Transcript The International Laboratory Accreditation Cooperation (ILAC

The International Laboratory Accreditation
Cooperation (ILAC)
The International Accreditation Forum (IAF)
Accreditation -Facilitating Global Trade
by
Peter Unger
ILAC Chair
BSCA Conference 5 June 2014
Accreditation in the TBT Agreement
“6.1.1 adequate and enduring technical
competence of the relevant conformity
assessment bodies in the exporting Member,
so that confidence in the continued reliability
of their conformity assessment results can
exist; in this regard, verified compliance, for
instance through accreditation, with relevant
guides or recommendations issued by
international standardizing bodies shall be
taken into account as an indication of
adequate technical competence;”
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Accreditation to Support the Market
Accreditation Bodies
Accreditation service
Conformity assessment bodies
Certification Inspection
Body
Body
Test
Lab
Cal
Lab
Conformity Assessment Service
Market
Product/
service
Suppliers
Conforming
product/service
Requirements
Purchasers
Regulators
Trade
Organizations
& Authorities
Demands for
competent
conformity
assessment
Demands for
facilitating trade
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Peer
Evaluation
ACCREDITATION
International Standards
CONFORMITY ASSESSMENT
BODIES
Standards / Regulatory requirements
/ Scheme criteria
PRODUCT & SERVICE PROVIDERS
CONFIDENCE
GOVERNMENT
TRUST
CONSUMERS
ASSURANCE
PURCHASERS
ILAC and IAF
ILAC and IAF—global networks of conformity
assessment accreditation bodies
– Recognition of competent conformity assessment
activities through global multi-lateral mutual
recognition arrangements
– Harmonization of conformity assessment practices
– Promotion of accredited conformity assessment as
an effective mechanism for providing confidence in
goods and services
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Global Vision
– Tested, inspected or certified
once, accepted everywhere'
– “Accredited once, accepted
everywhere”
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Regional Cooperation Bodies
The IAF and ILAC Arrangements are structured to
build on existing and developing regional MLAs/MRAs
established around the world
– The IAF MLA recognizes EA, PAC, IAAC
– The ILAC MRA recognizes EA, APLAC, IAAC
European
Pacific
Cooperation
Accreditation
for
Cooperation (PAC)
Accreditation
(EA)
Inter-American
Accreditation
Cooperation
(IAAC)
Asia Pacific
Laboratory
Accreditation
Cooperation
(APLAC)
Southern African
Development
Community
Accreditation
(SADCA)
African
Accreditation
Cooperation
(AFRAC)
Arab
Accreditation
Cooperation
(ARAC)
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The International Picture
ILAC
APLAC
EA
ARAC
AFRAC
IAAC
SADCA
EA
European Cooperation for Accreditation
APLAC
Asia Pacific Laboratory Accreditation Cooperation
ILAC
International Laboratory Accreditation Cooperation
IAAC
SADCA
AFRAC
ARAC
Inter-American Accreditation Cooperation
Southern African Development Community Accreditation
African Regional Accreditation Cooperation
Arab Accreditation Cooperation
Unaffiliated
Bodies
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Peer evaluated ABs who are not geographically located in one of the
established regions
Coverage of the ILAC MRA
ILAC MRA Signatories
ILAC Associate Members
ILAC Affiliate Members
(October 2013)
Status of the ILAC MRA
(March 2014)
– The ILAC network of members includes 148 bodies from
112 different economies (85 Full Members/MRA Signatories,
17 Associates, 17 Affiliates, 23 Stakeholders, 6 Regional
Cooperation Bodies)
– ILAC MRA covers testing, calibration and inspection
– Signatories represent about 95% of Global GDP
– 45,000 accredited laboratories
– About 7,500 accredited inspection bodies
– MRAs for accreditation of PTPs and RMPs underway
Coverage of the IAF MLA
IAF MLA Signatories
IAF Members not yet Signatories
(August 2013)
Status of the IAF MLA
– 91 members (69 Accreditation Bodies, 18 Association Members,
6 Regional Groups, 3 Observers); 60 IAF MLA Signatories from
55 economies
– Management Systems: 53 accreditation bodies and EA, PAC & IAAC
– ISO 9001 QMS: 53 accreditation bodies and EA, PAC & IAAC
– ISO 14001 EMS: 49 accreditation bodies and EA, PAC & IAAC
– ISO 22000 FSMS, ISO/IEC 27001 ISMS, ISO/IEC 20000 ITSMS and ISO
13485 medical devices: under development
– Product: 51 accreditation bodies EA, PAC & IAAC
– Global G.A.P, IFA CPCCs: 26 accreditation bodies
– Persons: under development
– GHG Verification & Validation Bodies: under development
The ILAC and IAF Arrangements
– Accreditation body members deemed competent through
a peer evaluation process:
– ISO/IEC 17011
– IAF-ILAC A series documents
– IAF MD documents & ILAC P-series documents
– Signatories must recognize certificates and reports
issued by organisations accredited by other Signatories
– Provides business with assurance that overseas bodies
operate to the same standard.
– Removes technical barriers to trade by eliminating
redundant conformity assessment
IAF/ILAC A1: Evaluation of a
Region
Two main sections; two main purposes:
– Requirements for a Region (Section 2)
– Flow Chart for a peer evaluation of a
region (Section 3)
Typical Evaluation of a Region
Visit to Secretariat Office(s)
Witnessing two AB peer evaluations
Observation of MLA Group Decision Making
Report of findings to the IAF/ILAC Arrangement
Management Committee(s)
IAF/ILAC A1: Evaluation of
a Region
• All Regional Groups also provide a report each year
to the respective IAF MLA Management Committee
(MC) and/or ILAC Arrangement Management
Committee (AMC) on their MLA and/or MRA
activities. Such reports should include any joint
activities, as outlined above and be provided to the
next TL-R who will evaluate the Regional Group.
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IAF/ILAC A2: Evaluation of an AB
Full Evaluation
– Four to six days duration
– Three to seven team members
– Several assessments witnessed
– Summary report of findings at end of visit
IAF/ILAC A2: Evaluation of an AB
Section 2.2 Supplementary Requirements
– Demonstrated competence and experience
– Acceptable routes for measurement
traceability
– Proficiency testing requirements
– Arrangement obligations
– Promotion of the Arrangements
– Contribute to peer evaluations
– Cross-frontier policy
IAF/ILAC A2: Evaluation of an AB
Qualifications of Evaluators
– Team members:
• At least 3 years experience as staff member or
assessor in a member accreditation body
• Evaluator training course completed
• English understood
– Team Leaders
• Senior AB staff
• Experience as a team member
IAF/ILAC A2: Evaluation of an AB
Full Evaluation
– Four to six days duration
– Three to seven team members
– Several assessments witnessed
– Summary report of findings at end of visit
IAF/ILAC A2: Evaluation of an AB
Full Evaluation Report Process
–
–
–
–
–
–
–
–
Summary report with Findings:
Draft full report
Formal response by AB to findings
Formal reaction of the evaluation team
Often more than one iteration
Follow-up visit possible
Final report to the Arrangement group
Decision by the Arrangement group
USA Specifiers of the Arrangements
– Consumer Product Safety Commission
– Federal Highway Administration
– U.S. Coast Guard
– General Services Administration
– Department of Defense
– Nuclear Regulatory Commission
– Food and Drug Administration
– Environmental Protection Agency
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Consumer Product Safety Commission
Statement by Scott Hey, program manager of the CPSC
Office of Hazard Identification and Reduction on the
benefits of the ILAC MRA:
“The MRA has had a tremendous impact on our group.
With all the products from manufacturers around the
world – cribs and bunk beds from China and the United
Kingdom, bike helmets and baby walkers from Taiwan
and Italy – knowing that they have all been through an
accepted standard of testing from an accredited lab
gives us a greater level of confidence in those products.
It provides a sense of consistency in quality.”
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Environmental Protection Agency
Statement by Eamon Monaghan, Program Integrity Lead,
ENERGYSTAR on the reason for using the ILAC MRA:
“We didn’t have to develop and implement our own set of rules. Any
kind of agency-specific rule creates costs or hassles for industry,
and that was something we really wanted to avoid. We currently
certify products in 65 categories, many of which are certified and
tested overseas. Referencing the ILAC MRA took the EPA off the
hook for developing a lot of criteria for labs or conducting our own
lab oversight. And, by working with only ILAC signatories, we have
the confidence that the labs have been appropriately assessed. We
now recognize 27 ILAC-signatory accreditation bodies around the
world.”
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Benefits for government
and regulators
• Cost effective tool to support
regulation
• Efficient monitoring
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Benefits for industry
• Greater acceptance of products
and services opening up markets
• Avoiding the costs of multiple
testing, inspection or certification
• Efficient management of suppliers
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Benefits for consumers
• Public confidence in goods and
services despite complex global
marketplace
• Reduces product failures
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The Economics of Accreditation:
UKAS/British Measurement and
Test Association study
March 2013
• Conformity assessment body benefits
estimated to be 295 million pounds per
annum
• Downstream commercial benefit estimated
to be 320 million pounds per annum
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Contact Details
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