1. Harmonised use of accreditation for assessing the competence of various Conformity Assessment Bodies Dr Andreas Steinhorst, EA ERA workshop 13 April 2016, Valenciennes

2.  The accreditation process determines the technical competence and integrity of organisations that offer testing, calibration, inspection, verification and certification services (collectively known as conformity assessment). WHAT IS ACCREDITATION? 2

3.  Accreditation operates in the public interest across all market sectors, providing a transparent and impartial assessment of these services against internationally recognised standards and sectoral requirements. WHAT IS ACCREDITATION? 3

4. Accreditation…  Is the preferred mechanism for identifying competent bodies to implement government policies and regulations aimed at safeguarding the public and building public confidence in activities that impact on such fields as safety, environment, and health. BENEFITS FOR GOVERNMENTS AND REGULATORS 4

5. Accreditation…  Helps to increase access to services of consistent and reliable quality and safety. BENEFITS FOR CONSUMERS 5

6. Regulation (EC) No 765/2008 ‘Accreditation’ shall mean an attestation by a national accreditation body that a conformity assessment body 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. DEFINITION OF ACCREDITATION 6

7. STANDARDS FOR ACCREDITATION 7 ISO/IEC 17011Accreditation Bodies Certification Bodies ISO/IEC 17021 Management Systems ISO/IEC 17024 Persons ISO/IEC 17065 Products and Services

8. STANDARDS FOR ACCREDITATION 8 ISO/IEC 17011Accreditation Bodies LaboratoriesInspection Bodies Testing, Calibration Examination Inspection ISO/IEC 17025 ISO/IEC 15189 ISO/IEC 17020 Verification Bodies ISO 14065 Verification

9.  Regulation (EC) No 765/2008 provides a legal framework for the provision of accreditation services across Europe.  The Regulation  has been strengthening EA’s role in both voluntary and regulated sectors  places an obligation on EU Member States to accept results issued by the conformity assessment bodies accredited by any of the EA MLA signatories  has been strengthening the use of accreditation and the EA MLA as a basis for notification REGULATION (EC) NO 765/2008 9

10.  When a Member State decides not to use accreditation, it shall provide the Commission and the other Member States with all the documentary evidence necessary for the verification of the competence of the conformity assessment bodies it selects for the implementation of the Community harmonisation legislation in question. REGULATION (EC) NO 765/2008 10

11.  a service of general interest  public authority  last level of control of conformity assessment  voluntary and mandatory fields  mandate of the government  full compliance with applicable rules  accountability to stakeholders  no predominance of any single interest group  non-profit distributing  no competition THE EUROPEAN ACCREDITATION MODEL 11

12. As the official guardian of the European accreditation infrastructure, EA has the overall strategic objective to safeguard the value and credibility of accredited conformity assessment services delivered by its Members and accredited conformity assessment bodies within the European market. EA: ROLE IN EUROPE 12

13.  EA is an association of national accreditation bodies in Europe.  EA Members are officially recognised by their national governments to assess and verify conformity assessment bodies (CABs).  CABs are organisations that carry out — against international standards — assessment services such as certification, verification, inspection, testing and calibration.  EA is responsible for harmonising accreditation within Europe, with the aim of reducing barriers to trade and protecting health, safety and the environment. ABOUT EA 13

14.  36 Full Members representing 36 European economies  12 Associate Members  3 Members have turned into a Bilateral Agreement with EA  Permanent EA Secretariat composed of 6 persons ABOUT EA 14

15. EA STRUCTURE 15 EA Advisory Board General Assembly Executive Committee Secretariat Multilateral Agreement council (MAC) Horizontal Harmonisation Committee Laboratory Committee Inspection Committee Certification Committee Communications & Publications Committee

16.  Defining, harmonising and building consistency in accreditation in Europe, by ensuring common interpretation and application of the standards used by its Members;  Ensuring transparency of the operations (including assessments) performed and results provided by its Members;  Maintaining a Multilateral Agreement on mutual recognition between accreditation activities and reciprocal acceptance of accredited conformity assessment services and results; EA’S MISSION (1) 16

17.  Acting as a technical resource on matters related to the implementation and operation of the European policies on accreditation;  Cooperate with the European Commission and other European and international stakeholders;  Develop accreditation criteria and guidelines supporting harmonisation of practices;  Managing a peer evaluation system consistent with international practices. EA’S MISSION (2) 17

18. The EA MLA is recognised at international level by ILAC (International Laboratory Accreditation Cooperation) and IAF (International Accreditation Forum). This means that a test report or certificate issued by a CAB, accredited by an EA MLA signatory, is also recognised by the signatories to the IAF and ILAC multilateral agreements. In this way, the EA MLA acts as an international passport to trade. INTERNATIONAL ACCEPTANCE OF ACCREDITATION 18

19. Accreditation is the preferred tool for demonstrating competence of CABs globally. Many countries require already “accredited certificates/ reports” for certain sectors. Trade Agreements are using or will using accreditation of CABs for recognition, even in the Rail area (e.g. CETA). INTERNATIONAL ACCEPTANCE OF ACCREDITATION 19

20. The objectives of an evaluation shall be to establish confidence that the NAB conducts its assessments and accreditations in accordance with and meet all the requirements of the criteria of ISO/IEC 17011 and the appropriate requirements of Regulation (EC) No 765/2008. EA PEER EVALUATION SYSTEM 20

21. ISO/IEC 17011 Requirements  Accreditation body - Legal Responsibility, Structure - Impartiality - Confidentiality - Accreditation activities  Management and Management System  Human Resources  Accreditation Process  Responsibilities of the AB and CAB EA PEER EVALUATION PROCESS 21

22.  Peer Evaluations are performed by qualified and trained experts from NABs. EA PEER EVALUATION PROCESS 22

23. EA PEER EVALUATION PROCESS 23 The national accreditation body applies for MLA signatory status (initial or extention of scopes). The national accreditation body has to specify and justify the scope (testing, calibration etc.) for which it is applying. The MLA Council secretariat reviews the application documents. The MAC secretariat appoints a team leader and deputy and team members The team performs the document review (quality management system documents, procedures of the national accreditation body etc.)

24. EA PEER EVALUATION PROCESS 24 Where applicable, a pre-evaluation is conducted. The team carries out the on-site evaluation. The evaluation combines evaluation of the management system at the national accreditation body office with observation of assessments carried out by the national accreditation body. The team drafts the evaluation report at the end of the evaluation. Findings are approved with the national accreditation body at the closing meeting. A task force group (TFG) appointed by the EA MLA Council management group looks at the evaluation report in order to issue a recommendation for the EA MLA Council on the result of the peer evaluation.

25. EA PEER EVALUATION PROCESS 25 The MLA Council makes a decision. The EA publications and website are updated accordingly.

26.  The European Commission and Stakeholder representatives take part at the MAC meetings.  National Authorities are invited to take part at the peer evaluation of its NAB and to take part at the MAC meeting, when the decision takes place about its NAB. EA PEER EVALUATION PROCESS 26

27.  NABs are the experts for the assessment of CABs (there is no need to establish another/parallel system). Otherwise you have to demonstrate that this system is equally reliable.  Have confidence in NABs and their accredited CABs.  Cooperate with NABs.  Use accreditation for demonstrating competence of CABs, even in the Rail sector. SUMMARY 27

28. EUROPEAN CO-OPERATION FOR ACCREDITATION 28 You want to learn more about EA and accreditation? Visit our website and consult our promotional materials: http://www.european- accreditation.org/promotional- information You want to learn more about EA and accreditation? Visit our website and consult our promotional materials: http://www.european- accreditation.org/promotional- information

29. CONTACT EA Secretariat 75 avenue Parmentier FR - 75544 Paris Cedex 11 France Phone: + 33 (0)1 40 21 24 -62 Email: secretariat@european-accreditation.orgsecretariat@european-accreditation.org www.european-accreditation.org 29