Overview of ANSI and the U S Standards

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

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 Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 2

WTO/TBT Definitions* n 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. n 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. n 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 Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 3

WTO/TBT Principles for the Development of International Standards* n n n 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 Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 4

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

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: n Develop and promote U. S. policies and positions n Accredit SDOs and approve American National Standards (ANS) n Accredit certifiers of products, personnel and management systems n Provide standards and compliance solutions domestically and internationally Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 6

What is 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. Standardization and Conformity Assessment System 2007 © ANSI Slide 7

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: n Public and private sectors are coequal partners n Impartiality n Market relevance Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 8

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

U. S. PUBLIC SECTOR U. S. PRIVATE 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 STANDARDS DEVELOPING ORGANIZATIONS (ISO, IEC) Overview of the U. S. Standardization and Conformity Assessment System REGIONAL STANDARDIZATION BODIES (COPANT, PASC, ESOs) 2007 © ANSI Slide 10

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) Ø Pacific Area Standards Congress (PASC) 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 U. S. ANSI & USTAGS ISO / IEC Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 11

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

The U. S. System: Comparisons Compared with many other countries, the U. S. system… n n n 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 Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 13

The U. S. System: Benefits n n n 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 Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 14

U. S. Regulatory Reliance on Voluntary Standards n n n 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. Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 15

The U. S. System: A Toolbox n n 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. ” Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 16

Standards Used in the U. S. : Different tools for different market needs National Participation • Treaty Organizations • Non-Treaty Organizations Direct Participation Consortia • Nationally Accepted • Internationally Accepted Examples ISO, IEC, ITU, CODEX, etc. Examples ASTM International, ASME, SAE, etc. Examples SNIA, W 3 C, IGRS, etc. Features Formality in process One country, one vote Features Direct link between technical experts and SDOs Features Wide range of processes and procedures allows flexibility Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 17

Standards Used in the U. S. : Different tools for different market needs National Participation • Treaty Organizations • Non-Treaty Organizations Direct Participation Consortia • Nationally Accepted • Internationally Accepted Examples ISO, IEC, ITU, CODEX, etc. Examples ASTM International, ASME, SAE, etc. Examples SNIA, W 3 C, IGRS, etc. Features Formality in process One country, one vote Features Direct link between technical experts and SDOs Features Wide range of processes and procedures allows flexibility Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 18

Standards Used in the U. S. : National Participation n Treaty Organizations: U. S. government agencies serve as national bodies. For example: Ø Ø Ø n 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: Ø Ø International Organization for Standardization (ISO) International Electrotechnical Commission (IEC) Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 19

Standards Used in the U. S. : Different tools for different market needs National Participation • Treaty Organizations • Non-Treaty Organizations Direct Participation Consortia • Nationally Accepted • Internationally Accepted Examples ISO, IEC, ITU, CODEX, etc. Examples ASTM International, ASME, SAE, etc. Examples IGRS, SNIA, W 3 C, etc. Features Formality in process through “one country, one vote” system Features Direct link between technical experts and SDOs Features Wide range of processes and procedures allows flexibility Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 20

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

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

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

Standards Used in the U. S. : Different tools for different market needs National Participation • Treaty Organizations • Non-Treaty Organizations Direct Participation Consortia • Nationally Accepted • Internationally Accepted Examples ISO, IEC, ITU, CODEX, etc. Examples ASTM International, ASME, SAE, etc. Examples SNIA, W 3 C, IGRS, etc. Features Formality in process through “one country, one vote” system Features Direct link between technical experts and SDOs Features Wide range of processes and procedures allows flexibility Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 24

Standards Used in the U. S. : Consortia Standards n 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. n Hundreds of consortia organizations operate in the global economy. Many have global membership, including both U. S. and international companies. n 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: W 3 C, OASIS, etc. ) n Companies often rely on consortia standards in areas where the technology changes rapidly. Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 25

The U. S. Standards System Government Private-Sector Regulators NIST coordinates Federal activities in voluntary standards CPSC, EPA. FCC, USDA, etc. Standards Developers Companies NGOs Consumers Government Academics Trade Associations Others NIST Procurement Agencies DOD, NASA, USDA, etc. Activities Carried out independent of the ANSI Structure 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 U. S. Policies and Positions Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 26

The U. S. Conformity Assessment System International Activities Domestic Activities IEC (IECEE, IECx, IECQ) ISO (CASCO) Designating Authorities Accreditors Testers, Inspectors & Certifiers ANSI (ANAB) UL A 2 LA U. S. Positions developed through ANSI/USNC IAF ANSI ILAC ABs Other No “official” U. S. representative Intertek TUV FCC (Telecom) NIST (NVLAP) Other International Fora USDA (Food) SDOC EPA (ENLAP) John Deere HP Includes accredited and non-accredited bodies Generally manufacturers of high-tech and lowvolume products Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 27

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. Standardization and Conformity Assessment System ANSI Procedures “Essential Requirements” Standards Developing Organizations and U. S. TAGs 2007 © ANSI Slide 28

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

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 Gary Kushnier Vice President – International Policy Phone: +1. 202. 331. 3604 E-mail: gkushnie@ansi. org 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. Standardization and Conformity Assessment System 2007 © ANSI Slide 30

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

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

ANSI in Numbers n Revenue Ø $25 million annual budget l l l 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 9, 915 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 Year ANSI was established 1918 Overview of the U. S. Standardization and Conformity Assessment System over 2007 © ANSI Slide 33

Standards and Conformity Assessment Bodies of the U. S. APMP IAAC TS SSD NVCASE ITAC 16 ANAB accredited QMS/EMS Certifiers ANSI accredited Product Certifiers ANSI accredited Personnel Certifiers SDOs with ANSI accredited procedures SSOs & Consortia without ANSI accreditation Certified Personnel ANSs (American National Standards) Non-ANS Standards Certified Products (Processes, Services) IPRPC USNC Technical US IEC ISO TAGs USNC IEC IEC TAGs Board Members US Private & Government Sectors: Organizations, Government, Companies, Trade Associations, Consumers, Educational Institutions, Individuals, Others ITU Sector Members Executive Office Of the President Other Agencies Regional International Government USPS DHS FEMA VA Treasury DOT NHTSA EB CIP State DOL OSHA DOJ DOI HUD Legend NSF ITU TPSC SC-S&TB ITAC ACICIP NRC CITEL APEC/ SCSC (Members) TSP OIE Other SDOs ICSP NASA APEC-TEL FDA HHS NPC ANSI ITC IPPC PPQ DOEd DOE ES&H DSP DOD Essential Requirements GSA USCO (Standardization-Telecom) Cabinet Departments USDA IPC ISO/IEC 17024 FCC FAS DOC CAPC ISO/IEC Guide 65 FTC FAO CODEX USDA APHIS Policy (Accreditation of SDOs) ISO/IEC Guides 62 / 66 (17021) QMS/EMS Certified Product/ Service Providers IEC (Standardization-SPS) Inquiry point FSIS JTC 1 Standardization Others Tested Products (Processes, Services) TBT SPS A 2 LA (Testing) US Private Sector Inquiry point WTO ACLASS Accredited Laboratories NCSCI ISO * Institute policy committees & councils ISO/IEC 17025 NVLAP Others ESOs (Accreditation of Certifiers) OMB US&FCS 200+ FCS Officers worldwide including 4 Regional Standards Attachés Other i. SDOs AIC (Certification) MAC ASQ L. A. B MAS IAS Laboratories / Metrology AIHA NIST Standards Liaison FQS-I TA PRI-Nadcap ITA NACLA NSBs ANSI Accreditation (Accreditation of Laboratories) DOC PASC IAF EPA SIM ILAC APLAC BIPM COPANT CPSC OIML (Standardization) PAC USTR APLMF (Accreditation of Certifiers) Recognition (via ISO/IEC 17011) (Standardization) (Accreditation of Laboratories) (Metrology) Non-Government Program / Body

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

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

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. Standardization and Conformity Assessment System 2007 © ANSI Slide 37

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. Standardization and Conformity Assessment System 2007 © ANSI Slide 38

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 (ANSI role) Enforcement Overview of the U. S. Standardization and Conformity Assessment System 2007 © ANSI Slide 39

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. Standardization and Conformity Assessment System 2007 © ANSI Slide 40

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. Standardization and Conformity Assessment System 2007 © ANSI Slide 41