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Overview of the U.S. Standardization System

Understanding the U.S. Voluntary Consensus Standardization and Conformity Assessment Infrastructure

A Brief Introduction

Shaped over more than a century by the changing face of this nation’s history, culture and values, the U.S. standardization system reflects a market-driven and highly diversified society. It is a decentralized system that is naturally partitioned into industrial sectors and supported by independent, private sector standards developing organizations (SDOs). It is a demand-driven system in which standards are developed in response to specific concerns and needs expressed by industry, government¹, and consumers. And it is a voluntary system in which both standards development and implementation are driven by stakeholder needs.

Standardization encompasses a broad range of considerations – from the actual development of a standard to its promulgation, acceptance and implementation. Also included are the methods of evaluating conformance to a standard – issues such as laboratory accreditation; certification of products, processes, systems, services and personnel; metrology and measurement; testing and sampling, and more. Standardization has become the key to market access and is inherently essential to a sound national economy and to the facilitation of global commerce.

A Reflection of American Values

The U.S. standardization infrastructure is firmly rooted in American history and experience. It reflects a basic national belief that society will benefit and innovation and creativity will flourish in a system that is free from centralized government control but strengthened through essential governmental participation.

Voluntary standards serve as the cornerstone of the distinctive U.S. infrastructure. These documents arise from a formal, coordinated, consensus-based and open process. Their development depends upon data gathering, a vigorous discussion of all viewpoints, and agreement among a diverse range of stakeholders. Thousands of individuals, companies, labor, consumer and industrial organizations, and government agencies at the federal, state and local level voluntarily contribute their knowledge, talents and efforts to standards-setting activities.

The costs for developing and implementing a voluntary standard are borne by those who will derive benefit from that document. Certain expenses are borne by the entity responsible for facilitating development of the standard and others by the parties – the subject matter experts and those who employ or support them – who participate in its creation. The end user bears the cost of purchase, if applicable, and assumes responsibility for implementation expenditures. The equitable distribution of expenses incurred during the standardization life cycle helps to mitigate the risk that any single group will attempt to exercise undue influence because it has borne an inordinate share of the expenses.

Voluntary refers only to the manner in which the standard was developed; it does not necessarily refer to whether compliance to a consensus standard is optional or whether a government entity or market sector has endorsed the document for mandatory use.

Most other countries adhere to a “top-down” approach to standardization where the government or groups closely coupled to government either serve as the standards setter or mandate what standards will be developed. Because of these differences, many other regions frequently perceive that no entity in the U.S. – neither the government, nor any central authority – is in charge.

Coordinating the Work of Diverse Organizations

In the late 1800’s and early part of the 20^th century, these observations would have been correct. As World War One was drawing to a close, it was apparent that there was a need for coordination among U.S. standards-setting groups to avoid duplication of effort. In October 1918, three government agencies and five private sector organizations² joined together to form a coordination body known as the American Engineering Standards Committee, the predecessor of what is now known as the American National Standards Institute (ANSI).

Since its formation, ANSI has held the unique responsibility of bringing together diverse private and public sector interests and accredited and non-accredited standards development organizations. The Institute has helped to forge the robust working partnership that now exists among all stakeholders. This relationship has led to the development of thousands of voluntary consensus standards for the United States, the effective representation of U.S. needs and viewpoints in regional and international standards-setting activities, and the minimization or elimination of overlap and duplication in standards-setting activities.

Nearly ninety years later, the U.S. standardization community is comprised largely of non-governmental SDOs and consortia; these groups are primarily supported by industry participation. The system is extremely flexible and provides great autonomy.

Scientific and professional societies like the American Society of Mechanical Engineers (ASME), the Acoustical Society of America (ASA), and the American Society of Safety Engineers (ASSE) are involved in standards development activities that further the work of their respective organizations and the professions that they support.

Trade associations, on the other hand, deal with a particular industry and promote its products or services. Some associations, such as the Telecommunications Industry Association (TIA) and the Aerospace Industries Association (AIA), develop standards for the products manufactured by their members, while others might focus on developing standards for products used by their industries.

Organizations such as the Institute for Electrical and Electronics Engineers (IEEE) and the Electronic Industries Association (EIA) develop technical standards that cut across many industries. Large umbrella groups such as ASTM International recognize standardization as its primary focus; yet other organizations, such as Underwriters Laboratories (UL), develop standards as a logical complement to their conformity assessment activities of testing and certification.

Consortia standards are developed by companies who agree to work together to solve a specific market need. Consortia documents may offer a solution to a problem, but participation in standards-setting is limited to members of the consortia. Membership often requires a substantial financial contribution.

De facto standards are normally developed outside the traditional framework and usually appeal to a more narrow market than standards written by voluntary standards-focused organizations. Often seen in areas of rapidly developing technologies, these “marketplace” standards can be produced more quickly than standards developed in a more formal process, but they do not feature the broad and open participation, due process or consensus-based approval sought by certain users, among them regulators and procurement agents.

Harmonizing U.S. Government and Private Sector Standardization Activities

Not surprisingly, the U.S. federal government is the largest single creator and user of specifications and standards – current estimates point to more than 44,000 distinct statutes, technical regulations or purchasing specifications. Decisions about which standards are most appropriate for U.S. government use are left to the discretion of individual agencies. Recent trends indicate that voluntary consensus standards are being increasingly referenced by U.S. agencies and regulatory bodies.

Add the more than 50,000 standards estimated to come from the private sector in America and the nation’s total inventory of standards quickly approaches 100,000. These documents are produced and maintained by nearly 600³ standards organizations in the United States, 200 of which are accredited by ANSI as developers of American National Standards (ANSs).⁴

While this decentralized approach works well for the U.S., there remains a need for the coordination of standards policy. Two significant initiatives help to provide the necessary guidance and direction:

• In the mid-1990s, Congress stepped forward with enactment of the National Technology Transfer and Advancement Act (Public Law 104-113) which assigned the responsibility for coordinating standards policy among federal agencies to the National Institute of Standards and Technology (NIST), a non-regulatory federal agency within the Technology Administration of the U.S. Department of Commerce. As NIST is also the federal agency responsible for measurement standards (weights and measures) in the U.S. it works in close collaboration with ANSI.
• In 1999-2000 the U.S. public and private sectors joined together under ANSI auspices to develop the first-ever National Standards Strategy for the United States, which reaffirmed reliance upon the basic structure of the U.S. system and made recommendations for improving it. The Strategy is being updated during 2005 (for more information: www.ansi.org/nss or www.ansi.org/usss).

Both U.S. government and private-sector stakeholders participate in both domestic and international standards activities in a variety of ways: through treaty organizations where governments are members; through non-treaty organizations where private-sector entities are members; through professional and technical organizations whose membership is on an individual or organizational basis; and through consortia and other forums.

Regardless of the venue, as a signatory of the World Trade Organization, the U.S. is responsible for pursuing standardization activities that are in full compliance with the WTO Agreement on Technical Barriers to Trade (WTO/TBT) and its internationally accepted principles of standardization – transparency, openness, impartiality, effectiveness and relevance, consensus, performance-based, coherence, due process, technical assistance. In addition, U.S. interests strongly agree that the process should be flexible, timely, and balanced.

Organizations that are accredited by ANSI to develop American National Standards or to serve as U.S. Technical Advisory Groups (U.S. TAGs) to the International Organization for Standardization (ISO), or organizations that are approved by ANSI’s U.S. National Committee (USNC) of the International Electrotechnical Commission (IEC) to serve as U.S. TAGs to IEC committees, are required to adhere to a set of essential requirements that are aligned with the WTO principles.

Government bodies such as the U.S. Department of Commerce and its agencies (e.g., NIST and the International Trade Administration (ITA)); the U.S. Department of State; the Office of the U.S. Trade Representative (USTR), and other regulatory agencies throughout the federal system work closely with each other, with ANSI, and with others in the private sector on issues affecting U.S. competitiveness in the global marketplace.

Examining the Other Side of the Coin

On the other side of the standardization coin is conformity assessment⁵, a term used to describe the evaluation of products, processes, systems, services or personnel to confirm adherence to the requirements identified in a specified standard. Conformity assessment activities such as testing, certification, and accreditation are closely associated with standards and provide the consumer or end user with a measure of confidence in the products and services being purchased. For this reason, conformity assessment has become a critically important aspect of conducting business in the global marketplace and is often made visible through product marking or other marketing and promotional efforts.

ANSI’s role in the conformity assessment arena includes accreditation of organizations that certify that products and personnel meet recognized standards. The ANSI-American Society for Quality National Accreditation Board (ANAB) serves as the U.S. accreditation body for management systems certification, primarily in areas such as quality (ISO 9000 family of standards) and/or the environment (ISO 14000 family of standards). ANSI also is involved in several international and regional organizations to promote multilateral recognition of conformity assessments across borders to preclude redundant and costly barriers to trade.

Conclusion

The U.S. commitment to global standardization and conformity assessment is strong and unequivocal, but it is a commitment made without bias to any specific organization or standards development methodology. The U.S. standardization system recognizes and respects the fact that many well-known international standards bodies coexist with hundreds of other entities that develop standards for global use and that no single method of standards development can satisfy the needs of all sectors.

Rapidly evolving technologies such as information technology, telecommunications, and nanotechnology, for example, have requirements that are far different from those of steel or textiles or highly regulated technologies such as medical devices and pharmaceuticals. The stakeholders in the standardization process — companies, government agencies, public interest organizations, and individuals — choose the method of standards development and the conformity assessment scheme appropriate for their particular needs.

The complexity of the U.S. standardization and conformity assessments system is balanced with its flexibility. The decentralized, sector-based and market-driven standards system is extremely responsive to changing market demands, guides the energy of U.S. innovation and enhances the global competitiveness of U.S. business while at the same time improving the U.S. quality of life. It is an outstanding example of how a strong, dynamic partnership between government and the private sector can help the nation achieve its economic and societal goals.

1. Unless a more specific indication is included in future references, “government” should be read as “government at all levels and all jurisdictions, whether federal, state or local.”

2. The American Institute of Electrical Engineers (now IEEE), the American Society of Mechanical

Engineers (ASME), the American Society of Civil Engineers (ASCE), the American Institute of Mining and Metallurgical Engineers (AIMME), the American Society for Testing Materials (now ASTM International), the U.S. Departments of War and the Navy (now Defense) and the U.S Department of Commerce.

3. Page 5, Standards & Competitiveness: Coordinating for Results, U.S. Department of Commerce, May 2004.

4. ANSI accredits standards developing organizations (SDOs) that meet a set of essential requirements and criteria that govern the management of consensus standards development in a fair and open manner. ANSI’s approval of a candidate standard as an ANS verifies that the principles of openness and due process have been followed and that a consensus of all interested parties has been reached. Due process requires that all proposed ANSs be circulated to the public at large for comment, that an attempt be made to resolve all comments, and that there is a right of appeal. In addition, ANSI considers any evidence that a proposed ANS is contrary to the public interest, contains unfair provisions or is unsuitable for national use. This basic formula has been the hallmark of the ANS process for decades, and it has garnered worldwide respect and acceptance.

5. Elements of conformity assessment include the accreditation of laboratories and certifiers; the certification of products, processes, systems, services and personnel; metrology and measurement; testing and sampling, inspection, supplier’s declaration of conformity, and more.