An Introduction to the American National Standards Institute and the United States Standards System Last update: January 2005

The international language of commerce is standards. Source: Former U.S. Secretary of Commerce – Donald Evans Report on Standards and Competitiveness – Removing Standards-Related Trade Barriers Through Effective Collaboration May 18, 2004 Standards have always been key to global trade As trade has grown, standards have gained importance

Standardization: A Global Community Standards Developers and Conformity Assessment Bodies Commercial and Consumer Acceptance Government Acceptance

The U.S. Standardization Model “One Approach Among Many in the World” The U.S. “standardization” model includes both standards-setting and conformity assessment programs resembles the nation’s political (federal) structure resembles the nation’s economic structure sector-based and driven by market needs relies strongly on diversity and decentralization In the U.S. alone, there are more than 95,000 recognized standards Most are developed and used on a voluntary basis The majority are developed by technical committees formed within the private sector, very often with government participation Government and industry representatives participate as “equal partners” in technical committees Costs are borne by the participants, not the standards developing organization

Compliance and Enforcement: Factors Influencing Standardization Examples from a U.S. perspective . . . Public opinion Example: Publicity about faulty or dangerous products will negatively impact the market Legal system Example: Laws allow consumers to return faulty products Consumers can sue producers of faulty or dangerous products Penalties include requiring companies to recall and withdraw products from the market Government agencies (federal, state or local) Example: The import of unsafe products can be denied Faulty or dangerous products can be recalled or removed from the market

The U.S. approach to market relevance In the U.S. alone, there are more than 95,000 recognized standards. These documents are being developed by more than 450 standards developing organizations (SDOs), with the twenty largest of these organizations producing approximately 80% of the standards at least 150 consortia hundreds of committees addressing the technical requirements of standards Most standards are developed and used on a voluntary basis In the U.S. alone, there are more than 95,000 recognized standards. These encompass: Product-Based Standards (ISO film speed code; banking and telephone cards) Performance-Based Standards (Safety of wire ropes; safety of toys) Management System Standards (ISO 9000 Quality and ISO 14000 Environmental Management Systems) Personnel Certification Standards (financial planners; food protection managers; others for services are expected)

Examples: Current Standardization Initiatives Homeland Security issues such as biometrics, radiation detector systems, “Safe Harbors” and others Nanotechnology terminology and nomenclature Federal election reform Example: An ANSI-accredited developer is working on equipment related standards Explicit requirements must drive all new standards and conformity assessment initiatives Sector-specific initiatives link standards development to the users’ priorities Examples: Currently underway are new or enhanced programs for Consumer issues (e.g., to meet the needs of older persons and those with disabilities) Service industries Security, health and safety (post 9/11/01 terror attacks on the U.S.) (e.g., biometrics)

Cardinal Principles of the U.S. System Due Process Consensus Openness – All materially affected parties may participate in standards development Transparency – Records, processes open and publicly available (no secret meetings) Consensus – Decisions by more than a simple majority (not unanimity) Due Process – Written, documented appeals process Openness Transparency

The Role of Government In the U.S., no single government agency has control over standards. Each government agency determines which standards meet its needs. The agency is responsible for determining whether a private sector standard already exists that is appropriate for its needs. If so, they will use the private sector standard. If not, the agency is expected to work with the private sector to develop the needed standard.

The Role of Government National Technology Transfer and Advancement Act (NTTAA) - 1995 (P.L. 104-113 – 1996) Encourages federal agencies to utilize voluntary consensus standards where feasible Encourages federal participation in voluntary consensus standards development activities Designates NIST as “coordinator” (no budgetary or policy authority) of government standards policy activities In the U.S., no single government agency has control over standards. Each government agency determines which standards meet its needs. The agency is responsible for determining whether a private sector standard already exists that is appropriate for its needs. If so, they will use the private sector standard. If not, the agency is expected to work with the private sector to develop the needed standard. Federal regulatory and procurement agencies are directed to rely upon private sector standards whenever possible – and to participate in their development. This is a substantive move away from the traditional “command and control” role of government and a move toward working with the private sector.

Summary Structure of the U.S. Standardization System ANSI Coordinator of the Private Sector Private sector, non-profit, membership organization Supported by membership fees, sale of publications NIST (National Institute of Standards and Technology) Coordinator of Federal Agencies Sets legal metrology standards; accredits laboratories Standards developing organizations (SDOs) Private trade and professional organizations, often non-profit Many, but not all, accredited by ANSI Responsibility for standardization and metrology activities is shared among the American National Standards Institute (ANSI), which serves as coordinator of the U.S. private-sector-led standardization system individual standards-setting bodies the National Institute of Standards and Technology (NIST), an agency of the technology administration of the U.S. Department of Commerce, which keeps the primary (physical) measurement standards

ANSI is not a government agency or a standards developer. Mission To enhance the global competitiveness of U.S. business and the American quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems and ensuring their integrity. The American National Standards Institute (ANSI) is a private, non-profit organization (501(c)3) that administers and coordinates the U.S. voluntary standardization and conformity assessment system. The Institute's mission is to enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems, and safeguarding their integrity. ANSI was founded by private and public sector organizations A Private- and Public-Sector Partnership Since 1918 ANSI is not a government agency or a standards developer.

Bringing the Private- & Public-Sectors Together A Federation of members representing . . . Academia Individuals Government Manufacturing Trade Associations Professional Societies Service Organizations Standards Developers Consumer and Labor Interests and many more Comprised of businesses, professional societies and trade associations, standards developers, government agencies, and consumer and labor organizations, the ANSI Federation represents the diverse interests of more than 120,000 entities and 3.2 million professionals worldwide. Currently, membership includes almost all industry sectors nearly 500 Member Companies (with revenues of more than $1.2+ trillion) 270+ Professional, Trade, Educational, Consumer and Labor Institutions 30+ Government Agencies (Federal, State and Local) Bringing the Private- & Public-Sectors Together

Member Participation BOARD OF DIRECTORS COMPANY MEMBER FORUM CONSUMER INTEREST ORGANIZATIONAL GOVERNMENT BOARD OF DIRECTORS The ANSI Federation comprises four broadly defined constituencies: company members, organizational members, government members, and consumer interests. The Company Member Forum, Government Member Forum, and Organizational Member Forum have as their charge to: Provide a forum for discussion and networking by a defined interest category; Provide a mechanism for “early warning” of relevant trends; Address issues of interest primarily to their membership and galvanize implementation of their constituent level; Identify broader-based issues to be addressed by an identified governance body; Assume an active role in ANSI membership recruitment and retention; Serve as the one place within ANSI where participants can represent their own organization’s interests. NOTE: The Consumer Interest Forum (CIF) works to facilitate the representation of consumer interests in voluntary standards and conformity assessment activities. Membership in ANSI is not a requirement for consumer representative organizations.

Organization Chart

U.S. PRIVATE U.S. GOVERNMENT SECTOR (PUBLIC SECTOR) U.S. DOMICILED STANDARDS DEVELOPING BODIES OTHER FOREIGN STANDARDIZATION BODIES INTERNATIONAL STANDARDIZATION BODIES REGIONAL STANDARDIZATION BODIES

ANSI’s Roles and Responsibilities to accredit U.S. Standards Developers, U.S. Technical Advisory Groups and conformity assessment programs to ensure integrity of the U.S. voluntary consensus standards system to provide regional and international access to offer a neutral policy forum Domestically Accredits U.S. Standards Developers, U.S. Technical Advisory Groups and conformity assessment programs Approves American National Standards Protects the public’s participation in standardization activities Ensures integrity of the U.S. voluntary consensus standards system Offers a neutral policy forum Provides a central resource for information and education on standards, conformity assessment and related activities Internationally Provides regional & international access and representation U.S. member body to ISO and, through the US National Committee, the IEC U.S. representative to other non-treaty international organizations, i.e., PASC and COPANT) Conducts international outreach on standards related issues for the U.S.

ANSI as an Accreditor ANSI accreditation, whether as a standards developer, Technical Advisory Group, or a certification program, provides an assurance of: Openness Balance Due process Transparency Consensus Key messages: The ANSI process is fair and open. Due process is a safeguard that prevents mischief from taking hold and improperly influencing the resulting standard. American National Standards make it clear how to improve the safety of products for the protection of consumers. ANSI serves all standardization efforts in the United States by providing and promoting a process that withstands scrutiny. ANSI serves all standardization efforts in the United States by providing and promoting a process designed to protect the rights and interests of every participant. Definitions Openness – All materially affected parties may participate in standards development Transparency – Records, processes open and publicly available (no secret meetings) Consensus – Decisions by more than a simple majority (not unanimity) Due Process – Written, documented appeals process

American National Standards (ANS) Developers Currently there are approximately 200 ANSI-accredited standards developers* Not all standards developed by these organizations are submitted for consideration as ANS There are approximately 10,000 American National Standards* *Information based on year-end 2003 data.

Examples of U.S. Standards Organizations ANSI American National Standards Institute API INCITS T1 Accredited Standards Committee T1 - Telecommunications (Secretariat: Alliance for Telecommunications Industry Solutions) American Petroleum Institute InterNational Committee for Information Technology Standards (Secretariat: Information Technology Industry Council) ASME International SAE ASTM International American Society of Mechanical Engineers Society of Automotive Engineers Others

ANS Development Cycle IDEAS COMMENTS VOTE

One Global Standard Accepted by All In a global marketplace, the objective of the standards development process must be a single, internationally recognized, technically valid standard that allows products to be distributed for commerce worldwide without change or modification. Key message: Globally-relevant standards and conformance assessment systems promote economic prosperity and trade. Sub-messages: A single, globally-accepted standard prevents regions from using local standards to favor local industries. The true test of an international standard is the extent to which it is used worldwide. One Global Standard Accepted by All

To this end, the U.S. will . . . . Submit American National Standards for adoption as regional or International Standards Adopt International Standards as American National Standards (where they meet the needs of the user community) Ensure that U.S. positions (policy and technical) are accept- ed by international and regional standards organizations

A National Standards Strategy (NSS) for the United States Confirming the importance of a market-driven, sectoral-focus In 1998, the U.S. standardization community set about to develop its “future vision” The result is the first-ever National Standards Strategy (NSS) for the U.S. (approved in August 2000). Implementation is the responsibility of all U.S. interests ANSI serves as the coordinator

International Organization for Standardization International Electrotechnical Commission The purpose of IEC (founded in 1906) is to promote inter-national cooperation on all questions of standardization in the fields of electricity, electronics and related technologies The purpose of ISO (founded in 1947) is to facilitate the internationalization and unification of standards and related activities over almost the entire range of technology (except that covered by IEC) The purpose of ITU is to promote international cooperation on all questions of standardization in the fields of telecommunications and radio communications. The U.S. link to ITU is via the U.S. Department of State. International Telecommunications Union

U.S. Member Body of the ISO International Organization for Standardization (ISO) – Geneva, Switzerland Comprised of 146 National Standards Bodies ANSI is 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 80% of Technical Committees administer 18% of TC Secretariats 22

U.S. National Committee of the IEC International Electrotechnical Commission (IEC) – Geneva, Switzerland Comprised of 60 National Committees (member nations) U.S. National Committee is one of 5 permanent members of the Council Board of 15 15 members of the Standardization Management Board participates in 91% of Technical Committees assigned Secretariats for 16% of TC Secretariats 23

U.S. Technical Advisory Groups (TAGs) Similar to Accredited Standards Developers, U.S. TAGs are accredited by ANSI and must follow the Institute’s cardinal principles of openness, balance, due process and transparency. ANSI sets policy for U.S. TAGs because the Institute is recognized as the official U.S. member of ISO and, through its U.S. National Committee (USNC), is the official U.S. member of IEC. ANSI pays total dues for U.S. membership in both ISO and IEC. Several ANSI-Accredited Standards Developers ALSO serve as Accredited Technical Advisory Groups for ISO and/or IEC technical committee activities. ANSI is the official U.S. member of ISO and, through its U.S. National Committee (USNC), is the official U.S. member of IEC The U.S. holds nearly 560* P” Memberships on ISO TCs and SCs More than 185 TAGs have been accredited by ANSI to develop the U.S. positions for these groups The USNC holds nearly 160* “P” Memberships on IEC TCs and SCs The USNC approves a Technical Advisor or TAG for each “P” membership held *Information based on year -end 2003 data.

Regional Standards Bodies COPANT (Pan-American Standards Commission) ANSI has membership on behalf of the U.S. PASC (Pacific Area Standards Congress) CEN (European Committee for Standardization) ANSI has access as a liaison via the ISO/CEN Vienna Agreement CENELEC (European Committee for Electrotechnical Standardization) ANSI has access as a liaison via the IEC/CENELEC Dresden Agreement ETSI (European Telecommunications Standards Institute) U.S. companies which qualify may apply for membership

COPANT (Pan-American Standards Commission) Standards setting body for Latin and South American countries Founded as the Pan American Technical Standards Committee in 1949 to develop regional standards Executive Secretariat is in Caracas, Venezuela Currently 28 Active and 7 Adherent member countries Oriented towards international standards, but develops regional technical standards when none exists at the international level Objective of COPANT: to promote the development of technical standardization and related activities in its member countries with the aim of promoting their industrial, scientific and technological development in benefit of an exchange of goods and the provision of services, while facilitating cooperation in intellectual, scientific, and social fields.

PASC (Pacific Area Standards Congress) Founded in 1972 in Honolulu, Hawaii Currently 25 members Membership open to any country or territory bordering on the Pacific Rim whose standards organization is a member of ISO and IEC, or national organization that PASC determines is capable of making a contribution Secretariat responsibility rotates among members Does not set standards, rather coordinates on standards issues PASC is a consensus-based organization with objectives to: exchange of information and actions necessary to ensure that international standardization activities are properly coordinated to meet world needs and to foster international trade and commerce provide geographically convenient forum for countries and territories of the Pacific Rim to develop recommendations for ISO and IEC work provide consultative liaison with international and regional standards bodies to communicate recommendations of PASC members

Standards Bodies of the European Union European Standardization Policy Established in 1984 in the General Guidelines for Co-operation between the EU and EFTA and the European Standards bodies Goals are to strengthen the competitiveness of European industry and to improve the functioning of the European market “New Approach” Directives state that the European Union shall look towards the private sector to develop standards Three organizations (CEN, CENELEC, and ETSI) now constitute the European forum for standardization These bodies are made up of diverse parties that form more than 1,500 technical groups Work to develop national standards within the European Union has essentially ceased

Standards Organizations U.K. BSI CANADA SCC GERMANY DIN JAPAN JISC FRANCE AFNOR/UTE U.S. ANSI BRAZIL ABNT AUSTRALIA SAA Examples of National Standards Organizations

Characteristics of the U.S. Conformity Assessment System Conformity assessment activities are not centrally organized Activities are a mix of government (regulatory programs) and private sector (market-based programs) Approaches vary among sectors

Conformity Assessment Goals Promote and achieve global acceptance of products and services through conformity assessment activities for Product certifiers Personnel certifiers ISO 9000 & 14000 registrars (via the ANSI/ANAB partnership) International Accreditation Forum (IAF) Laboratory Accreditation Working Group - National Council for Laboratory Accreditation Key messages: Standards are just good ideas unless products, processes, systems and personnel conform to them. Accreditation enhances consumer and public confidence in a certification program. ANSI Accreditation Programs Product Certifiers - Yes Management System Registrars - Yes Personnel Certifiers - Yes Laboratories - No Inspection Bodies - No Standards Developers - Yes

National Conformity Assessment Principles Document (NCAP) Articulates principles for U.S. conformity assessment activities Guidance document to be considered in conjunction with the U.S. National Standards Strategy Improves the ability of consumers, buyers, sellers, regulators and other interested parties to have confidence in the processes of providing Certification services Approved in 2002 Implementation is the responsibility of all U.S. interests

ANSI Accreditation Programs Conformity Assessment Standards ISO/IEC Guide 65 ISO/IEC Guides 62 and 66 ISO/IEC17024 ANSI Procedures Product Certifiers ISO 9000 / ISO 14000 Certifiers Personnel Certifiers Standards Developing Organizations and U.S. TAGs

ANSI as an Information Provider Standards development and implementation has become yet one more arena in which to compete — and excel — in order to ensure business success. There is a price to be paid, but none so high as the cost of competing against the consensus choice of the key participants in an open standards system. ANSI provides access to timely, relevant, and actionable information for its members and customers. Key message: ANSI is a one-stop resource for instant access to standards and standards information. Knowledge Provides Advantage

Web-Based Information Tools ANSI Online (http://www.ansi.org) News and information Standards Action for public notice ANSI Reporter for news and editorial coverage NSSN: A National Resource for Global Standards (http://www.nssn.org) Key-word or document number searches; bibliographic data on standards; up-to-date reports on new development projects, and much more. Electronic Standards Store (http://webstore.ansi.org) E-commerce site for real-time electronic publication sales

Education & Training Services Promote use and value of standards Promote Strategic Standardization Management Provide training on standardization participation, leadership, and administration

ANSI as a Policy Forum Facilitate U.S. standardization policy development Promote U.S. standardization policies globally ANSI is the bridge for standardization between industry and government among and within industries Key message: Voluntary standards serve U.S. interests well because government, consumers and industry work together to create them. ANSI – Coordinator of the Private Sector Private sector, non-profit, membership organization, Supported by membership fees, sale of publications NIST – Coordinator of Federal Agencies Sets Legal Metrology Standards; Accredits Laboratories Standards developing organizations (SDOs) Private trade and professional organizations, often non-profit Many, but not all, are accredited by ANSI

ANSI Partnership with U.S. Government on Standards and Trade Issues Influence via: ANSI | U.S. Government ISO and IEC WTO COPANT FTAA PASC APEC CEN/CENELEC/ETSI TABD ISO International Organization for Standardization IEC International Electrotechnical Commission WTO World Trade Organization COPANT Pan-American Standards Commission FTAA Free Trade Agreement of the Americas PASC Pacific Area Standards Congress APEC Asia-Pacific Economic Cooperation CEN European Committee for Standardization CENELEC European Committee for Electrotechnical Standardization ETSI European Telecommunications Standards Institute TABD Trans Atlantic Business Dialogue EOTC European Organization for Testing and Certification US -EU United States - European Union Mutual Recognition MRA’s Agreements

The same guidance applies to all agencies Public Law 104-113 known as the “National Technology Transfer and Advancement Act of 1995” Signed into law on 7 March 1996 Guidance document is OMB Circular A-119 Public Law 104-113 (Sec. 12. Standards Conformity) Paragraph d - Utilization of Consensus Standards by Federal Agencies; Reports. (1) . . . all federal agencies and department shall use voluntary consensus standards (2) . . . Federal agencies and departments shall consult and . . . participate with such bodies in the development of technical standards (3) . . . a Federal agency or department may elect to use technical standards that are not developed or adopted by voluntary consensus standards bodies but must provide an explanation for doing so to the Office of Management and Budget . . . “technical standards” means performance-based or design-specific technical specifications and related management systems practices. In the U.S., no single government agency has control over standards. Each government agency determines which standards meet its needs. Federal regulatory and procurement agencies are directed to rely on private sector standards whenever possible – and to participate in their development. The agency is responsible for determining whether a private sector standard already exists that is appropriate for its needs. If so, they will use the private sector standard. If not, the agency is expected to work with the private sector to develop the needed standard. This is a substantive move away from the traditional “command and control” role of government and a move toward working with the private sector.

Value of ANSI Membership Influence ANSI Federation policies ISO/IEC policies WHAT standards are written WHERE If you don’t do it, your competitors will If the private sector does not do it, the federal Government may take the lead Assurance of a level playing field for standards and conformity assessment programs Access to a major source of information and expertise Domestic and global networking opportunities Key message: Affiliation with ANSI provides a one-of-a-kind credibility.

Benefits to Companies Protection Knowledge Positioning The strong voice, influence and networks necessary to help ensure that standards are not written that will exclude your products, processes or technologies Knowledge Early awareness of new requirements Close customer and supplier contact Early assessment of new market directions Positioning Influence at the leading edges of technology Key message: Standards quicken the market acceptance of products.

Benefits to Organizations Global relevance Self regulation Shared costs Reduced liability Reduced redundancy Market place acceptance of standards

Benefits to Consumers Greater selection Easier choices Better and consistent quality Lower costs Enhanced safety & health Key message: American National Standards make it clear how to improve the safety of products for the protection of consumers.

Benefits to Government Lower costs for procurement and regulatory agencies Increased U.S. competitiveness, employment and economic growth Private sector cooperation World Trade Organization (WTO) compliance Legislative compliance Key message: Voluntary standards help the government fulfill its mandate to ensure public safety and health

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