1. 06/08 1 APLAC PR 007 issue no 24 APLAC - ITS ROLE AND STRUCTURE

2. 06/08 2 APLAC PR 007 issue no 24 APLAC - ITS ROLE & STRUCTURE What is APLAC? The Role of APLAC Structure of APLAC Accreditation APLAC Mutual Recognition Arrangement APLAC MRA - supporting G2G MRAs and trade in the APEC region

3. 06/08 3 APLAC PR 007 issue no 24 Asia Pacific Laboratory Accreditation Cooperation Established 1992 Mutual Recognition Arrangement (MRA) inaugural signing 1997 Inaugural signing of extended MRA for inspection November 2003 Inaugural signing of extended MRA for RMP December 2007 Incorporated in 2006: APLAC Constitution

4. 06/08 4 APLAC PR 007 issue no 24 APLAC Membership Laboratory, inspection body and reference material producer (RMP) accreditation bodies in APEC economies Laboratory, inspection body and reference material producer (RMP) accreditation bodies in other economies with approval of two-thirds majority Commitment to compliance with ISO/IEC 17011

5. 06/08 5 APLAC PR 007 issue no 24 APLAC Membership ctd Laboratories accredited to ISO/IEC 17025 (ISO 15189 for medical laboratories) Inspection bodies accredited to ISO/IEC 17020 RMPs accredited to ISO Guide 34 in combination with ISO/IEC 17025

6. 06/08 6 APLAC PR 007 issue no 24 Current APLAC Membership All APEC economies except Chile Also Bangladesh, India, Mongolia, Pakistan, Sri Lanka 37 full members 4 associate members

7. 06/08 7 APLAC PR 007 issue no 24 APLAC Full Members Australia: NATA Brunei Darussalam Canada: SCC; CAEAL People’s Republic of China: CNAS Hong Kong China: HKAS India: NABL Indonesia: KAN

8. 06/08 8 APLAC PR 007 issue no 24 APLAC Full Membership, ctd Japan: JAB; IAJapan; VLAC; JCLA Korea: KOLAS Malaysia: SM Mexico: ema Mongolia: MASM New Zealand: IANZ Pakistan: PNAC

9. 06/08 9 APLAC PR 007 issue no 24 APLAC Full Membership, ctd Papua New Guinea: PNGLAS Peru: Indecopi Philippines: PAO Russia: AAC Analitica Singapore: SAC Sri Lanka: SLAB Chinese Taipei: TAF

10. 06/08 10 APLAC PR 007 issue no 24 APLAC Full Membership, ctd Thailand: DMSc; DSS; TLAS USA: A2LA; ACLASS; AIHA; IAS; L-A-B; NVLAP; PJL Vietnam: BoA Australasia: JAS-ANZ

11. 06/08 11 APLAC PR 007 issue no 24 APLAC Associate Membership Bangladesh: BAB Korea: KOTRIC; NIER Chinese Taipei: NIEA

12. 06/08 12 APLAC PR 007 issue no 24 APLAC’s Role Development of laboratory, inspection body and RMP accreditation procedures and practices in the APEC region Promotion of laboratory, inspection body and RMP accreditation as a trade facilitation tool Assistance to developing accreditation systems

13. 06/08 13 APLAC PR 007 issue no 24 APLAC’s Role Recognition of competent test and calibration facilities, inspection bodies and reference material producers in the APEC region

14. 06/08 14 APLAC PR 007 issue no 24 APLAC’s Role Cooperation with other regional laboratory and inspection body accreditation organisations such as EA, IAAC, SADCA Strong links with APEC SCSC & other APEC Specialist Regional Bodies, APLMF, APMP, PAC, PASC APLAC is a recognised Regional Cooperation Body Member of ILAC

15. 06/08 15 APLAC PR 007 issue no 24 APLAC’s Structure General Assembly Board of Management MRA Council 5 permanent Committees –Proficiency Testing Committee –Public Information Committee –Technical Committee –Training Committee –Nominations Committee

16. 06/08 16 APLAC PR 007 issue no 24 APLAC’s Structure

17. 06/08 17 APLAC PR 007 issue no 24 APLAC’s Structure Board of Management –meets at least twice a year –oversees management of APLAC’s activities –oversees the work of the APLAC committees Committees report to members at each annual General Assembly

18. 06/08 18 APLAC PR 007 issue no 24 Proficiency Testing Calibration Measurement (some with APMP) Testing Inter-regional Programs

19. 06/08 19 APLAC PR 007 issue no 24 Public Information “APLAC News Notes” published every 3 months by a different APLAC member each time Publicity and information material APLAC web site: http://www.aplac.org

20. 06/08 20 APLAC PR 007 issue no 24 Technical Guidance and interpretation documents –APLAC documents management reviews; internal audits reporting compliance with a specification measurement uncertainty in testing guidance on ISO/IEC 17020 guidance for food testing laboratories guidance on accreditation of RMPs –adoption of ILAC and EA documents Input into ILAC documents

21. 06/08 21 APLAC PR 007 issue no 24 Training Accreditation body staff APLAC & ILAC MRA evaluators Train the trainers –Technical assessors –Laboratory staff

22. 06/08 22 APLAC PR 007 issue no 24 APLAC - Primary Objective Acceptance of test, calibration and inspection reports and reference material certificates amongst all signatories’ economies –demands mutual confidence in technical competence Confidence cannot be legislated

23. 06/08 23 APLAC PR 007 issue no 24 APLAC - Subsidiary Objecives Information exchange Exchange of experts Training Proficiency Testing

24. 06/08 24 APLAC PR 007 issue no 24 APLAC MRA Signatories NATA CAEAL SCC CNAL HKAS NABL KAN JAB IAJapan VLAC KOLAS DSM ema IANZ PAO (suspended 06/08) SAC

25. 06/08 25 APLAC PR 007 issue no 24 APLAC MRA Signatories ctd TAF DSS DMSc TLAS A2LA ACLASS LAB IAS NVLAP PJLA BoA JAS-ANZ

26. 06/08 26 APLAC PR 007 issue no 24 Accreditation Assessment of laboratory, inspection body and RMP performance against international criteria (ISO/IEC 17025; ISO/IEC 17020; ISO Guide 34) Means of determining competence of laboratories, inspection bodies and RMPs to perform specific measurements, calibrations, tests or inspections, or to certify reference materials competently Formal recognition of that competence

27. 06/08 27 APLAC PR 007 issue no 24 Accreditation ctd 3 rd party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks (ISO/IEC 17000) Key phrases –competence –specific…. tasks

28. 06/08 28 APLAC PR 007 issue no 24 Accreditation ctd Demonstrated competence –Specific tests –Defined measurements –Types of calibrations –Particular testing techniques –Specific types of inspections –Specific types of reference materials

29. 06/08 29 APLAC PR 007 issue no 24 Accreditation ctd Technical competence Integrity Transparency (as defined by WTO TBT) Fairness Scope of accreditation –products; types of test parameters types of inspections;matrices –measurement techniques, range, accuracy –test specification; test method

30. 06/08 30 APLAC PR 007 issue no 24 Accreditation Hierarchy of Criteria 1General technical competence and systems compliance criteria 2Additional field-specific criteria, eg for emc testing laboratories 3Additional test, calibration, inspection method criteria ISO/IEC 17025/17020 Supplementary, Field-specific criteria (eg Electrical Testing) Technical Requirements of Specific Test Methods and Procedures

31. 06/08 31 APLAC PR 007 issue no 24 Accreditation Hierarchy of Criteria 1General technical competence and systems compliance criteria 2Additional field-specific criteria, eg for emc testing laboratories 3Additional test, calibration, inspection method criteria 4Additional, regulator-specific criteria (eg reporting formats, labelling etc) ISO/IEC 17025/17020 Supplementary, Field-specific criteria (eg Electrical Testing) Technical Requirements of Specific Test Methods and Procedures Regulatory Requirements

32. 06/08 32 APLAC PR 007 issue no 24 APLAC MRA Single multilateral MRA for testing and calibration, 1997 Extended to include inspection, 2003 ISO 15189 separated out, 2007 Extended to include RMP, 2007 Replaced network of bilateral MRAs Regional component of global ILAC Arrangement, November 2000 (test and calibration only)

33. 06/08 33 APLAC PR 007 issue no 24 APLAC MRA ctd Facility accredited by one MRA partner has equivalent competence to facility accredited by other partners Each signatory acknowledges equivalence of all other signatories Signatories demonstrate compliance with ISO/IEC 17011 Procedure: APLAC MR 001 Re-evaluation every 4 years maximum –shorter interval for various causes

34. 06/08 34 APLAC PR 007 issue no 24 APLAC Procedure MR 001 Application; pre-evaluation; evaluation Maintenance of signatory status Criteria for accreditation bodies –ISO/IEC 17011 Qualifications of evaluators –Expanded on in APLAC MR 004

35. 06/08 35 APLAC PR 007 issue no 24 APLAC Procedure MR 001 ctd Criteria for accredited bodies –ISO/IEC 17025: laboratories –ISO 15189: medical laboratories –ISO/IEC 17020: inspection bodies –ISO Guide 34 in combination with ISO/IEC 17025: RMPs

36. 06/08 36 APLAC PR 007 issue no 24 APLAC MRA - Supplementary Requirements Access to appropriate measurement traceability system Avoidance of conflict of interest Confidentiality Access to adequate comprehensive proficiency testing programs

37. 06/08 37 APLAC PR 007 issue no 24 APLAC MRA - Evaluation Team Peer review Balance of skills and technical expertise Evaluators –experienced in laboratory accreditation –technical expertise –proficiency testing experience –free from conflict of interest

38. 06/08 38 APLAC PR 007 issue no 24 APLAC MRA - Evaluation Preparation On-site visit –accreditation body –accredited & applicant facilities Report –corrective actions identified –acceptance of corrective actions –schedule for implementation Full review by APLAC MRA Council

39. 06/08 39 APLAC PR 007 issue no 24 APLAC MRA - Maintenance of Signatory Status Accreditation body notifies changes –name; legal status; organisation structure –key staff –operational procedures Re-evaluation –maximum every 4 years –after a shorter period with due cause –focus on changes –new team leader

40. 06/08 40 APLAC PR 007 issue no 24 APLAC MRA - Assisting Trade APLAC MRA enhances acceptance of test, calibration and inspection reports, and RM certificates amongst signatory economies APLAC MRA signatories recognise equivalence of each others’ accredited facilities APLAC MRA is an international recognition for accredited laboratories, inspection bodies and RMPs

41. 06/08 41 APLAC PR 007 issue no 24 APLAC MRA - Assisting Trade APLAC MRA reduces or eliminates need for re-testing or re-inspection of imported goods Entry into global ILAC Arrangement (for testing and calibration only)

42. 06/08 42 APLAC PR 007 issue no 24 APLAC MRA & Regulators Laboratories and inspection bodies accredited for compliance with domestic & foreign regulations MRA evaluations assure competence to assess to domestic & foreign regulations APLAC MRA underpins APEC G2G MRAs

43. 06/08 43 APLAC PR 007 issue no 24 Contact APLAC web site: http://www.aplac.org email: aplac@nata.asn.au