4-assessment bodies-nobo-debo-asbo.pdf

Athens, 16th DEC 2014

Luca TRINCA, Interoperability Unit

Assessment bodies: NoBo, DeBo, AsBo for RA

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CONTENT

1. INTRODUCTION ON ASSESSMENT BODIES

2. ACCREDITATION AND RECOGNITION

3. NOTIFIED BODIES

4. DESIGNATED BODIES

5. ASSESSMENT BODIES FOR CSM-RA

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CONTENT



3. NOTIFIED BODIES



CONFORMITY ASSESSMENT: GENERAL

Conformity assessment

means the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled

Conformity assessment body (CAB)

means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

(Reg. (EC) No. 765/2008)

The same approach is valid in all the regulated European industrial sector

(e.g. ships, toys, gas emissions)

CONFORMITY ASSESSMENT: RAILWAYS

3 types of CABs, depending on the assessment against:

- TSIs called Notified Bodies (NoBo ref. art 28 of IOD);

- NNTR (notified national technical rules) called designated Bodies (DeBo ref. art 17 of IOD);

- Risk Assessment performed under the CSM called Assessment Bodies (AsBo ref. 6 of Reg. 402/2013).

ATTENTION

NoBo and DeBo are related to the IOD only for the authorisation of components, subsystems and vehicles;

AsBo has double nature: under the IOD (art 15, 2nd para, 2nd bullet point) for the APIS (if requested by the TSI and for the safe integration) but also under the Safety Railways Directive (49/2004/EC) for the modification to the SMS for RU and IM (DV29bis, 38 -> 41)

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3. NOTIFIED BODIES



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TWO PATHS: ACCREDITATION AND RECOGNITION

Accreditation

Means an attestation by a national accreditation body (NAB) that a conformity assessment body (CAB) meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity.

Recognition

This term is not defined, however art 5(2) of Reg. (EC) No. 765/2008 allows the Member State to select the specific CAB, giving evidence of the comparable requirements to the accreditation.

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KEY WORDS

NATIONAL ACCREDITATION BODY

national accreditation body shall mean the sole body in a Member State that performs accreditation with authority derived from the State. (Reg. (EC) No. 765/2008)

In Greece is the E.SY.D. (http://www.esyd.gr/portal/p/esyd/en/esyd.jsp)

HARMONISED STANDARDS

A harmonised standard is a European standard elaborated on the basis of a request from the EC to a recognised European Standards Organisation (CEN, CLC, ETSI) to develop a European standard that provides solutions for compliance with a legal provisions (http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm )

SECTORAL SCHEME

Documents containing criteria supplementary (amplified or detailed) to those contained in Harmonised standards (ref. lev 4. to guide EA 1/06 available here:

http://www.european-accreditation.org/publication/ea-1-06re-published-november-2014).

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ACCREDITATION/RECOGNITION: WHY DO THEY EXIST ?

CONFORMITY ASSESSMENT

BODY (3rd party)

MANUFACTURER/ SERVICE PROVIDER

(1st party)

END USER e.g. Authorities,

consumers (2nd party)

No contractual relationship

Technical Activity

From other country

ACCREDITATON BODY

- Repetition of activities (tests!)

-Technical Barriers to Trade

+ Costs

CONFIDENCE

accredits

CERTIFICATE/ REPORT

CERTIFICATE/ REPORT

INFORMATION ON ACCREDITATION

STATUS

APPLICATION

Mutual trust!

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TRIANGLE OF ROLES (GENERAL)

CONFORMITY ASSESSMENT

BODY (3rd party)

MANUFACTURER/ SERVICE PROVIDER

(1st party)

END USER (2nd party)

e.g. Authorities, consumers

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CONTENT



3. NOTIFIED BODIES



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NOBOs IN EU

In EU there are 58 NoBos (source NANDO @May 2014) under the Interoperability Directive 2008/57/EC.

NoBos can work in the whole Europe

40 accredited and 18 recognised:

The accredited NoBos have been assessed according several ISO standards, mainly 17020, 17021 and 17065

In some cases the competence of the recognised NoBos has been assessed according to ISO standards OR according the requirements of Annex VIII to IOD

EC Declaration of Conformity for IC // EC Declaration of Suitability for Use for IC // EC Declaration of Verification of the Subsystem

Notified Body (IOD 2008/57/EC)

Non-Accredited Conformity Assessment Body

Accredited Conformity Assessment Body

National Accreditation Body

Member State (Recognition and Notification)

Member State (Notification)

European co-operation for Accreditation (EA)

ERA accreditation scheme (with EA)

Modules Decision 2010/713/EU)

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TWO PATHS for NOBOs IN DETAILS

ACCREDITATION RECOGNITION

HERE THE CABS BECOME NoBoS

The scope description of the accreditation must be the same scope description as the notification.

RAILWAY PECULIARITIES

Today in EU there are several way of apply the EN ISO standards. The accreditation scheme will harmonise them

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SECTORAL SCHEME FOR NOBOs

ERA is developing, with EA (European cooperation for accreditation), a specific sectoral accreditation scheme for notified bodies for railways under the interoperability directive 2008/57/EC.

This scheme would facilitate the trust amongst EU NoBos and the notification process (accreditation -> Notification)

The scheme must cover the technical capacity necessary for the NoBos to properly perform their duties. (ERA WP 2014: ABS 4.5(2) http://www.era.europa.eu/Document-Register/Pages/Work-progamme-2014.aspx)

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Bilateral meetings with EA-European cooperation for accreditation and NAB-National accreditation bodies (art. 14(6) and 4 of 765/2008). Meetings with EA, BELAC, COFRAC, RVA, SWEDAC, UKAS, EBA and PCA until beginning 2015.

Ad hoc task force with external members (EA, NB-Rail) + NSAs, OTIF (as observers): active from February to December 2015

Kick off: 11 FEB 2015 Progress: 29 MAY 2015 Intermediate: 22 SEP 2015 Final: 04 DEC 2015

FINAL DELIVERABLE ACCREDITATION SCHEME: DEC 2015

SECTORAL SCHEME FOR NOBOs 1

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THE SCHEME WOULD BE BASED ON

EN ISO/IEC 17065

Focus on the product certifications the main activity of NoBo in IOD

Allow the use of the tools and techniques described in 17020 and 17021 details on surveillance and witnessing

Provide clear identification of resources tasks allocations

Mechanism to safeguard the impartiality (flexible)

EN ISO/IEC 17011

Possibility to have as external experts staff from NSA and/or from ERA -> linked to the expertise in field for the assessment team

Duration of accreditation -> linked to overall cost

EVERYTHING TO BE DISCUSSED IN THE TASK FORCE IN 2015


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ACCREDITATION

Project start

ERA analysis of current status

Proposal for accreditation scheme

Outcome of the ad hoc task force + Advice to EC

Today

2014 2015

Ad hoc task force

MAR 2014 OCT 2014 APR 2015 DEC 2015

Kick off meeting


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MODULES WHAT THEY ARE

On the basis of international standards, Europe developed conformity assessment procedures and rules for their selection and use. Those procedures are called the modules. The modules are set out in a manner to favour their selection from the lightest (internal control of production) for simple products or products not necessarily presenting serious risks, moving to the most comprehensive (full quality assurance), where the risks are more severe or the products/technologies more complex. In most of the industrial sectors the modules are the same, described by ANNEX II of the Decision 768/2008. The blue guide 2014 provides also an interesting reading (http://ec.europa.eu/DocsRoom/documents/4942)

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MODULES IN RAILWAYS 2

However, the specificities of sectoral needs may provide grounds for recourse to other regulatory solutions or specific adaptation of the common principles. THIS IS THE CASE FOR RAILWAYS DUE TO TSIs (ICs & SS) with the Decision 713/2010. This Decision provides for a menu of modules for railways, enabling the legislator to choose in proportion to the level of risk involved and the level of safety required. Those modules are identified by the TSIs and shall be followed by the manufacturer with the collaboration of NoBos.

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MODULES FOR ICs

Defined in the TSIs from the Decision 713/2010

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The C at the beginning indicates the reference to the constituents. The modules are in principle the same as the general modules for other industrial sectors.

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MODULES FOR SUBSYSTEMS

Defined in the TSIs from the Decision 713/2010

The S at the beginning indicates the reference to the subsystems. The modules are in principle the same as the general modules for other industrial sectors.

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HOW TO CHOSE A MODULE

According to the choice given in the TSI, there are always two possibilities: with QMS or without QMS.

Cost

Size of serial

production

SB

QMS

SB+SD or SH1

SG SB+SF

The choice of the module may have an important impact on the cost and time. The choice depends on the particular situation of each company and specific characteristics of the products.

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Balance between fixed cost, mass production and marginal cost. As a rule of thumb, SB modules for mass production (vehicles) and SG for specific developments (fixed installation). (http://www.era.europa.eu/Document-Register/Pages/TSI-Application-Guide-Conformity-assessment-and-EC-verification.aspx )

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3. NOTIFIED BODIES



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DeBos & NoBos

The NoBo approach should be used for DeBo mutatis mutandi

The same general requirements should apply (e.g. accreditation against 17065, ). The detailed technical competence should be related to the NNTR and

not to the TSIs -> specific for each MS!

Modules apply only to TSIs, not to NNTR (maybe in the future?) NOTE the IOD mention in 26(5) the possibility to use modules D and E for the declaration of conformity to type (see definition 2(w) in IOD).

Today not monitored at EU level (maybe in the future?)

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CONTENT



3. NOTIFIED BODIES



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OVERALL VISION ON SAFETY - 1

Maintain at least the existing level of safety in the EU railways, and increase it when reasonably practicable

Create a basis for mutual trust

with many new railway actors and interfaces

It is necessary to set up a common approach for:

Safety regulation: WHO does WHAT

Safety management: CSM

Safety supervision: check of compliance with the applicable legislation

Please for any communication refer to: [email protected]

OVERALL VISION ON SAFETY - 2

EU railway legislation

Safety Management

Safety Supervision

Safety Regulation

Definition by EU legislation of Roles and Responsibilities of railway stakeholders

Responsibility for safety of railway system put on those who OPERATE and MAINTAIN railways:

RUs, IMs must manage and monitor safely their activities through a Safety Management System (SMS)

ECMs must manage and monitor maintenance activities through a System of Maintenance

NSAs & other bodies (e.g. ECM Certification Body, NoBo, DeBo, etc.) guarantee RUs, IMs and ECMs comply with their obligations

CSM-RA and SMS

The implementation of a Safety Management System (SMS) requires the application of the CSM for Risk Assessment for any modification.

The APIS requires also the application of the CSM-RA.

BOTH PROCESSES ARE CONTROLLED BY THE ASBO DESCRIBED IN THE CSM-RA

Regulations 402/2013 (replacing Regulation 352/2009)

Common: harmonised method at the European level ensuring equal treatment for all railway actors

Safety: it is to be used by railway actors to manage safely changes made to the European railway system

Method: tool to be applied for controlling risks in a harmonised way. It is not replacing the technical railway knowledge

CSM for risk assessment is a European regulation it is legally binding and there is no need of national transposition

CSM for Risk Assessment

AsBo is the body who checks the correct application of the CSM-RA

It shall be either (Article 7):

(a) ACCREDITED by the national accreditation body using the criteria defined in Annex II, or;

(b) RECOGNISED by the recognition body using the criteria defined in Annex II, or;

(c) the NATIONAL SAFETY AUTHORITY designated by the Member State as able to conduct independent assessment

When Member State recognises NSA as an assessment body, it is the responsibility of that Member State to ensure that NSA fulfils requirements set out in Annex II.

In this case, Assessment Body functions of NSA shall be demonstrably independent of the other functions of NSA (art 9.2 of the 402/2013)

AsBo for CSM-RA

An assessment body shall carry out an independent assessment of both the suitability of the application of the risk management process described in Annex I and of the appropriateness of its results.

The proposer (of the change) shall appoint its own assessment body at the earliest appropriate stage of the risk assessment process.

PROCESS FOR ASSESSMENT

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ACTIVITIES PERFORMED BY AsBo

To perform the independent assessment, the assessment body shall:

(a) ensure it has a thorough understanding of the significant change based on the documentation;

(b) conduct an assessment of the processes used for managing the safety and quality;

(c) conduct an assessment of the application of those safety and quality processes

Fulfil all requirements of ISO/IEC 17020 standard

Exercise professional judgement in performing the inspection work defined in that standard

Fulfil the general criteria concerning competence and independence in that standard and the following specific competence criteria:

(a) competence in risk management: knowledge and experience of the standard safety analysis techniques and of the relevant standards;

(b) all relevant competences for assessing the parts of the railway system affected by the change ( i.e. for assessing change + its integration in railway system);

(c) competence in the correct application of safety and quality management systems or in auditing management systems.

CRITERIA FOR AsBo FOR CSM-RA

By analogy to Article 28 of Directive 2008/57/EC on NoBos, AsBo shall be accredited or recognised for the different areas of competence within the railway system, or parts of it for which an essential safety requirement exists, including the area of competence involving the operation and maintenance of the railway system.

For example, possible classifications of competence can be:

Infrastructure Energy Control command and signalling Rolling Stock Braking components Operation and Traffic management Overall consistency and system approach (System Level)

AN HARMONISATION WITH THE ACCREDITATION OF NOBOs IS ENVISAGED (not yet planned)

SCOPE OF THE ACCREDITATION

Making the railway system work better for society.

era.europa.eu

4-assessment bodies-nobo-debo-asbo.pdf

Documents

assessment bodies asbo

conformity assessment

general conformity assessment

csmra conformity assessment

notified bodies nobo

designated bodies debo

recognition accreditation

iod risk assessment