1. Confidence with competence The Development of European Accreditation Daniel PIERRE EA Vice-Chairman

2. Confidence with competence The new European legislative package Regulation (EC) 765/2008 Sets out requirements for accreditation and market surveillance (July 2008) Decision 768/2008/EC A common framework for the marketing of products Regulation (EC) 764/2008 Procedures relating to national technical rules

3. Confidence with competence European Regulation 765/08  The European legislation on accreditation and market surveillance  Legal basis for accreditation and EA  Strengthens use of accreditation and the EA MLA as the basis for notification  New role of EA recognised as the official European Accreditation infrastructure (Article 14)

4. Confidence with competence Main requirements of Regulation (EC) 765/2008  One National Accreditation Body (NAB) per Member State - formally recognized and appropriately resourced by MS  Public authority activity  Independent, not-for-profit activity  Not compete with conformity assessment bodies  NABs to be members of EA  Balanced participation of interested parties and stronger accountability towards them

5. Confidence with competence Additional requirements of Regulation (EC) 765/2008  Non-competition between NABs  Cross-frontier accreditation restrictions  Monitoring of NABs by national authorities based on EA peer-evaluation  Conformity assessment bodies must not impose excessive burden on economic operators

6. Confidence with competence Impact on EA’s relationships with ABs outside Europe The European Commission recognises:  The continued value of accreditation to underpin trade  That EA should maintain full collaboration with other Regional accreditation cooperations  That EA should maintain strong links with ILAC and IAF

7. Confidence with competence Impact of Regulation (EC) 765/2008 outside Europe  ABs that are not Members of EA may not meet all of the criteria specified in Regulation (EC) 765/2008 that EA Members have to meet from 1 January 2010 (EA recognition)  BUT … Acceptance in the EU of conformity assessment attestation certificates issued under accreditation by non-European ABs does not depend on the recognition between ABs

8. Confidence with competence Acceptance of accredited conformity assessment attestations in the EU (1) Voluntary Conformity Assessment area:  Conformity assessment attestations issued under accreditation by non-European ABs not complying with the new European requirements, but signatories to IAF and ILAC MLA/MRA, can continue to be used on the European market  Specifiers and the marketplace are free to decide on acceptability

9. Confidence with competence Acceptance of accredited conformity assessment attestations in the EU (2) Mandatory conformity assessment area:  National authorities of EU Member states may refuse attestations of conformity issued under accreditation by non-European ABs not complying with the new European requirements but signatories to IAF and ILAC MLA/MRA  except where an “EU to Country” MRA is in place

10. Confidence with competence EA policy on BLAs and Cooperation Agreements: statement of equivalence (1)  Accredited reports and certificates issued under the accreditation of an ILAC or IAF accreditation body signatory are considered to be equally reliable to those issued under accreditation within the EA MLA and Bilateral Agreements

11. Confidence with competence EA policy on BLAs and Cooperation Agreements: statement of equivalence (2)  ABs that have a Bilateral Agreement (BLA) with EA shall, by 1 January 2012, be required to meet the same requirements as an EA Full Member that is a signatory to the EA MLA  ABs that have a Cooperation Agreement with EA shall, by 1 January 2012, be required to meet the same requirements as an EA Full Member that is not an MLA signatory

12. Confidence with competence EA’s relationship with the European Commission General Guidelines for Cooperation between EA and the European Commission, the European Free Trade Association and the competent National Authorities (signed 1 April 2009) Framework Partnership Agreement between EA and the European Commission (to be signed by end 2009)

13. Confidence with competence The challenges for EA  Consistent approach for the assessment and accreditation of Notified Bodies  Operate a peer evaluation meeting the expectations of national authorities  Build upon existing experience  Association of ABs  Technical competence and expertise of people  Robust peer evaluation system  Continually improve processes  Ever stronger, more professional organisation

14. Confidence with competence EA Development Strategy  Prepare for the new role  Reconsider, improve organisation and structure  Increase resources appropriately  Reinforce relations with all European and international stakeholders  Reinforce influence in ILAC and IAF  Reinforce cooperation with ABs of countries falling within the European Neighbourhood Policy (ENP) and of third countries

15. Confidence with competence EA Policy for relations with Accreditation Bodies of ENP countries and of third countries in general

16. Confidence with competence EA-1/13 Policy for relationships with ABs of countries outside the EU or EFTA (published in May 2009) covers: EU/EFTA neighbour countries falling within the European Neighbourhood Policy (“ENP countries”) Potential candidates for EU membership Third countries not being EU/EFTA neighbour countries

17. Confidence with competence The EA Neighbourhood Policy (EANP) covers: “ ENP countries ” : Algeria, Armenia, Azerbaijan, Belarus, Egypt, Georgia, Israel, Jordan, Lebanon, Libya, Moldova, Morocco, The Palestinian Authority, Syria, Tunisia, Ukraine “ Potential candidates for EU membership ” as stated by the European Council meeting in Feira in June 2000: Albania, Bosnia and Herzegovina, Kosovo (under UN Security Council Resolution 1244), Montenegro, Serbia

18. Confidence with competence EA’s relationships with ABs of EANP countries  Able to contribute to and cooperate with EA, while being given rights and obligations  Commit themselves to follow all EA policies  Willing to sign ILAC/IAF agreements only through having been evaluated to join the EA MLA through a bilateral agreement  BLA signatories subject to the same peer- evaluation process as that applied to EA full members

19. Confidence with competence EA’s relationships with ABs of third countries (1)  Should be managed through the ILAC or IAF arrangements: no special policy or status is needed for these countries  Possibility of signing a Cooperation Agreement in exceptional cases:  upon the EC’s or EFTA’s request  if EA agrees on a relevant interest  Cooperation agreement ONLY IF:  all specific requirements of Regulation 765 are met  if willing to sign a BLA: evaluation by EA qualified evaluators and under the EA MLA Council’s control

20. Confidence with competence EA’s relationships with ABs of third countries (2)  Future recognition mechanism for ABs in third countries demonstrating compliance with the additional requirements of Regulation (EC) 765/2008 over and above the requirements of the ILAC and IAF arrangements

21. Confidence with competence For more information:  EA website: www.european-accreditation.org  EA Secretariat: secretariat@european-accreditation.org