Overview of the U S Standards and Conformance

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

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

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

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 Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 4

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

Voluntary vs. Mandatory n “Voluntary Standards” become mandatory only when: Ø Ø 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. Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 6

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

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

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

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

ANSI in Numbers n Revenue Ø $25 million annual budget l l l n n n n n Development of Standards 0% Sale of Publications 50% ($12. 5 m) Membership Dues and Fees 20% Accreditation Services 19% ($4. 8 m) Other 11% ($2. 7 m) Est. total public sector portion of all of the above ($0. 0 m) ($5. 0 m) 10% ($2. 5 m) ISO/IEC Annual Dues $2. 1 million Technical Committees of ANSI 0 Number of Standard Developing Organizations (SDOs) accredited by ANSI 208 Technical Committees of ANSI’s SDO members 565 Number ANSI Standards Panels 5 Total number of American National Standards published as of 12/31/05 Estimated number of voluntary standards published in the U. S. 100, 000 Number of voluntary standards referenced in U. S. laws & regulations 6, 000 Number of company interests represented by ANSI 125, 000 Number of professionals represented by ANSI 3. 5 million Overview of the U. S. Standards and Conformance Systems 9, 915 over 2007 © ANSI Slide 11

American National Standards Institute (ANSI) A Federation of members representing. . . • • • Academia Individuals Government Manufacturing Trade Associations • • • Professional Societies Service Organizations Standards Developers Consumer and Labor Interests and many more A Private- and Public-Sector Partnership Since 1918 ANSI is not a government agency or a standards developer Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 12

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

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

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

ANSI Accredited Standards Developing Organizations (SDOs) 3 -A ASC X 9 ASA ACCA AMCA ARI ATIS AA AAMVA ABMA ABYC ABMA ACC ACI ADA AFPA 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 HL 7 HPS HFES HI IESNA ITSDF IEEE IEST IIE INMM 12 AMA IAF IAAMC IAPMO ICPA ICC ITI NETA I 3 A IIAR ISEA ISANTA IWCA IPC ISA JCSEE KCMA LIA MSS MHI MBC NACE NAHBRC NAAMM NBBPVI NBFAA NCMA NCSL NCPDP NECA NEMA NFPA NGCMA NISO NIMS NIST/ ITL NPPC 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 UCC VITA WQA WDMA WCMA WMMA Click Here online for the full list of ANSI accredited SDOs

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

The Role of Government Agencies n The National Technology Transfer and Advancement Act (NTTAA, Public Law 104 -113) Ø Each government agency is encouraged to seek existing private sector standards that are appropriate for its needs Ø If so, the agency will use (i. e. reference) the private sector standard Ø If not, the agency is expected to work with the private sector to develop the needed standards, and to reference them in its regulations Ø Agencies creating their own standards must report to the Administration and Congress on an annual basis the justifications for doing so Ø NIST has the legal responsibility of implementing the NTTAA Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 18

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

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

ANSI International Interaction (Standardization) n ANSI serves as the official U. S. member and sets policy for U. S. participation in the Ø International Organization for Standardization (ISO) Ø International Electrotechnical Commission (IEC) n U. S. technical positions for ISO and IEC activities are developed by Technical Advisory Groups (US TAGs) Ø Allows all affected parties (including U. S. government) to participate in standardization activities Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 21

ANSI Regional Interaction (Standardization) n ANSI serves as the official U. S. member of two regional bodies Ø Ø n 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 Overview of the U. S. Standards and Conformance Systems ESOs 2007 © ANSI Slide 22

Pacific Area Standards Congress (PASC) Members n n n Australia (SAI) Brunei Darussalam (CPRU) Canada (SCC) China (SAC) Colombia (ICONTEC) Fiji (FTSQCO) Hong Kong – China (ITCHSKAR) Indonesia (BSN) Japan (JISC) Republic of Korea (KATS) Malaysia (DSM) n n n n n Mexico (DGN) Mongolia (MASM) New Zealand (SNZ) Papua New Guinea (NISIT) Philippines (BPS) Singapore (SPRING SG) South Africa (SABS) Thailand (TISI) USA (ANSI) Vietnam (STAMEQ/TCVN) ACCSQ economies not in PASC n Cambodia (ISC), Laos (DISM), Myanmar (MSTRD) Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 23

ANSI Regional Interaction (Asia Pacific) The United States is highly engaged in Asia Pacific Standards and conformance activities: n ANSI is the official U. S. member of the Pacific Area Standards Congress (PASC) and the Pacific Accreditation Cooperation (PAC) n The U. S. is also represented in other Asia Pacific Specialist Regional Bodies (SRBs) n The five APEC-SCSC recognized Specialist Regional Bodies (SRBs) are: Ø Ø Ø Pacific Area Standards Congress (PASC) Pacific Accreditation Cooperation (PAC) Asia Pacific Laboratory Accreditation Cooperation (APLAC) Asia-Pacific Legal Metrology Forum (APLMF) Asia-Pacific Metrology Programme (APMP) n The SRBs provide critical specialized support to the APEC Committee for Trade and Investment (CTI) – Subcommittee on Standards and Conformance (SCSC) n 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 n Many ANSI members and accredited SDOs currently engaged in specific technical cooperation activities with partners in the region Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 24

APEC Specialist Regional Bodies (SRBs) Specialist Regional Body (SRB) Australia APLMF APMP PASC PAC APLAC Legal Metrology www. aplmf. org Economies Measurement Standards www. apmpweb. org Standards www. pascnet. org Accreditation (of Certifiers) www. apec-pac. org Accreditation (of Laboratories) www. aplac. org NMIA, ARPANSA, ANSTO SA JAS-ANZ NATA Brunei Darussalam Min of Dev. CPRN Canada Meas. Cmt. SCC Chile Min of Ecn. INN People's Republic of China Min of Dev. SCC ACCSQ NIM SAC CNAS Hong Kong, China C&ED HKSCL, GL ITCHSKAR HKAS Indonesia DOM KIM-LIPI BSN KAN Japan NMIJ/AIST, NICT, CERI JISC JAB, JASC JAB, IAJAPAN, JCLA, VLAC Republic of Korea KATS KRISS KATS KAB, KAS KOLAS Min of Trd, SIRIM- Berhad, MINT DSM SM DGN EMA Malaysia Mexico New Zealand Papua New Guinea Peru Philippines Russian Federation Singapore Chinese Taipei Thailand United States Viet Nam DGN, CENAM MAPSS MSL, IR SNZ IANZ NISIT INDECOPI ITDI BPS VNIIM GOST R SPRING BSMI CMS, ITRI, INER CBWM NIMT, DSS, TISTR STAMEQ VMI PAB SAC TAF TISI NAC BLA-DSSITISI ANSI NIST, NCWM PAO ANSI A 2 LA, ACLASS, IAS, NVLAP, PJL, L-A-B STAMEQ BOA

APEC Specialist Regional Bodies (SRBs) Specialist Regional Body (SRB) Economies APLMF APMP PASC Legal Metrology www. aplmf. org Measurement Standards www. apmpweb. org Standards www. pascnet. org PAC APLAC Accreditation (of Certifiers) www. apec-pac. org Accreditation (of Laboratories) www. aplac. org NABCB NABL OTHER ECOOMIES INVOLVED IN VARIOUS SRBs Bangladesh BSTI Cambodia DOM Colombia SIC Egypt ICONTEC NIS Fiji DTCI NPLI, BARC India FTSQCO BIS Iran IAS Jordan JNMI DPR of Korea SAQM Laos DISM Mongolia MASM CIQM MASM Myanmar Nepal NBSM Pakistan NPSL South Africa NML/CSIR Sri Lanka MUSSD Syria NSCL Legend Member Associate Member Not a Member PNAC SABS SLABCA

ANSI Regional Interaction (Americas) The United States is engaged in standards and conformance activities in the Americas: n ANSI is the official U. S. member of the Pan American Standards Commission (COPANT) and a full member of the Inter. American Accreditation Cooperation (IAAC) n The U. S. is also represented in the Inter. American Metrology System (SIM) by NIST n The three Specialist Regional Bodies (SRBs) of the Americas are: Ø Ø Ø Pan American Standards Commission (COPANT) Inter. American Accreditation Cooperation (IAAC) Inter. American Metrology System (SIM) n The SRBs provide specialized support in the areas of standardization, accreditation and metrology in the Americas n Many ANSI members and accredited SDOs currently engaged in specific technical cooperation activities with partners in the region Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 27

European Standards Organizations (ESOs) n 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) n The ESO’s are composed of the national standards bodies of Europe n CEN the European Committee for Standardization, produces European standards in all areas except for electrotechnical and telecommunications n CENELEC the European Committee for Electrotechnical Standardization, works to produce a single set of harmonized electrotechnical standards in Europe n ETSI the European Telecommunications Standards Institute, determines and produces European telecommunications standards n ANSI interacts with the ESOs in various ways, including holding 20 ANSIESO dialogues since 1989. In 2005, ANSI began holding smaller delegation meetings with the ESO’s Joint Presidents Group (JPG). Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 28

European Standards Organizations (ESOs) Current Issues n Interoperability n Reconciling differing US-EU policy approaches to government regulation and private sector standardization n Examining differing regional approaches to international standardization, especially with technical assistance programs in developing countries like China n Intellectual Property Rights / Digital Rights Management (IPR/DRM) n Visibility regarding the value of standards with Industry/Government Executives n Global Relevance Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 29

Internationally Accepted Standards and Conformity Assessment Principles • Agreed to by. . . • WTO • ISO • IEC • ANSI Due Process • ANSI Accredited SDOs Consensus Openness Transparency Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 30

The United States Standards Strategy (USSS) Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 31

USSS - Highlights n Strategy contains 12 initiatives focused on: Ø Ø Ø 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 Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 32

USSS - Highlights n 12 initiatives (continued): Ø Ø Ø 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 Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 33

Globalization & The Growing Impact of International Standards on Trade Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 34

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 Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 35

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 Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 36

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

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

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

Conformity Assessment n Facilitates trade globally and eliminate barriers n Builds confidence and reduces risk for customers n Offers a range of tools to assist in procurement Ø Ø Suppliers Declaration of Conformity (SDo. C) to Third-party testing and certification Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 40

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

Conformity Assessment System Accreditation Bodies (ABs) Certification Bodies Testing Laboratories Products (Procedures, Services) QMS/EMS (ISO 9000 / ISO 14000) Personnel Inspection Bodies Buildings, Facilities, Mines, Procedures, Services, etc. Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 42

Accreditation Programs Standards Conformity Assessment (ISO/IEC 17011) Various Programs ISO/IE ISO/IE C C C Guide Guide 17025 17020 65 17021 17024 Test Labs Inspection Bodies Product Certifiers QMS/EMS Certifiers Personnel Certifiers Overview of the U. S. Standards and Conformance Systems ANSI Procedures “Essential Requirements” Standards Developing Organizations and U. S. TAGs 2007 © ANSI Slide 43

Key Characteristics of U. S. CA System n In the United States, conformity assessment activities are not centrally organized n Activities are a mix of government (regulations) and private sector (market activities) n Approaches vary among sectors Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 44

Conformity Assessment - Summary n U. S. System is complex and uses private-public sector partnership that insures industry sector input and supported by Federal legislation n Conformity Assessment system, like Standards system, evolved in decentralized manner n Conformity Assessment ranges from Self Declaration of Conformity (SDo. C) to 3 rd-party review (accreditation) n Is generally effective, open, and transparent n Designed to provide more confidence in the quality of the product, service, or system by consumers, the public, and employers Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 45

For more information: American National Standards Institute Headquarters 1819 L Street, NW Sixth Floor Washington, DC 20036 Tel: +1 202. 293. 8020 Fax: +1 202. 293. 9287 Contacts n Steven Bipes Director – International Policy Regional & Bilateral Programs Phone: +1. 202. 331. 3607 E-mail: sbipes@ansi. org www. ansi. org | webstore. ansi. org | www. nssn. org Overview of the U. S. Standards and Conformance Systems 2007 © ANSI Slide 46