2.
Cont
inua
l im
prov
emen
t7.
2.1.
The
org
anis
atio
n sh
all
cont
inua
lly im
prov
e th
e ad
equa
cy a
nd e
ffect
iven
ess
of it
s sa
fety
man
agem
ent
syst
em, t
akin
g in
to a
ccou
nt
the
fram
ewor
k se
t out
in
Regu
latio
n (E
U) N
o 10
78/2
012
and
at le
ast t
he o
utpu
ts o
f the
fo
llow
ing
activ
ities
:
(a) m
onito
ring
(see
6.1
. M
onito
ring)
;I.4
(in
gene
ral),
Art
. 4(
4), A
rt. 7
(1),
Art
. 9(3
)
162
7.
IMPR
OVE
MEN
T7.
2.
Cont
inua
l im
prov
emen
t7.
2.1.
The
org
anis
atio
n sh
all
cont
inua
lly im
prov
e th
e ad
equa
cy a
nd e
ffect
iven
ess
of it
s sa
fety
man
agem
ent
syst
em, t
akin
g in
to a
ccou
nt
the
fram
ewor
k se
t out
in
Regu
latio
n (E
U) N
o 10
78/2
012
and
at le
ast t
he o
utpu
ts o
f the
fo
llow
ing
activ
ities
:
(b) i
nter
nal a
uditi
ng (s
ee 6
.2.
Inte
rnal
aud
iting
);I.4
(in
gene
ral)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
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(01/
03/2
021)
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olle
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hen
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ted.
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urop
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ncy
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ailw
ays.
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right
s re
serv
ed.
158
No.
Sect
ion
Sub-
sect
ion
Mai
n re
quire
men
t1s
t lev
el re
quire
men
t2n
d le
vel r
equi
rem
ent
Art
icle
s an
d A
nnex
II
- cor
resp
ondi
ng
requ
irem
ents
163
7.
IMPR
OVE
MEN
T7.
2.
Cont
inua
l im
prov
emen
t7.
2.1.
The
org
anis
atio
n sh
all
cont
inua
lly im
prov
e th
e ad
equa
cy a
nd e
ffect
iven
ess
of it
s sa
fety
man
agem
ent
syst
em, t
akin
g in
to a
ccou
nt
the
fram
ewor
k se
t out
in
Regu
latio
n (E
U) N
o 10
78/2
012
and
at le
ast t
he o
utpu
ts o
f the
fo
llow
ing
activ
ities
:
(c) m
anag
emen
t rev
iew
(see
6.3
. M
anag
emen
t rev
iew
);I.4
(in
gene
ral)
164
7.
IMPR
OVE
MEN
T7.
2.
Cont
inua
l im
prov
emen
t7.
2.1.
The
org
anis
atio
n sh
all
cont
inua
lly im
prov
e th
e ad
equa
cy a
nd e
ffect
iven
ess
of it
s sa
fety
man
agem
ent
syst
em, t
akin
g in
to a
ccou
nt
the
fram
ewor
k se
t out
in
Regu
latio
n (E
U) N
o 10
78/2
012
and
at le
ast t
he o
utpu
ts o
f the
fo
llow
ing
activ
ities
:
(d) l
earn
ing
from
acc
iden
ts a
nd
inci
dent
s (s
ee 7
.1. L
earn
ing
from
ac
cide
nts
and
inci
dent
s).
I.4 (i
n ge
nera
l)
165
7.
IMPR
OVE
MEN
T7.
2.
Cont
inua
l im
prov
emen
t7.
2.2.
The
org
anis
atio
n sh
all
prov
ide
mea
ns to
mot
ivat
ing
staff
and
oth
er in
tere
sted
pa
rtie
s to
be
activ
e in
im
prov
ing
safe
ty a
s pa
rt o
f its
or
gani
satio
nal l
earn
ing.
166
7.
IMPR
OVE
MEN
T7.
2.
Cont
inua
l im
prov
emen
t7.
2.3.
The
org
anis
atio
n sh
all p
rovi
de a
str
ateg
y to
co
ntin
ually
impr
ove
its s
afet
y cu
lture
, rel
ying
on
the
use
of e
xper
tise
and
reco
gnis
ed
met
hods
to id
entif
y be
havi
oura
l iss
ues
affec
ting
the
diffe
rent
par
ts o
f the
saf
ety
man
agem
ent s
yste
m a
nd
to p
ut in
pla
ce m
easu
res
to
addr
ess
thes
e.
159
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ion
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ncy
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ailw
ays.
All
right
s re
serv
ed.
AN
NEX
Ann
ex II
I
REG
ULA
TIO
N 2
019/
779
Art
.15
ECM certified for F
reight W
agon
based on
Reg 445
/201
1
ECM certificate iss
ued un
der R
eg 445
/201
1 is eq
uivalent to
ECM
certificate issued
und
er Reg 779
/201
9 and is valid
for its orig
inal period
of validity
Expiratio
n of equ
ivalen
t ECM
Certificate after 1
6 of Ju
ne 202
0
Application for a
new
/ren
ewed
ECM
certificate based
on Reg 779
/201
9 is requ
ested from
16 of Ju
ne 202
0
ECM certificate is valid
up to 5 years (1
)
New
App
licant (ne
wcomer) E
CM fo
r Freight W
agon
s
NOTE
(1) By
virtue
of 3
.4.8 of the
ECM
Ce
rtificatio
n sche
me, ECM
certificate is
limite
d to 1 year for new
comer (app
licant
never registered
as E
CM in
the NVR
s)
Regulatio
n EU
201
9/77
9
(Sou
rce: Art. 3(2)‐a
, Art. 7(8), A
rt.16)
FLOW DIAGRA
M VALID ONLY FOR FREIGHT
WAG
ONS
(Before 16
of Jun
e 20
20)
(After 16 of Ju
ne 202
0)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
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ion
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ailw
ays.
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right
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serv
ed.
160
ECM has a CB attestation of ECM
for v
ehicles (no
t Freight W
agon
s)
based on
national law
s app
licable in
the fie
ld of R
egulation
779/20
19 re
leased
Attestation is eq
uivalent to
ECM
certificate issue
d un
der R
eg 779/2019 and is
valid
until its expira
tion date (at the
latest until 16
of Jun
e 2023)
Expiratio
n of attestatio
n (equ
ivalen
t to EC
M Certification) after 16 of
June
202
0
Application for E
CM certification based on
Reg
779/20
19 is re
quested from
16 of Ju
ne 202
0
ECM certificate is valid
up to 5 years (1
)EC
M fo
r veh
icle (n
ot freight w
agon
s)
with
out C
B attestation
(2)
ne
w App
licant (ne
wcomer) E
CM fo
r vehicles (n
ot freight w
agon
s) (2
)
NOTE
(1) By
virtue
of 3
.4.8 of the
ECM
Ce
rtificatio
n sche
me, ECM
certificate is
limite
d to 1 year for new
comer (app
licant
never registered
as E
CM in
the NVR
s)
Regulatio
n EU
201
9/77
9
(Sou
rce: Art. 7(8), Art. 15
(2), Art. 17
)
NOTE
(2) If EC
M
is also RU/IM se
e specific slide
7
FLOW DIAGRA
M VALID FOR VE
HICLES OTH
ERTH
AN FRE
IGHT
WAG
ONS
(After 16 of Ju
ne 202
0)
Before 16 of Ju
ne 202
0
161
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
ECM fo
r veh
icles (no
t Freight W
agon
s) has a CB attestation of
conformity
with
the principles and
criteria equ
ivalen
t to the
requ
iremen
ts of A
nnex III of R
egulation 44
5/20
11 issued
Attestation is eq
uivalent to
ECM
certification issue
d un
der R
eg 779
/2019
and is valid
until its expira
tion date (at the
latest until 16
of Jun
e 2023)
Expiratio
n of attestatio
n (equ
ivalen
t ECM
Certificate) after 16 of
June
202
0
Application for E
CM certification based on
Reg
779/20
19 is re
quested from
16 of Ju
ne 202
0
ECM certificate is valid
up to 5 years (1
)EC
M fo
r veh
icle (n
ot freight w
agon
s)
with
out C
B attestation
(2)
ne
w App
licant (ne
wcomer) E
CM fo
r vehicles (n
ot freight w
agon
s) (2
)
NOTE
(1) By
virtue
of 3
.4.8 of the
ECM
Ce
rtificatio
n sche
me, ECM
certification is
limite
d to 1 year for new
comer (app
licant
never registered
as E
CM in
the NVR
s)
NOTE
(2) If EC
M
is also RU/IM se
e specific slide
7
Regulatio
n EU
201
9/77
9
(Sou
rce: Art. 7(8), Art. 15
.3, A
rt. 17)
FLOW DIAGRA
M VALID FOR VE
HICLES OTH
ERTH
AN FRE
IGHT
WAG
ONS
(After 16 of Ju
ne 202
0)
(Before 16
of Jun
e 2019
)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
162
New
App
licant for CB attestation of con
form
ity fo
r ou
tsou
rced
mainten
ance fu
nctio
ns based
on
natio
nal law
s on the fie
ld of R
eg 779
/201
9 for
vehicles (n
ot freight w
agon
s), app
licable before 16
of Ju
ne 201
9,
Application for n
ew/ren
ewed
attestatio
n of
conformity
for o
utsourced mainten
ance fu
nctio
ns
Expiratio
n of attestatio
n (equ
ivalen
t to EC
M certificate)
for o
utsourced mainten
ance fu
nctio
ns after 16 of Ju
ne
2020
app
lication for certification for o
utsourced mainten
ance fu
nctio
ns
based on
Reg 779/201
9 may be requ
ested from
16 of Ju
ne 202
0
Outsourced mainten
ance fu
nctio
ns
certificate is valid 5 years (1
)
Outsourced mainten
ance fu
nctio
ns with
out
CB attestatio
n of con
form
ity fo
r veh
icles
(not freight w
agon
s)
Outsourced mainten
ance fu
nctio
ns fo
r all
kind
of veh
icles
New
App
licants outsourced mainten
ance
functio
ns fo
r all kind
of veh
icles
NOTE
(1) By
virtue
of 3
.4.8 of the
ECM
Ce
rtificatio
n sche
me, certificate is lim
ited
to 1 year for new
comer (app
licant n
ever
coverin
g the role of o
utsourced maint.
functio
n)
Regulatio
n EU
201
9/77
9
(Sou
rce: Art. 7(8), Art. 10, A
rt. 15(4), A
rt. 17)
Outsourced mainten
ance fu
nctio
n has a
CB attestation
of con
form
ity based
on natio
nal law
s on the fie
ld of R
eg
779/20
19 fo
r veh
icles (no
t freight wagon
s), app
licable
before 16 of Ju
ne 201
9, re
leased
Expiratio
n of CB attestation of con
form
ity after 16 of Ju
ne
2020
CB issues attestatio
n of con
form
ity before 16
of Jun
e 2022
Attestation of con
form
ity is equ
ivalen
t to certificatio
n for
outsou
rced
mainten
ance fu
nctio
ns issued
und
er Reg 779
/201
9 and
is valid
until its expira
tion date (at the
latest until 16
of Jun
e 20
25)
OR
Voluntary
(Before 16
of Jun
e 20
22)
(Before 16
of Jun
e 20
22)
(After 16 of Ju
ne 202
0)
163
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
AN
NEX
ECM fo
r veh
icles (no
t Freight W
agon
s) not
subjected to Art. 15(2), 15(3), 15(4)
ECM fo
r veh
icles listed in Art. 15(1) of Safety Directive EU
20
16/798
and
not su
bjected to Art. 15(2), 15(3), 15(4)
(see
NOTE
for list of veh
icles)
They are re
quested to com
ply with
Reg EU 201
9/77
9 by
16 of Ju
ne 202
2 at th
e latest (2
)
NOTE
(2) If EC
M
is also RU/IM se
e specific slide
7
NOTE
Vehicles as in Art. 15(1) o
f Safety Directive 2016/798
(a) veh
icles registered
in a th
ird cou
ntry and
maintaine
d in accordance with
the law of that cou
ntry;
(b) veh
icles used
on ne
tworks or lines th
e track gauge of which is differen
t from th
at of the
main rail ne
twork with
in th
e Union
and
in re
spect o
f which fu
lfilm
ent o
f the
requ
iremen
ts laid dow
n in Article
14(2) is e
nsured
by international agreemen
ts with
third
cou
ntrie
s;
(c) freight wagon
s and pa
ssen
ger coa
ches which are in sh
ared
use with
third
cou
ntrie
s the
track gauge of which is differen
t from th
at of the
main rail ne
twork with
in th
e Union
; (d) veh
icles used
on the ne
tworks re
ferred
to in
Article 2(3), and military equ
ipmen
t and
special transpo
rt re
quiring
an ad
hoc national safety authority
permit to be de
livered
prio
r to their e
ntry into
service. In
this case derogations sh
all be granted for p
eriods not longer th
an 5 years.
Sub‐NOTE
for v
ehicles used
on pa
rticular network (le
tter (d
) abo
ve) a
s in Art. 2(3) of Safety Dire
ctive 2016/798
(a) p
rivately ow
ned railw
ay infrastructure, including
sidings, used by th
e ow
ner o
r by an
ope
rator for th
e pu
rpose of th
eir respe
ctive freight a
ctivities or for th
e transport o
f persons fo
r non
‐com
mercial
purposes, and
veh
icles u
sed exclusively on
such infrastructure;
(b) infrastructure and vehicles re
served
for strictly
local, historical or tou
rist u
se;
(c) light ra
il infrastructure occasionally used by heavy ra
il vehicles und
er th
e op
erational con
ditio
ns of the
light rail system, w
here it is necessary fo
r the
purpo
ses o
f con
nectivity
of tho
se veh
icles o
nly;
and
(d) veh
icles p
rimarily used on
light rail infrastructure bu
t equ
ippe
d with
some he
avy rail compo
nents n
ecessary to
enable transit to
be effected
on a confined
and
limite
d section of heavy ra
il infrastructure fo
r con
nectivity
purpo
ses o
nly.
Regulatio
n EU
201
9/77
9 and Re
gulatio
n EU
202
0/78
0
(Sou
rce: Art. 15(5), A
rt. 17)
FLOW DIAGRA
M VALID FOR VE
HICLES
OTH
ER THA
N FRE
IGHT
WAG
ONS
(After 16 of Ju
ne 202
0)(After 16 of Ju
ne 202
0)
GU
IDA
NC
E O
N E
CM
CER
TIFI
CA
TIO
N P
RO
CES
S
Vers
ion
9.0
(01/
03/2
021)
. Unc
ontr
olle
d w
hen
prin
ted.
Dow
nloa
d th
e la
test
ver
sion
at e
ra.e
urop
a.eu
.©
202
1 EU
Age
ncy
for R
ailw
ays.
All
right
s re
serv
ed.
164
Application for E
CM certification based on
Reg EU 201
9/77
9
may be requ
ested
(at the
latest until 16
of Jun
e 20
22)
RU/IM com
pliance with
ECM
Regulation
checked via Safety Certification/Au
thorisa
tion
Process throu
gh:
‐ first issue
(ERA
/NSA
)‐ ren
ewal (E
RA/N
SA)
‐ Managem
ent o
f change by
RU/IM
for n
ewcomer ECM
(at the
latest until 16
of Jun
e 20
22)
NSA
ann
ual sup
ervisio
n
NOTE
(1) By
virtue
of 3
.4.8 of the
ECM
Ce
rtificatio
n sche
me, ECM
certificate is
limite
d to 1 year for new
comer (app
licant
never registered
as E
CM in
the NVR
s)
RU/IM (o
r new
comer RU/IM) registered
as
ECM or a
pplying for the
role of E
CM fo
r vehicles (n
ot Freight W
agon
s) used for its
own op
erations
RU/IM com
pliance with
ECM
Regulation may be
checked via Safety Certification/Au
thorisa
tion Process
through:
‐ ren
ewal (E
RA/N
SA)
‐ Managem
ent o
f change by
RU/IM
for registered
ECM
(at the
latest until 16
of Jun
e 20
22)
ECM certificate is valid
up to 5 years (1
)
OR
ECM certification is de
emed
evide
nce of com
pliance
with
5.2.4, 5.2.5 of A
nnex I and An
nex II of CSM
SMS
(Reg EU 201
8/76
2)
Regulatio
n EU
201
9/77
9 and Re
gulatio
n EU
20
20/780
(Sou
rce: Art. 3(2)‐b
, Art. 3(3), Art. 3(4), A
rt. 3(5), Art 7
(8), Art.
15(5), Art. 17
)
FLOW DIAGRA
M VALID FOR VE
HICLES OTH
ERTH
AN FRE
IGHT
WAG
ONS
(After 16 of Ju
ne 202
0)
European Union Agency for Railways120 rue Marc LefrancqBP 20392FR-59307 Valenciennes CedexTel. +33 (0)327 09 65 00
era.europa.euTwitter @ERA_railways
Print ISBN 978-92-9477-302-9 doi:10.2821/423550 TR-04-20-455-EN-CPDF ISBN 978-92-9477-303-6 doi:10.2821/731954 TR-04-20-455-EN-N
Guidance for ECM certification: ▶ Understanding the concept of ECM ▶ Clarification on the obligation of parties involved in the
maintenance process of vehicles