How to meet the requirements of STCW

regarding QA for medical examiners

Øyvind Olsen – Quality Director Sjøfartsdirektoratet

29.08.2014

29.08.2014

«It is about health and safety for people working in demanding environment ….and in a industry with high HSE requirements»

Foto: Finn Belden – Odin Viking «Fotokonkurransen for sjøfolk»

REQUIREMENTS FOR

THE NORWEGIAN MARITIME AUTHORITY

Quality Management System

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EEA Agreement and Directive 2009/21/EC

Directive 2009/21/EC - Article 8:

Quality management system and internal evaluation

1. By 17 June 2012 each Member State shall develop, implement and maintain a quality management system for the operational parts of the flag State-related activities of its administration. Such quality management system shall be certified in accordance with the applicable international quality standards.

2. 2. Member States which appear on the black list or which appear, for two consecutive years, on the grey list as published in the most recent annual report of the Paris Memorandum of Understanding on Port State Control (hereinafter the Paris MOU) shall provide the Commission with a report on their flag State performance no later than four months after the publication of the Paris MOU report. The report shall identify and analyse the main reasons for the lack of compliance that led to the detentions and the deficiencies resulting in black or grey status.

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Paris MoU «Flag Performance List 2013»

RESOURCE Control

PROCESS Control

STRATEGY PERFORMANCE Management

CONTINUAL IMPROVEMENT

Customers Stakeholders

Suppliers / partners

Quality Management System

The Norwegian Maritime Authority

Quality Management System System Requirements Performance Guideline

Strategy and performance management ISO 9001 section 4 and 5 ISO 9004 section 4 and 5

Resource control ISO 9001 section 6 ISO 9004 section 6

Process control ISO 9001 section 7 ISO 9004 section7

Continual improvement ISO 9001 section 8 ISO 9004 section 8 and 9

«Outsourcing» of activities to suppliers/partners

• Doctors declaration (Quality system) when applying for new/renewal approval – A quality system is implemented based on ”Regulations of 5 June 2014 No. 805 on medical

examination of employees on Norwegian ships and mobile offshore units”

– The quality system is in accordance with an internationally recognised standard and/or NMA guidelines

– The quality system is implemented and the organization use the system in the daily work

– Management perform periodic evaluation in order to improve of the quality system

• Risk Based Inspection

– Reports of unconformities from seafarers, doctors, other health authorities..

– Doctors practise «Medical Certificate» / «Declaration of Unfitness»

– Random sampling

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REQUIREMENTS FOR

THE SEAFARER’S DOCTOR

Quality Management System

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Regulations of 5 June 2014 No. 805 on medical examination of employees on Norwegian ships and mobile offshore units

Section 7: Requirements for approval as seafarer's doctor

Approval as seafarer's doctor requires that the medical practitioner is authorised in accordance with national requirements in the country where he or she has their practice, and he or she: • a) has completed a course in maritime medicine approved by the Norwegian Maritime Authority; • b) can perform medical examinations of employees pursuant to these Regulations to such an extent that

competence in maritime medicine is maintained; • c) participates in a refresher course in maritime medicine during the approval period; • d) has access to the equipment needed to complete the examinations pursuant to these Regulations; • e) has normal colour vision or has made arrangements so that the employee's colour vision can be properly

examined; • f) has command of Norwegian or English; • g) has necessary knowledge of Norwegian legislation, particularly these Regulations and the Public Administration

Act; • h) has a quality system in accordance with an internationally recognised standard.

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What is a Quality Management System ?

How do you run your business ? … in compliance with ……

Is QUALITY one of your key success factors ? YES/ NO

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General Requirements to Quality Systems Source: ISO 9001:2008

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Medical Certificate Declaration of Unfitness

Determine the processes needed to be in compliance with regulations and objectives.

Determine criteria and methods needed to ensure that both the operation and control of these processes are effective.

Monitor, measure where applicable, and analyse these processes

Ensure the availability of resources and information necessary to support the operation and monitoring of these processes.

Implement actions necessary to achieve planned results and continual improvement of these processes

Regulations Objectives Agreements

Doctor processes

NMA Guideline – Quality Systems

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Quality Policy

Control of normative documents

Business Processes Nonconformity and Improvement

Control of records

Quality Manual Management Review

Will you make it

simple or complex ?

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Thank you for your attention

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