Overview of the U.S. Standards and Conformity Assessment System

1. Overview of the U.S. Standards and Conformity Assessment System International Policy Department American National Standards Institute June 2009

2. Table of Contents • Importance of Standards and Conformance • The U.S. Approach to Standards and Conformance • Overview of the ANSI Federation • Overview of Conformity Assessment

3. Key Terms / Concepts StandardsMarket-drivenspecifications for a product, service, person, process or system, with which compliance is voluntary Technical RegulationsMandatoryspecifications, which may include (or reference) particular standards or conformity assessment procedures Conformity AssessmentProcesses used to verify the compliance of a product, service, person, process or system to either a standard or a regulation (examples include: testing, certification, inspection, accreditation)

4. Importance of Standards International standards harmonize cross-border requirements – opening markets for large, medium and small enterprises. The global market follows standards.

5. The U.S. Approach to Standards and Conformance

6. Top Down Bottom Up U.S. Standards and Conformity Assessment Systemcomparison with many other economies (continued) Standards bodies drive standardization activities Standards users drive standardization activities

7. U.S. Standards and Conformity Assessment SystemThe public-private partnership • No single government agency has control over standards • Each agency determines which standards meet its needs • National Technology Transfer and Advancement Act (NTTAA)(Public Law 104-113) • Encourages each government agency to seek existing private sector standards that are appropriate for its purpose and mission

8. The Role of Government Agencies • OMB Circular A-119 • The National Technology Transfer and Advancement Act(NTTAA, Public Law 104-113) • Before regulating, each government agency is required to seek and consider using existing private sector standards that are appropriate for its needs • If so, the agency will use (i.e. reference) the private sector standard • If not, the agency is expected to work with the private sector to develop the needed standards, and to reference them in its regulations • Agencies creating their own standards must report to the Administration and Congress on an annual basis the justifications for doing so • NIST has the legal responsibility of implementing the NTTAA

9. The Role of Government Agencies • Significant elements of OMB Circular A-119 and The NTTAA: • U.S. regulators and procurement officials can use any standard from any source in the world which help them meet their Congressional mandates • These standards do not need to first be transposed into American National Standards by ANSI • These directly referenced standards include ISO, IEC, SDOs • These standards may also be consortia standards • Regulators and procurement officials may make reference to applicable parts of standards – i.e. are not limited to referencing only whole standards

10. U.S. Standards and Conformity Assessment SystemReliable - Flexible - Responsive • Market driven • Flexible and sector-based • Industry-led and government-supported As defined in the United States Standards Strategy, this system is designed to . . . • Support stakeholder engagement • Address emerging priorities • Allow stakeholders to find custom-fit solutions www.us-standards-strategy.org

11. Guiding Principles of the United StatesStandardization System The U.S. endorses the globally accepted standardizationprinciples of the World Trade Organization Technical Barriers to Trade Agreement and Related Decisions

12. The WTO Principles Transparency Openness Impartiality and Consensus Effectiveness and Relevance Coherence Development Dimension

13. The U.S. is supportive of any international standard that: • is technically suitable • is used throughout a given market sector worldwide, and • was developed in accordance with the WTO principles

14. Emphasizes private-sector standards solutions Relies on private-sector compliance verification for both regulatory and non-regulatory functions Provides greater authority to standards users and stakeholders U.S. Standards and Conformity Assessment System comparison with many other economies

15. U.S. Standards SystemDifferent tools for developing globally-relevant standards .

16. The ANSI Federation

17. The American National Standards Institute facilitates voluntary consensus standards, conformity assessment and related activities in the United States.

18. ANSI’s missionis to enhance the global competitiveness of U.S. business and the American quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems and ensuring their integrity.

19. Academia Individuals Government Manufacturing Trade Associations Professional Societies Service Organizations Standards Developers Consumer and Labor Interests and many more Members of the ANSI Federation include . . . The ANSI Federation represents more than 125,000 companies and organizations and 3.5 million professionals worldwide

20. Examples of ANSI-Accredited Standards Developers and U.S. TAGs ASTM International American Society of MechanicalEngineers International Code Council American Dental Association NationalElectrical Manufacturers Association National Fire Protection Association Society of Automotive Engineers Institute of Electrical andElectronics Engineers Underwriters Laboratories Inc. American Society of Civil Engineers American Petroleum Institute And more than 200 additional organizations

21. ANSI Accredited Standards Developing Organizations (SDOs) 3-A ASC X9 ASA ACCA AMCA ARI ATIS AA AAMA AAMVA ABMA ABYC ABMA ACC ACI ADA AFPA AGA AGMA AH&LA AIHA AIAA AISC AITC AISI ALI ANS ANLA API ASNT ASQ ASAE ASB ASCE ASHRAE ASME ASSE AWWA AWS AWEA ATA ACMI ASIS AIIM AMT NPES AAMI ACDE AHAM ARMA ASTM AIM AGRSS ALI BHMA BICSI BOMA BIFMA CCPA CSAA CAPA CLSI CFPMI CAP CPA CAGI CGA CAM-I CEA CSPA CEMA CTI CSA DISA DASMA EIMA EASA EIA ESTA EIA EOS/ESD FCI FM GTEEMC GICC GEIA GEI HPVA HIBCC HL7 HPS HFES HI IESNA ITSDF IEEE IEST IIE INMM 12AMA IAF IAAMC IAPMO ICPA ICC ITI NETA I3A IIAR ISEA ISA ISANTA IWCA IPC ISA JCSEE KCMA LIA MSS MHI MBC NACE NAHBRC NAAMM NBBPVI NBFAA NCMA NCSL NCPDP NECA NEMA NFPA NGA NGCMA NISO NIMS NIST/ITL NPPC NSC NSAA NADCA NERC NAESB NALFA NASPO NSF NIRMA OLA OPCC OEOSC OPEI PMMI PSA PCA PWMA PMI RPTIA RSTC RVIA RESNA RIA RMA SIA SSFI SIA SMA SPRI SBS SAE SCTE SMPTE SVIA SAAMI SES SDI SJI SSCI TIA TCATA CI TMS SPI TCA TOY-TIA TAPS TCIA TPI USDA USPRO UL UAMA UAMA UCC VITA WQA WDMA WCMA WMMA Link to full list of ANSI accredited and non-ANSI accredited SDOs: www.nssn.org/sdoinfo.aspx

22. Structure of the U.S. Standardization System • ANSI – Coordinator of the Private Sector-led System • Responsible for coordinating U.S. private sector participation in the U.S. private sector-led / public sector-supported standards and conformance systems • The National Standards Body for the United States – Represent the U.S. in international non-governmental standards fora • An Accreditation Body for private sector programs – Represent the U.S. in international non-governmental accreditation fora • Private-sector, non-profit, membership organization • Supported by membership fees, sale of publications, funded programs, accreditation programs, and periodic government grants

23. Structure of the U.S. Standardization System • Standards Developing Organizations (SDOs) • Responsible for the development of standards for the specific technical sectors • Some, but not all, are ANSI-accredited standards developers • Can administer U.S. mirror committees to ISO and IEC • ANSI-accredited Technical Advisory Groups (TAGs) to ISO • U.S. National Committee (USNC)-approved TAGs to IEC • Private trade and professional organizations, often non-profit • Business models vary by sector

24. Structure of the U.S. Standardization System • Conformity Assessment Bodies (CABs) • Testing Laboratories, Certification Bodies, Inspection Bodies • Responsible for demonstrating compliance with standards (including those referenced by mandatory technical regulations) • Some, but not all, accredited by ANSI • Business models vary by sector (non-profit, for-profit, public sector, etc.)

25. Structure of the U.S. Standardization System • NIST – National Institute of Standards & Technology – U.S. Department of Commerce • Coordinates the activities of Federal agencies in the U.S. private sector led standards and conformance systems • National Metrology Institute for the U.S. – Represents the U.S. in international and regional metrology fora • Accreditation Body for public-sector programs – Represent the U.S. in international and regional accreditation fora • U.S. government public-sector body

26. Specifics:ANSI’s Roles and Responsibilities Internationally, Regionally, and Bilaterally

27. U.S. PUBLIC SECTOR U.S. PRIVATE SECTOR U.S. GOVERNMENT COMPANIES TRADE ASSOCIATIONS U.S.-Headquartered STANDARDS DEVELOPING ORGANIZATIONS EUROPEAN COMMISSION / APEC CONSUMER INTERESTS OTHERS REGIONAL STANDARDIZATION BODIES (COPANT, PASC, ESOs) Geneva-Headquartered INTERNATIONAL STANDARDIZATION BODIES (ISO, IEC) FOREIGN NATIONAL STANDARDS BODIES (ANSI PEER BODIES)

28. ANSI International Activities (Standardization) • ANSI serves as the official U.S. member and sets policyfor U.S. participation in the • International Organization for Standardization (ISO) • International Electrotechnical Commission (IEC) • U.S. technical positions for ISO and IEC activities are developed by Technical Advisory Groups (US TAGs) • Allows all affected parties (including U.S. government) to participate in standardization activities

29. ANSI Regional Activities (Standardization) • ANSI serves as the official U.S. member of two regional bodies • Pan American Standards Commission (COPANT) • Pacific Area Standards Congress (PASC) • The Institute has a dialogue with representatives of the European Standards Organizations (ESOs)(CEN, CENELEC and ETSI), the European Commission and EFTA • ANSI has MOUs with various countries in the Middle East to coordinate Standardization and Conformity Assessment activities ESOs

30. Overview of Conformity Assessment

31. 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”

32. U.S. Standards and Conformity Assessment Systemreliable – flexible – responsive • The National Conformity Assessment Principles (NCAP) for the United States document explains key aspects of compliance verification. The NCAP is a guidance document that can be considered in conjunction with the United States Standards Strategy (USSS). National Conformity Assessment Principles for the United States www.ansi.org/ncap

33. Conformity Assessment • Facilitates trade globally and eliminate barriers • Builds confidence and reduces risk for customers • Offers a range of tools to assist in procurement • Suppliers Declaration of Conformity (SDoC) to • Third-party testing and certification

34. Accredited 3rd-Party Hierarchy(ISO/IEC 17011 standard for accreditation bodies) Accreditation bodies Assess competence Conformity assessment bodies Audit conformity Supplier Organization

35. Components of Conformity Assessment • Metrology and measurement capabilities • Sampling • Testing • Inspection • Declaration of conformity • Certification (products, services, personnel) • Management system registration/certification • Accreditation (ANSI role) • Enforcement

36. International Recognition is Essential IAF International Accreditation Forum PAC Pacific Accreditation Cooperation EA European Accreditation Cooperation ILAC International Laboratory Accreditation Cooperation APLAC Asia-Pacific Laboratory Accreditation Cooperation IAAC Inter American Accreditation Cooperation

37. Examples of Accreditation Programsin the United States Conformity Assessment (ISO/IEC 17011) Standards Accreditation Bodies: ANSI Accreditation Bodes: A2LA ANSI-ASQ NAB IAS, L-A-B PJLA, NVLAP Accreditation Bodies: A2LA ANSI-ASQ NAB IAS Accreditation Bodies: ANSI Accreditation Bodies: A2LA ANSI IAS Accreditation Bodies: ANSI-ASQ NAB ANSI Procedures“EssentialRequirements” ISO/IEC 17025 ISO/IEC 17024 ISO/IEC 17020 ISO/IEC Guide 65 ISO/IEC 17021 ISO/IEC 14065 Greenhouse Gas Verifiers InspectionBodies PersonnelCertifiers QMS/EMSCertifiers ProductCertifiers TestLabs Standards Developing Organizations and U.S. TAGs Buildings, Facilities, Mines, Procedures, Services, etc. Green-house Gas Emissions Products (Procedures, Services) QMS/EMS (ISO 9000/ ISO 14000) Personnel Products (Procedures, Services)

38. For more information American National Standards Institute HeadquartersOperations 1819 L Street, NW 25 West 43rd Street Sixth Floor Fourth Floor Washington, DC 20036 New York, NY 10036 T: 202.293.8020 T: 212.642.4900 F: 202.293.9287 F: 212.398.0023 www.ansi.org | webstore.ansi.org | www.nssn.org Gary Kushnier Vice President, International Policy 202.331.3604 gkushnie@ansi.org