Understanding the U.S. Standards System: A Comprehensive Overview

1. An Introductionto theAmerican National Standards Instituteand theUnited States Standards System Last update: January 2005

2. The international language of commerce is standards. Source: Former U.S. Secretary of Commerce – Donald Evans Report on Standards and Competitiveness – Removing Standards-Related Trade Barriers Through Effective Collaboration May 18, 2004

3. Standardization: A Global Community Standards Developers and Conformity Assessment Bodies Commercial and Consumer Acceptance Government Acceptance

4. The U.S. Standardization Model“One Approach Among Many in the World” • The U.S. “standardization” model includes both standards-setting and conformity assessment programs • resembles the nation’s political (federal) structure • resembles the nation’s economic structure • sector-based and driven by market needs • relies strongly on diversity and decentralization

5. Compliance and Enforcement: Factors Influencing Standardization Examples from a U.S. perspective . . . • Public opinion • Example: Publicity about faulty or dangerous products will negatively impact the market • Legal system • Example: Laws allow consumers to return faulty products • Consumers can sue producers of faulty or dangerous products • Penalties include requiring companies to recall and withdraw products from the market • Government agencies (federal, state or local) • Example: The import of unsafe products can be denied • Faulty or dangerous products can be recalled or removed from the market

6. The U.S. approach to market relevance • In the U.S. alone, there are more than 95,000 recognized standards. • These documents are being developed by • more than 450 standards developing organizations (SDOs), with the twenty largest of these organizations producing approximately 80% of the standards • at least 150 consortia • hundreds of committees addressing the technical requirements of standards

7. Examples:Current Standardization Initiatives • Homeland Security issues such as biometrics, radiation detector systems, “Safe Harbors” and others • Nanotechnology terminology and nomenclature • Federal election reform • Example: An ANSI-accredited developer is working on equipment related standards

8. Cardinal Principles of the U.S. System Due Process Consensus Openness Transparency

9. The Role of Government • In the U.S., no single government agency has control over standards. • Each government agency determines which standards meet its needs. • The agency is responsible for determining whether a private sector standard already exists that is appropriate for its needs. • If so, they will use the private sector standard. • If not, the agency is expected to work with the private sector to develop the needed standard.

10. The Role of Government • National Technology Transfer and Advancement Act (NTTAA) - 1995 (P.L. 104-113 – 1996) • Encourages federal agencies to utilize voluntary consensus standards where feasible • Encourages federal participation in voluntary consensus standards development activities • Designates NIST as “coordinator” (no budgetary or policy authority) of government standards policy activities

11. SummaryStructure of the U.S. Standardization System • ANSI • Coordinator of the Private Sector • Private sector, non-profit, membership organization • Supported by membership fees, sale of publications • NIST (National Institute of Standards and Technology) • Coordinator of Federal Agencies • Sets legal metrology standards; accredits laboratories • Standards developing organizations (SDOs) • Private trade and professional organizations, often non-profit • Many, but not all, accredited by ANSI

12. Mission 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. A Private- and Public-Sector Partnership Since 1918 ANSI is not a government agency or a standards developer.

13. A Federation of members representing . . . • Academia • Individuals • Government • Manufacturing • Trade Associations • Professional Societies • Service Organizations • Standards Developers • Consumer and Labor Interests • and many more Bringing the Private- & Public-Sectors Together

14. COMPANY MEMBER FORUM GOVERNMENT MEMBER FORUM BOARD OFDIRECTORS ORGANIZATIONAL MEMBER FORUM CONSUMER INTEREST FORUM Member Participation

15. Organization Chart

16. U.S. GOVERNMENT (PUBLIC SECTOR) U.S. PRIVATE SECTOR REGIONAL STANDARDIZATION BODIES INTERNATIONAL STANDARDIZATION BODIES U.S. DOMICILED STANDARDS DEVELOPING BODIES OTHER FOREIGN STANDARDIZATION BODIES

17. ANSI’s Roles and Responsibilities • to accredit U.S. Standards Developers, U.S. Technical Advisory Groups and conformity assessment programs • to ensure integrity of the U.S. voluntary consensus standards system • to provide regional and international access • to offer a neutral policy forum

18. ANSI as an Accreditor • ANSI accreditation, whether as a standards developer, Technical Advisory Group, or a certification program, provides an assurance of: • Openness • Balance • Due process • Transparency • Consensus

19. American National Standards (ANS) Developers • Currently there are approximately 200 ANSI-accredited standards developers* • Not all standards developed by these organizations are submitted for consideration as ANS • There are approximately 10,000 American National Standards* *Information based on year-end 2003 data.

20. Examples of U.S.Standards Organizations ANSI American National Standards Institute INCITS T1 API Accredited Standards Committee T1 - Telecommunications (Secretariat: Alliance for Telecommunications Industry Solutions) InterNational Committee forInformation Technology Standards (Secretariat: Information Technology Industry Council) American Petroleum Institute ASME International SAE ASTM International American Society of Mechanical Engineers Society of Automotive Engineers Others

21. ANS Development Cycle IDEAS COMMENTS VOTE

22. In a global marketplace, the objective of the standards development process must be a single, internationally recognized, technically valid standard that allows products to be distributed for commerce worldwide without change or modification. One Global Standard Accepted by All

23. To this end, the U.S. will . . . . Submit American National Standards for adoption as regional or International Standards Adopt International Standards as American National Standards (where they meet the needs of the user community) Ensure that U.S. positions (policy and technical) are accept- ed by international and regional standards organizations

24. A National Standards Strategy (NSS) for the United States • Confirming the importance of a market-driven, sectoral-focus • In 1998, the U.S. standardization community set about to develop its “future vision” • The result is the first-ever National Standards Strategy (NSS) for the U.S. (approved in August 2000). • Implementation is the responsibility of all U.S. interests • ANSI serves as the coordinator

25. International Organization for Standardization International Electrotechnical Commission International Telecommunications Union

26. U.S. Member Body of the ISO • International Organization for Standardization (ISO) – Geneva, Switzerland • Comprised of 146 National Standards Bodies • ANSI is one of • 5 permanent members to the Council of 18 • 4 permanent members to the Technical Management Board of 12 • ANSI and its members • participate in 80% of Technical Committees • administer 18% of TC Secretariats

27. U.S. National Committee of the IEC • International Electrotechnical Commission (IEC) – Geneva, Switzerland • Comprised of 60 National Committees (member nations) • U.S. National Committee is one of • 5 permanent members of the Council Board of 15 • 15 members of the Standardization Management Board • participates in 91% of Technical Committees • assigned Secretariats for 16% of TC Secretariats

28. U.S. Technical Advisory Groups (TAGs) • Similar to Accredited Standards Developers, U.S. TAGs are accredited by ANSI and must follow the Institute’s cardinal principles of openness, balance, due process and transparency. • ANSI sets policy for U.S. TAGs because the Institute is recognized as the official U.S. member of ISO and, through its U.S. National Committee (USNC), is the official U.S. member of IEC. • ANSI pays total dues for U.S. membership in both ISO and IEC.

29. Regional Standards Bodies • COPANT(Pan-American Standards Commission) • ANSI has membership on behalf of the U.S. • PASC(Pacific Area Standards Congress) • ANSI has membership on behalf of the U.S. • CEN(European Committee for Standardization) • ANSI has access as a liaison via the ISO/CEN Vienna Agreement • CENELEC (European Committee for Electrotechnical Standardization) • ANSI has access as a liaison via the IEC/CENELEC Dresden Agreement • ETSI (European Telecommunications Standards Institute) • U.S. companies which qualify may apply for membership

30. COPANT (Pan-American Standards Commission) • Standards setting body for Latin and South American countries • Founded as the Pan American Technical Standards Committee in 1949 to develop regional standards • Executive Secretariat is in Caracas, Venezuela • Currently 28 Active and 7 Adherent member countries • Oriented towards international standards, but develops regional technical standards when none exists at the international level

31. PASC(Pacific Area Standards Congress) • Founded in 1972 in Honolulu, Hawaii • Currently 25 members • Membership open to any country or territory bordering on the Pacific Rim whose standards organization is a member of ISO and IEC, or national organization that PASC determines is capable of making a contribution • Secretariat responsibility rotates among members • Does not set standards, rather coordinates on standards issues

32. Standards Bodies of the European Union • European Standardization Policy • Established in 1984 in the General Guidelines for Co-operation between the EU and EFTA and the European Standards bodies • Goals are to strengthen the competitiveness of European industry and to improve the functioning of the European market • “New Approach” Directives state that the European Union shall look towards the private sector to develop standards • Three organizations (CEN, CENELEC, and ETSI) now constitute the European forum for standardization • These bodies are made up of diverse parties that form more than 1,500 technical groups • Work to develop national standards within the European Union has essentially ceased

33. U.K. BSI CANADA SCC GERMANY DIN JAPAN JISC FRANCE AFNOR/UTE U.S. ANSI BRAZIL ABNT AUSTRALIA SAA Examples of National Standards Organizations

34. Characteristics of the U.S. Conformity Assessment System • Conformity assessment activities are not centrally organized • Activities are a mix of government (regulatory programs) and private sector (market-based programs) • Approaches vary among sectors

35. Conformity Assessment Goals • Promote and achieve global acceptance of products and services through conformity assessment activities for • Product certifiers • Personnel certifiers • ISO 9000 & 14000 registrars (via the ANSI/ANAB partnership) • International Accreditation Forum (IAF) • Laboratory Accreditation Working Group - National Council for Laboratory Accreditation

36. National Conformity Assessment Principles Document (NCAP) • Articulates principles for U.S. conformity assessment activities • Guidance document to be considered in conjunction with the U.S. National Standards Strategy • Improves the ability of consumers, buyers, sellers, regulators and other interested parties to have confidence in the processes of providing Certification services • Approved in 2002 • Implementation is the responsibility of all U.S. interests

37. ANSI Accreditation Programs Standards Conformity Assessment ISO/IEC Guide 65 ISO/IEC Guides 62 and 66 ISO/IEC17024 ANSI Procedures ProductCertifiers ISO 9000 / ISO 14000Certifiers PersonnelCertifiers Standards Developing Organizations and U.S. TAGs

38. ANSI as anInformation Provider • Standards development and implementation has become yet one more arena in which to compete — and excel — in order to ensure business success. • There is a price to be paid, but none so high as the cost of competing against the consensus choice of the key participants in an open standards system. • ANSI provides access to timely, relevant, and actionable information for its members and customers. Knowledge Provides Advantage

39. Web-Based Information Tools • ANSI Online (http://www.ansi.org)News and information • Standards Action for public notice • ANSI Reporter for news and editorial coverage • NSSN: A National Resource for Global Standards (http://www.nssn.org) Key-word or document number searches; bibliographic data on standards; up-to-date reports on new development projects, and much more. • Electronic Standards Store(http://webstore.ansi.org)E-commerce site for real-time electronic publication sales

40. Education & Training Services • Promote use and value of standards • Promote Strategic Standardization Management • Provide training on standardization participation, leadership, and administration

41. ANSI as a Policy Forum • Facilitate U.S. standardization policy development • Promote U.S. standardization policies globally ANSI is the bridge for standardization • between industry and government • among and within industries

42. ANSI Partnership with U.S. Governmenton Standards and Trade Issues Influence via: ANSI | U.S. Government WTO ISO and IEC FTAA COPANT APEC PASC TABD CEN/CENELEC/ETSI

43. The same guidanceapplies to all agencies • Public Law 104-113 • known as the “National Technology Transfer and Advancement Act of 1995” • Signed into law on 7 March 1996 • Guidance document is OMB Circular A-119

44. Value of ANSI Membership • Influence • ANSI Federation policies • ISO/IEC policies • WHAT standards are written WHERE • If you don’t do it, your competitors will • If the private sector does not do it, the federal Government may take the lead • Assurance of a level playing field for standards and conformity assessment programs • Access to a major source of information and expertise • Domestic and global networking opportunities

45. Benefits to Companies • Protection • The strong voice, influence and networks necessary to help ensure that standards are not written that will exclude your products, processes or technologies • Knowledge • Early awareness of new requirements • Close customer and supplier contact • Early assessment of new market directions • Positioning • Influence at the leading edges of technology

46. Benefits to Organizations • Global relevance • Self regulation • Shared costs • Reduced liability • Reduced redundancy • Market place acceptanceof standards

47. Benefits to Consumers • Greater selection • Easier choices • Better and consistent quality • Lower costs • Enhanced safety & health

48. Benefits to Government • Lower costs for procurement and regulatory agencies • Increased U.S. competitiveness, employment and economic growth • Private sector cooperation • World Trade Organization (WTO) compliance • Legislative compliance

49. 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: 202.293.8020 Tel: 212.642.4900 Fax: 202.293.9287 Fax: 212.398.0023 www.ansi.org | webstore.ansi.org | www.nssn.org