The Commerce Department’s National Institute of Standards and Technology will meet, on March 19, with government and private-sector experts to begin devising ways to simplify procedures used to assess product worthiness as part of a Clinton Administration effort to ensure that U.S. firms and their products remain competitive in the global market.
"At present, often-complex methods for assessing a product’s conformity to government regulations or voluntary standards have a significant impact on the competitiveness of U.S. companies and their products at home and abroad," said NIST Director Ray Kammer.
The upcoming meeting, to be held at the Commerce Department, stems from a recent national workshop convened to discuss conformity-assessment issues arising from the welter of test, product-certification and other requirements that confront business in the United States and in foreign markets.
At the workshop, some 150 representatives of companies, trade associations, government agencies and laboratory accreditors called for efforts to simplify and streamline conformity assessment procedures. The meeting was sponsored by NIST, the American National Standards Institute, and ACIL (formerly, the American Council of Independent Laboratories).
Conformity assessment refers to the varied activities involved in assuring that products, processes or systems comply with regulations or voluntary standards. These activities range from tests of components to accreditation methods that assess the competence of testing laboratories to procedures for evaluating accreditor performance. Participants complained that even the vocabulary of the field is so complex that experts often disagree on the precise meaning of terms.
"In many sectors," Kammer said, "we still see duplicative, redundant conformity assessment activities. Various players—in government and in the private sector—refuse to accept each other’s audits, tests and certificates, even when they are essentially equivalent to one another."
U.S. exporters face two types of conformity assessment hurdles. Other nations may not recognize test results and product approvals issued by accredited U.S. laboratories, or they may impose entirely different sets of requirements that entail additional testing by laboratories in the destination market. Either way, the effect is a barrier to market entry that increases the cost of doing business.
Because of the large size of the U.S. system and the diversity of approaches that have evolved to serve different industries, ANSI President Sarge Mazza advised against pursuing one all-encompassing approach to conformity assessment issues. "Every sector has unique needs," Mazza said. "Each requires an individualized response."
In some sectors, for example, testing by accredited, third-party laboratories may be required for companies to prove regulatory compliance. In others, a so-called supplier’s declaration of conformity, or SDoC, may be sufficient. Under a SDoC scheme, endorsed by U.S. and European firms participating in the Transatlantic Business Dialogue, companies assume full responsibility for meeting requirements. Market-surveillance mechanisms can be used to monitor performance.
SDoC minimizes costs, shortens time to market and offers other advantages that ultimately benefit customers, according to Joel Urman, IBM director of corporate standards. "SDoC should be an available option that is treated equally with other forms of conformity assessment," he said.
Several workshop participants noted that small companies are especially disadvantaged by the current situation. They recommended that steps to streamline conformity assessment also should be designed to "level the playing field" for small business.
The federal government’s appropriate role also remains to be defined. In many European countries, national governments play a direct role, conferring formal recognition on bodies that accredit testing laboratories. In the United States, each government agency chooses its own approach to conformity assessment.
Depending on the sector and relevant regulations, some agencies provide it directly, while others work through third parties. As a result, a laboratory, product certifier, or other conformity assessment body may have to undergo multiple audits for many different governmental and industry programs, even when there is considerable overlap.
Maryland Congresswoman Constance Morella maintained that government has an important job to perform—as a facilitator and catalyst of private-sector agreements. Morella was the primary sponsor of the National Technology Transfer and Advancement Act of 1995, which gives NIST federal responsibility for coordinating conformity-assessment and other standards-related activities.
Morella told the audience that she remained committed to the goals of the NTTAA, and to working with NIST, other federal agencies, and the private sector to sort out the challenges arising from the unique U.S. approaches to standards and conformity assessment.
For example, in the United States, there are an estimated 50,000 testing laboratories and more than 150 laboratory accreditation programs—nearly all of them in the private sector. This decentralized conformity assessment system, according to workshop participants, has resulted in high levels of safety and consumer protection. But its complexity also results in inefficiency and imposes unnecessary costs.
Participants endorsed the concept behind the fledgling National Cooperation for Laboratory Accreditation, a public-private initiative to build a comprehensive infrastructure for U.S. laboratory accreditation. Spearheaded by NIST, ACIL and ANSI, NACLA aims to facilitate straightforward national and international acceptance of results provided by laboratories accredited as competent according to uniform procedures based on national and international guidelines.
While they generally supported the NACLA approach, participants also urged the organization to speed up its efforts. NACLA will hold its first annual general membership meeting on March 25, 1999, at NIST.
Besides assisting in the development of NACLA and other tools to make it easier for companies to prove compliance with regulations and specifications, Kammer suggested that NIST can take other steps. For example, he said, NIST can "work to cajole" federal agencies to recognize equivalency of conformity assessment results, which would reduce duplicative testing.
As a non-regulatory agency of the U.S. Department of Commerce's Technology Administration, NIST promotes economic growth by working with industry to develop and apply technology, measurements and standards through four partnerships: the Measurement and Standards Laboratories, the Advanced Technology Program, the Manufacturing Extension Partnership and the Baldrige National Quality Program.