APLAC - ITS ROLE AND STRUCTURE 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

Asia Pacific Laboratory Accreditation Cooperation ctd Incorporated in 2006: APLAC Constitution 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue 40

APLAC Membership ctd Commitment to compliance with ISO/IEC 17011 Laboratories accredited to ISO/IEC 17025 (ISO 15189 for medical laboratories) Inspection bodies accredited to ISO/IEC 17020 RMPs accredited to ISO/IEC 17034 and Guide 34 PTPs accredited to ISO/IEC 17043 2017/07 APLAC PR 007 issue no 40

Current APLAC Membership All APEC economies except Chile Also Bangladesh, Bhutan, Cambodia, Gulf Region, India, Kazakhstan, Kuwait, Mongolia, Nepal, Pakistan, Saudi Arabia, Sri Lanka, Turkey, UAE 46 full members 13 associate members 2017/07 APLAC PR 007 issue no 40

APLAC Full Members Australia: NATA Bangladesh: BAB Brunei Darussalam: ABCi Canada: SCC; CALA; IQMH; DAP People’s Republic of China: CNAS Gulf Region: GAC Hong Kong: HKAS 2017/07 APLAC PR 007 issue no 40

APLAC Full Membership, ctd India: NABL, NABCB Indonesia: KAN Japan: JAB; IAJapan; VLAC Kazakstan: NCA Korea: KOLAS Malaysia: Standards Malaysia Mexico: ema Mongolia: MNAS 2017/07 APLAC PR 007 issue no 40

APLAC Full Membership, ctd New Zealand: IANZ Nepal: AERSSC Pakistan: PNAC Papua New Guinea: PNGLAS Peru: INACAL Philippines: PAB Russian Federation: AAC Analitica, RusAccreditation 2017/07 APLAC PR 007 issue no 40

APLAC Full Membership, ctd Saudi Arabia: SAC Singapore: SAC Sri Lanka: SLAB Chinese Taipei: TAF Thailand: BLA-DSS; BLQS-DMSc; NSC-ONSC USA: A2LA; AIHA-LAP, LLC; ANAB; IAS; NVLAP; PJLA Inc. 2017/07 APLAC PR 007 issue no 40

APLAC Full Membership, ctd UAE: ENAS Vietnam: BoA; AOSC Australasia: JAS-ANZ 2017/07 APLAC PR 007 issue no 40

APLAC Associate Membership Australia: PTA; ALAB Bhutan: NAFP Cambodia: NAFP CANC Korea: KTR; RRA; KASTO; KTC Kuwait: KAAS, PAI Mongolia: CGL Chinese Taipei: NIEA 2017/07 APLAC PR 007 issue no 40

APLAC Associate Membership ctd Thailand: FHI 360 (Thailand Office) Turkey: NAC 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

APLAC’s Role Recognition of competent test and calibration facilities, inspection bodies, reference material producers and proficiency testing providers in the APEC region 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

APLAC’s Structure 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

Proficiency Testing Calibration Measurement (some with APMP) Testing Inter-regional Programs 2017/07 APLAC PR 007 issue no 40

Public Information “APLAC News Notes” published every 6 months by the APLAC Secretariat Publicity and information material APLAC website: https://www.aplac.org 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

Training Accreditation body staff APLAC & ILAC MRA evaluators Train the trainers Technical assessors Laboratory staff 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

APLAC - Subsidiary Objectives Information exchange Exchange of experts Training Proficiency Testing 2017/07 APLAC PR 007 issue no 40

APLAC MRA Signatories NATA BAB CALA IQMH SCC CNAS GAC HKAS NABCB NABL KAN JAB IAJapan VLAC NCA KOLAS 2017/07 APLAC PR 007 issue no 40

APLAC MRA Signatories ctd Standards Malaysia ema MNAS IANZ PNGLAS PNAC PAB AAC Analitica RusAccreditation SAC SLAB TAF BLA-DSS BLQS-DMSc NSC-ONSC AIHA-LAP, LLC A2LA ANAB 2017/07 APLAC PR 007 issue no 40

APLAC MRA Signatories ctd IAS NVLAP PJLA Inc. BoA JAS-ANZ 2017/07 APLAC PR 007 issue no 40

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) 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

Accreditation ctd Formal recognition of that competence 3rd 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 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

Accreditation Hierarchy of Criteria ISO/IEC 17025/17020 Supplementary, Field-specific criteria (eg Electrical Testing) Technical Requirements of Specific Test Methods and Procedures 1 General technical competence and systems compliance criteria 2 Additional field-specific criteria, eg for emc testing laboratories 3 Additional test, calibration, inspection method criteria 2017/07 APLAC PR 007 issue no 40

Accreditation Hierarchy of Criteria ISO/IEC 17025/17020 Supplementary, Field-specific criteria (eg Electrical Testing) Technical Requirements of Specific Test Methods and Procedures Regulatory Requirements 1 General technical competence and systems compliance criteria 2 Additional field-specific criteria, eg for emc testing laboratories 3 Additional test, calibration, inspection method criteria 4 Additional, regulator-specific criteria (eg reporting formats, labelling etc) 2017/07 APLAC PR 007 issue no 40

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 Extended to include PTP, 2014 Replaced network of bilateral MRAs 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

APLAC MRA ctd Procedure: APLAC MR 001 Re-evaluation every 4 years maximum shorter interval for various causes 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

APLAC MRA - Supplementary Requirements Access to appropriate measurement traceability system Avoidance of conflict of interest Confidentiality Access to adequate comprehensive proficiency testing programs 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

APLAC MRA - Evaluation Preparation On-site visit Report accreditation body accredited & applicant facilities Report corrective actions identified acceptance of corrective actions schedule for implementation Full review by APLAC MRA Council 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

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) 2017/07 APLAC PR 007 issue no 40

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 2017/07 APLAC PR 007 issue no 40

Contact APLAC website: https://www.aplac.org email: secretariat@aplac.org 2017/07 APLAC PR 007 issue no 40