2014/11 1 APLAC PR 007 issue no 37 APLAC - ITS ROLE AND STRUCTURE

2014/11 2 APLAC PR 007 issue no 37 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

2014/11 3 APLAC PR 007 issue no 37 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 Inaugural signing of extended MRA for PTP June 2014

Asia Pacific Laboratory Accreditation Cooperation ctd Incorporated in 2006: APLAC Constitution 2014/11 4 APLAC PR 007 issue no 37

2014/11 5 APLAC PR 007 issue no 37 APLAC Membership Laboratory, inspection body, reference material producer (RMP) and proficiency testing producer (PTP) accreditation bodies in APEC economies Laboratory, inspection body, reference material producer (RMP) and proficiency testing provider (PTP) accreditation bodies in other economies with approval of three-fourths majority

2014/11 6 APLAC PR 007 issue no 37 APLAC Membership ctd Commitment to compliance with ISO/IEC Laboratories accredited to ISO/IEC (ISO for medical laboratories) Inspection bodies accredited to ISO/IEC RMPs accredited to ISO Guide 34 PTPs accredited to ISO/IEC 17043

2014/11 7 APLAC PR 007 issue no 37 Current APLAC Membership All APEC economies except Chile Also Bangladesh, Bhutan, Gulf Region, India, Mongolia, Pakistan, Sri Lanka, Syria 41full members 11 associate members

2014/11 8 APLAC PR 007 issue no 37 APLAC Full Members Australia: NATA Bangladesh: BAB Brunei Darussalam: ABCi Canada: SCC; CALA; IQMH People’s Republic of China: CNAS Gulf Region: GAC Hong Kong China: HKAS India: NABL, NABCB

2014/11 9 APLAC PR 007 issue no 37 APLAC Full Membership, ctd Indonesia: KAN Japan: JAB; IAJapan; VLAC Korea: KOLAS Malaysia: Standards Malaysia Mexico: ema Mongolia: MNAS New Zealand: IANZ Pakistan: PNAC

2014/11 10 APLAC PR 007 issue no 37 APLAC Full Membership, ctd Papua New Guinea: PNGLAS Peru: Indecopi Philippines: PAO Russia: AAC Analitica Singapore: SAC Sri Lanka: SLAB Chinese Taipei: TAF

2014/11 11 APLAC PR 007 issue no 37 APLAC Full Membership, ctd Thailand: BLQS-DMSc; BLA-DSS; NSC-ONSC USA: A2LA; ACLASS & FQS; AIHA-LAP, LLC; IAS; A-S-B; NVLAP; PJLA Inc. Vietnam: BoA; AoV Australasia: JAS-ANZ

2014/11 12 APLAC PR 007 issue no 37 APLAC Associate Membership Australia: PTA Bhutan, NAFP Korea: KTR; NIER; RRA; KASTO; KTC Mongolia: CGL Chinese Taipei: NIEA Syria: SASC Thailand: FHI 360 (Thailand Office)

2014/11 13 APLAC PR 007 issue no 37 APLAC’s Role Development of laboratory, inspection body, RMP and PTP accreditation procedures and practices in the APEC region Promotion of laboratory, inspection body, RMP and PTP accreditation as a trade facilitation tool Assistance to developing accreditation systems

2014/11 14 APLAC PR 007 issue no 37 APLAC’s Role Recognition of competent test and calibration facilities, inspection bodies, reference material producers and proficiency testing providers in the APEC region

2014/11 15 APLAC PR 007 issue no 37 APLAC’s Role Cooperation with other regional laboratory and inspection body accreditation organisations such as EA, IAAC, SADCA, AFRAC, ARAC Strong links with APEC SCSC & other APEC Specialist Regional Bodies, APLMF, APMP, PAC, PASC APLAC is a recognised Regional Cooperation Body of ILAC

2014/11 16 APLAC PR 007 issue no 37 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

2014/11 17 APLAC PR 007 issue no 37 APLAC’s Structure

2014/11 18 APLAC PR 007 issue no 37 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

2014/11 19 APLAC PR 007 issue no 37 Proficiency Testing Calibration Measurement (some with APMP) Testing Inter-regional Programs

2014/11 20 APLAC PR 007 issue no 37 Public Information “APLAC News Notes” published every 3 months by a different APLAC member each time Publicity and information material APLAC website:

2014/11 21 APLAC PR 007 issue no 37 Technical Guidance and interpretation documents –APLAC documents management reviews; internal audits reporting compliance with a specification measurement uncertainty in testing guidance on ISO/IEC guidance for food testing laboratories guidance on accreditation of RMPs –adoption of ILAC and EA documents Input into ILAC documents

2014/11 22 APLAC PR 007 issue no 37 Training Accreditation body staff APLAC & ILAC MRA evaluators Train the trainers –Technical assessors –Laboratory staff

2014/11 23 APLAC PR 007 issue no 37 APLAC - Primary Objective Acceptance of test, calibration and inspection reports, reference material certificates and proficiency testing provider reports amongst all signatories’ economies –demands mutual confidence in technical competence Confidence cannot be legislated

2014/11 24 APLAC PR 007 issue no 37 APLAC - Subsidiary Objectives Information exchange Exchange of experts Training Proficiency Testing

2014/11 25 APLAC PR 007 issue no 37 APLAC MRA Signatories NATA CALA IQMH SCC CNAS HKAS NABCB NABL KAN JAB IAJapan VLAC KOLAS Standards Malaysia ema MNAS IANZ PNGLAS

2014/11 26 APLAC PR 007 issue no 37 APLAC MRA Signatories ctd PNAC PAO AAC Analitica SAC SLAB TAF BLA-DSS BLQS-DMSc NSC-ONSC AIHA-LAP, LLC A2LA ACLASS & FQS A-S-B IAS NVLAP PJLA Inc. BoA JAS-ANZ

2014/11 27 APLAC PR 007 issue no 37 Accreditation Assessment of laboratory, inspection body, RMP and PTP performance against international criteria (ISO/IEC 17025; ISO 15189; ISO/IEC 17020; ISO Guide 34 and ISO/IEC 17043)

2014/11 28 APLAC PR 007 issue no 37 Accreditation ctd Means of determining competence of laboratories, inspection bodies, RMPs and PTPs to perform specific measurements, calibrations, tests or inspections, to certify reference materials competently, or the development and operation of proficiency testing schemes

Accreditation ctd Formal recognition of that competence 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 2014/11 29 APLAC PR 007 issue no 37

2014/11 30 APLAC PR 007 issue no 37 Accreditation ctd Demonstrated competence –Specific tests –Defined measurements –Types of calibrations –Particular testing techniques –Specific types of inspections –Specific types of reference materials –of providers of proficiency testing schemes

2014/11 31 APLAC PR 007 issue no 37 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

2014/11 32 APLAC PR 007 issue no 37 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

2014/11 33 APLAC PR 007 issue no 37 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

2014/11 34 APLAC PR 007 issue no 37 APLAC MRA Single multilateral MRA for testing and calibration, 1997 Extended to include inspection, 2003 ISO separated out, 2007 Extended to include RMP, 2007 Extended to include PTP, 2014 Replaced network of bilateral MRAs

2014/11 35 APLAC PR 007 issue no 37 APLAC MRA ctd Regional component of global ILAC Arrangement, November 2000 (test and calibration only) and October 2012 (inspection) 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

APLAC MRA ctd Procedure: APLAC MR 001 Re-evaluation every 4 years maximum –shorter interval for various causes 2014/11 36 APLAC PR 007 issue no 37

2014/11 37 APLAC PR 007 issue no 37 APLAC Procedure MR 001 Application; pre-evaluation; evaluation Maintenance of signatory status Criteria for accreditation bodies –ISO/IEC Qualifications of evaluators –Expanded on in APLAC MR 004

2014/11 38 APLAC PR 007 issue no 37 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: RMPs –ISO/IEC 17043: PTPs

2014/11 39 APLAC PR 007 issue no 37 APLAC MRA - Supplementary Requirements Access to appropriate measurement traceability system Avoidance of conflict of interest Confidentiality Access to adequate comprehensive proficiency testing programs

2014/11 40 APLAC PR 007 issue no 37 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

2014/11 41 APLAC PR 007 issue no 37 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

2014/11 42 APLAC PR 007 issue no 37 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

2014/11 43 APLAC PR 007 issue no 37 APLAC MRA - Assisting Trade APLAC MRA enhances acceptance of test, calibration and inspection reports, RM certificates and PTP reports amongst signatory economies APLAC MRA signatories recognise equivalence of each others’ accredited facilities APLAC MRA is an international recognition for accredited laboratories, inspection bodies,RMPs and PTPs

2014/11 44 APLAC PR 007 issue no 37 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)

2014/11 45 APLAC PR 007 issue no 37 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

2014/11 46 APLAC PR 007 issue no 37 Contact APLAC website: