The International Laboratory Accreditation Cooperation (ILAC)
The International Accreditation Forum (IAF)
Accreditation --Facilitating Global Trade
byPeter UngerILAC Chair
BSCA Conference 5 June 2014
“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;”
Accreditation in the TBT Agreement
2
Demands for facilitating trade
Trade Organizations& Authorities
Product/service
Suppliers
PurchasersRegulators
Conforming product/serviceRequirements
Market
CertificationBody
InspectionBody
Test Lab
Cal Lab
Conformity assessment bodies
Conformity Assessment Service
CertificationBody
InspectionBody
Test Lab
Cal Lab
Conformity assessment bodies
Conformity Assessment Service
Demands for competent conformity
assessment
Accreditation Bodies
Accreditation service
Accreditation to Support the Market
3
ACCREDITATION
CONFORMITY ASSESSMENTBODIES
PRODUCT & SERVICE PROVIDERS
PeerEvaluation
International Standards
Standards / Regulatory requirements / Scheme criteria
GOVERNMENT CONSUMERS PURCHASERS
CONFIDENCE TRUST ASSURANCE
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
5
Global Vision
– Tested, inspected or certified once, accepted everywhere'
– “Accredited once, accepted everywhere”
6
Regional Cooperation BodiesThe IAF and ILAC Arrangements are structured to build on existing and developing regional MLAs/MRAs established around the world
7
– The IAF MLA recognizes EA, PAC, IAAC
– The ILAC MRA recognizes EA, APLAC, IAAC
European Cooperation
for Accreditation
(EA)
Asia Pacific Laboratory
Accreditation Cooperation
(APLAC)
Inter-American Accreditation Cooperation
(IAAC)
Pacific Accreditation
Cooperation (PAC)
Southern African Development
Community Accreditation
(SADCA)
African Accreditation Cooperation
(AFRAC)
Arab Accreditation Cooperation
(ARAC)
8
ILAC
EA APLACIAAC
SADCA
The International Picture
ILAC International Laboratory Accreditation Cooperation
EA European Cooperation for Accreditation
APLAC Asia Pacific Laboratory Accreditation Cooperation
IAAC Inter-American Accreditation Cooperation
AFRAC African Regional Accreditation Cooperation
Unaffiliated Bodies Peer evaluated ABs who are not geographically located in one of the established regions
SADCA Southern African Development Community Accreditation
ILAC
EA APLACIAAC
AFRAC
ARAC
ARAC Arab Accreditation Cooperation
ILAC MRA Signatories
ILAC Associate Members
ILAC Affiliate Members
Coverage of the ILAC MRA (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
IAF MLA Signatories
IAF Members not yet Signatories
Coverage of the IAF MLA (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.
16
IAF/ILAC A2: Evaluation of an ABFull 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 ABSection 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 ABQualifications 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 ABFull 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 ABFull 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
22
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.”
23
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.”
24
Benefits for government and regulators
•Cost effective tool to support regulation
•Efficient monitoring
25
Benefits for industry
• Greater acceptance of products and services opening up markets
• Avoiding the costs of multiple testing, inspection or certification
• Efficient management of suppliers26
Benefits for consumers
•Public confidence in goods and services despite complex global marketplace
•Reduces product failures
27
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
28
