The International Laboratory Accreditation Cooperation (ILAC) & The International Accreditation Forum (IAF) The Role of ILAC & IAF in the International Recognition of Conformity Assessment Results of Products that are Subject to Technical Regulations Peter Unger, ILAC Chair First International Congress on Market Surveillance in Technical Regulations Medellin, Colombia May 14, 2015 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;” What is accreditation? ‘Independent evaluation of conformity assessment bodies against recognized standards to ensure their impartiality and competence to carry out specific activities, such as tests, calibrations, inspections and certifications.’ 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 4 Accredited Conformity Assessment purchaser, regulator, the public Is it OK if we buy it? Product Service Can we rely on the lab, IB or CB? Laboratory, Inspection Body, Certification Body We check conformance on behalf of you ! We assure you of the competence of the Lab, IB or CB ! Can we rely on the AB? ILAC & IAF Accreditation Body We evaluate whether or not the AB is competent ! Peer Evaluation ACCREDITATION International Standards CONFORMITY ASSESSMENT BODIES Standards / Regulatory requirements / Scheme criteria PRODUCT & SERVICE PROVIDERS CONFIDENCE GOVERNMENT TRUST CONSUMERS ASSURANCE PURCHASERS IAF and ILAC – an Introduction ILAC and IAF are global networks of accreditation bodies and organisations involved in conformity assessment activities. – Recognition of competent conformity assessment activities through Global Arrangements – Development and harmonization of accreditation practices – Promotion of accreditation as an effective mechanism for providing confidence in goods and services IAF and ILAC Objectives – Maintain the Arrangements, and expand coverage into new economies – Increase cooperation with all relevant stakeholders – Act as a central ‘hub’ to harmonise conformity assessment best practice – Provide appropriate support to new accreditation activities in developing countries Global Vision To support world trade by eliminating technical barriers, realizing the free-trade goal of ‘tested, inspected or certified once and accepted everywhere' . ILAC – The Membership • ILAC is the oversight body for laboratory and inspection body accreditation. Full Members Associate Members Affiliates Regional Cooperation Bodies Stakeholders IAF– The Membership • IAF is the oversight body in the fields of the certification of management systems, personnel and products. Accreditation Bodies Certification Body Associations Regional Cooperation Bodies Industry Associations Stakeholders and Scheme Owners IAF / ILAC timeline 2001 1st Joint IAF-ILAC General Assembly 2000 ILAC MRA Testing & 2012 ILAC MRA Calibration Inspection 1977 – ILAC established 1996 – ILAC MOU 1993 – IAF established 1998 IAF MLA for QMS IAF Bylaws IAF Incorporated 2003 - ILAC Incorporated 2004 – IAF MLAs for EMS and Product The ILAC and IAF Arrangements – Accreditation bodies deemed competent through peer evaluation: – ISO/IEC 17011 – IAF-ILAC A series documents – Signatories recognize certificates, reports, and results issued by organizations 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 Regional Cooperation Bodies • The IAF and ILAC Arrangements are structured to build on existing and developing regional MLAs/MRAs established around the world. Pacific European Cooperation Accreditation Cooperation for (PAC) Accreditation (EA) Inter-American Accreditation Cooperation (IAAC) Asia Pacific Southern African Development Laboratory Community Accreditation Accreditation Cooperation (SADCA) (APLAC) • The IAF MLA recognizes EA, PAC, IAAC • The ILAC MRA recognizes EA, APLAC, IAAC African Accreditation Cooperation (AFRAC) Arab Accreditation Cooperation Coverage of the ILAC MRA ILAC MRA Signatories ILAC Associate Members ILAC Affiliate Members (May 2015) Status of the ILAC MRA (May 2015) – ILAC membership includes 147 bodies from 112 different economies (89 Full Members/MRA Signatories, 16 Associates, 13 Affiliates, 23 Stakeholders, 6 Regional Cooperation Bodies) – 89 ILAC MRA Signatories representing 74 economies – ILAC MRA covers testing, calibration and inspection – Signatories represent about 95% of Global GDP – More than 49,000 accredited laboratories – About 8,000 accredited inspection bodies Coverage of the IAF MLA IAF MLA Signatories IAF Members not yet Signatories (May 2015) Status of the IAF MLA There are 60 IAF MLA Signatories, representing 55 economies – Main scope: – Management systems: 53 Accreditation Bodies and EA, PAC & IAAC – Product certification: 51 Accreditation Bodies and EA, PAC & IAAC – Sub scope Level 4 – Global G.A.P. IFA General Regulations: 26 Accreditation Bodies – Sub Scope Level 5 – ISO 9001 QMS: 53 Accreditation Bodies and EA, PAC & IAAC – ISO 14001 EMS: 49 Accreditation Bodies and EA, PAC & IAAC – Global G.A.P. CPCCs: 26 Accreditation Bodies Accepting applications: MDMS, FSMS, ISMS, Persons, GHG, V&V Some Specifiers of the ILAC MRA http://ilac.org/news/category/good-news-stories/ – WTO Technical Barriers to Trade Program – Canadian Department of Environment and Conservation – Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF) – US Federal Government Agencies: – Consumer Product Safety Commission – Federal Highway Administration – Federal Aviation Administration – Coast Guard – Department of Defense – Nuclear Regulatory Commission – Food and Drug Administration – Environmental Protection Agency – General Services Administration Some Specifiers of the ILAC MRA http://ilac.org/news/category/good-news-stories/ – WTO Technical Barriers to Trade Program – Canadian Department of Environment and Conservation – Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF) – US Federal Government Agencies: – Consumer Product Safety Commission – Federal Highway Administration – Federal Aviation Administration – Coast Guard – Department of Defense – Nuclear Regulatory Commission – Food and Drug Administration – Environmental Protection Agency – General Services Administration Federal Highway Administration Testing of crash mitigation equipment and devices need to be tested in accordance with FHWA specifications by a laboratory accredited by an ILAC MRA signatory accreditation body Rule in effect since 2010. Statement by Nicolas Armitovich, FHWA highway engineer: “Even though being part of the MRA has had no impact on the work of the agency, the overall requirement for crash tests to be conducted by accredited laboratories has improved our confidence in the results received.” 21 Environmental Protection Agency • Water Sense Program requires test results from a laboratory accredited by an ILAC MRA signatory accreditation body • Energy Star Program requires test results from a laboratory accredited by an ILAC MRA signatory accreditation body • Both programs require products to be certified by an accredited certification body accredited by an IAF MLA signatories • Proposed rule to control formaldehyde emissions from composite wood products requires test results from a laboratory accredited by an ILAC MRA signatory accreditation body 22 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.” 23 General Services Administration • Testing of star-of-life ambulances procured by the U.S. Government must be tested by an ILAC MRA signatory accreditation body • The agency still does its own inspection but has confidence that the critical components of the ambulance have been tested by competent laboratories 24 Nuclear Regulatory Commission • NRC has been using NVLAP and A2LA accreditation for calibration laboratories • NRC extended the accreditation recognition to ILAC MRA signatories in Europe and the Far East • Nuclear Energy Institute (NEI) evaluated the ILAC MRA peer evaluation process • NEI recommended using the ILAC MRA • NRC recognized in early 2015 the ILAC MRA 25 U.S. Coast Guard • Testing of equipment and devices used on Coast Guard vessels need to be tested in accordance with Coast Guard specifications by a laboratory accredited by an ILAC MRA signatory accreditation body • Third-party certification of certain products also required 26 U.S. Coast Guard Statement by Kurt Heinz, chief, life saving and fire safety, U.S. Coast Guard on the benefit of the ILAC MRA: “Obviously, avoiding duplicative tests saves a lot of time. A lot of the safety materials we use in ship construction, like the fire-resistant coatings we use on bulkheads and other areas, are manufactured in Europe and Asia, so being able to accept and depend on test results from labs in those countries makes sense. And, less time spent doing routine approval work translates into more time spent on policy and standard development – which is a good thing.” 27 U.S. Coast Guard • Testing of equipment and devices used on Coast Guard vessels need to be tested in accordance with Coast Guard specifications by a laboratory accredited by an ILAC MRA signatory accreditation body • Third-party certification of certain products also required 28 Food and Drug Administration • Draft 2008 guidance recommends test data for imported food should be from an ISO/IEC 17025 accredited laboratory • Accreditation should be done by an ILAC MRA signatory accreditation body • Food Safety Modernization Act calls for laboratory accreditation with FDA leaning toward using the ILAC MRA to recognize accreditation bodies • FDA supports state public health laboratories to get accredited by ILAC MRA signatories by August 2017 29 Consumer Product Safety Commission • CPSC regulations issued to protect children under the Consumer Product Improvement Act of 2008 • Lists laboratories accredited by ILAC MRA signatory accreditation bodies • Standard and test methods must appear on the scope • Many children’s products continue to be added within the scope of this requirement for accreditation • CPSC market surveillance activities identify less substandard products as a result 30 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.” 31 The Benefits For Government • Facilitator of trade • An efficient enforcement and monitoring tool For Business • Greater acceptance of products and services • Avoid costs associated with repeat conformity assessment • Informed procurement For Consumers • Public confidence in goods and services • Minimises product failures or recalls Summary – Commitment to developing a harmonized global approach for accreditation practices – Maintaining the Arrangements to ensure equal reliability of accredited services. – Promoting greater acceptance by regulators and businesses to remove technical barriers to trade, and avoiding the need for duplicate certifications, testing or inspections. – Supporting developing economies to establish an accreditation infrastructure. Contact Details For more information contact: For more information contact: The IAF Secretariat Elva Nilsen 28 Chemin Old Chelsea Box 1811 Chelsea, Quebec Canada J9B 1A0 The ILAC Secretariat PO Box 7507 Silverwater NSW 2128 Australia Phone: +1 (613) 454 8159 Email: iaf@iaf.nu Phone: +612 9736 8374 Email: ilac@nata.com.au www.iaf.nu www.ilac.org