Accreditation -- Facilitating Global Trade by Peter Unger ILAC Chair BSCA Conference 5 June 2014

1. The International Laboratory Accreditation Cooperation (ILAC)The International Accreditation Forum (IAF) Accreditation -- Facilitating Global Trade by Peter Unger ILAC Chair BSCA Conference 5 June 2014

2. “6.1.1 adequate and enduring technical competence of the relevant conformity assessment bodies in the exporting Member, so that confidence in the continued reliability of their conformity assessment results can exist; in this regard, verified compliance, for instance through accreditation, with relevant guides or recommendations issued by international standardizing bodies shall be taken into account as an indication of adequate technical competence;” Accreditation in the TBT Agreement

3. Accreditation to Support the Market Accreditation Bodies Accreditation service Conformity assessment bodies Conformity assessment bodies Certification Body Certification Body Inspection Body Inspection Body Test Lab Test Lab Cal Lab Cal Lab Conformity Assessment Service Conformity Assessment Service Market Demands for competent conformity assessment Conforming product/service Purchasers Regulators Product/ service Requirements Trade Organizations & Authorities Suppliers Demands for facilitating trade

4. Peer Evaluation ACCREDITATION International Standards CONFORMITY ASSESSMENT BODIES Standards / Regulatory requirements / Scheme criteria PRODUCT & SERVICE PROVIDERS CONFIDENCE TRUST ASSURANCE PURCHASERS GOVERNMENT CONSUMERS

5. ILAC and IAF ILAC and IAF—global networks of conformity assessment accreditation bodies • Recognition of competent conformity assessment activities through global multi-lateral mutual recognition arrangements • Harmonization of conformity assessment practices • Promotion of accredited conformity assessment as an effective mechanism for providing confidence in goods and services

6. Global Vision • Tested, inspected or certified once, accepted everywhere' • “Accredited once, accepted everywhere”

7. Regional Cooperation Bodies The IAF and ILAC Arrangements are structured to build on existing and developing regional MLAs/MRAs established around the world • The IAF MLA recognizes EA, PAC, IAAC • The ILAC MRA recognizes EA, APLAC, IAAC European Cooperation for Accreditation (EA) Inter-American Accreditation Cooperation (IAAC) Asia Pacific Laboratory Accreditation Cooperation (APLAC) Southern African Development Community Accreditation (SADCA) Pacific Accreditation Cooperation (PAC) African Accreditation Cooperation (AFRAC) Arab Accreditation Cooperation (ARAC)

8. The International Picture ILAC ILAC APLAC APLAC EA EA IAAC IAAC SADCA EA European Cooperation for Accreditation APLAC Asia Pacific Laboratory Accreditation Cooperation ILAC International Laboratory Accreditation Cooperation IAAC Inter-American Accreditation Cooperation AFRAC African Regional Accreditation Cooperation Unaffiliated Bodies Peer evaluated ABs who are not geographically located in one of the established regions ARAC AFRAC SADCA Southern African Development Community Accreditation ARAC Arab Accreditation Cooperation

9. Coverage of the ILAC MRA (October 2013) ILAC MRA Signatories ILAC Associate Members ILAC Affiliate Members

10. Status of the ILAC MRA (March 2014) • The ILAC network of members includes 148 bodies from 112 different economies (85 Full Members/MRA Signatories, 17 Associates, 17 Affiliates, 23 Stakeholders, 6 Regional Cooperation Bodies) • ILAC MRA covers testing, calibration and inspection • Signatories represent about 95% of Global GDP • 45,000 accredited laboratories • About 7,500 accredited inspection bodies • MRAs for accreditation of PTPs and RMPs underway

11. Coverage of the IAF MLA (August 2013) IAF MLA Signatories IAF Members not yet Signatories

12. Status of the IAF MLA • 91 members (69 Accreditation Bodies, 18 Association Members, 6 Regional Groups, 3 Observers); 60 IAF MLA Signatories from 55 economies • Management Systems: 53 accreditation bodies and EA, PAC & IAAC • ISO 9001 QMS: 53 accreditation bodies and EA, PAC & IAAC • ISO 14001 EMS: 49 accreditation bodies and EA, PAC & IAAC • ISO 22000 FSMS, ISO/IEC 27001 ISMS, ISO/IEC 20000 ITSMS and ISO 13485 medical devices: under development • Product: 51 accreditation bodies EA, PAC & IAAC • Global G.A.P, IFA CPCCs: 26 accreditation bodies • Persons: under development • GHG Verification & Validation Bodies: under development

13. The ILAC and IAF Arrangements • Accreditation body members deemed competent through a peer evaluation process: • ISO/IEC 17011 • IAF-ILAC A series documents • IAF MD documents & ILAC P-series documents • Signatories must recognize certificates and reports issued by organisations accredited by other Signatories • Provides business with assurance that overseas bodies operate to the same standard. • Removes technical barriers to trade by eliminating redundant conformity assessment

14. IAF/ILAC A1: Evaluation of a Region Two main sections; two main purposes: • Requirements for a Region (Section 2) • Flow Chart for a peer evaluation of a region (Section 3)

15. Typical Evaluation of a Region Visit to Secretariat Office(s) Witnessing two AB peer evaluations Observation of MLA Group Decision Making Report of findings to the IAF/ILAC Arrangement Management Committee(s)

16. IAF/ILAC A1: Evaluation of a Region • All Regional Groups also provide a report each year to the respective IAF MLA Management Committee (MC) and/or ILAC Arrangement Management Committee (AMC) on their MLA and/or MRA activities. Such reports should include any joint activities, as outlined above and be provided to the next TL-R who will evaluate the Regional Group.

17. IAF/ILAC A2: Evaluation of an ABFull Evaluation • Four to six days duration • Three to seven team members • Several assessments witnessed • Summary report of findings at end of visit

18. IAF/ILAC A2: Evaluation of an ABSection 2.2 Supplementary Requirements • Demonstrated competence and experience • Acceptable routes for measurement traceability • Proficiency testing requirements • Arrangement obligations • Promotion of the Arrangements • Contribute to peer evaluations • Cross-frontier policy

19. IAF/ILAC A2: Evaluation of an ABQualifications of Evaluators • Team members: • At least 3 years experience as staff member or assessor in a member accreditation body • Evaluator training course completed • English understood • Team Leaders • Senior AB staff • Experience as a team member

20. IAF/ILAC A2: Evaluation of an ABFull Evaluation • Four to six days duration • Three to seven team members • Several assessments witnessed • Summary report of findings at end of visit

21. IAF/ILAC A2: Evaluation of an ABFull Evaluation Report Process • Summary report with Findings: • Draft full report • Formal response by AB to findings • Formal reaction of the evaluation team • Often more than one iteration • Follow-up visit possible • Final report to the Arrangement group • Decision by the Arrangement group

22. USA Specifiers of the Arrangements • Consumer Product Safety Commission • Federal Highway Administration • U.S. Coast Guard • General Services Administration • Department of Defense • Nuclear Regulatory Commission • Food and Drug Administration • Environmental Protection Agency

23. Consumer Product Safety Commission Statement by Scott Hey, program manager of the CPSC Office of Hazard Identification and Reduction on the benefits of the ILAC MRA: “The MRA has had a tremendous impact on our group. With all the products from manufacturers around the world – cribs and bunk beds from China and the United Kingdom, bike helmets and baby walkers from Taiwan and Italy – knowing that they have all been through an accepted standard of testing from an accredited lab gives us a greater level of confidence in those products. It provides a sense of consistency in quality.”

24. Environmental Protection Agency Statement by Eamon Monaghan, Program Integrity Lead, ENERGYSTAR on the reason for using the ILAC MRA: “We didn’t have to develop and implement our own set of rules. Any kind of agency-specific rule creates costs or hassles for industry, and that was something we really wanted to avoid. We currently certify products in 65 categories, many of which are certified and tested overseas. Referencing the ILAC MRA took the EPA off the hook for developing a lot of criteria for labs or conducting our own lab oversight. And, by working with only ILAC signatories, we have the confidence that the labs have been appropriately assessed. We now recognize 27 ILAC-signatory accreditation bodies around the world.”

25. Benefits for government and regulators • Cost effective tool to support regulation • Efficient monitoring

26. Benefits for industry • Greater acceptance of products and services opening up markets • Avoiding the costs of multiple testing, inspection or certification • Efficient management of suppliers

27. Benefits for consumers • Public confidence in goods and services despite complex global marketplace • Reduces product failures

28. The Economics of Accreditation: UKAS/British Measurement and Test Association study March 2013 • Conformity assessment body benefits estimated to be 295 million pounds per annum • Downstream commercial benefit estimated to be 320 million pounds per annum

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