2014/11 1 aplac pr 007 issue no 37 aplac - its role and structure

2014/11 1APLAC PR 007 issue no 37

APLAC - ITS ROLE AND STRUCTURE


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


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 LaboratoryAccreditation Cooperation ctd

• Incorporated in 2006: APLAC Constitution



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


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 Guide 34

• PTPs accredited to ISO/IEC 17043


Current APLAC Membership

• All APEC economies except Chile

• Also Bangladesh, Bhutan, Gulf Region, India, Mongolia, Pakistan, Sri Lanka, Syria

• 41full members

• 11 associate members


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


APLAC Full Membership, ctd

• Indonesia: KAN

• Japan: JAB; IAJapan; VLAC

• Korea: KOLAS

• Malaysia: Standards Malaysia

• Mexico: ema

• Mongolia: MNAS

• New Zealand: IANZ

• Pakistan: PNAC



• Papua New Guinea: PNGLAS

• Peru: Indecopi

• Philippines: PAO

• Russia: AAC Analitica

• Singapore: SAC

• Sri Lanka: SLAB

• Chinese Taipei: TAF



• 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


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)


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


APLAC’s Role

• Recognition of competent test and calibration facilities, inspection bodies, reference material producers and proficiency testing providers in the APEC region


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


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


APLAC’s Structure

N om inatonsCom m ittee

Com m ittee 1Train ing

Com m ittee

Com m ittee 2Public

I nform ationCom m ittee

Com m ittee 3Proficiency

TestingCom m ittee

Com m ittee 4Technical

Com m ittee

Boardof

M anagem ent

M R ACouncil

G eneralAssem bly


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


Proficiency Testing

• Calibration

• Measurement (some with APMP)

• Testing

• Inter-regional Programs


Public Information

• “APLAC News Notes” published every 3 months by a different APLAC member each time

• Publicity and information material

• APLAC website: https://www.aplac.org


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


Training

• Accreditation body staff

• APLAC & ILAC MRA evaluators

• Train the trainers

– Technical assessors

– Laboratory staff


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


APLAC - Subsidiary Objectives

• Information exchange

• Exchange of experts

• Training

• Proficiency Testing


APLAC MRA Signatories

• NATA

• CALA

• IQMH

• SCC

• CNAS

• HKAS

• NABCB

• NABL

• KAN

• JAB

• IAJapan

• VLAC

• KOLAS

• Standards Malaysia

• ema

• MNAS

• IANZ

• PNGLAS


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


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)


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

• 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



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


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


Accreditation Hierarchy of Criteria

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

ISO/IEC17025/17020

Supplementary, Field-specific

criteria (eg Electrical Testing)

Technical Requirements of Specific Test Methods and Procedures


Accreditation Hierarchy of Criteria

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)

ISO/IEC17025/17020

Supplementary, Field-specific

criteria (eg Electrical Testing)

Technical Requirements of Specific Test Methods and Procedures

Regulatory Requirements


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


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



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


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


APLAC MRA - Supplementary Requirements

• Access to appropriate measurement traceability system

• Avoidance of conflict of interest

• Confidentiality

• Access to adequate comprehensive proficiency testing programs


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


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


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


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


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)


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


Contact APLAC

• website: https://www.aplac.org

• email: [email protected]

2014/11 1 aplac pr 007 issue no 37 aplac - its role and structure

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