1. 1 Overview of the U.S. Standardization and Conformity Assessment Systems Overview of ANSI and the U.S. Standards System

2. 2007 © ANSI Slide 2 Overview of the U.S. Standardization and Conformity Assessment System Importance of Standards “The international language of commerce is Standards” Source: Donald L. Evans, Former U.S. Secretary of Commerce, From Standards & Competitiveness: Coordinating for Results

3. 2007 © ANSI Slide 3 Overview of the U.S. Standardization and Conformity Assessment System WTO/TBT Definitions* Standard - Document that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method. Technical Regulations – Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. Conformity Assessment (Conformance) – Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled. (e.g., testing, certification) *World Trade Organization Technical Barriers to Trade Agreement, Annex 1 http://www.wto.org/english/docs_e/legal_e/17-tbt_e.htm

4. 2007 © ANSI Slide 4 Overview of the U.S. Standardization and Conformity Assessment System WTO/TBT Principles for the Development of International Standards* Transparency Openness Impartiality and Consensus Effectiveness Coherence Development Dimension *World Trade Organization Technical Barriers to Trade Agreement Second Triennial Review, Annex 4 http://docsonline.wto.org/DDFDocuments/t/G/TBT/9.doc

5. 2007 © ANSI Slide 5 Overview of the U.S. Standardization and Conformity Assessment System The ANSI Federation

6. 2007 © ANSI Slide 6 Overview of the U.S. Standardization and Conformity Assessment System What is ANSI? ANSI is the “Umbrella Organization” for and coordinator of the U.S. voluntary standards and conformity assessment systems. Duties and responsibilities include: Develop and promote U.S. policies and positions Accredit SDOs and approve American National Standards (ANS) Accredit certifiers of products, personnel and management systems Provide standards and compliance solutions domestically and internationally

7. 2007 © ANSI Slide 7 Overview of the U.S. Standardization and Conformity Assessment System A Private- and Public-Sector Partnership Since 1918 ANSI is not a government agency or a standards developer Academia Individuals Government Manufacturing Trade Associations A Federation of members representing... Professional Societies Service Organizations Standards Developers Consumer and Labor Interests and many more What is ANSI?

8. 2007 © ANSI Slide 8 Overview of the U.S. Standardization and Conformity Assessment System ANSI: A Private-Sector Organization ANSI is an independent not-for-profit (501(c)3) organization. ANSI does not receive government oversight or subsidization. Advantages: Public and private sectors are coequal partners Impartiality Market relevance

9. 2007 © ANSI Slide 9 Overview of the U.S. Standardization and Conformity Assessment System ANSI’s Member-Driven Policy Development Approach in the U.S. Approach in many other countries Standards Users (e.g. regulators, companies, etc.) National Standards Body (e.g. ANSI, SAC) Standards Developers (Including Consortia) ANSI’s strength comes through effective representation of member interests Other National Standards Bodies receive authority and funding through legal mandate

10. 2007 © ANSI Slide 10 Overview of the U.S. Standardization and Conformity Assessment System U.S. PRIVATE SECTOR U.S.-Headquartered STANDARDS DEVELOPING ORGANIZATIONS FOREIGN NATIONAL STANDARDS BODIES (ANSI PEER BODIES) Geneva-Headquartered STANDARDS DEVELOPING ORGANIZATIONS (ISO, IEC) REGIONAL STANDARDIZATION BODIES (COPANT, PASC, ESOs) EUROPEAN COMMISSION U.S. PUBLIC SECTOR COMPANIES TRADE ASSOCIATIONS CONSUMER INTERESTS OTHERS U.S. GOVERNMENT 2007 © ANSI Slide 10

11. 2007 © ANSI Slide 11 Overview of the U.S. Standardization and Conformity Assessment System ANSI serves as the official U.S. member and sets policy for U.S. participation in the  International Organization for Standardization (ISO)  International Electrotechnical Commission (IEC)  Pacific Area Standards Congress (PASC) 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 ANSI International Interaction (Standardization) ISO / IEC ANSI & USTAGS U.S.

12. 2007 © ANSI Slide 12 Overview of the U.S. Standardization and Conformity Assessment System The U.S. Standards System

13. 2007 © ANSI Slide 13 Overview of the U.S. Standardization and Conformity Assessment System The U.S. System: Comparisons Compared with many other countries, the U.S. system… Emphasizes private-sector solutions to ensure quality and protect Environment, Health and Safety (EHS) Places a higher degree of confidence in private-sector conformity assessment activities for regulatory and non-regulatory functions Provides a stronger voice and greater authority to standards users and individual stakeholders Relies on a strong judicial system, brand-name recognition, open media and corporate social responsibility Is highly decentralized

14. 2007 © ANSI Slide 14 Overview of the U.S. Standardization and Conformity Assessment System The U.S. System: Benefits Speed and flexibility – solutions are delivered to market and implemented quickly Participation – able to accommodate input from a wide spectrum of stakeholders Efficiency – prevents unnecessary or costly regulation and allows multiple approaches to ensure health, safety, and quality The U.S. approach facilitates economic development and innovation

15. 2007 © ANSI Slide 15 Overview of the U.S. Standardization and Conformity Assessment System U.S. Regulatory Reliance on Voluntary Standards U.S. regulators use voluntary standards to offset the need for additional regulations or to enhance existing regulations. When regulations are necessary, U.S. regulators are required by law to use voluntary standards whenever possible. When appropriate voluntary standards do not exist, regulators work in partnership with private-sector SDOs to develop suitable standards.

16. 2007 © ANSI Slide 16 Overview of the U.S. Standardization and Conformity Assessment System The U.S. System: A Toolbox Rather than mandating a “one-size fits all” solution, the U.S. system allows players to find the tools and solutions that best fit their needs. Approaches, philosophies and positions often vary across industry sectors. Such variations are seen as beneficial and are promoted in the “U.S. Standards Strategy.”

17. 2007 © ANSI Slide 17 Overview of the U.S. Standardization and Conformity Assessment System Standards Used in the U.S.: Different tools for different market needs National Participation Treaty Organizations Non-Treaty Organizations Direct Participation Nationally Accepted Internationally Accepted Consortia Examples ISO, IEC, ITU, CODEX, etc. Features Formality in process One country, one vote Examples ASTM International, ASME, SAE, etc. Features Direct link between technical experts and SDOs Examples SNIA, W3C, IGRS, etc. Features Wide range of processes and procedures allows flexibility

18. 2007 © ANSI Slide 18 Overview of the U.S. Standardization and Conformity Assessment System Standards Used in the U.S.: Different tools for different market needs National Participation Treaty Organizations Non-Treaty Organizations Direct Participation Nationally Accepted Internationally Accepted Consortia Examples ISO, IEC, ITU, CODEX, etc. Features Formality in process One country, one vote Examples ASTM International, ASME, SAE, etc. Features Direct link between technical experts and SDOs Examples SNIA, W3C, IGRS, etc. Features Wide range of processes and procedures allows flexibility

19. 2007 © ANSI Slide 19 Overview of the U.S. Standardization and Conformity Assessment System Standards Used in the U.S.: National Participation Treaty Organizations: U.S. government agencies serve as national bodies. For example:  CODEX (U.S. Department of Agriculture)  ITU (U.S. Department of State)  OECD (U.S. Department of State) Non-Treaty Organizations: ANSI Serves as national body and coordinates broad spectrum of private-sector input:  International Organization for Standardization (ISO)  International Electrotechnical Commission (IEC)

20. 2007 © ANSI Slide 20 Overview of the U.S. Standardization and Conformity Assessment System Standards Used in the U.S.: Different tools for different market needs National Participation Treaty Organizations Non-Treaty Organizations Direct Participation Nationally Accepted Internationally Accepted Consortia Examples ISO, IEC, ITU, CODEX, etc. Features Formality in process through “one country, one vote” system Examples ASTM International, ASME, SAE, etc. Features Direct link between technical experts and SDOs Examples IGRS, SNIA, W3C, etc. Features Wide range of processes and procedures allows flexibility

21. 2007 © ANSI Slide 21 Overview of the U.S. Standardization and Conformity Assessment System Standards Used in the U.S.: Accredited/Approved Standards ANSI is responsible for accrediting SDOs and approving standards as “American National Standards.” National and international SDOs voluntarily choose to receive ANSI accreditation/approval (the U.S. has no legal requirement) Accreditation and approval do not guarantee U.S. market acceptance; individual users have complete freedom to choose which standards best suit their needs. ANSI accreditation and approval processes do not evaluate a standard’s technical merit, but only evaluate the process by which a standard was developed.

22. 2007 © ANSI Slide 22 Overview of the U.S. Standardization and Conformity Assessment System Accredited/Approved Standards: ANSI Essential Requirements Openness Transparency Consensus Due Process Balance

23. ANSI Accredited Standards Developing Organizations (SDOs) 3-A AGMA ASC X9ASA ACCA AH&LAAIHAAIAA ASSE BHMA AWWAAWSAWEA BICSIBOMABIFMA CSA HPS DISADASMAEIMA HFESHIIESNA IIAR NCMA ISEAISAISANTA NCSLNCPDPNECA NASPO SIA NSFNIRMAOLA SSFISIASMA TMSSPITCATOY-TIA AMCA AISC ARIATISAA AITCAISIALI ATA CCPA ACMIASISAIIM CSAACAPACLSI EASA ITSDF EIAESTAEIA IEEEIESTIIE IWCA NEMA IPCISAJCSEE NFPANGANGCMA OPCC SPRI OEOSCOPEIPMMI SBSSAESCTE TAPSTCIATPIUSDA AAMA ANS AAMVAABMAABYC ANLAAPIASNT AMT CFPMI NPESAAMIACDE CAPCPACAGI EOS/ ESD INMM FCIFMGTEEMC 12AMAIAFIAAMC KCMA NISO LIAMSSMHI NIMS NIST/ ITL NPPC PSA SMPTE PCAPWMAPMI SVIASAAMISES USPROULUAMA ABMA ASQ ACCACIADA ASAEASBASCE AHAM CGA ARMAASTMAIM CAM-ICEACSPA GICC IAPMO GEIAGEIHPVA ICPAICCITI MBC NSC NACENAHBRCNAAMM NSAANADCANERC RPTIA SDI RSTCRVIARESNA SJISSCITIA UCCVITAWQAWDMA AFPAAGA ASHRAEASME AGRSSALI CEMACTI HIBCCHL7 NETAI3A NBBPVINBFAA NAESBNALFA RIARMA TCATACI WCMAWMMA

24. 2007 © ANSI Slide 24 Overview of the U.S. Standardization and Conformity Assessment System Standards Used in the U.S.: Different tools for different market needs National Participation Treaty Organizations Non-Treaty Organizations Direct Participation Nationally Accepted Internationally Accepted Consortia Examples ISO, IEC, ITU, CODEX, etc. Features Formality in process through “one country, one vote” system Examples ASTM International, ASME, SAE, etc. Features Direct link between technical experts and SDOs Examples SNIA, W3C, IGRS, etc. Features Wide range of processes and procedures allows flexibility

25. 2007 © ANSI Slide 25 Overview of the U.S. Standardization and Conformity Assessment System Standards Used in the U.S.: Consortia Standards Consortia consist of groups of like-minded participants who place a priority on developing standards quickly enough to meet market demands or to harmonize or differentiate specifications within an industry. Hundreds of consortia organizations operate in the global economy. Many have global membership, including both U.S. and international companies. Consortia usually have a narrow focus, with some only developing a single specification. However, some consortia are very broad and develop a large number of standards (examples: W3C, OASIS, etc.) Companies often rely on consortia standards in areas where the technology changes rapidly.

26. 2007 © ANSI Slide 26 Overview of the U.S. Standardization and Conformity Assessment System The U.S. Standards System Private-Sector Activities Carried out independent of the ANSI Structure Standards Developers Trade Associations Companies Consumers NGOsAcademics Others Government U.S. Policies and Positions Government Agencies are members of ANSI and of SDOs. Agencies participate directly in voluntary standards development and policy setting and use voluntary standards when it supports their missions Government Regulators CPSC, EPA. FCC, USDA, etc. Procurement Agencies DOD, NASA, USDA, etc. NIST NIST coordinate s Federal activities in voluntary standards

27. 2007 © ANSI Slide 27 Overview of the U.S. Standardization and Conformity Assessment System The U.S. Conformity Assessment System International Activities Domestic Activities Designating Authorities Accreditors Testers, Inspectors & Certifiers SDOC A2LA FCC (Telecom) USDA (Food) ANSI (ANAB) NIST (NVLAP) EPA (ENLAP) UL Intertek TUV John Deere HP Includes accredited and non-accredited bodies IEC (IECEE, IECx, IECQ) ISO (CASCO) Other International Fora U.S. Positions developed through ANSI/USNC IAF ILAC Other ANSI ABs Other Generally manufacturers of high-tech and low- volume products No “official” U.S. representative

28. 2007 © ANSI Slide 28 Overview of the U.S. Standardization and Conformity Assessment System Conformity Assessment (ISO/IEC 17011) Inspection Bodies QMS/EMS Certifiers Personnel Certifiers Standards Developing Organizations and U.S. TAGs ANSI Procedures “Essential Requirements” Standards ISO/IE C Guide 17025 ISO/IE C Guide 17020 ISO/IE C Guide 65 ISO/IE C Guide 17021 ISO/IE C Guide 17024 Test Labs Product Certifiers Accreditation Programs Various Programs

29. 2007 © ANSI Slide 29 Overview of the U.S. Standardization and Conformity Assessment System U.S. System “The Drivers” Companies, Government Agencies and other Standards Users “The Vehicle” Standards Developers & Conformity Assessment Bodies “The Road” ANSI

30. 2007 © ANSI Slide 30 Overview of the U.S. Standardization and Conformity Assessment System For more information: Headquarters 1819 L Street, NW Sixth Floor Washington, DC 20036 Tel: +1 202.293.8020 Fax: +1 202.293.9287 www.ansi.org | webstore.ansi.org | www.nssn.org American National Standards Institute Contacts Gary Kushnier Vice President – International Policy Phone: +1.202.331.3604 E-mail: gkushnie@ansi.orggkushnie@ansi.org Steven Bipes Director – International Policy Regional & Bilateral Programs Phone: +1.202.331.3607 E-mail: sbipes@ansi.orgsbipes@ansi.org

31. 2007 © ANSI Slide 31 Overview of the U.S. Standardization and Conformity Assessment System Questions or Comments?

32. 2007 © ANSI Slide 32 Overview of the U.S. Standardization and Conformity Assessment System Additional slides

33. 2007 © ANSI Slide 33 Overview of the U.S. Standardization and Conformity Assessment System ANSI in Numbers Revenue  $25 million annual budget Development of Standards0%($0.0m) Sale of Publications50%($12.5m) Membership Dues and Fees20%($5.0m) Accreditation Services19%($4.8m) Other11%($2.7m) Est. total public sector portion of all of the above10%($2.5m) ISO/IEC Annual Dues$2.1 million Technical Committees of ANSI0 Number of Standard Developing Organizations (SDOs) accredited by ANSI208 Technical Committees of ANSI’s SDO members 565 Number ANSI Standards Panels5 Total number of American National Standards published 9,915 Estimated number of voluntary standards published in the U.S.100,000 Number of voluntary standards referenced in U.S. laws & regulationsover 6,000 Number of company interests represented by ANSI125,000 Number of professionals represented by ANSI3.5 million Year ANSI was established1918

34. Cabinet Departments DOC ANSI TA ITA NACLA APLAC ILAC APEC/ SCSC ISO PRI-Nadcap FQS-I APLMF BIPM APMP OIML IAS AIHA SSOs & Consortia without ANSI accreditation TPSC SC-S&TB IAAC IAF JTC1IEC COPANT PAC Executive Office Of the President USTR OMB Standards and Conformity Assessment Bodies of the U.S. International Regional Government Non-Government Program / Body L.A.B ASQ ANAB accredited QMS/EMS Certifiers ANSI accredited Product Certifiers ANSI accredited Personnel Certifiers SDOs with ANSI accredited procedures CAPC USNC IPC Board IEC TAGs IEC TAGs USNC IEC TAGs IEC TAGs IEC TAGs US ISO TAGs ISO/IEC Guides 62 / 66 (17021) ISO/IEC Guide 65 ISO/IEC 17024 QMS/EMS Certified Product/ Service Providers Certified Products (Processes, Services) Certified Personnel ANSs (American National Standards) US Private & Government Sectors: Organizations, Government, Companies, Trade Associations, Consumers, Educational Institutions, Individuals, Others NPC (Accreditation of Certifiers) Non-ANS Standards AIC (Accreditation of Laboratories) A2LAACLASS Accredited Laboratories Tested Products (Processes, Services) ITU Sector Members ITAC Policy Technical (Accreditation of SDOs) * Institute policy committees & councils SIM NIST State US&FCS MAC MAS FSIS Standards Liaison Laboratories / Metrology 200+ FCS Officers worldwide including 4 Regional Standards Attachés Others USDA APHIS OIE DOEDODVATreasuryDOLDOJDOIHUDHHSDOEd USDADOC FDA OSHA ES&H DSP Other Agencies NSFUSPSFCCEPANRCNASAITCGSAFTCCPSC TSP Recognition (via ISO/IEC 17011) PASC Standardization Accreditation Other iSDOs FAS (Accreditation of Certifiers) (Accreditation of Laboratories) (Metrology) (Standardization) (Standardization-Telecom) (Certification) (Testing) (Standardization) ANSI Essential Requirements ISO/IEC 17025 DHS USCO IPPC CODEX WTO SPS TBT FAO Inquiry point ICSP (Members) ITAC16 US Private Sector APEC-TEL Inquiry point (Standardization-SPS) ITU CITEL Legend PPQ ACICIP EB CIP NSBs ESOs Others Other SDOs DOT NHTSA FEMA Members IPRPC TS SSD NVCASE NVLAP NCSCI

35. 2007 © ANSI Slide 35 Overview of the U.S. Standardization and Conformity Assessment System *Documentary Standards, excluding “national participation models” Coordinates U.S. System and policy development Coordinates USG use & participation Participates in U.S. policy development Provides technical input for standards development Independently runs standards development activities* Legal metrology & TBT Inquiry Point ANSI XX Standards Developers (Including Consortia) XX Companies XX Government Agencies (regulators and procurement) XX NIST XXXX The U.S. Standards System: Who’s Who

36. 2007 © ANSI Slide 36 Overview of the U.S. Standardization and Conformity Assessment System Additional Slides on Conformity Assessment

37. 2007 © ANSI Slide 37 Overview of the U.S. Standardization and Conformity Assessment System What is Conformity Assessment? Conformity Assessment Demonstration that specified requirements relating to a product, process, system, person or body are fulfilled ISO/IEC 17000:2004 Conformity Assessment – Vocabulary and general principles

38. 2007 © ANSI Slide 38 Overview of the U.S. Standardization and Conformity Assessment System 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

39. 2007 © ANSI Slide 39 Overview of the U.S. Standardization and Conformity Assessment System Metrology and measurement capabilities Sampling Testing Inspection Declaration of conformity Certification (products, services, personnel) Management system registration/certification Accreditation (ANSI role) Enforcement Components of Conformity Assessment

40. 2007 © ANSI Slide 40 Overview of the U.S. Standardization and Conformity Assessment System Conformity Assessment System Accreditation Bodies (ABs) Testing LaboratoriesCertification BodiesInspection Bodies Products (Procedures, Services) QMS/EMS (ISO 9000 / ISO 14000) Personnel Buildings, Facilities, Mines, Procedures, Services, etc.

41. 2007 © ANSI Slide 41 Overview of the U.S. Standardization and Conformity Assessment System Key Characteristics of U.S. CA System In the United States, conformity assessment activities are not centrally organized Activities are a mix of government (regulations) and private sector (market activities) Approaches vary among sectors