APLAC - ITS ROLE AND
STRUCTURE
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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
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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
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Asia Pacific Laboratory
Accreditation Cooperation ctd
• Incorporated in 2006: APLAC
Constitution
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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
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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
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Current APLAC Membership
• All APEC economies except Chile
• Also Bangladesh, Bhutan, Gulf Region,
India, Mongolia, Pakistan, Sri Lanka,
Syria
• 41full members
• 11 associate members
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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
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APLAC Full Membership, ctd
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Indonesia: KAN
Japan: JAB; IAJapan; VLAC
Korea: KOLAS
Malaysia: Standards Malaysia
Mexico: ema
Mongolia: MNAS
New Zealand: IANZ
Pakistan: PNAC
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APLAC Full Membership, ctd
• Papua New Guinea: PNGLAS
• Peru: Indecopi
• Philippines: PAO
• Russia: AAC Analitica
• Singapore: SAC
• Sri Lanka: SLAB
• Chinese Taipei: TAF
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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
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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)
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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
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APLAC’s Role
• Recognition of competent test and
calibration facilities, inspection bodies,
reference material producers and
proficiency testing providers in the APEC
region
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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
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APLAC’s Structure
• General Assembly
• Board of Management
• MRA Council
• 5 permanent Committees
– Proficiency Testing Committee
– Public Information Committee
– Technical Committee
– Training Committee
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– Nominations Committee
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APLAC’s Structure
General
Assembly
Nominatons
Committee
Committee 1
Training
Committee
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Board
of
Management
Committee 2
Public
Information
Committee
MRA
Council
Committee 3
Proficiency
Testing
Committee
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Committee 4
Technical
Committee
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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
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Proficiency Testing
• Calibration
• Measurement (some with APMP)
• Testing
• Inter-regional Programs
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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
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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
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Training
• Accreditation body staff
• APLAC & ILAC MRA evaluators
• Train the trainers
– Technical assessors
– Laboratory staff
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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
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APLAC - Subsidiary Objectives
• Information exchange
• Exchange of experts
• Training
• Proficiency Testing
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APLAC MRA Signatories
• NATA
• JAB
• CALA
• IAJapan
• IQMH
• VLAC
• SCC
• KOLAS
• CNAS
• Standards Malaysia
• HKAS
• ema
• NABCB
• MNAS
• NABL
• IANZ
• KAN
• PNGLAS
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APLAC MRA Signatories ctd
• PNAC
• AIHA-LAP, LLC
• PAO
• A2LA
• AAC Analitica
• ACLASS & FQS
• SAC
• A-S-B
• SLAB
• IAS
• TAF
• NVLAP
• BLA-DSS
• PJLA Inc.
• BLQS-DMSc
• BoA
• NSC-ONSC
• JAS-ANZ
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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)
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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
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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
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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
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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
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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
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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)
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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
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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
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APLAC MRA ctd
• Procedure: APLAC MR 001
• Re-evaluation every 4 years maximum
– shorter interval for various causes
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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
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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
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APLAC MRA - Supplementary
Requirements
• Access to appropriate measurement
traceability system
• Avoidance of conflict of interest
• Confidentiality
• Access to adequate comprehensive
proficiency testing programs
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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
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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
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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
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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
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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)
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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
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Contact APLAC
• website: https://www.aplac.org
• email: [email protected]
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