1 Overview of the U.S. Standards and Conformance Systems Steven Bipes Director – International Policy – Regional & Bilateral Programs American National Standards Institute Overview of the U.S. Standards and Conformance Systems

2007 © ANSI Slide 2 Overview of the U.S. Standards and Conformance Systems Premise Source: U.S. Secretary of Commerce – Donald Evans Report on Standards and Competitiveness – Removing Standards-Related Trade Barriers Through Effective Collaboration May 18, 2004 The international language of commerce is standards.

2007 © ANSI Slide 3 Overview of the U.S. Standards and Conformance Systems What is a Standard?

2007 © ANSI Slide 4 Overview of the U.S. Standards and Conformance Systems A Standard is a Document Standard Document established by consensus and approved by recognized body that provides for common and repeated use, rules, guidelines or characteristics for activities … ISO/IEC Guide 2:2004 Standardization and related activities – General vocabulary Voluntary Consensus Standard Conformity Assessment Procedure Technical Regulation Metrology Standard

2007 © ANSI Slide 5 Overview of the U.S. Standards and Conformance Systems Most standards are developed and used on a voluntary basis Most standards are developed by technical committees formed within the private sector Government and industry representatives participate as “equal partners” in many of these technical committees Costs are borne by the participants

2007 © ANSI Slide 6 Overview of the U.S. Standards and Conformance Systems Voluntary vs. Mandatory “Voluntary Standards” become mandatory only when:  They are incorporated into contracts; or  They are referenced or adopted by government agencies as part of a regulation to protect public health, safety, and the environment.

2007 © ANSI Slide 7 Overview of the U.S. Standards and Conformance Systems The U.S. Standardization Model A Unique Approach Among Many in the World resembles the nation’s governmental (federal) structure resembles the nation’s economic structure  sector-based and driven by market needs relies strongly on diversity and decentralization

2007 © ANSI Slide 8 Overview of the U.S. Standards and Conformance Systems ANSI – Coordinator of the Private Sector  Private sector, non-profit, membership organization  Supported by membership fees, sale of publications, funded programs and a periodic government grant Standards Developing Organizations (SDOs)  Private trade and professional organizations, often non-profit  Some, but not all, accredited by ANSI NIST (National Institute of Standards & Technology – US Department of Commerce)  Coordinates the standards activities of Federal agencies  Sets Legal Metrology Standards; Accredits Laboratories Structure of the U.S. Standardization System

2007 © ANSI Slide 9 Overview of the U.S. Standards and Conformance Systems The ANSI Federation and its Roles & Responsibilities

2007 © ANSI Slide 10 Overview of the U.S. Standards and Conformance Systems American National Standards Institute (ANSI) Founded in 1918 by five professional / technical societies and three federal government agencies From the beginning, a private- and public-sector partnership Only accreditor of U.S. standards developers Only body that approves standards as American National Standards (ANS)

2007 © ANSI Slide 11 Overview of the U.S. Standards and Conformance Systems 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 Panels4 Total number of American National Standards published as of 12/31/059,915 Estimated number of voluntary standards published in the U.S.100,000 Number of voluntary standards referenced in U.S. laws & regulationsover 3,000 Number of company interests represented by ANSI125,000 Number of professionals represented by ANSI3.5 million

2007 © ANSI Slide 12 Overview of the U.S. Standards and Conformance Systems 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 American National Standards Institute (ANSI)

2007 © ANSI Slide 13 Overview of the U.S. Standards and Conformance Systems ANSI’s Roles and Responsibilities Domestically Accreditation. ANSI Accredits:  U.S. Standards Developing Organizations (SDOs)  Certifiers of Products  Certifiers of Personnel  Certifiers of Quality and Environmental Management Systems (QMS/EMS) together with ASQ under the ANSI-ASQ National Accreditation Board (ANAB) Approves American National Standards (ANSs) Ensures integrity of the U.S. voluntary consensus standards system Protects the public’s participation in standardization activities Offers a neutral policy forum Provides a central resource for information and education on standards, conformity assessment and related activities

2007 © ANSI Slide 14 Overview of the U.S. Standards and Conformance Systems Facilitates U.S. standardization policy development Develops and promotes global standardization policies ANSI is the bridge for standardization  between industry and government  among and within industries American National Standards Institute (ANSI)

2007 © ANSI Slide 15 Overview of the U.S. Standards and Conformance Systems Institute of Electrical and Electronics Engineers IEEE American National Standards Institute ANSI Air-Conditioning and Refrigeration Institute ARI Underwriters Laboratories, Inc. UL American Society of Mechanical Engineers ASME Examples of U.S. Standards Organizations Accredited by ANSI NEMA ASTM International Approximately 200 Others U.S. Government (Federal, State and Local) National Electrical Manufacturers Association

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 Click HereClick Here online for the full list of ANSI accredited SDOs

2007 © ANSI Slide 17 Overview of the U.S. Standards and Conformance Systems The Role of Government In the U.S., no single government agency has control over standards National Institute of Standards & Technology (NIST) – Technology Administration (TA) - U.S. Department of Commerce  Coordinates the standards activities of Federal agencies  Sets Legal Metrology Standards; Accredits Laboratories International Trade Administration (ITA) – U.S. Department of Commerce  Looks at standards issues as they are implemented and the role they play in ensuring market access for international trade Each government agency determines which standards meet its needs

2007 © ANSI Slide 18 Overview of the U.S. Standards and Conformance Systems The Role of Government Agencies The National Technology Transfer and Advancement Act (NTTAA, Public Law )  Each government agency is encouraged to seek 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

2007 © ANSI Slide 19 Overview of the U.S. Standards and Conformance Systems ANSI’s Roles and Responsibilities Internationally, Regionally, and Bilaterally

U.S. PRIVATE SECTOR U.S.-Headquartered STANDARDS DEVELOPING ORGANIZATIONS FOREIGN NATIONAL STANDARDS BODIES (ANSI PEER BODIES) Geneva-Headquartered INTERNATIONAL STANDARDIZATION BODIES (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 21 Overview of the U.S. Standards and Conformance Systems 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) 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)

2007 © ANSI Slide 22 Overview of the U.S. Standards and Conformance Systems ESOs 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) and the European Commission ANSI Regional Interaction (Standardization)

2007 © ANSI Slide 23 Overview of the U.S. Standards and Conformance Systems The United States is highly engaged in Asia Pacific Standards and conformance activities: ANSI is the official U.S. member of the Pacific Area Standards Congress (PASC) and the Pacific Accreditation Cooperation (PAC) The U.S. is also represented in other Asia Pacific Specialist Regional Bodies (SRBs) The five APEC-SCSC recognized Specialist Regional Bodies (SRBs) are:  Pacific Area Standards Congress (PASC) Pacific Area Standards Congress (PASC)  Pacific Accreditation Cooperation (PAC) Pacific Accreditation Cooperation (PAC)  Asia Pacific Laboratory Accreditation Cooperation (APLAC) Asia Pacific Laboratory Accreditation Cooperation (APLAC)  Asia-Pacific Legal Metrology Forum (APLMF) Asia-Pacific Legal Metrology Forum (APLMF)  Asia-Pacific Metrology Programme (APMP) Asia-Pacific Metrology Programme (APMP) The SRBs provide critical specialized support to the APEC Committee for Trade and Investment (CTI) – Subcommittee on Standards and Conformance (SCSC) ANSI, PASC, the other SRBs and the SCSC are working closely with the APEC Business Advisory Council (ABAC) to facilitate trade and provide critical infrastructure in the Asia Pacific region in standards and conformance Many ANSI members and accredited SDOs currently engaged in specific technical cooperation activities with partners in the region ANSI Regional Interaction (Asia Pacific)

2007 © ANSI Slide 24 Overview of the U.S. Standards and Conformance Systems PASC is one of five Specialist Regional Bodies (SRBs) which are recognized by APEC as having specialized expertise in the areas of:  Standardization (PASC)  Accreditation (PAC, APLAC)  Metrology (APMP, APLMF) The five Asia Pacific SRBs are:  Pacific Area Standards Congress (PASC)PASC  Pacific Area Cooperation (PAC)PAC  Asia Pacific Laboratory Accreditation Cooperation (APLAC)APLAC  Asia-Pacific Legal Metrology Forum (APLMF)APLMF  Asia-Pacific Metrology Programme (APMP)APMP The SRBs provide critical specialized support to the APEC Committee for Trade and Investment (CTI) – Subcommittee on Standards and Conformance (SCSC) The SCSC is composed of the government trade representatives of the APEC region who meet to ensure that standards and conformance issues do not create technical barriers PASC, together with the other SRBs and the SCSC, are working closely with the APEC Business Advisory Council (ABAC) to facilitate trade and provide critical infrastructure in the Asia Pacific region in the area of standards and conformance PASC-APEC-SRB Relationships

2007 © ANSI Slide 25 Overview of the U.S. Standards and Conformance Systems PASC (and APEC) Membership PASC PAC APLAC APLMF APMP

2007 © ANSI Slide 26 Overview of the U.S. Standards and Conformance Systems The United States is engaged in standards and conformance activities in the Americas: ANSI is the official U.S. member of the Pan American Standards Commission (COPANT) and a full member of the InterAmerican Accreditation Cooperation (IAAC) The U.S. is also represented in the InterAmerican Metrology System (SIM) by NIST The three Specialist Regional Bodies (SRBs) of the Americas are:  Pan American Standards Commission (COPANT) Pan American Standards Commission (COPANT)  InterAmerican Accreditation Cooperation (IAAC) InterAmerican Accreditation Cooperation (IAAC)  InterAmerican Metrology System (SIM) InterAmerican Metrology System (SIM) The SRBs provide specialized support in the areas of standardization, accreditation and metrology in the Americas Many ANSI members and accredited SDOs currently engaged in specific technical cooperation activities with partners in the region ANSI Regional Interaction (Americas)

2007 © ANSI Slide 27 Overview of the U.S. Standards and Conformance Systems European Standards Organizations (ESOs) CEN, CENELEC, and ETSI are the European counterparts to the ISO, IEC, and ITU-T and are known collectively as the European Standards Organizations (ESOs) The ESO’s are composed of the national standards bodies of Europe CEN the European Committee for Standardization, produces European standards in all areas except for electrotechnical and telecommunications CENELEC the European Committee for Electrotechnical Standardization, works to produce a single set of harmonized electrotechnical standards in Europe ETSI the European Telecommunications Standards Institute, determines and produces European telecommunications standards ANSI interacts with the ESOs in various ways, including holding 19 ANSI- ESO dialogues since In 2005, ANSI began holding smaller delegation meetings with the ESO’s Joint Presidents Group (JPG).

2007 © ANSI Slide 28 Overview of the U.S. Standards and Conformance Systems Current Issues Interoperability Reconciling differing US-EU policy approaches to government regulation and private sector standardization Examining differing regional approaches to international standardization, especially with technical assistance programs in developing countries like China Intellectual Property Rights / Digital Rights Management (IPR/DRM) Visibility regarding the value of standards with Industry/Government Executives Global Relevance European Standards Organizations (ESOs)

2007 © ANSI Slide 29 Overview of the U.S. Standards and Conformance Systems ANSI – ESO Interaction Ongoing interaction 20 dialogues since 1989 February 2007, EC-CEN Biofuels Conference November 7, 2007, ANSI meeting with ESO Joint Presidents Group (JPG) and European Commission – Brussels February 6-7, 2008, CEN/CENELEC/ETSI/ANSI Interoperability Conference – Warsaw, Poland European Standards Organizations (ESOs)

2007 © ANSI Slide 30 Overview of the U.S. Standards and Conformance Systems The United States Standards Strategy (USSS)

2007 © ANSI Slide 31 Overview of the U.S. Standards and Conformance Systems USSS - Highlights Strategy contains 12 initiatives focused on:  Participation of government  Importance of health, safety and the environment  Responsiveness to consumer interests, balance  Globally accepted principles for standards development  Government use of standards to meet regulatory needs  Preventing the use of standards as technical barriers to trade

2007 © ANSI Slide 32 Overview of the U.S. Standards and Conformance Systems USSS - Highlights 12 initiatives (continued):  Outreach to promote consensus-based, market-driven processes – in the U.S. and internationally  Efficiency in development and distribution of standards  Cooperation and coherence within the U.S. system  Standards education as a high priority  Stable funding models for the U.S. system  Emerging national priorities and converging/cross-cutting technologies

2007 © ANSI Slide 33 Overview of the U.S. Standards and Conformance Systems Globalization & The Growing Impact of International Standards on Trade

2007 © ANSI Slide 34 Overview of the U.S. Standards and Conformance Systems Internationally Accepted Standards and Conformity Assessment Principles Transparency Openness Due Process Consensus Agreed to by...Agreed to by... WTOWTO ISOISO IECIEC ANSIANSI ANSI Accredited SDOsANSI Accredited SDOs

2007 © ANSI Slide 35 Overview of the U.S. Standards and Conformance Systems Roughly 80 percent of global merchandise trade is affected by standards and by regulations that embody standards. Source: National Institute of Standards and Technology Testimony before the U.S. House of Representatives – Committee on Science, Subcommittee on Technology September 13, 2000

2007 © ANSI Slide 36 Overview of the U.S. Standards and Conformance Systems Objective One Standard : One Test : One Acceptance ( 1:1:1) In a global marketplace, the objective of the standardization process must be a single, technically valid and globally relevant standard with a single test of conformance to that standard. This will allow products to be distributed for worldwide commerce without change or modification. One Standard – One Test – One Acceptance

2007 © ANSI Slide 37 Overview of the U.S. Standards and Conformance Systems Increasing use and adoption of international standards Increasing implementation of governmental regulations that reference voluntary consensus standards and conformity assessment programs Increasing participation in international and regional standards development and conformity assessment activities by all stakeholders (government, industry, local standards developers, and consumers) Increasing standards development in accordance with the WTO-TBT criteria: Transparency, Openness, Consensus, Due Process Standards and conformity assessment programs increasingly globally relevant, responsive to real world needs, and performance-based Global Impact to Trade – Trends

2007 © ANSI Slide 38 Overview of the U.S. Standards and Conformance Systems Conformity Assessment

2007 © ANSI Slide 39 Overview of the U.S. Standards and Conformance Systems 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

2007 © ANSI Slide 40 Overview of the U.S. Standards and Conformance Systems 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

2007 © ANSI Slide 41 Overview of the U.S. Standards and Conformance Systems Metrology and measurement capabilities Sampling Testing Inspection Declaration of conformity Certification (products, services, personnel) Management system registration/certification Accreditation Enforcement Components of Conformity Assessment

2007 © ANSI Slide 42 Overview of the U.S. Standards and Conformance Systems 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.

2007 © ANSI Slide 43 Overview of the U.S. Standards and Conformance Systems 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

2007 © ANSI Slide 44 Overview of the U.S. Standards and Conformance Systems U.S. System is complex and uses private-public sector partnership that insures industry sector input and supported by Federal legislation Conformity Assessment system, like Standards system, evolved in decentralized manner Conformity Assessment ranges from Self Declaration of Conformity (SDoC) to 3 rd -party review (accreditation) Is generally effective, open, and transparent Designed to provide more confidence in the quality of the product, service, or system by consumers, the public, and employers Conformity Assessment - Summary

2007 © ANSI Slide 45 Overview of the U.S. Standards and Conformance Systems For more information: Gary Kushnier, Vice President of International Policy Steven Cornish, Director – International Policy – ISO Charlie Zegers, Director – International Policy – IEC Steven Bipes, Director – International Policy – Regional & Bilateral Programs Bridgette Dziedzic – Program Administrator – Regional & Bilateral Programs Elise Owen, China Policy – ANSI Representative for Priority Markets (China, India) ANSI International Policy Department Contacts

2007 © ANSI Slide 46 Overview of the U.S. Standards and Conformance Systems For more information: Headquarters 1819 L Street, NW Sixth Floor Washington, DC Tel: Fax: | webstore.ansi.org | American National Standards Institute Contacts Gary Kushnier Vice President – International Policy Phone: Steven Bipes Director – International Policy Regional & Bilateral Programs Phone: