2011/SOM1/SCSC/CON1/014 Session 8 Strengthening International Systems of Conformity Assessment Submitted by: International Laboratory Accreditation Cooperation (ILAC) 6 th Conference on Good Regulatory Practice Washington, D.C., United States 1-2 March 2011
Strengthening International Systems of Conformity Assessment Peter Unger ILAC Chair A2LA President & CEO APEC SCSC 6 th Conference on Good Regulatory Practice March 2, 2011 1 Topics Accreditation: Role in Trade and Regulation International Laboratory Accreditation Cooperation (ILAC) ILAC Mutual Recognition Arrangement (MRA) Regulatory Use of the ILAC MRA 2
Accreditation in the Market Place Accreditation Bodies Accreditation service Conformity assessment bodies Certification Inspection Test Cal Body Body Lab Lab Conformity Assessment Service Product/ service Market Conforming product/service Requirements Purchasers Regulators Demands for competent conformity assessment Suppliers Trade Organizations & Authorities Demands for facilitating trade 3 What is ILAC? International Laboratory Accreditation Cooperation The international authority on laboratory and inspection body accreditation with membership of accreditation bodies and affiliated organizations throughout the world. ILAC s main role is to: Maintain a Mutual Recognition Arrangement (MRA) among accreditation bodies to facilitate trade and to eliminate the need for duplicate accreditations Develop and maintain state-of-the-art accreditation practice Assist developing accreditation programs in every part of the world 4
The International Picture ILAC EA APLAC IAAC SADCA EA APLAC ILAC IAAC SADCA European Cooperation for Accreditation Asia Pacific Laboratory Accreditation Cooperation International Laboratory Accreditation Cooperation Inter-American Accreditation Cooperation Southern African Development Community Accreditation Unaffiliated Bodies Peer evaluated ABs who are not geographically located in one of the established regions 5 Conformity Assessment Accreditation Hierarchy Cooperation ILAC Government & Industry Recognition Cooperation IAF Mutual Recognitions EA, APLAC, IAAC, SADCA Mutual Recognitions EA, PAC, IAAC Accreditation Bodies accredit labs & inspection bodies A2LA, FQS, ASCLD LAB ISO/IEC 17011 Accreditation Bodies accredit certification bodies ANSI, A2LA ISO/IEC 17011 Laboratories test, products, materials ISO/IEC 17025 Inspection Bodies inspect products, items, structures ISO/IEC 17020 Certification Bodies certify persons ISO/IEC 17024 Certification Bodies certify management systems ISO/IEC 17021 Products tested per specifications Products inspected per specifications Persons certified in specific disciplines QMS or EMS certified ISO 9001, TS 16949 ISO 14001
Status of ILAC MRA 71 Full Members from 58 economies are ILAC MRA signatories MRAs of the recognized regions underpin the ILAC MRA MRAs of 3 of 4 Regional Cooperation Body members in ILAC are recognized by ILAC (i.e., EA, APLAC, IAAC) Recognition of region achieved after successful ILAC peer evaluation Re-evaluation by ILAC at maximum intervals of 4 years Signatories to EA, APLAC and IAAC MRAs entitled to become ILAC MRA signatories 7 ILAC Membership 138 member bodies representing: 91 economies (about 98% of global l GDP) 71 full member MRA signatories, 58 economies 39,000 accredited laboratories 37 associate & affiliate accreditation bodies 26 stakeholder associations 4 regional cooperation bodies 8
Primary Objective of the ILAC MRA Eliminate testing as a Technical Barrier to Trade through Recognition of Competence between Accreditation Bodies to facilitate Acceptance of accredited test results 9 US Regulatory Use of the ILAC MRA Examples of Federal agencies citing the ILAC MRA: Consumer Product Safety Commission (CPSC) Environmental Protection Agency (EPA) Nuclear Regulatory Commission (NRC) Food and Drug Administration (FDA) 10
Consumer Product Safety Commission CPSC regulations issued to protect children under Consumer Product Safety Improvement Act of 2008 Lists laboratories accredited by ILAC MRA signatories to test in accordance with CPSC-mandated test methods Methods must appear on scopes of accreditation 11 Environmental Protection Agency Water Sense Program requires test results from laboratories accredited d by an ILAC MRA signatory Energy Star Program requires test results from laboratories accredited by an ILAC MRA signatory Formaldehyde emissions of composite wood products Methods must appear on scopes of accreditation 12
Nuclear Regulatory Commission Regulates components for nuclear reactors Recognizes certain US-based ILAC MRA signatories for accreditation of calibration laboratories Wants to expand recognition to foreign accreditation bodies for testing as well as calibration Observation of the ILAC/regional peer evaluation process is underway 13 Food and Drug Administration Draft guidance document, Submission of Laboratory Packages by Accredited Laboratories For biological products, drugs, devices and food Be an ISO/IEC 17025 accredited laboratory Also meet AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analysis of Food and Pharmaceuticals Be accredited by an ILAC MRA signatory 14
ILAC-MRA Mark 15 ILAC-MRA Mark (cont d) 47 ILAC Full Members have signed Licensing Agreements with ILAC, for the use of the Combined MRA Mark. The Combined MRA Mark, is the ILAC-MRA Mark used in combination with the accreditation body s own symbol. Once licensed, accreditation bodies can enter into a Sub- Licensing Agreement with their accredited laboratories for the use of the ILAC Laboratory Combined MRA Mark. 16
Government Benefits of Using the ILAC MRA Eliminates expense of government administered programs Increases confidence in results used to determine compliance with regulations; provides oversight Reduces duplication in testing by reliance on recognized accreditation bodies & results of their accredited laboratories Reduces costs of trade Encourages testing at sources of supply Upholds WTO Technical Barriers to Trade treaty commitments Establishes a basis for multi-lateral international recognition 17 For more information.. ILAC Secretariat Email: ilac@nata.com.au Web: www.ilac.org 18