Standards, Conformity Assessment, and Trade Into the 21st Century (1995) / Chapter Skim
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3 Conformity Assessment
3 Conformity Assessment
Pages 65-102
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From page 65... ...
A standard that meets these criteria, however, still fails to have the effect its developers intended if products designed to conform to it do not, in practice, conform. Conformity assessment is the comprehensive term for measures taken by manufacturers, their customers, regulatory authorities, and independent, third parties to assess conformity to standards.
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From page 66... ...
The third area is certification, formal verification by an unbiased third party, through testing and other means, that a product conforms to specific standards. Familiar examples of certification, among many others, are the Underwriters Laboratories product safety certification (the UL mark)
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From page 67... ...
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From page 68... ...
It is therefore in the manufacturer's interest to verify compliance with relevant standards. Certification of conformity by a third party does not free the manufacturer from liability.
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From page 69... ...
In these situations, assessment by a neutral third party is necessary or desirable. First, concerns about the safety, health, or environmental impact of a product are sometimes too important to be left to the manufacturer's own assessment and too expensive or technically difficult for the customer to perform.
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From page 70... ...
One major retail chain, as a matter of policy, rarely markets electrical appliances not bearing the UL label.~3 Many voluntary product safety standards, and the institutional mechanisms that assess conformity to them, were in fact developed to meet needs not covered by government regulations. In some cases, private certification programs are developed by an industry to forestall government regulatory intervention.
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From page 71... ...
This survey provides an indication of the size and rapid rate of growth of the independent testing industry. Testing laboratories (Standard Industrial Classification Code 8734)
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From page 72... ...
Many of the more than 400 members of the American Council of Independent Laboratories (ACIL) , the industry association for testing laboratories, are classified as engineering services firms rather than laboratories.
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From page 73... ...
Evaluation of the manufacturer's quality assurance system is part of some certification schemes, as discussed in the next section. Private and Public Certification Programs in the United States There are more than 110 private-sector product certifiers in the United States.27 Many private-sector certifiers are also independent testing laboratories.
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From page 74... ...
In addition to providing testing services, many of these laboratories take the additional step of certifying products as meeting particular standards. Members of the ACIL that test and certify products include, among many others, ETL Testing Laboratories, for consumer appliances, sports equipment, safety glass, and other areas; United States Testing Company, for areas such as toy safety and toxicology; and MET Electrical Testing Company, for workplace safety, telecommunications equipment, and others.29 A number of broadly familiar certification programs, many of which incorporate their own certification marks, are conducted by private, not-for-profit organizations.
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From page 75... ...
To meet this responsibility, hundreds of these agencies have established mandatory requirements by reference to private certification programs. Private programs are operated by a variety of model building code organizations.
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From page 76... ...
accepts manufacturers' declarations, is one example. Independent testing is generally performed by NHTSA only in the event of an actual or suspected product failure.4i Numerous other federal certification programs exist in connection with the broad mandates of regulatory agencies, such as the Federal Aviation Administration, for aircraft components, and the Food and Drug Administration, for pharmaceutical products.42 The third category of federal certification programs concerns product testing for public procurement.
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From page 77... ...
conformity assessment system is the rapid spread of quality system registration. This trend has been stimulated by European Union regulations for product safety and by a growing market demand particularly, outside the United States for independent assessment of producers' quality management systems.45 The best-known and fastest-growing aspect of this trend is registration to the ISO 9000 standards, a series of quality system standards published in 1987.
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From page 78... ...
The appropriateness of the product's design is outside the scope of the standards.50 Furthermore, although there is the potential for documentation systems such as those prescribed by the ISO 9000 series to improve U.S. manufacturers' quality, other management tools such as Total Quality Management (TQM' or the guidelines for the Department of Commerce's Malcolm Baldrige National Quality Award are better suited to meeting those goals for many firms.51 Quality system registration to standards similar to ISO 9000 has a proper role in the U.S.
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From page 79... ...
, for example, requires that suppliers of regulated components for nuclear power plants be registered to a quality system standard developed by the USNBC, 10 C.F.R. 50, Appendix B.56 The DoD Qualified Manufacturers List is another, separate quality system standard, as are the ISO 9000 standards.
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From page 80... ...
This removes the need for manufacturers, for example, to conduct their own costly and time-consuming evaluations of independent laboratories.64 Many large manufacturers require their suppliers' testing laboratories to be accredited as a condition for accepting suppliers'
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From page 81... ...
(Many certifiers are also testing laboratories, however, and are eligible for accreditation of their testing services.) The National Voluntary Laboratory Accreditation Program (NVLAP)
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From page 83... ...
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From page 86... ...
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From page 87... ...
All of these accreditations evaluate the same laboratory for the same area of competence. This redundancy imposes unnecessary, unjustifiable costs on laboratories and their customers.72 A General Accounting Office study in 1989 identified an area of significant overlap in laboratory accreditation programs operated by the federal government.
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From page 93... ...
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From page 94... ...
Council of American Building Officials / National Evaluation Service ETL Testing Laboratories, I no. Insulating Glass Certification Council International Association of Plumbing and Mechanical Officials International Conference of Building Officials Chemical, construction materials, electrical, mechanical, nondestructive, and thermal Construction materials Electrical, mechanical, and ionizing radiation Chemical, construction materials, electrical, mechanical, nondestructive, and thermal Mechanical and thermal Chemical and mechanical .
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From page 95... ...
Acoustic/vibration measurement, chemical, construction, electrical, mechanical, metrology, and thermal MTL Certification Services Co., Inc. Mechanical National Association of Independent Laboratories for Protective Equipment Testi ng Chemical, electrical, and mechanical National Board of Boiler and Pressure Vessel Inspectors Construction materials, mechanical, and thermal National Certified Testing Laboratories Mechanical and thermal National Electrical Testing Association Construction materials and electrical National Environmental Balancing Bureau Acoustic/vibration measurement, mechanical, and metrology National Marine Manufacturers Association Acoustic/vibration measurement, chemical, electrical, mechanical, and optics and photometry National Safe Transit Association Mechanical National Wood Window and Door Association Construction materials, mechanical, and thermal Performance Review Institute / NADCAP Precast/Prestressed Concrete Institute Safety Glazing Certification Council Solar Rating and Certification Program Southern Building Code Congress International U.S.
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From page 96... ...
The ASTM standard for radiant panel testing is only one of many standard test methods subject to this degree of multiple accreditation.74 Data from three private, independent testing laboratories illustrate the cost burden of multiple accreditation in the U.S. system.
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From page 97... ...
By relying on competent, private accreditation services to evaluate testing laboratories, instead of performing those evaluations directly, government agencies can reduce costs while continuing to meet their need for confidence in the reliability of product testing data. Recognition programs, as indicated in Table 1-1, are in an early stage of development.
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From page 98... ...
In contrast to NVCASE, which applies only to exported products, NIST's activities under the Fastener Quality Act apply to conformity assessment associated with domestic regulatory requirements. The purpose of the act is to regulate the quality of fasteners for private commerce and public procurement.82 The act requires NIST to establish programs both to accredit the competence of laboratories to test fasteners, and to recognize private accreditors of testing laboratories.
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From page 99... ...
The procedures for carrying out this function are known collectively as conformity assessment. Product testing, certification, and laboratory accreditation services are key elements of the U.S.
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From page 100... ...
11. For an overview of areas regulated through federal conformity assessment programs, see Breitenberg, ea., Directory of Federal Government Certification Programs.
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From page 101... ...
54. Breitenberg, Q&A on ISO 9000; and Performance Review Institute, National Aerospace and Defense Contractors Accreditation Program, brochure, n.d.
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From page 102... ...
67. See NIST, National Voluntary Laboratory Accreditation Program: Procedures and General Requirements.
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