1 2010 Overview of the U.S. Standards and Conformity Assessment System.

1 2010 Overview of the U.S. Standards and Conformity Assessment System

Table of Contents Importance of Standards and Conformance The U.S. Approach to Standards and Conformance Overview of the ANSI Federation Overview of Conformity Assessment

Overview of the U.S. Standards and Conformity Assessment System Slide 3 Importance of Standards and Conformance

Overview of the U.S. Standards and Conformity Assessment System Slide 4 Key Terms / Concepts Standards Market-driven specifications for a product, service, person, process or system, with which compliance is voluntary Technical Regulations Mandatory specifications, which may include (or reference) particular standards or conformity assessment procedures Conformity Assessment Processes used to verify the compliance of a product, service, person, process or system to either a standard or a regulation (e.g., testing, certification)

Overview of the U.S. Standards and Conformity Assessment System Slide 5 Statistics: Standards and Trade According to the WTO, in 2007 global export trade in merchandise surpassed $13.5 trillion, and global export trade in commercial services surpassed $3.2 billion The U.S. Commerce Department estimates that standards impact roughly 80% of all world commodity trade, and that number is growing every day Those who understand how to effectively influence standardization and compliance programs will have the greatest success in the global marketplace

Overview of the U.S. Standards and Conformity Assessment System Slide 6 Importance of Standards and Conformance When developed and used responsibly, standards facilitate a company’s ability to open and access markets When overlooked, standards can negatively impact a company’s ability to do business in the U.S. and abroad Standards and conformance impact your bottom line Standards and conformance impact your ability to do business internationally

Overview of the U.S. Standards and Conformity Assessment System Slide 7 For example: Coke and Pepsi in India Full or partial bans of Coke and Pepsi in seven Indian States Allegations that Coke and Pepsi contain excessive pesticide residue – unsafe Loss of market share and brand integrity for U.S. soft drink giants Avoidable with globally acceptable food safety and hygiene standards and certification

Overview of the U.S. Standards and Conformity Assessment System Slide 8 The U.S. Approach to Standards and Conformance

Overview of the U.S. Standards and Conformity Assessment System Slide 9 Guiding Principles of the United States Standardization System Standards and their related compliance criteria should meet societal and market needs and should not be developed to act as barriers to trade

Overview of the U.S. Standards and Conformity Assessment System Slide 10 Guiding Principles of the United States Standardization System The U.S. endorses the globally accepted standardization principles of the World Trade Organization Technical Barriers to Trade Agreement

Overview of the U.S. Standards and Conformity Assessment System Slide 11 The WTO Principles Transparency Openness Impartiality and Consensus Effectiveness and Relevance Coherence Development Dimension

Overview of the U.S. Standards and Conformity Assessment System Slide 12 The U.S. is supportive of any international standard that: is technically suitable is used throughout a given market sector worldwide, and was developed in accordance with the WTO principles

Overview of the U.S. Standards and Conformity Assessment System Slide 13 U.S. Standards and Conformity Assessment System Reliable - Flexible - Responsive Market driven Flexible and sector-based Industry-led and government-supported www.us-standards-strategy.org As defined in the United States Standards Strategy, this system is designed to...  Support stakeholder engagement  Address emerging priorities  Allow stakeholders to find custom-fit solutions

Overview of the U.S. Standards and Conformity Assessment System Slide 14 United States Standards Strategy (USSS) Reaffirms U.S. commitment to a sector-based approach to voluntary standardization activities, domestically and globally. Built upon the traditional strengths of the U.S. system – such as consensus, openness, and transparency – while giving additional emphasis to speed, relevance, and meeting the needs of public interest constituencies. www.ansi.org/usss

Overview of the U.S. Standards and Conformity Assessment System Slide 15 U.S. Standards and Conformity Assessment System Reliable - Flexible - Responsive The National Conformity Assessment Principles for the United States document helps consumers, buyers, sellers, regulators and other interested parties understand key aspects of compliance verification. www.ansi.org/ncap The NCAP is a guidance document that can be considered in conjunction with the United States Standards Strategy

Overview of the U.S. Standards and Conformity Assessment System Slide 16 U.S. Standards and Conformity Assessment System comparison with many other economies Emphasizes private-sector standards solutions Relies on private-sector compliance verification for both regulatory and non-regulatory functions Provides greater authority to standards users and stakeholders

Overview of the U.S. Standards and Conformity Assessment System Slide 17 Standards users drive standardization activities Standards bodies drive standardization activities U.S. Standards and Conformity Assessment System comparison with many other economies (continued) Bottom Up Top Down

Overview of the U.S. Standards and Conformity Assessment System Slide 18 The U.S. System: A Toolbox Rather than mandating a “one-size fits all” solution, the U.S. system allows users 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. Standards and Conformity Assessment System Slide 19 U.S. Standards System Different tools for developing globally-relevant standards National ParticipationDirect Participation Consortia  Treaty Organizations  Non-Treaty Organizations  Nationally Accepted  Internationally Accepted Examples Non-Treaty: ISO, IEC Treaty: ITU, CODEX Examples ASTM International, ASME, SAE, etc. Examples IGRS, W3C, etc.

Overview of the U.S. Standards and Conformity Assessment System Slide 20 Summary of U.S. Participation in ISO and IEC ISO Participation in 620 TCs and SCs (roughly 79% of total)  P Memberships: 570  O Memberships: 50 U.S. – held International Secretariats: 18% of total IEC Participation in 153 TCs and SCs (roughly 89% of total)  P Memberships: 153  O Memberships: 0 U.S. – held International Secretariats: 14% of total

Overview of the U.S. Standards and Conformity Assessment System Slide 21 ANSI: Coordinator for U.S. Participation U.S. Reps. to ISO Council / IEC CB  ANSI staff on ISO Council -- 1  USNC President on IEC Council Board -- 1 U.S. Reps. to TMB/SMB  ANSI Staff – 1 on TMB and 1 on SMB  Volunteers – 1 (on SMB) ISO and IEC International Secretariats  Most U.S. – held Secretariats are administered by volunteers  ANSI staff administer U.S. – held Secretariats only at the request of ANSI constituents.  13 U.S. – held Secretariats are administered by ANSI staff. Leadership of U.S. mirror committees (TAGs)  Leadership positions on U.S. TAGs are held by ANSI member volunteers. U.S. Technical Expert Participation  U.S. technical contributions to ISO and IEC are provided by ANSI member volunteers. U.S. Contributions to ISO and IEC ANSI Staff ANSI delegates most ISO and IEC work to volunteers within the U.S. system (e.g. companies, trade associations, SDOs, etc)

Overview of the U.S. Standards and Conformity Assessment System Slide 23 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.

Overview of the U.S. Standards and Conformity Assessment System Slide 24 Many American National Standards (ANS) are International Standards CriteriaWTO/TBT PrinciplesCriteria Reflected in the ANS Process Transparency Openness Impartiality & Consensus Effectiveness & Relevance * Coherence Development Dimension ** * Although the ANS process does not directly evaluate Effectiveness & Relevance, adherence to the other ANS criteria helps to assure the effectiveness and global relevance of ANS. ** Although the ANS process does not evaluate for this criteria, it is strongly encouraged in the U.S. Standards Strategy, and many SDOs engage in extensive international outreach and development activities

Overview of the U.S. Standards and Conformity Assessment System Slide 25 Examples of ANSI-Accredited SDOs American Dental Association National Electrical Manufacturers Association National Fire Protection Association International Code Council American Society of Mechanical Engineers ASTM International Society of Automotive Engineers Institute of Electrical and Electronics Engineers Underwriters Laboratories Inc. American Society of Civil Engineers American Petroleum Institute And more than 200 additional organizations

Overview of the U.S. Standards and Conformity Assessment System Slide 26 Getting Involved in U.S.-Based SDOs

Overview of the U.S. Standards and Conformity Assessment System Slide 27 Getting Involved in U.S.-Based SDOs (2)

Overview of the U.S. Standards and Conformity Assessment System Slide 29 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.

Overview of the U.S. Standards and Conformity Assessment System Slide 30 U.S. Standards System Multiple Path Approach to Standard-Setting Traditional SDOs and consortia each have a role to play Consortia and other forums have become more clearly recognized – and embraced – as an integral part of the global standards system

Overview of the U.S. Standards and Conformity Assessment System Slide 31 The Role of Government in the U.S. Standards and Conformance Systems

Overview of the U.S. Standards and Conformity Assessment System Slide 32 U.S. Standards and Conformity Assessment System The public-private partnership No single government agency has control over standards  Each agency determines which standards meet its needs National Technology Transfer and Advancement Act (NTTAA) (Public Law 104-113)  Encourages each government agency to seek existing private sector standards that are appropriate for its purpose and mission

Overview of the U.S. Standards and Conformity Assessment System Slide 33 The Role of Government Agencies OMB Circular A-119 The National Technology Transfer and Advancement Act (NTTAA, Public Law 104-113) The National Technology Transfer and Advancement Act (NTTAA, Public Law 104-113)  Before regulating, each government agency is required to seek and consider using 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

Overview of the U.S. Standards and Conformity Assessment System Slide 34 The Role of Government Agencies Significant elements of OMB Circular A-119 and The NTTAA:OMB Circular A-119The NTTAA  U.S. regulators and procurement officials can use any standard from any source in the world which help them meet their Congressional mandates  These standards do not need to first be transposed into American National Standards by ANSI  These directly referenced standards include ISO, IEC, SDOs  These standards may also be consortia standards  Regulators and procurement officials may make reference to applicable parts of standards – i.e. are not limited to referencing only whole standards

Overview of the U.S. Standards and Conformity Assessment System Slide 35 ANSI – Coordinator of the Private Sector led System  Responsible for coordinating U.S. private sector participation in the U.S. private sector led Standards and Conformance systems  The National Standards Body for the United States – Represent the U.S. in intl. and regional standards fora  An Accreditation Body for private sector programs – Represent the U.S. in intl. and regional accreditation fora  Private sector, non-profit, membership organization  Supported by membership fees, sale of publications, funded programs, accreditation programs and periodic government grants Standards Developing Organizations (SDOs)  Responsible for the development of standards for the specific technical sectors  Some, but not all, accredited by ANSI  When accredited, can administer U.S. mirror committees to ISO and IEC  Private trade and professional organizations, often non-profit  Business models vary by sector Conformity Assessment Bodies (CABs)  Testing Laboratories, Certification Bodies, Inspection Bodies  Responsible for demonstrating compliance with standards (including those referenced by mandatory technical regulations)  Some, but not all, accredited by ANSI  Business models vary by sector (non-profit, for-profit, public sector, etc.) NIST – National Institute of Standards & Technology – U.S. Department of Commerce  Coordinates the activities of Federal agencies in the U.S. private sector led Standards & Conformance Systems  National Metrology Institute for the U.S. – Represents the U.S. in international and regional metrology fora  Accreditation Body for public sector programs – Represent the U.S. in international and regional accreditation fora  U.S. government public sector body Structure of the U.S. Standardization System

Overview of the U.S. Standards and Conformity Assessment System Slide 36 *Documentary Standards, excluding “national participation models” U.S. Standards System Examples of roles and responsibilities

Overview of the U.S. Standards and Conformity Assessment System Slide 37 U.S. Standards System: policy development

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

Summary of the U.S. System “The Drivers” Companies, Government Agencies and other Standards Users “The Road” ANSI “The Vehicle” Standards Developers & Conformity Assessment Bodies

Overview of the U.S. Standards and Conformity Assessment System Slide 40 The ANSI Federation

Overview of the U.S. Standards and Conformity Assessment System Slide 41

Overview of the U.S. Standards and Conformity Assessment System Slide 42 ANSI is the “Umbrella Organization” for the U.S. standards and conformance systems. Represents U.S. globally Ensures integrity of the standards and conformity assessment system Offers neutral forum Accredits standards developers and conformity assessment organizations

Overview of the U.S. Standards and Conformity Assessment System Slide 43 Members of the ANSI Federation include... Academia Individuals Government Manufacturing Trade Associations Professional Societies Service Organizations Standards Developers Consumer and Labor Interests and many more The ANSI Federation represents more than 125,000 companies and organizations and 3.5 million professionals worldwide

Overview of the U.S. Standards and Conformity Assessment System Slide 44 American Dental Association National Electrical Manufacturers Association National Fire Protection Association Examples of ANSI-Accredited Standards Developers and U.S. TAGs International Code Council American Society of Mechanical Engineers ASTM International Society of Automotive Engineers Institute of Electrical and Electronics Engineers Underwriters Laboratories Inc. American Society of Civil Engineers American Petroleum Institute And more than 200 additional organizations

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 Link to full list of ANSI accredited and non-ANSI accredited SDOs: www.nssn.org/sdoinfo.aspxwww.nssn.org/sdoinfo.aspx

Overview of the U.S. Standards and Conformity Assessment System Slide 46 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 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 6,000 Number of company interests represented by ANSI125,000 Number of professionals represented by ANSI3.5 million Year ANSI was established1918

Overview of the U.S. Standards and Conformity Assessment System Slide 47 ANSI promotes alignment with Internationally Recognized Principles for Standards Development WTO TBT Committee Third Triennial Review – Annex 4 ANSI Essential Requirements for the development of American National Standards openness transparency due process consensus Referenced in the United States Standards Strategy

Overview of the U.S. Standards and Conformity Assessment System Slide 48 ANSI Standards Panels

Overview of the U.S. Standards and Conformity Assessment System Slide 49 Coordination and Harmonization Activities ANSI Standards Panels are cross-sector coordinating bodies established to promote the development and compatibility of voluntary consensus standards and conformity assessment programs necessary to support national and global priorities Coordinate the efforts of the private and public sectors Identify existing standards and compliance programs Define where gaps exist Recommend where additional work is needed Identify organizations that can perform the needed work

Overview of the U.S. Standards and Conformity Assessment System Slide 50 Coordination and Harmonization Activities ANSI Standards Panels 2003 Homeland Security Standards Panel 2004 Nanotechnology Standards Panel 2005 Healthcare Information Technology Standards Panel 2006 ID Theft Prevention and ID Management Standards Panel 2007 Biofuels Standards Coordination Panel

Overview of the U.S. Standards and Conformity Assessment System Slide 51 Coordination and Harmonization Activities ANSI Standards Panels (continued) Healthcare Information Technology Standards Panel Contract with the U.S. Department of Health and Human Services to support widespread interoperability among healthcare software applications, accelerate decision making, and eliminate barriers to standards harmonization. Nanotechnology Standards Panel Established at the request of the Office of Science and Technology Policy, Executive Office of the President of the United States to facilitate the development of standards supporting nomenclature/terminology; materials properties; and testing, measurement and characterization procedures. Homeland Security Standards Panel Partnership with the U.S. Department of Homeland Security to accelerate development and adoption of consensus standards critical to homeland security. Support also provided to the 9-11 Commission for private sector preparedness.

Overview of the U.S. Standards and Conformity Assessment System Slide 52 Coordination and Harmonization Activities ANSI Standards Panels (continued) ID Theft Prevention and ID Management Standards Panel Partnering with the Better Business Bureau to facilitate within 18 months the timely development of voluntary consensus standards aimed at minimizing the scope and scale of identity theft and fraud. Biofuels Standards Coordination Panel Launched in conjunction with the U.S. Department of Energy and several other federal agencies to promote the development and compatibility of voluntary consensus standards and related conformity assessment programs necessary to support the large- scale commoditization of biofuels.

Overview of the U.S. Standards and Conformity Assessment System Slide 53 Specifics: ANSI’s Roles and Responsibilities

Overview of the U.S. Standards and Conformity Assessment System Slide 54 ANSI’s Roles and Responsibilities help advance U.S. industries’ global competitiveness Advance acceptance of U.S. innovation and technology in global trade accredit SDOs and approve American National Standards (ANS) accredit certifiers of products, personnel and management systems develop and promote standards and conformity assessment-related policies and positions for the United States represent U.S. standardization stakeholders in domestic, regional and international forums

Overview of the U.S. Standards and Conformity Assessment System Slide 55 ANSI’s Roles and Responsibilities (continued) U.S. member of ISO U.S. member of the IEC, via ANSI’s U.S. National Committee member of regional forums in the Pacific Rim and the Americas liaison with groups in Europe, Africa and the Middle East bilateral agreements with other national standards bodies

Overview of the U.S. Standards and Conformity Assessment System Slide 56 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 / APEC U.S. PUBLIC SECTOR COMPANIES TRADE ASSOCIATIONS CONSUMER INTERESTS OTHERS U.S. GOVERNMENT

Overview of the U.S. Standards and Conformity Assessment System Slide 57 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 Activities (Standardization) ISO / IEC ANSI & USTAGS U.S.

Overview of the U.S. Standards and Conformity Assessment System Slide 58 ISO – Geneva, Switzerland ANSI 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 79% of Technical Committees (570)  administer 18% of TC Secretariats (118) ANSI Participation in ISO ISO ANSI U.S.

Overview of the U.S. Standards and Conformity Assessment System Slide 59 IEC - Geneva, Switzerland U.S. National Committee to the IEC (USNC)  A board level committee of ANSI  one of 5 permanent members of the council board of 15  participates in 89% of Technical Committees (153)  assigned Secretariats for 16% of TC Secretariats (23) ANSI Participation in IEC IEC USNC ANSI U.S.

Overview of the U.S. Standards and Conformity Assessment System Slide 60 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), the European Commission and EFTA ANSI has MOUs with various countries globally to coordinate Standardization and Conformity Assessment activities ANSI Regional Activities (Standardization)

Overview of the U.S. Standards and Conformity Assessment System Slide 61 Regional Standards Organizations

Overview of the U.S. Standards and Conformity Assessment System Slide 62 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)... ANSI Regional Interaction (Asia Pacific)

Overview of the U.S. Standards and Conformity Assessment System Slide 63 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

Overview of the U.S. Standards and Conformity Assessment System Slide 64 PASC PAC APLAC APLMF APMP

Overview of the U.S. Standards and Conformity Assessment System Slide 65 Pacific Area Standards Congress (PASC) Members Australia (SA) Brunei Darussalam (CPRU) Canada (SCC) Chile (INN) China (SAC) Colombia (ICONTEC) Fiji (FTSQCO) Hong Kong – China (ITCHSKAR) Indonesia (BSN) Japan (JISC) Republic of Korea (KATS) Malaysia (DSM) Mexico (DGN) Mongolia (MASM) New Zealand (SNZ) Papua New Guinea (NISIT) Peru (INDECOPI) Philippines (BPS) Russia (GOST-R) Singapore (SPRING SG) South Africa (SABS) Thailand (TISI) USA (ANSI) Vietnam (STAMEQ/TCVN) ASEAN / ACCSQ economies (in blue) (Note: Cambodia (ISC), Laos (DISM), Myanmar (MSTRD) not in APEC / PASC)

Overview of the U.S. Standards and Conformity Assessment System Slide 66 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)

Overview of the U.S. Standards and Conformity Assessment System Slide 67 Pan American Standards Commission (COPANT) - Members Argentina (IRAM) Barbados (BNSI) Bolivia (IBNORCA) Brazil (ABNT) Canada (SCC) Colombia (ICONTEC) Costa Rica (INTECO) Cuba (NC) Chile (INN) Dominican Republic (DIGENOR) Ecuador (INEN) El Salvador (CONACYT) Guatemala (COGUANOR) Grenada (GDBS) Guyana (GNBS) Honduras (COHCIT) Jamaica (JBS) Mexico (DGN) Nicaragua (MIFIC) Panama (COPANIT) Paraguay (INTN) Peru (INDECOPI) Saint Lucia (SLBS) Trinidad & Tobago (TTBS) USA (ANSI) Uruguay (UNIT) Venezuela (FONDONORMA)

Overview of the U.S. Standards and Conformity Assessment System Slide 68 Middle East and Africa ANSI also interfaces with representatives of regional standards organizations from the Middle East and Africa In 2005, ANSI participated in an ASTM International Open House for standards leaders from the Middle East and Africa. The following countries and organizations were represented:  Gulf Standardization Organization (GSO) for the GCC (Gulf Cooperation Council - an economic and political policy-coordinating forum for the six member states Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the UAE)  Arab Industrial Development and Mining Organization (AIDMO)  Bahrain (BSMD)  India (BIS)  Iraq (COSQC)  Israel (SII)  Lebanon (LIBNOR)  Jordan (JISM)  Kuwait (PAI)  Morocco (SNIMA)  Oman (DGSM)  Pakistan (PSQCA)  Palestine (PSI)  Qatar (QGOSM)  Saudi Arabia (SASO)  Tunisia (INORPI)  UAE (ESMA)  Yemen (YSMO)

Overview of the U.S. Standards and Conformity Assessment System Slide 69 Middle East and Africa In 2007, ANSI participated in an ASTM International Open House for standards leaders from Sub-Saharan Africa. The following countries and organizations were represented: Botswana (BOBS) Congo (OCC) QUAE (Ethiopia) Ghana (GSB) Lesotho (LSQAS) Malawi (MBS) Mauritius (MSB) Nigeria (SON) Rwanda (RBS) South Africa (SABS) Swaziland (SQAS) Zambia (ZABS) Zimbabwe (SAZ) ANSI also works with:  ARSO – the African Organization for Standardization, and  SADCSTAN – The Southern African Development (SADC) Cooperation in Standardization  via SABS which is the designated coordinator for African standardization from the Pacific Area Standards Congress

Overview of the U.S. Standards and Conformity Assessment System Slide 70 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 20 ANSI-ESO dialogues since 1989. In 2005, ANSI also began holding delegation meetings with the ESO ’ s Joint Presidents Group (JPG).

Overview of the U.S. Standards and Conformity Assessment System Slide 71 European Standards Organizations (ESOs) ANSI – ESO Partnership 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 September 23, 2008, ANSI-ESO/JPG meeting with EC and EFTA September 24, 2008, ANSI-ESO Workshop on U.S.-EU Standards and Conformance

Overview of the U.S. Standards and Conformity Assessment System Slide 72 ANSI meeting with ESO Joint Presidents Group (JPG) and European Commission, EFTA The ANSI-ESO Dialogue represents the leadership of the U.S. and EU standards and conformance systems. Format is a four-sided table: U.S. Private Sector U.S. Government EU Private Sector European Commission, EFTA

Overview of the U.S. Standards and Conformity Assessment System Slide 73 International Projects and Initiatives

Overview of the U.S. Standards and Conformity Assessment System Slide 74 Overview of Regional and Bilateral Initiatives

Overview of the U.S. Standards and Conformity Assessment System Slide 75 China Program Genesis ANSI hired a Representative for China Affairs (Elise Owen) and launched China Program in 2006, responding to member focus on issues and opportunities in China Three main priority areas for ANSI China Program:  Communicate and promote U.S. positions for standardization and conformity assessment in China  Work to ensure that standards facilitate trade  Promote the benefits of the U.S. Standards System in China 2007 ANSI Membership Survey defined overarching areas of concern for China, including transparency, conformity assessment policies, and inconsistent U.S. message China Program facilitates “continuous engagement” through senior and working-level communication, workshops, projects, etc. to effectively advance U.S. priorities

Overview of the U.S. Standards and Conformity Assessment System Slide 76 China Program: Recent Accomplishments April 2008: MOU with Certification and Accreditation Administration of China (CNCA) that builds on a longstanding MOU with the Standardization Administration of China (SAC) Supporting Initiatives to advance the safety of products exported from China to the U.S. (e.g. toys) Increasing outreach to and visibility in Chinese industry Addressing high-level China policy concerns (e.g. TC participation policies, revisions to CCC regulations, etc.) Launching ANSI Manufacturer Member Roundtable in China Development of StandardsPortal

Overview of the U.S. Standards and Conformity Assessment System Slide 77 Why StandardsPortal? Problem:  No central resource to help companies find the standards, conformity assessment and technical regulations needed to enter and compete in target markets. Solution:  StandardsPortal answers key questions exporters face when attempting to enter their target markets

Overview of the U.S. Standards and Conformity Assessment System Slide 78

Overview of the U.S. Standards and Conformity Assessment System Slide 79 ANSI Engagement in India January 2007: ANSI President and CEO India Networking Visit March 2007: ANSI and U.S. Department of Commerce (DOC) Staff-level Fact- finding Mission December 2007: ANSI signs tripartite MOU with Bureau of Indian Standards (BIS) and Confederation of Indian Industry (CII) September 2008: ANSI, CII and BIS co-organize workshop on “Leveraging the TBT Agreement” sponsored by U.S. DOC and Indian Ministry of Commerce and Industry March 2009: U.S. – India Standards and Conformance Cooperation Program (SCCP) launched in Washington and Delhi (www.standardsportal.org/us- indiasccp)www.standardsportal.org/us- indiasccp

Overview of the U.S. Standards and Conformity Assessment System Slide 80 Southeast Asia 2007/2008: ANSI Carries out U.S. Trade and Development Agency (USTDA) sponsored Vietnam Standards Training Program (VSTP) September 2008: ANSI delivers presentation to ASEAN Consultative Committee for Standards and Quality (ACCSQ) plenary meeting Ongoing: Working to identify additional opportunities for projects and programs in individual Southeast Asian countries

Overview of the U.S. Standards and Conformity Assessment System Slide 81 Future Areas of Focus: International Projects ANSI will continue its commitment to policy activities while also working to increase externally funded projects that support ANSI’s international policy objectives Benefits to ANSI Members: Maximize international impact with limited resources Strengthen international alliances and partnerships Increase opportunities to address issues and concerns before they arise

Overview of the U.S. Standards and Conformity Assessment System Slide 82 Overview of Conformity Assessment

Overview of the U.S. Standards and Conformity Assessment System Slide 83 What is Conformity Assessment? ISO/IEC 17000: “ demonstration that specified requirements relating to a product, process, system, person or body are fulfilled ” “ Note: includes activities such as testing, inspection and certification as well as the accreditation of conformity assessment bodies ”

Overview of the U.S. Standards and Conformity Assessment System Slide 84 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 Conformity Assessment

Overview of the U.S. Standards and Conformity Assessment System Slide 85 U.S. Standards and Conformity Assessment System reliable – flexible – responsive The National Conformity Assessment Principles (NCAP) for the United States document explains key aspects of compliance verification. National Conformity Assessment Principles for the United States www.ansi.org/ncap The NCAP is a guidance document that can be considered in conjunction with the United States Standards Strategy (USSS).

Overview of the U.S. Standards and Conformity Assessment System Slide 86 U.S. Conformity Assessment System Standards are just good ideas unless products, processes, systems and personnel conform to them. The U.S. conformity assessment system, much like the standards system, evolved in decentralized manner.  Conformity assessment activities are not centrally organized  Approaches vary among sectors

Overview of the U.S. Standards and Conformity Assessment System Slide 87 U.S. Conformity Assessment System Activities are a mix of government (regulatory programs) and private sector (market- based programs) The system relies on private sector mechanisms to achieve both non-regulatory and regulatory conformance 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 Conformity Assessment System Slide 88 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

Overview of the U.S. Standards and Conformity Assessment System Slide 89 3 rd Party Conformity Assessment System Structure Accreditation Bodies (ABs) Testing LaboratoriesCertification BodiesInspection Bodies Products (Procedures, Services) QMS/EMS (ISO 9000 / ISO 14000) Personnel Buildings, Facilities, Mines, Procedures, Services, etc.

Overview of the U.S. Standards and Conformity Assessment System Slide 90 Standards Developing Organizations and U.S. TAGs ANSI Procedures “Essential Requirements” Standards Examples of Accreditation Programs in the United States Conformity Assessment (ISO/IEC 17011) Personnel Certifiers Accreditation Bodies: ANSI ISO/IE C 17024 QMS/EMS Certifiers ISO/IE C 17021 Accreditation Bodies: ANSI-ASQ NAB ISO/IE C Guide 65 Product Certifiers Accreditation Bodies: A2LA ANSI IAS Inspection Bodies ISO/IE C 17025 ISO/IE C 17020 Test Labs Accreditation Bodies: A2LA ANSI-ASQ NAB IAS Accreditation Bodes: A2LA ANSI-ASQ NAB IAS, L-A-B PJLA, NVLAP Products (Procedures, Services) Personnel QMS/EMS (ISO 9000/ ISO 14000) Buildings, Facilities, Mines, Procedures, Services, etc. Products (Procedures, Services) Accreditation Bodies: ANSI ISO/IE C 14065 Greenhouse Gas Verifiers Green- house Gas Emissions

Overview of the U.S. Standards and Conformity Assessment System Slide 91 IAF International Accreditation Forum IAAC Inter American Accreditation Cooperation PAC Pacific Accreditation Cooperation APLAC Asia-Pacific Laboratory Accreditation Cooperation EA European Accreditation Cooperation ILAC International Laboratory Accreditation Cooperation International Recognition is Essential

Overview of the U.S. Standards and Conformity Assessment System Slide 92 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

Overview of the U.S. Standards and Conformity Assessment System Slide 93 The Conformity Assessment Balance valueconfidence for suppliers for acceptance interests

Overview of the U.S. Standards and Conformity Assessment System Slide 94 Conformity Assessment and Risk Perceived Risk Independence and Rigor of Conformity Assessment Supplier’s Declaration 1 st party conformity assessment Certification 3 rd party conformity assessment

Overview of the U.S. Standards and Conformity Assessment System Slide 95 Confidence/Regulation Spectrum very regulated unregulated complete trust 100% verification paperclip produce pharmaceuticals

Overview of the U.S. Standards and Conformity Assessment System Slide 96 Objective One Standard : One Test : Accepted Everywhere ( 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 – Accepted Everywhere

Overview of the U.S. Standards and Conformity Assessment System Slide 97 For more information American National Standards Institute HeadquartersOperations 1819 L Street, NW25 West 43rd Street Sixth FloorFourth Floor Washington, DC 20036New York, NY 10036 T: 202.293.8020T: 212.642.4900 F: 202.293.9287F: 212.398.0023 www.ansi.org | webstore.ansi.org | www.nssn.org

1 2010 Overview of the U.S. Standards and Conformity Assessment System.

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1 2010 Overview of the U.S. Standards and Conformity Assessment System.

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