APLAC - ITS ROLE AND STRUCTURE

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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
• Incorporated in 2006 APLAC Constitution

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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

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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

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Current APLAC Membership

• All APEC economies except Chile
• Also Bangladesh, India, Mongolia, Pakistan, Sri
  Lanka
• 37 full members
• 4 associate members

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APLAC Full Members

• Australia NATA
• Brunei Darussalam
• Canada SCC CAEAL
• Peoples Republic of China CNAS
• Hong Kong China HKAS
• India NABL
• Indonesia KAN

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APLAC Full Membership, ctd

• Japan JAB IAJapan VLAC JCLA
• Korea KOLAS
• Malaysia SM
• Mexico ema
• Mongolia MASM
• 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 DMSc DSS TLAS
• USA A2LA ACLASS AIHA IAS L-A-B NVLAP PJL
• Vietnam BoA
• Australasia JAS-ANZ

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APLAC Associate Membership

• Bangladesh BAB
• Korea KOTRIC NIER
• Chinese Taipei NIEA

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APLACs 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

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APLACs Role

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

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APLACs 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

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APLACs Structure

• General Assembly
• Board of Management
• MRA Council
• 5 permanent Committees
• Proficiency Testing Committee
• Public Information Committee
• Technical Committee
• Training Committee
• Nominations Committee

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APLACs Structure
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APLACs Structure

• Board of Management
• meets at least twice a year
• oversees management of APLACs 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 web site http//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 and reference material certificates
  amongst all signatories economies
• demands mutual confidence in technical competence
• Confidence cannot be legislated

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APLAC - Subsidiary Objecives

• Information exchange
• Exchange of experts
• Training
• Proficiency Testing

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APLAC MRA Signatories

• NATA
• CAEAL
• SCC
• CNAL
• HKAS
• NABL
• KAN
• JAB

• IAJapan
• VLAC
• KOLAS
• DSM
• ema
• IANZ
• PAO (suspended 06/08)
• SAC

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APLAC MRA Signatories ctd

• TAF
• DSS
• DMSc
• TLAS
• A2LA
• ACLASS

• LAB
• IAS
• NVLAP
• PJLA
• BoA
• JAS-ANZ

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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

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Accreditation ctd

• 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

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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
  inspectionsmatrices
• measurement techniques, range, accuracy
• test specification test method

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Accreditation Hierarchy of Criteria
1 General technical competence and systems
compliance criteria 2 Additional field-specific
criteria, eg for emc testing laboratories 3 Additi
onal test, calibration, inspection method criteria
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Accreditation Hierarchy of Criteria
1 General technical competence and systems
compliance criteria 2 Additional field-specific
criteria, eg for emc testing laboratories 3 Additi
onal 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
• Replaced network of bilateral MRAs
• Regional component of global ILAC Arrangement,
  November 2000 (test and calibration only)

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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

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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 in combination with ISO/IEC 17025
  RMPs

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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, 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

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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

• web site http//www.aplac.org
• email aplac_at_nata.asn.au