© A2LA Understanding the Accreditation Hierarchy - Who’s Who and What’s What ? NCSL International Conference Orlando, FL August 7, 2008 by Roxanne M. Robinson Vice President/COO, A2LA

2© A2LA 2008 Topics of Talk Introduction Introduction Definitions of Conformity Assessment terms Definitions of Conformity Assessment terms The Recognition of Accreditation Bodies The Recognition of Accreditation Bodies Tested Once, Accepted Everywhere Tested Once, Accepted Everywhere

3© A2LA 2008 Conformity Assessment Bodies (CAB) CABs are the laboratories, ISO 9000 registrars, product certification bodies and inspection bodies who determine conformity to a particular requirement, standard or method CABs are the laboratories, ISO 9000 registrars, product certification bodies and inspection bodies who determine conformity to a particular requirement, standard or method

Certification Written assurance by a third party that a product, process, or service conforms to specified requirements (from ISO/IEC 17000) Written assurance by a third party that a product, process, or service conforms to specified requirements (from ISO/IEC 17000) Definition applies to ISO 9000, AS 9000, TS certifiers, better known in the United States as Registrars, and Definition applies to ISO 9000, AS 9000, TS certifiers, better known in the United States as Registrars, and Product certifiers Product certifiers

5© A2LA 2008 The ISO 9001 Management Systems Auditor Asks... Have you defined your policies and procedures? Have you defined your policies and procedures? Are they documented in accordance with the standard? Are they documented in accordance with the standard? Are you following them? Are you following them?

6© A2LA 2008 Laboratory Accreditation Third-party attestation related to a conformity assessment body (laboratory) conveying formal demonstration of its competence to carry out specific conformity assessment tasks (testing or calibration) (from ISO/IEC 17011) Third-party attestation related to a conformity assessment body (laboratory) conveying formal demonstration of its competence to carry out specific conformity assessment tasks (testing or calibration) (from ISO/IEC 17011) ISO/IEC ISO/IEC Scope of Accreditation Scope of Accreditation

The Laboratory Accreditation Assessor Asks... Have you defined and validated your procedures? Have you defined and validated your procedures? Are they documented in accordance with the standard? Are they documented in accordance with the standard? Are you following them? Are you following them? Do your procedures ensure accurate and reliable results? Do your procedures ensure accurate and reliable results?

And... Do you understand the science behind the procedures? Do you understand the science behind the procedures? Can you foresee and cope with any technical problems that may arise? Can you foresee and cope with any technical problems that may arise? Do you have the correct equipment and adequate personnel? Do you have the correct equipment and adequate personnel? Have you calculated your uncertainties ? Have you calculated your uncertainties ? Judges competence, but no guarantee Judges competence, but no guarantee

9© A2LA 2008 Product Certification Remember the definition for “certification”…Written assurance by a third party that a product, process, or service conforms to specified requirements (from ISO/IEC 17000) but… Remember the definition for “certification”…Written assurance by a third party that a product, process, or service conforms to specified requirements (from ISO/IEC 17000) but… Comes with a guarantee Comes with a guarantee

10© A2LA 2008 Conformity Assessment Hierarchy Registration Accreditation Certification BroadISO 9001:2000 Specific Tasks ISO/IEC 17025:2005 GuaranteeProduct Specs

11© A2LA 2008 Conformity Assessment Accreditation Hierarchy Cooperation ILAC Gov’t & Industry Recognition Cooperation IAF Mutual Recognitions EA, APLAC, IAAC Accreditation bodies Accredit labs & Inspection bodies A2LA, NVLAP, IAS, ACLASS, LAB, PJLA ISO/IEC Mutual Recognitions EA, PAC, IAAC Accreditation bodies Accredit Certification bodies ANSI, OSHA, ANAB ISO/OEC Laboratories test products, materials ISO/IEC IBs inspect products items, structures, products ISO/IEC Certification bodies certify products ISO/IEC Guide 65 Registrars certify Mgt. systems ISO/IEC Products tested per specification Products inspected per specification Products marked per specification safety requirement QMS or EMS certified ISO 9000, QS9000, TS 16949

12© A2LA 2008 ILAC Organization General Assembly Executive Committee Arrangement Management Committee Arrangement Committee Accreditation Committee Marketing & Communication Committee Laboratory Committee Arrangement Council

13© A2LA 2008 Typical Regional Cooperation Organization (e.g. EA, APLAC, IAAC)

14© A2LA 2008 Mutual Recognition Arrangements ILAC EA APLAC IAACInter-American Accreditation Cooperation EAEuropean co-operation for Accreditation APLACAsia Pacific Laboratory Accreditation Cooperation ILAC International Laboratory Accreditation Cooperation

15© A2LA 2008 MRA Peer Evaluation Process - Application Submit application to secretariat of the cooperation (ILAC or the region) Submit application to secretariat of the cooperation (ILAC or the region) Series of documents must address: Series of documents must address: the ISO/IEC requirements the ISO/IEC requirements measurement traceability policy (ILAC P10) measurement traceability policy (ILAC P10) laboratories’ participation in proficiency testing (ILAC P9) laboratories’ participation in proficiency testing (ILAC P9) Laboratories use of the accreditation symbol (ILAC P 8) Laboratories use of the accreditation symbol (ILAC P 8) pre-evaluation is possible pre-evaluation is possible

16© A2LA 2008 MRA Peer Evaluation Process - Evaluators Team leader recruited/assigned Team leader recruited/assigned generally senior accreditation body staff generally senior accreditation body staff trained through observing and then serving as evaluator trained through observing and then serving as evaluator also trained at international seminars for evaluators or specifically, team leaders also trained at international seminars for evaluators or specifically, team leaders

17© A2LA 2008 MRA Peer Evaluation Process-Evaluators Team leader chooses team members Team leader chooses team members Technical backgrounds coincide with kinds of laboratories that the applicant accredits Technical backgrounds coincide with kinds of laboratories that the applicant accredits usually four, sometimes six members usually four, sometimes six members If calibration is included, one team member must have a strong metrology background If calibration is included, one team member must have a strong metrology background often a NMI staff person joins the team often a NMI staff person joins the team

18© A2LA 2008 MRA Peer Evaluation Process- the Evaluation Document review Document review Evaluation of headquarters operations conformance to ISO/IEC and international requirements Evaluation of headquarters operations conformance to ISO/IEC and international requirements Witness assessments for laboratories’ conformance to ISO Witness assessments for laboratories’ conformance to ISO effectiveness of the assessors is determined effectiveness of the assessors is determined technical expertise technical expertise assessment skills assessment skills

19© A2LA 2008 MRA Peer Evaluation Process - the Evaluation Determining arrangements for ensuring traceability to the appropriate primary standards Determining arrangements for ensuring traceability to the appropriate primary standards visiting the National Metrology Institute visiting the National Metrology Institute evaluating the level of participation in international laboratory comparisons sponsored by other NMIs or BIPM evaluating the level of participation in international laboratory comparisons sponsored by other NMIs or BIPM

20© A2LA 2008 MRA Peer Evaluation Process - Signatory Status Respond in writing to any non conformances or concerns resulting from the evaluation Respond in writing to any non conformances or concerns resulting from the evaluation Team leader coordinates the review of the corrective action Team leader coordinates the review of the corrective action Full evaluation information provided to the cooperation’s acceptance panel Full evaluation information provided to the cooperation’s acceptance panel Decision made to include or continue as a signatory, possibly with conditions. Decision made to include or continue as a signatory, possibly with conditions.

21© A2LA 2008 MRA Peer Evaluation Process - Continue Signatory Status Evaluation every four years Evaluation every four years Appeals mechanism for negative decisions Appeals mechanism for negative decisions Alert partners to changes Alert partners to changes Participate in international committee work Participate in international committee work Provide a liaison officer Provide a liaison officer Participate in international laboratory comparisons (ILCs) Participate in international laboratory comparisons (ILCs) Promote acceptance of test data across borders – tested once, accepted everywhere Promote acceptance of test data across borders – tested once, accepted everywhere

22© A2LA 2008 Conclusion Proven system to determine competence of the laboratories and the organizations that accredit them Proven system to determine competence of the laboratories and the organizations that accredit them Promotes acceptance of calibration and test results between MRA countries Promotes acceptance of calibration and test results between MRA countries ABs working to reduces barriers to trade by increasing regulator acceptance of accreditation ABs working to reduces barriers to trade by increasing regulator acceptance of accreditation

23© A2LA 2008 Contact information ILAC ILAC IAF IAF APLAC APLAC EA EA IAAC IAAC Roxanne Robinson Phone: