The Handbook of Standardization
Standards are a fundamental part of our daily lives for a multitude of reasons. They open channels of communication and commerce, promote understanding of the products of technology, ensure compatibility, enable mass production, and most importantly they form the basis of achieving health, safety, and a higher quality of life.
We are literally surrounded by standards. The buildings we live in, the airplanes we fly on, the roads we travel, the computers we operate, even the clothes we wear are all manufactured in accordance with standards. All these things "work" smoothly and efficiently if the standards to which they were manufactured were properly developed and applied.
Because of the ever-growing importance of standards, this booklet has been developed to cover the standards system in the United States and its relationship to global standards. It explains how standards are developed by the private and public sectors, and gives an overview of the major organizations involved with standards. When examples are given to illustrate a point, ASTM will be cited. ASTM is one of the worlds largest standards developing organizations.
What Is a Standard?
Thousands of such standards are readily available, and thanks to the common language of standardization, buyer and seller have little difficulty communicating.
The U.S. Standards System
In the United States, there are essentially two broad categories of standards with regard to regulation--mandatory and voluntary.
Mandatory standards are set by government and can be either procurement or regulatory standards. A procurement standard sets out the requirements that must be met by government suppliers; regulatory standards may set health, safety, environmental, or other criteria.
Voluntary standards--In the United States, the voluntary standards development system is called "voluntary" for two reasons. First, participation in the system is voluntary. Second, the standards produced usually are intended for voluntary use. Voluntary consensus standards are developed through the participation of all interested stakeholders including producers, users, consumers, and representatives of government and academia.
In the United States, the distinction between voluntary and mandatory standards is not clear cut. Often, government standards developers refer in their regulations to privately developed standards, and in that reference give the standard the force of federal, state, or local law. Building codes, for example, reference hundreds of standards developed by voluntary standards organizations. Since building codes are the province of government, the referenced standards have the force of law and must be adhered to. Regulatory agencies such as the Environmental Protection Agency, the Food and Drug Administration, and the Department of Housing and Urban Development also reference hundreds, if not thousands of voluntary consensus standards in lieu of developing their own documents. These too, have the force of law once they are referenced in a government regulation. In the wake of the U.S. National Technology Transfer and Advancement Act (Public Law 104--113), which requires government agencies to use privately developed standards whenever it is at all possible, this practice is on the increase, saving taxpayers millions of dollars in formerly duplicative standards development efforts.
Who Develops Standards in the United States?
ANSI--The American National Standards Institute is as close as the United States comes to a central voice for standards development. A not-for-profit, non-governmental organization based in New York, N.Y., ANSI does not develop standards; its major role is to serve as the U.S. member body to the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), coordinating the U.S. position in the development of these international standards. In addition, ANSI accredits standards developing organizations (SDOs) according to their consensus processes and accredits standards developed by SDOs as American National Standards. (www.ansi.org)
NIST--The National Institute of Standards and Technology (NIST) has the explicit mission of assisting U.S. industry to advance its performance in the development and application of technology. Today, NIST is the U.S. government agency with leading expertise in the area of technology standards and industry standardization issues and its staff is involved in both U.S. and international voluntary consensus standards development activities. (www.nist.gov)
Government Agencies--As mentioned above, the U.S. government is also a standards developer. While the National Technology Transfer and Advancement Act encourages less and less actual development of standards within government agencies, government employees participate in the development of, and reference, standards developed in the private sector. U.S. government agencies that rely on standards run the gamut from the Department of Agriculture, through the General Services Administration, to the Department of Veterans Affairs.
Other types of SDOs in the United States include professional societies, industry associations, membership organizations, and consortia.
Standards Development Abroad
ISO--The International Organization for Standardization, a private international agency, headquartered in Geneva, Switzerland, is dedicated to the development of voluntary standards. Its membership consists of the recognized national standards bodies of 133 nations. ISO has over 180 technical committees devoted to almost all areas of international standardization except for electrical and electronic standards (covered by the IEC, see below) and telecommunications (covered by the ITU, see below). The final publication of an ISO standard requires the majority consensus of technical committee members and 75 percent of the ISO voting membership. (www.iso.ch)
IEC--The International Electrotechnical Commission, an international voluntary organization headquartered in Geneva, is responsible for international standards in the area of electrical and electronic engineering. Its main concern is the development of specification standards for products and devices. Its membership consists of the presidents from the national committees of over 50 countries. In addition to developing and issuing standards, IEC issues publications and recommendations for international standards, as well as promoting safety, compatibility, interchangeability, and acceptability. (www.iec.ch)
ITU--The International Telecommunications Union is the only international SDO that is non-voluntary. It is a treaty organization run under the auspices of the United Nations. Governments, not industry, administer and enforce the regulatory telecommunications standards that come out of the ITU. The U.S. Department of State is the U.S. representative to the ITU. (www.itu.int) For both ISO and IEC, ANSI is the member body representing the United States. ANSI coordinates technical advisory groups (TAGs) that represent U.S. interests at both ISO and IEC. ASTM holds close to 200 TAGs in ISO.
How Do Voluntary Standards Get Written?
As mentioned, a full consensus standard is developed by a cross-section of stakeholders with an interest in its use. When there is a need for new standards, requests can come from trade associations, governmental agencies, and professional societies that do not create their own standards; or manufacturers, consumer groups, and even individuals. The exact process of forming technical committees and developing and approving the draft standard varies from SDO to SDO.
Generally, standards-writing committees are groups of experts who volunteer their time in draft-development sessions. They are seeking the mutual benefit of all concerned through consensus. As an illustration of how SDOs develop standards, well follow the ASTM system.
ASTM--The diversity of ASTMs membership is perhaps its most distinct quality and is a large part of what distinguishes the Societys development and approval process from other organizations. Standards development at ASTM means working alongside competitors, customers, regulatory bodies, and other stakeholders to debate technical issues, share research data, and exchange knowledge. Through the ASTM process, these stakeholders learn to capitalize on their diversity and work in partnership with each other to resolve their differences during the standards development process rather than after.
Coupled with this cooperative system of standards development
is the ensuring of fairness through:
Understanding the hierarchy within ASTM is integral to appreciating the value of the ASTM standards development and approval process. The hierarchy comprises three basic levels: main committees, subcommittees, and task groups. Task groups perform most of the "leg-work" and research that forms the basis of draft standards. Once the group completes its work, it forwards these drafts through the hierarchy for review and voting. The standard must gain subcommittee, main committee, and Society approval before becoming an official ASTM standard.
At each level, voting requirements are enforced to ensure fairness. When the draft has been reviewed and accepted at all levels, the draft becomes an ASTM standard and is published. Depending upon the need for the standard, drafting and approval can occur in a few months, a year, or more.
The Standards Incentive
Standards are seldom the products of altruism. Individuals and organizations become involved in standards writing for very specific reasons. Among them are:
The Economic Incentive--Both producers and consumers reap the benefits of standards, which are the ability to manufacture and purchase more economically through mass production, to lower inventories by eliminating unnecessary grades, and to improve quality control.
The Public Service Incentive--Virtually every government agency is active in the standards forum because each has an obligation to act in the public interest. In the development of standards, representatives of government often serve as the spokesmen or voting voice of the consumer.
The Individual Incentive--Participation on a standards committee provides an outstanding opportunity for individual professional growth. Participants become more proficient in their fields and develop broader understanding, which often leads to wide recognition among their peers.
The Shared Work Incentive--Simply stated, it is far easier to arrive at solutions when
the knowledge and practical skills of many are brought to bear
on a problem. This is precisely what happens at the standards
tablethe members lend their collective expertise to producing
meaningful documents and at the same time, by their participation,
they preclude the development of standards that would serve only
narrow interests. Inevitably, the final product is far greater
than the sum of its parts.
In the more than 100 years since, ASTM has met the standards development needs of over 100 sectors, from construction materials and environmental risk assessment, to medical devices and petroleum products.
ASTM provides a voluntary consensus system for managing standards
development and makes its standards available in a variety of
print and electronic formats, as well as providing laboratory
proficiency testing programs and training in the use of standards.
100 Barr Harbor Drive
West Conshohocken, PA 19428-2959
www.astm.org Phone: 610/832-9500
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