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 20th 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.
