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Introductory note:

International Conformity Assessment System. Introductory note:

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Introductory note:

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  1. International Conformity Assessment System Introductory note: The information contained in this presentation was compiled by the American National Standards Institute (ANSI). The primary purpose of the chart is to attempt to portray a representation of the various actors in global conformity assessment – on one slide. While many organizations have many subdivisions, only those subdivisions most directly related to conformity assessment are shown. The chart is one perspective of the system, with emphasis on identification and representation of the various entities. The chart would look different if the entities were drawn proportional to their relative work volumes in the systems, or if they were drawn proportional to their respective standards and conformity assessment revenues or budgets. Such a representation will have inaccuracies which will require correction. The chart is a work in progress and we welcome comments and suggestions for consistent improvement for purposes of accuracy and education. Thank you, The ANSI International Policy Department Please send comments or suggestions to: intl@ansi.org

  2. Importers Companies Purchaser/User Suppliers Buildings, Facilities, Mines, Procedures, Services, etc. Products (Processes, Services) QMS/EMS Personnel Greenhouse Gas Verifiers Inspection Bodies Certification Bodies Testing/Cal. Labs Snapshot of the International Conformity Assessment Systemwith relationships to regional and national systems National Stds Developers NSBs, NCs, SDOs, SSOs, Consortia, etc. Regional International Accreditation Govs CA Requirements Voluntary Standards, Testing Criteria, Use Cases, Other CA Criteria Mandatory Tech Regs (inc. Laws) IAF ILAC IEC ISO MRA MLA ISO/IEC Guides 17000 – Conformity Assessment 17011 – Accreditation 17020 – Inspection Bodies 17021 – Management Systems Guide 65 – Products (17065) 17024 – Personnel 17025 – Testing Labs 14065 – Greenhouse Gas Verification 17050 – Self Declaration of Conformity CAB CASCO Liaison Members BIPM IAF IFAN IFIA IQNet ILAC IPC OIML UILI IAF-ILAC-ISO MOU Joint Working Group Systems IECQ IECEx IECEE – CB Scheme IECEE – CB-FCS Scheme IAAC SADCA PAC EA APLAC PAC MLA IAAC MLA EA MLA APLAC MRA Various National Accreditation Bodies (see separate slides 14+) Corporate Inventory/ Project Assertion 1st Party: Producer and Supplier testing, etc. 3rd Party: Independent Party testing, inspection, certification, etc. 2nd Party: Buyer testing, etc.

  3. What is Conformity Assessment? ISO/IEC 17000: “demonstration that specified requirements relating to a product, process, system, person or body are fulfilled” “NOTE…includes activities…such as testing, inspection and certification as well as the accreditation of conformity assessment bodies”

  4. Conformity Assessment’s Role Confidence Money Supplier Buyer, User Standards and Contract Standards and Technical Requirements Technical Requirements Product, Service or System Supplier's Regulation Inspection Certification Registration Declaration Testing Calibration Laboratory Laboratory Certification Accreditation Registrar Inspection Accreditation Government Accreditation Accreditation Accreditation This slide is courtesy of Underwriters Laboratories

  5. The Conformity Assessment Balance value confidence for acceptance interests for suppliers

  6. Confidence/Regulation Spectrum complete trust paperclip produce very regulated unregulated pharmaceuticals 100% inspection

  7. Certification 3rd party conformity assessment Supplier’s Declaration 1st party conformity assessment Perceived Risk Independence and Rigor of Conformity Assessment Conformity Assessment and Risk

  8. Accredited Third-Party Hierarchy(ISO/IEC 17011 standard for accreditation bodies) Accreditation bodies Assess competence1 Conformity assessment bodies Assess conformity2 Supplier Organization 1: More specifically, ABs access fulfillment of competence requirements 2: More specifically, CABs assess fulfillment of product, process, service, or personnel requirements

  9. Third Party Conformity Assessment Structure ISO/IEC 17011 Accreditation Bodies (ABs) ISO/IEC 14065 ISO/IEC 17025 ISO/IEC 17020 ISO/IEC 17021 ISO/IEC 17024 ISO/IEC Guide 65 CABs ProductCertifiers PersonnelCertifiers QMS/EMSCertifiers TestLabs InspectionBodies Greenhouse Gas Verifiers QMS/EMS (ISO 9000/ ISO 14000) Personnel Products (Procedures, Services) Buildings, Facilities, Mines, Procedures, Services, etc. Products (Procedures, Services) Greenhouse Gas Emissions

  10. 1st, 2nd, and 3rd Party Conformity Assessment • First-Party Conformity Assessment • Conformity Assessment measures completed internally by companies, suppliers or importers • Second-Party Conformity Assessment • Conformity Assessment measures completed by acceptance interests(e.g., buyers, purchasers, regulators, users) • Third-Party Conformity Assessment • Conformity Assessment measures completed by an independent party called a Conformity Assessment Body (CAB, e.g., testing laboratory, inspection body, etc.) which is accredited by another independent party called an Accreditation Body (AB). • A party qualifies as independent in that they do not possess an interest in the person or organization that provides the object for conformity assessment or any user interests in that object.

  11. 1st, 2nd, and 3rd Party Conformity Assessment • Testing • Completed by 1st, 2nd, or 3rd parties, testing occurs at the end of the design or production cycle to determine that one or more characteristics of an object comply with the appropriate technical standards and requirements. • Inspection • Completed by 1st, 2nd, or 3rd parties as a series of examinations of a product design, product, process, or installation that determines its conformity to specific requirements. • Supplier’s Declaration of Conformity (SDoC) • Procedure by which a 1st party conveys assurance that the object of conformity fulfills specified requirements. • Certification/Registration • Attestation by a 3rd party declaring that specified requirements pertaining to a product, person, process, or management system have been met. Certification also involves an element of surveillance. Under international standards, the term self-certification does not exist. • Accreditation • Statement from an independent 3rd party (Accreditation Body) declaring that specific requirements related to conformity assessment bodies have been met and that the accredited body is competent to perform certain functions. Accreditation bodies conduct evaluations based on criteria set forth in the ISO/IEC Guides.

  12. Roles in Mutual Recognition Agreements (MRAs) Regulatory Authority (RA) Government agency which develops and publishes mandatory technical regulations. Designating Authority (DA) Government entity responsible for designating competent conformity assessment bodies (CABs). Responsible for accrediting competent CABs in accordance with international standards and to the importing party’s technical requirements. Accreditation Body (AB) Responsible for testing and/or approving products in accordance to the importing party’s technical requirements. Conformity Assessment Body (CAB) Supplier Manufacturers and importers of products must ensure that they comply with all necessary requirements. Consumers are the end users of products and as a result, trust that products sold on the market are safe to own and operate. Consumer

  13. Clarification of Terms(Mutual Recognition Arrangements and Agreements) • Multilateral/Mutual Recognition Arrangementsare non-governmental commitments between accreditation bodies to accept each others accreditations, eliminating the need for CABs to be re-accredited by various national accreditation bodies, thereby reducing barriers to trade: • IAF, PAC, IAAC, and EA haveMultilateral Recognition Arrangements (MLAs) • ILAC and APLAC haveMutual Recognition Arrangements (MRAs) • Mutual Recognition Agreements/Arrangements (MRAs) are government-to-government agreements that help to facilitate trade by promoting acceptance of the results of each party’s conformity assessment procedures by allowing products to be tested in one country to another country’s technical requirements. This reduces the time it takes a product to be placed on the market, reduces costs, and increases transparency of technical regulations, laws, policies, and procedures. “Arrangements” are agreed templates for such “Agreements.”

  14. International Accreditation Organizations • International Accreditation Forum (IAF) • www.iaf.nu • World association of Accreditation Bodies in the fields of management systems, products, services, personnel and other similar programs of conformity assessment. • The list of current IAF members and MLA signatories is available at theIAF Website. • International Laboratory Accreditation Cooperation (ILAC) • www.ilac.org • An international cooperation of laboratory and inspection accreditation bodies. • The list of current ILAC members and MRA signatories is available at theILAC Website.

  15. International Accreditation Forum (IAF) MLA Signatories The mechanism by which IAF implements its objective is the IAF Multilateral Recognition Arrangement (MLA). Accreditation body members of IAF are admitted to the MLA only after a most stringent evaluation of their operations by a peer evaluation team which is charged to ensure that the applicant member complies fully with both the international standards and IAF requirements. Once an accreditation body is a member of the MLA it is required to recognize the certificates issued by certification/registration bodies accredited by all other members of the MLA. IAF has also granted Special Recognition to two Regional Accreditation Groups, the European co-operation for Accreditation (EA) and the Pacific Accreditation Cooperation (PAC), on the basis of acceptance of the mutual recognition arrangements established within these organizations. Membership of the IAF MLA is recognized as being satisfied by membership of either the EA MLA or PAC MLA and IAF members who are also signatories of these regional MLAs are automatically accepted into the IAF MLA. Special Recognition was granted to the Interamerican Accreditation Cooperation (IAAC) for Quality Management Systems. Please click here for a full list of the International Accreditation Forum (IAF) Multilateral Recognition Arrangement (MLA) Signatories.

  16. International Laboratory Accreditation Cooperation (ILAC) MRA Signatories The ILAC Arrangement supports international trade by promoting international confidence and acceptance of accredited laboratory data. Technical barriers to trade, such as retesting products each time they enter a new economy would be reduced. The aim of the ILAC Arrangement is to develop a global network of accredited testing, calibration and inspection facilities that can be relied on to provide accurate data. Each ILAC Arrangement signatory must go through an intensive evaluation carried out by peers and in accordance with the relevant rules and procedures outlined in the ISO/IEC guidance documents. The European cooperation for Accreditation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the Inter-American Accreditation Cooperation (IAAC) are the current ILAC-recognized regions with acceptable mutual recognition arrangements (MRAs) and evaluation procedures. The Southern African Development Community in Accreditation (SADCA) is currently developing their MRA evaluation processes for recognition by ILAC. Please click here for a full list of the ILAC Arrangement (MRA) Signatories.

  17. IEC Conformity Assessment Board (IEC CAB) The IEC Conformity Assessment Board (IEC-CAB), represents the IEC’s Conformity Assessment community. It sets IEC’s conformity assessment policy and oversees all IEC conformity assessment activities (IECEE, IECQ, and IECEx). The IEC has three multilateral conformity assessment systems: the IECEE, the IECQ, and the IECEx. Using IEC standards for certification at the national level ensures that a certified product has been manufactured and type-tested to well-established international standards. • IECEE: The IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components. The IECEE has two branches: • CB Scheme for mutual recognition of test certificates for electrotechnical equipment and components • CB-FCS Scheme for mutual recognition of conformity assessment certificates for electrotechnical equipment and components • IECQ: The IEC Quality Assessment System for Electronic Components • IECEx: The IEC System for Certification to Standards relating to Equipment for use in Explosive Atmospheres. • The US National Committee to the IEC (USNC) is a committee of ANSI. • The US member body to the IECEE is the National Electrical Manufacturers Association (NEMA) which works in collaboration with the USNC.

  18. IECEx: IEC System for Certification to Standards relating to Equipment for use in Explosive Atmospheres. • The IECEx has as part of its scheme an international mark.  (www.iecex.com) • Review of the program rules (next slide) can provide parties with a better understanding of what is involved with a global conformity assessment mark from an operational view. • Use of the “Ex Mark” is based on a Type 5 product certification scheme. • The Ex Mark Licensing system for IECEx and the operational documents have been produced on the basis that a full and thorough Conformity Assessment System exists to underpin the Mark Licensing system. • Thus a manufacturer can only get a Mark License if their products are covered by an IECEx Certificate through the IECEx 02 Certified Equipment Scheme, which has its own set of rules and Operational Documents.

  19. IECEx Rules The administration of the IECEx System is governed by the IECEx Rules which are available for free: (www.iecex.com/rules.htm) • IECEx 01 IEC System for Certification to Standards relating to Equipment for use in Explosive Atmospheres (IECEx System) - Basic Rules • IECEx 02 IEC Scheme for Certification to Standards relating to Equipment for use in Explosive Atmospheres (IECEx Scheme) - IECEx 02 – Equipment Certification Program covering equipment for use in explosive atmospheres - Rules of Procedure • IECEx 03 IEC Scheme for Certification to Standards relating to Equipment for use in Explosive Atmospheres (IECEx Scheme) - IECEx Certified Service Facilities Program covering repair and overhaul of Ex equipment - Rules of Procedure • IECEx 04 IEC Scheme for Certification to Standards relating to Equipment for use in Explosive Atmospheres (IECEx Scheme) - IECEx Conformity Mark Licensing System – Regulations • IECEx 04 Supplement A IECEx Guide - Guidance for making Application for and Use of IECEx Conformity Mark

  20. ISO Committee on Conformity Assessment (CASCO) ISO/CASCO is ISO’s policy development committee on conformity assessment. CASCO has a number of external liaisons with international organizations concerns with various specific aspects such as accreditation and testing. The aim underlying many of these liaisons is to promote cross-border mutual recognition arrangements (MRAs) between conformity assessment bodies, including accreditation bodies. CASCO also has a liaison with ISO’s standardization partner, the International Electrotechnical Commission (IEC). The vast majority of CASCO documents are published as joint ISO and IEC documents (guides). ANSI is the US National Standards Body member to ISO. The ANSI International Conformity Assessment Committee (ICAC) is the US mirror committee which formulates input to CASCO.

  21. Regional Accreditation Organizations • Pacific Accreditation Cooperation (PAC) • www.apec-pac.org • PAC is the APEC Specialist Regional Body for the Accreditation of certification and registration bodies. It is an association of accreditation bodies and other interested parties whose objective is to facilitate trade and commerce among economies in the Asia Pacific region (one of the five APEC-SCSC SRBs together with PASC, APLAC, APMP, APLMF). The U.S. member to PAC is ANSI. • Asia Pacific Laboratory Accreditation Cooperation (APLAC) • www.aplac.org APLAC is the APEC Specialist Regional Body for the Accreditation of laboratories, inspection bodies and reference material producers. It is a group of accreditation bodies in the Asia Pacific region responsible for accrediting calibration, testing and inspection facilities (one of the five APEC-SCSC SRBs together with PASC, PAC, APMP, APLMF). U.S. members to APLAC are: A2LA, IAS, ACLASS, National Voluntary Laboratory Accreditation Program (NVLAP-NIST), Perry Johnson Laboratories, and the Laboratory Accreditation Bureau. • InterAmerican Accreditation Cooperation (IAAC) • www.iaac-accreditation.org • An association of accreditation bodies in the Americas and other organizations interested in conformity assessment.The U.S. full members to the IAAC are: A2LA (and MLA signatory), ACLASS, ANSI-ASQ National Accreditation Board (ANAB), American Society of Crime Laboratory Directors / Laboratory Accreditation Board (ASCLD/LAB) (Associate), IAS, National Voluntary Laboratory Accreditation Program (NVLAP-NIST). The U.S. IAAC stakeholder members are: Intertek Testing Services (ITS). • European Cooperation for Accreditation (EA) • www.european-accredition.org • EA is a network of nationally recognized accreditation bodies located in the European geographical area. The U.S. testing and calibration organization, A2LA, has a contract of cooperation with the EA. • Southern African Development Community Accreditation (SADCA) • www.sadca.org • The regional accreditation structure of Standardization, Quality Assurance, Accreditation and Metrology (SQAM) tasked with defining a suitable accreditation infrastructure, enabling organizations in the SADC Member States to access accreditation services from internationally recognized National Accreditation Bodies within their countries.

  22. Pacific Accreditation Cooperation - MLA Multilateral Recognition ArrangementMembers of the who have successfully completed a peer review process for accreditation of certification bodies have signed a Multilateral Recognition Arrangement (MLA) for Quality Management Systems (QMS), Environmental Management Systems (EMS), and/or accreditation of Product Certification Bodies (Product). Under the terms of the arrangement, certification bodies accredited by PAC MLA signatories are recognized as equivalent, and users of services can have the same confidence in organizations accredited by one PAC member as in those accredited by other PAC members. For a complete list of PAC MLA signatories please click here.

  23. PAC MLA Signatories(as of Aug 2009)

  24. Asia Pacific Laboratory Accreditation Cooperation - MRA Multilateral Recognition Arrangement One of the primary aims of APLAC is to harmonize accreditation practices in the region and to extend the APLAC Mutual Recognition Arrangement (MRA). The APLAC MRA forms a regional network of laboratories and inspection bodies accredited by accreditation bodies that have been peer-evaluated and recognized as being competent. This network facilitates the acceptance of test, calibration and inspection reports in the region, thus contributing to the facilitation of trade. Currently 27 of 37 full APLAC members are signatories to the APLAC MRA for various scopes. For a full list of APALC MRA signatories and their scopes, please click here.

  25. APLAC MRA Signatories(as of Aug 2009) • PNAC (Pakistan) – testing • PAO (Philippines) – testing, calibration • AAC Analitica (Russian Federation) – testing • SAC (Singapore) – testing, calibration, inspection • TAF (Chinese Taipei) – testing, calibration, inspection • DMSc (Thailand) – testing • DSS (Thailand) - testing • TLAS (Thailand) – testing, calibration • A2LA (US) – testing, calibration, inspection • ACLASS (US) – testing, calibration • IAS (US) – testing, calibration, inspection • LAB (US) – testing, calibration • NVLAP (US) – testing, calibration • PJLA (US) – testing, calibration • BOA (Vietnam) – testing, calibration, inspection • JAS-ANZ (Australasia) - inspection • NATA (Australia) – testing, calibration, inspection • SCC (Canada) – testing, calibration • CALA (Canada) – testing • CNAS (PR China) – testing, calibration, inspection • HKAS (Hong Kong) – testing, calibration, inspection • NABL (India) – testing, calibration, inspection • KAN (Indonesia) – testing, calibration, inspection • JAB (Japan) – testing, calibration • IA Japan – testing, calibration • VLAC (Japan) – testing • KOLAS (Republic of Korea) – testing, calibration • Standards Malaysia – testing, calibration • EMA (Mexico) – testing, calibration, inspection • IANZ (New Zealand) – testing, calibration, inspection • PNAC (Pakistan) – testing, calibration

  26. InterAmerican Accreditation Cooperation - MLA Multilateral Recognition Arrangement The IAAC Multilateral Recognition Arrangement (MLA) is an agreement among accreditation bodies by which they recognize the accreditations issued by each other. By reducing the need for multiple assessments, IAAC’s MLAs facilitate international trade by encouraging regional and worldwide acceptance of valid certificates, registrations and results issued by signatory accreditation bodies. IAAC MLA Signatories are highlighted in the IAAC Members section.

  27. IAAC MLA Signatories(as of Aug 2009)

  28. European cooperation for Accreditation - MLA Multilateral Recognition Arrangement The EA MLA is an agreement signed between the EA accreditation body members to recognize the equivalence, reliability and therefore acceptance of accredited certifications, inspections, calibration certificates and test reports across Europe. The MLA eliminates the need for suppliers of products or services to be certified in each country where they sell their products or services. EA has MLAs for calibration, testing, product certification, quality systems certification, certification of persons, EMS certification, and inspection. Click here for a full list of EA MLA signatories.

  29. EA MLA Signatories(as of Aug 2009) • LA (Lithuania • NAB-MALTA (Malta) • RvA (Netherlands) • NA (Norway) • PCA (Poland) • IPAC (Portugal) • RENAR (Romania) • SNAS (Slovakia) • SA (Slovenia) • ENAC (Spain) • SWEDAC (Sweden) • SAS (Switzerland) • TURKAK (Turkey) • UKAS (United Kingdom) • BMWA (Austria) • BELAC (Belgium) • BAS (Bulgaria) • CAI (Czech Republic) • DANAK (Denmark) • EAK (Estonia) • FINAS (Finland) • COFRAC (France) • DACH, DAP, DKD, TGA (Germany) • ESYD (Greece) • INAB (Ireland) • SINAL, SINCERT, SIT (Italy) • LATAK (Latvia)

  30. EA Bilateral Agreements

  31. Common Acronyms TERMS • AB Accreditation Body • ANS American National Standard • CA Conformity Assessment • CAB Conformity Assessment Body (e.g. testing laboratory, inspection body, certification body, etc.), can be accredited by an AB • DA Designating Authority • EMS Environmental Management System • IECEE IEC System for Conformity Testing, Safety of Electrical Equipment • IECEx IEC System for Certification to Standards Relating to Equipment for use in Explosive Atmospheres • IECQ IEC Quality Assessment System for Electronic Components • MLA Multilateral Recognition Arrangement • MRA Mutual Recognition Arrangement • MRA Mutual Recognition Agreement • NC National Committee (to IEC) • NSB National Standards Body (to ISO) • QMS Quality Management System • RA Regulatory Authority • SDO Standards Developing Organization • SDoC Supplier’s Declaration of Conformity • SSO Standards Setting Organization • TBT Technical Barriers to Trade (WTO Agreement/Committee) Please click here for additional acronyms, definitions, and resources related to standards and conformity assessment.

  32. Acronyms (continued) ORGANIZATIONS • A2LA American Association for Laboratory Accreditation • ACIL American Council of Independent Laboratories • ACLASS Assured Calibration and Laboratory Accreditation Select Service • ANAB ANSI-ASQ National Accreditation Board • ANSI American National Standards Institute • AOAC Association of Official Analytical Chemists, International • APLAC Asia Pacific Laboratory Accreditation Cooperation • COPANT Pan-American Standards Commission • EA European Accreditation Cooperation • IAAC InterAmerican Accreditation Cooperation • IAF International Accreditation Forum • IAS International Accreditation Service • ICAC ANSI’s International Conformity Assessment Committee • IEC International Electrotechnical Commission • IEC-CAB IEC Conformity Assessment Board • ILAC International Laboratory Accreditation Cooperation • ISO International Organization for Standardization • ISO CASCO ISO Council Committee on Conformity Assessment • NACLA National Cooperation for Laboratory Accreditation • NCSL National Conference of Standards Laboratories • NEMA National Electrical Manufacturers Association • NFSTC National Forensic Science Technology Center • NVLAP National Voluntary Laboratory Accreditation Program • PAC Pacific Accreditation Cooperation • PASC Pacific Area Standards Congress • SADCA South African Development Community Accreditation • USNC U.S. National Committee of the IEC (Committee of ANSI)

  33. American National Standards Institute (ANSI) General Information • www.ansi.org • The American National Standards Institute (ANSI) is a private, non-profit organization that administers and coordinates the U.S. voluntary standardization and conformity assessment systems. As the voice of these system, the Institute works in close collaboration with stakeholders from industry, government and other stakeholder groups to identify consensus-based solutions to national and global priorities. • The Institute's mission is to enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems, and safeguarding their integrity. • ANSI was founded in 1918 through a public-partnership between three government agencies and five private-sector organizations. • Today ANSI’s membership is comprised of government agencies, companies, standards developing organizations (SDOs), conformity assessment bodis (CABs), academia, and other interests. ANSI represents the interests of more than 125,000 companies and 3.5 million professionals worldwide. • ANSI is the U.S. representative and dues-paying member of the two major non-treaty international standards organizations, the International Organization for Standardization (ISO), and, via the U.S. National Committee (USNC), the International Electrotechnical Commission (IEC). • ANSI is the U.S. representative of two major regional standards organizations: the Pacific Area Standards Congress (PASC) and the Pan American Standards Commission (COPANT). • ANSI is the U.S. member of the Pacific Accreditation Cooperation (PAC). The ANSI-ASQ National Accreditation Board (ANAB) is a U.S. member of the International Accreditation Forum (IAF) and the Inter-American Accreditation Cooperation (IAAC). The ANSI Federation membership also includes Accreditation Bodies which are also U.S. member bodies to various international accreditation fora. • ANSI is the sole accreditor of developers of American National Standards (ANSs).

  34. For more information: American National Standards Institute HeadquartersOperations 1819 L Street, NW25 West 43rd Street Sixth Floor Fourth Floor Washington, DC 20036 New York, NY 10036 Tel: +1 202.293.8020 Tel: +1 212.642.4900 Fax: +1 202.293.9287 Fax: +1 212.398.0023 www.ansi.org | webstore.ansi.org | www.nssn.org Please send comments or suggestions to: intl@ansi.org

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