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Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
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3
Conformity Assessment

In Chapter 1, seven functions of product and process standards were described: fostering commercial communication; diffusing technology; raising productive efficiency; enhancing market competition; ensuring physical and functional compatibility; improving process management; and enhancing public welfare (see Table 1-1). To succeed in these functions, standards must be well designed, based in sound technology, appropriate to the task at hand, and accepted as valid and useful by the population of users. The U.S. system for developing standards that meet these conditions is examined in Chapter 2.

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. Conformity assessment and standardization are separate activities. The two are, however, closely related. Conformity assessment depends on the existence of unambiguous standards against which products, processes, and services are assessed. Conformity assessment enhances the value of standards by increasing the confidence of buyers, users, and regulators that products actually conform to claimed standards.1

The United States has an extensive and increasingly complex conformity assessment system.2 Like the standards development system, it has evolved in a decentralized manner. As the needs of industry, government and society have changed and grown, particularly in the past 20 years, new elements and new layers of complexity have become part of the system. While each element has been motivated by specific marketplace or regulatory demands, the overall growth

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
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of the system has been uncoordinated. As discussed in this chapter, the result is the imposition of large costs associated with duplication, redundancy, and unnecessary complexity on testing laboratories, product certifiers, manufacturers, and ultimately, their customers.

Conformity assessment comprises four areas (see Figure 3-1). For convenience of discussion, the terms used in this figure focus on manufactured products.3 The same concepts, however, also apply to conformity of processes and services. The first area, manufacturer's declaration of conformity, is assessment by the manufacturer based on internal testing and quality assurance mechanisms. Second is testing of products, parts, and materials performed by independent laboratories as a service to the manufacturer. Independent testing may be of value to the manufacturer as an outside confirmation of in-house test results; it may be required by a customer as a condition of sale; or it may be mandated by a regulatory agency. Independent testing services may also enable small manufacturing firms to operate without the need to maintain an in-house testing capacity. 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) and the U.S. Department of Agriculture quality grade for meat and poultry. The final area is quality system registration, the result of independent audit and approval of the manufacturer's quality system. A quality system is a management system, including procedures, training, and documentation, for ensuring consistency in product quality. Quality system registration is not an assurance of product quality; rather, it is a component of broader mechanisms for assessing products.

The purpose of these conformity assessment activities is to provide the relevant parties—such as the purchaser of a product or the regulatory agency with authority over a product—with whatever degree of confidence is needed in a particular circumstance. For a purchaser, that circumstance is the decision on whether to buy; for a regulator, it is the decision to approve or disallow the product for use or installation. In the absence of independent assurance of product conformity to standards, a purchaser or regulator must take the manufacturer's word that the product conforms. In most situations, as discussed below, this level of assurance—the manufacturer's declaration of conformity—is entirely sufficient and appropriate. Other elements of the conformity assessment system have evolved to meet the need for additional assurance in specific situations. The uncoordinated manner in which the system has grown and continues to grow, however, has raised costs and created obstacles to both domestic and international commerce.

This chapter identifies strengths and weaknesses in the U.S. conformity assessment system. To the extent possible, given the limited availability of economic data about the system, the economic impact of these inefficiencies is also examined. Interconnections between U.S. and international conformity assessment

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

 

 

THIRD—PARTY ACTIVITIES

 

Manufacturer's Declaration of Conformity

Product Testing

Product Certification

Manufacturing Processes: Quality System Registration

LEVEL 1:

ASSESSMENT

Manufacturer's own testing and quality assurance;

BY: manufacturer

Testing of products, components, materials, etc.;

BY: independent laboratory

Certification of products against a standard or set of standards;

BY: product certifier

Audit and registration of manufacturer's quality assurance system (e.g., against ISO 9000 standards);

BY: quality system registrar

LEVEL 2:

ACCREDITATION

Acceptance;

BY: customer or regulatory authority

Accreditation of laboratory's competence;

BY: laboratory accreditation program (private or government)

Accreditation of certifier;

BY: certifier accreditation program (private or government)

Accreditation of quality system registrar;

BY: registrar accreditation program (private or government)

LEVEL 3:

RECOGNITION

Acceptance;

BY: customer or regulatory authority

Official recognition of laboratory accreditation program;

BY: government*

Official recognition of certifier accreditation program;

BY: government*

Official recognition of registrar accreditation program;

BY: government*

FIGURE 3-1 Conformity Assessment System Framework (mechanisms for ensuring that products conform to standards).

NOTE: ISO = International Organization for Standardization.

* Government recognition programs are in very early stages of development.

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
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systems and their effect on U.S. international trade performance are discussed in Chapter 4.

Conformity Assessment System Framework

The first level of the framework shown in Figure 3-1, assessment, represents the primary level at which the four activities of conformity assessment take place. At level 1, manufacturers, testers, certifiers, and quality system registrars evaluate products, processes, and services. These evaluations are the direct substance of conformity assessment—the comparison of a product to a standard. The second and third levels of the framework, accreditation and recognition, represent activities to evaluate the competence of the assessors operating at levels 1 and 2, respectively. Accreditation (of laboratories, certifiers, and registrars) and recognition (of accreditors) add additional layers of complexity and expense to the system. They have evolved in response to specific commercial and public sector demands. They add cost to the system, however, and have frequently been implemented in an uncoordinated, redundant fashion. This is the case in both the public and the private sectors, discussed below.

Manufacturers' internal assessment procedures, leading to a manufacturer's declaration of conformity, are the simplest and oldest form of conformity assessment. The vast majority of commercial transactions take place without third-party assessment of product conformity.4 Most manufacturers, especially large-and medium-sized firms, conduct their own testing and quality assurance to some degree of precision. In the marketplace, the buyer looks at a product, reads the packaging or advertising, and makes a decision. The buyer accepts the manufacturer's statements about the features of a product based on trust—and, to the extent feasible, on inspection of the product before buying it. This trust is, of course, founded on the customer's freedom to switch to a competitor's product if dissatisfied. Success and failure in the marketplace give manufacturers powerful incentives to support claims and maintain consistent quality. Truth-in-advertising laws, which are enforced by the Federal Trade Commission, also motivate manufacturers to ensure that products conform to advertised characteristics.5

The threat of private liability claims related to nonconforming products is also a strong incentive facing manufacturers. Conformity to safety standards—whether voluntary or regulatory—does not necessarily protect manufacturers against damage awards in product liability lawsuits. A finding that a product that harmed someone failed to conform6 to relevant standards, however, is highly likely to result in an award of compensation. 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. As a result, manufacturers of potentially dangerous products generally maintain internal testing and assurance procedures, even if they also seek third-party assessment.7

In some situations, a purchaser needs a stronger guarantee of product conformity

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

than is provided by the freedom to change suppliers. This is increasingly true in capital-goods sectors. A case in point is that of manufacturers who purchase large volumes of parts, systems, or materials from suppliers (who, in turn, may purchase from lower-tier suppliers). The purchase contract between manufacturer and supplier provides formal specifications, or standards, that the supplied products must meet. If the purchaser must wait until delivery to inspect the product and send defective parts back to the supplier, the cost of delays in production while waiting for replacement parts—or finding a new supplier—can be very high. The rise of "just-in-time" manufacturing processes, with minimized inventories and requirements for instant supply of defect-free parts from external suppliers, has increased the cost of delays.8

Second-party conformity assessment is an outgrowth of this type of demand for assurance. In second-party assessment, only the two parties, supplier and purchaser, are involved, and the purchaser's own inspectors perform the assessment. By inspecting the supplier's production line, manufacturing processes, and samples or batches of parts before they leave the supplier's factory, a purchaser can gain confidence in the supplied products and reduce the potential for delays in his or her own production line. The benefit of obtaining this assurance, however, must be weighed against the cost of performing assessments.9

Third-party assessment is the sector of the conformity assessment system that has grown most in recent years.10 In most commercial interactions, there is no need for the added expense and complexity of third-party conformity assessment. There are, however, two sets of circumstances in which relying on the manufacturer's declaration and the purchaser's own assessment is inadequate. 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. This is true, for example, of products whose failure could lead to injury, illness, property damage, or loss of life. In these cases, it is unacceptable to discover the product's nonconformity after a failure has occurred.

Much of the U.S. conformity assessment system exists specifically to address this type of safety, health, and environmental concern. In regulated product sectors, such as aircraft, automobiles, agricultural chemicals, heavy machinery, and drugs, a regulatory authority requires competent, prior assurance of conformity to relevant standards before a product can be accepted and used.11 At lower levels of risk, this assurance may simply be the manufacturer's own declaration of conformity. This level of assurance imposes the least costs on industry and consumers. Many regulations, however, require third-party assessment to verify product safety. Drug safety certification required by the Food and Drug Administration is an example of a federal program of this type.12 Third-party assessment requirements for regulatory enforcement should be limited, ideally, to product

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

sectors in which serious risk of harm justifies the cost burden of imposing third-party assessment.

Unregulated products may also be subject to third-party assessment as a result of marketplace demands. Purchasers may choose to demand independent, private assessment of product safety. They may, for example, buy only products bearing a recognized third-party certification mark, such as the Underwriters Laboratories UL mark or the American Gas Association Laboratories seal. One major retail chain, as a matter of policy, rarely markets electrical appliances not bearing the UL label.13 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.14

The second category of demand for independent assessment applies primarily to the relationship between manufacturers and their primary, secondary, and tertiary suppliers of parts and materials. As noted previously, purchasers may demand prior assurance that parts will conform to contract specifications, rather than relying on postdelivery inspection. The purchaser may choose to rely on a neutral third party to provide this assurance, rather than performing these assessments directly. Whether assessment is second party or third party, a range of approaches is available. For completeness, every single part could be inspected for conformity to the contract specification. Inspection of 100 percent of the parts is costly, however, and justifiable only if the consequences of a single nonconformity would be severe. An intermediate form of assessment involves inspection of samples of the supplier's product, combined with an assessment of the supplier's overall system for maintaining consistent product quality.

In select circumstances, third-party conformity assessment has advantages over second party for meeting the needs of suppliers and manufacturers. In an industry in which each supplier sells to many purchasers, it is redundant for each supplier to be audited and approved by every manufacturer, all performing essentially the same assessment. A single assessment of the supplier by a competent third party can, in this case, replace multiple second-party assessments.15

The remainder of this chapter focuses on third-party conformity assessment, rather than second party or manufacturer's declaration. There are two reasons for this focus. First, the activities of a manufacturer and purchaser to assess conformity are less a matter of public policy than they are the internal, competitive concern of the firm. They are intimately tied to research and development, testing, manufacturing process management, inventory control, and other activities within a firm's operations. As such, they are not directly within the scope of this study. Second, third-party assessment is the portion of the system in which the greatest growth and complexity have appeared, as discussed in the next two sections.

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

Testing And Certification

Product Testing

Independent laboratories that perform testing services for clients comprise the largest share of the U.S. conformity assessment system. The Bureau of the Census publishes an annual survey of U.S. service industries. 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) that are subject to federal taxes accounted for a total revenue of more than $5.1 billion in 1992, an increase of 6.8 percent over 1991 (see Table 3-1). An average annual growth of 13.5 percent from 1985 to 1992 indicates a very high rate of expansion in this sector, mirroring the overall rapid growth in third-party conformity assessment in the United States.16 More detailed data are available in the

TABLE 3-1 —U.S. Independent Laboratory Testing Services—Total Revenues (millions of dollars)

YEAR

TOTALa

FOR-PROFIT FIRMS

NOT-FOR-PROFIT FIRMSa

1985

2,324

2,121

203

1986

2,370

2,163

207

1987

2,624

2,395

229

1988

3,438

3,138

300

1989

4,180

3,815

365

1990

4,977

4,543

434

1991

5,330

4,817

460

1992

5,637

5,145

492

a Estimated, except 1987.

SOURCES: U.S. Bureau of the Census. Census of Service Industries: Subject Series, Miscellaneous Subjects. Summary pp. 4-9 and 4-11. Washington, D.C.: U.S. Government Printing Office, 1987.

U.S. Bureau of the Census. Service Annual Survey: 1992. P. 18. Washington, D.C.: U.S. Government Printing Office, 1994.

U.S. Bureau of the Census. Service Annual Survey: 1991. P. 25. Washington, D.C.: U.S. Government Printing Office, 1993.

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

Census of Service Industries, published every five years. The most recent edition, for 1987, divides revenues in the industry between firms subject to federal income tax (91 percent of the total) and tax-exempt, or not-for-profit, institutions (9 percent).17

These data do not, however, capture the full scale of third-party testing. 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.18 These firms are members of ACIL because a significant share of their business consists of testing services. Their revenues from testing are not, however, separately identified in the Census Bureau data.19 Engineering services totaled $61.5 billion in revenue in 1992.20 When the number and size of ACIL members that identify themselves as engineering services firms are taken into account, and the Census data are scaled accordingly, independent laboratory services in the United States are estimated to be a $10.5 billion industry.

Testing services encompass a broad spectrum of technical activities and competencies. The International Organization for Standardization (ISO) definition of a test, in the context of conformity assessment, is a "technical operation that consists of the determination of one or more characteristics of a given product, process or service according to a specified procedure."21 Materials, parts, and completed products may all be tested for their physical properties, such as strength and durability; physical dimensions; electrical characteristics, including interference with other electrical devices; acoustical properties; chemical composition; presence of toxic contaminants; and multitudes of other features.

Testing laboratories serve several categories of clients. The 1987 Census of Service Industries separates the receipts of independent testing laboratories, by class of client, into 8.7 percent federal government, 4.9 percent state and local governments, and 86.4 percent other clients—mainly private industry. Manufacturers rely on independent testing as a check against their own tests. Testing against specific standards provides independent data to support manufacturer's declarations of conformity to purchaser specifications or government regulations. Purchasers—including large manufacturers and government procurement agencies—rely on third-party testing to verify the conformity of parts and products to their stated specifications. Regulations frequently require manufacturers to show compliance through results of independent testing. The Occupational Safety and Health Administration (OSHA), for example, requires equipment used in the workplace to be tested by an independent laboratory accredited under OSHA's Nationally Recognized Testing Laboratory (NRTL) program.22

Product Certification

Certification is a form of conformity assessment that involves determining whether a product, process, or service meets a specific standard or set of standards.

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

Certification is a ''procedure by which a third party gives written assurance that a product, process or service conforms to specified requirements."23 It is, by definition, exclusively a third-party activity. In the past, the manufacturer's declaration of conformity was sometimes referred to as "self-certification." The term caused confusion, however, and has been dropped both internationally and by the American National Standards Institute (ANSI) accredited committee for writing certification procedural standards, Committee Z34.24

Certification usually requires performance of product tests. The testing component of U.S. certification activities is included in the industry revenues data in Table 3-1; however, aggregate data on revenues from certification as a whole are not available. Certification is distinguished from testing by three key features. Certification always measures a product (or process or service) against one or more specific standards, whether mandatory, voluntary, or de facto. Testing, by contrast, does not necessarily measure against any specific standard. Second, certification is always performed by a third party, independent of either the supplier or the purchaser. Finally, certification results in a formal statement of conformity—a certificate—that can be used by the manufacturer to show compliance with regulations, meet purchasing specifications, and enhance the product's marketability. The certifier often licenses the manufacturer to print a certification mark on the product or its packaging, potentially increasing its acceptability to the buying public. Certification marks are the property of the certifier and are registered with the U.S. Patent and Trademark Office.25

Certification may encompass many different levels of complexity and expense, depending on the characteristics of the product and the degree of need for confidence in the product's conformity to standards. The more complex and intrusive the certification program is, the greater is its cost.26 In sectors with high demands for safety and reliability, certifiers may require a relatively intensive certification process, involving multiple tests, one or more factor inspections, and testing of large numbers of product samples. Lower levels of need for assurance may be satisfied by type testing—the testing of one or a few samples as typical of all products with the same design and materials. Some certification programs require follow-up testing of additional samples obtained at the factory or on the open market in order to maintain certified status. 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. Some certifiers, mainly those operating smaller programs, certify products on the basis of tests performed by other facilities. These tests must be performed by laboratories that are independent of the manufacturer. Whether testing is performed

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

by the certifier or an independent laboratory, the certifier's role is to interpret the standard and judge whether the test results justify declaring the product to be in conformance.28

The majority of third-party certifiers in the United States are private, for-profit testing laboratories. As discussed in the previous section, these represent a large and growing service industry. 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. Underwriters Laboratories (UL), founded in 1894, is one of the oldest certifiers in this country. UL is a major standards developer in the consumer product safety area, with more than 600 published safety standards.30 It is also a leading tester and certifier of products, devices, and materials. UL certification of product safety—known as "listing" the product—authorizes the manufacturer to print UL's certification mark on the product or its packaging. Another not-for-profit testing and certification organization is the Factory Mutual Research Corporation. Factory Mutual tests and lists approved products as part of a series of activities to reduce industrial property damage.31

NSF International is a private, not-for-profit certifier in the areas of public health and the environment. NSF, like UL, is also a developer of ANSI-approved consensus standards. NSF's product standards and certification activities include, for example, a drinking water additives program initiated in 1985 under a cooperative agreement with the U.S. Environmental Protection Agency (EPA). NSF certifies products for compliance with ANSI/NSF Standards 60 and 61, for drinking water treatment chemicals and water system components. These certifications are accepted for regulatory purposes by the EPA and state regulators.32

The American Gas Association (AGA) certification program has been in operation since 1925. AGA tests in its own laboratories and certifies gas appliances and accessories, including furnaces and cooking appliances. Requirements for AGA certification, besides testing, include a review of design information and construction parameters, as well as factory and quality control inspections.33 Other industry association-operated certification programs include those of the Air Conditioning and Refrigeration Institute, for air conditioners and water coolers, and the Association of Home Appliance Manufacturers, for refrigerators, air conditioners, and dehumidifiers.

The National Board of Boiler and Pressure Vessel Inspectors certifies boilers and components, water heaters, and nuclear reactor installations for compliance

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

with the American Society of Mechanical Engineers' Boiler and Pressure Vessel Code. A professional association-operated program that is likely familiar to many consumers is that of the American Dental Association (ADA), whose certification mark is printed on toothpaste tubes. The ADA assesses product specifications provided by the manufacturer and tests samples purchased on the open market.34

Construction and building materials certification is an area of great activity and complexity in the U.S. system that overlaps the public and private sectors. As noted in the previous chapter, state and local governments are responsible for establishing safe building codes. 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. These include the Building Officials and Code Administrators International, the International Conference of Building Officials, and the Southern Building Code Congress International.35 These organizations compete with one another for certification business. In the absence of reciprocal recognition among these programs, manufacturers of building products and materials must seek multiple, redundant certifications to sell in multiple jurisdictions.36

States are active in other areas of product certification in addition to building materials. The most recent comprehensive directory of such programs, compiled by NIST in 1987, identifies states with regulations in products sectors ranging from agriculture and alcoholic beverages to consumer goods, machinery, and transportation.37 Some of the sectors with the broadest coverage among states are agricultural commodities, regulated by 43 states; plant nursery stock, 47 states; road and bridge construction materials, 49 states; and measuring and weighing devices, all 50 states.

Requirements for certification in most product sectors vary by state. Activities to harmonize these requirements on a nationwide basis, however, are limited. One exception is in the area of weighing and measuring devices. These devices are required to be certified in order to ensure accurate, reliable measurement of commodities for sale. Under the leadership of the National Institute of Standards and Technology (NIST), the National Conference on Weights and Measures has worked to foster mutual recognition among more than 3,000 state and local weights and measures authorities throughout the United States. Through a network of agreements among these authorities, products may be weighed, measured, and packaged in one jurisdiction without having to be remeasured when shipped elsewhere in the United States.38 Although specific estimates of U.S. economic benefit from this program do not exist, it is clear that the economies of scale created by this country's large domestic market would be reduced if the free flow of domestic commerce were interrupted for reweighing of packaged products at state lines.

A 1988 directory published by NIST lists 84 certification programs run by federal agencies. These draw their authority from a range of federal laws and

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

regulations. Public sector certification programs serve three principal functions.39 The first is to create a level playing field for commerce by assessing and enforcing standards for the quality of products for sale. An example is U.S. Department of Agriculture (USDA) certification of meat and poultry quality. Certification against USDA standards is voluntary, but the marketing advantage it provides is sufficient incentive for many producers to participate.40 This category of activity relates closely to the federal role in maintaining reference standards as a public service, as discussed in Chapter 2.

A second set of federal programs certifies products against health, safety, and environmental regulations. Not all federal regulatory standards are accompanied by third-party certification requirements. In many industries, regulators accept the manufacturer's declaration of conformity to regulations. The automotive industry, in which the National Highway and Traffic Safety Administration (NHTSA) accepts manufacturers' declarations, is one example. Independent testing is generally performed by NHTSA only in the event of an actual or suspected product failure.41 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. The Department of Defense (DoD) is the main agency conducting this type of activity. For example, DoD requires manufacturers to show conformity to military specifications through independent testing, resulting in DoD certification. Through the Qualified Products List (QPL) program, DoD also conducts its own testing and certification of parts, materials, and products in order to guarantee their quality for military use. The QPL program also has the aim of streamlining the procurement process, by eliminating the need for manufacturers to recertify products for each separate purchase.43

No currently available data indicate the total cost to manufacturers and their customers of federal, state, and local certification mandates associated with regulatory and procurement standards. Apart from several directories of public and private programs compiled by NIST at several-year intervals, no comprehensive source of information about certification exists.44 Determinations to impose regulatory and procurement certification decisions, which add layers of conformity assessment to affected manufacturing processes and commercial transactions, should be weighed against the benefits to the public interest of added assurance. The lack of data on which to base these decisions is, accordingly, cause for concern.

The proliferation of programs in the federal, state, local government, and private sectors suggests strongly, nevertheless, that significant savings could be achieved through consolidating U.S. certification programs. In a $ 10.5 billion independent testing industry, plus an as-yet-unmeasured level of expenditure linked to manufacturer's internal testing against certification criteria, streamlining

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

could potentially achieve savings to industry and to consumers measured in the billions of dollars. Streamlining could be accomplished through such means as mutual recognition of equivalent certification programs; harmonization of programs to achieve equivalence; privatization of public certification programs; and central coordination of federal certification policy. These options are discussed in detail in the section on accreditation in this chapter.

Quality System Registration

The most recent element in the growth of the U.S. 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. Adoption of these standards by the Commission of the European Community in 1989, as part of its Global Approach to Testing and Certification, significantly accelerated their use worldwide, including in the United States. The number of U.S. firms registered to ISO 9000 has grown rapidly, from 279 at the end of the first quarter of 1992, and 1,259 in the first quarter of 1993, to 3,165 in the first quarter of 1994.46

Quality system registration is the assessment and periodic follow-up audit of a manufacturer's quality assurance system. Assessment and audit are performed by an independent party, the quality system registrar. The concept of quality embodied in modern quality assurance originated with Dr. W. Edwards Deming. Following the Deming model, a quality assurance system is a production management tool for monitoring and controlling variables in the manufacturing process that introduce variability and lead to defects. The system comprises elements such as documentation, training, statistical monitoring of results, and continuous improvement.47

Awareness of quality system registration has expanded rapidly in recent years, in conjunction with global growth in demand for the ISO 9000 series of standards. ISO 9000, like other quality system documentation standards, was designed primarily as an instrument for supporting high-volume transactions, such as those between manufacturers and their parts and materials suppliers. There is danger that much of this demand is due to misunderstanding of the ISO 9000 series' link to product quality—in some instances through overpromotion by the burgeoning service industry of quality system auditors, registrars, trainers, and consultants.48 Despite its rising popularity in European consumer markets, it was not intended, and is not appropriate, as a certificate of product quality for use in the consumer marketplace. It is the total quality of the product, including its design and features as well as its freedom from defects, that is of concern to customers.49

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

Registration evaluates the quality assurance system, not the quality of the products themselves. The purpose of third-party quality system registration is to support the manufacturer's claim that a system is capable of delivering a product of consistent quality with little or no variation. Product quality is the result of two factors: consistent manufacturing processes and good design. A product that conforms consistently, with zero defects, to a poorly designed standard is not a product that most customers would consider high quality. Such a product could conceivably, however, be produced by an ISO 9000-registered production facility. The ISO 9000 standards require the manufacturer to document production processes and develop procedures to improve them. 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. manufacturing system, not as a standard for products, but as a conformity assessment tool. In specific, confidence in the supplier's quality system can simplify the certification process. This may be the case, for example, in the supplier-purchaser relationship. If the supplier has a sound quality system, once a sample of a product has been approved (by either the customer or a third party, such as a certifier), the customer can be confident that the supplier will be able to reproduce that success repeatedly with few or no defective units.52 Quality assurance removes the need to inspect every item individually (100 percent testing). The producer's ability to deliver consistently identical parts—as assessed and verified by the quality system registrar—enables the purchaser to inspect a small subset of the delivered items and have confidence that the rest are identical to those that were inspected.53

In comparison to manufacturer's declaration and other, less intrusive forms of certification, third-party quality system registration is considerably more costly and is justified only by a strong need for independent assurance of conformity. As a replacement for 100 percent inspection and testing, however, a regime of batch testing combined with quality system registration can be less costly. For high-volume transactions requiring a high degree of confidence in product conformity, quality system registration may be appropriate. It has been applied in purchasing arrangements by government agencies (particularly the General Services Administration and the Department of Defense) and large manufacturers (such as automobile and aerospace firms).54

Quality system registration was applied successfully, for example, in a DoD pilot program for acquisition of electronic microcircuits. This program substituted assessment of manufacturers' processes for inspection of individual products. Approved manufacturers were placed on a Qualified Manufacturers List

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

(QML), allowing streamlined acquisition from those sources. A Defense Science Board study on the use of commercial components in military systems concluded that a QML-style program implemented throughout DoD could save $800 million annually in microcircuits alone.55

The DoD case, however, also illustrates a serious problem in the spread of quality system registration—the growing cost of multiple registrations. Regulators and procurers in DoD and other federal agencies, as well as major manufacturers in the private sector, are increasingly requiring suppliers to have their quality systems registered by third-party assessors. These requirements, however, frequently cite different quality system standards. The U.S. Nuclear Regulatory Commission (USNRC), for example, requires that suppliers of regulated components for nuclear power plants be registered to a quality system standard developed by the USNRC, 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.

As a result, many producers now face mandates for registration to multiple—but substantially equivalent—quality system standards. For example, a producer of capital equipment could easily be faced with the cost of registration to a federal standard—such as DoD's QML program or the 10 C.F.R. 50 standard; to ISO 9000 for export to European markets; and to the specific quality requirements of major private customers, such as Ford Motor Company's Quality One standards.57 Even in circumstances where registration is justified, multiple registration of a single producer's quality system is clearly redundant and wasteful.

The cost of registration can be substantial, even for large firms with quality systems already in place. For example, one large manufacturer, IBM Corporation, has estimated that registering its facilities to ISO 9000 in order to meet European market requirements cost the firm $100 million. Because IBM's facilities already had quality assurance systems in operation that met market demands, obtaining ISO 9000 registration yielded limited additional improvement in quality.58

In 1993, a survey of all North American firms registered to ISO 9000 found an average total cost of registration of more than $245,000 per firm. This excludes the additional cost of follow-up surveillance audits by registrars.59 Although some survey respondents anticipated recouping their expenses through cost savings associated with improvement in their management systems, approximately half of respondents expected only limited savings and considered ISO 9000 registration a largely irrecoverable business expense.60

In summary, the proliferation of quality system registration requirements presents a serious burden to many U.S. manufacturers. To the extent that critical needs for independent quality assurance do exist in some circumstances, duplicative quality system registration requirements should clearly be eliminated. Consolidation of duplicative requirements will yield significant savings, both to U.S. industry and to federal regulatory and procurement agencies. Some initial

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

progress has been made in this regard. In 1994, both DoD and the General Services Administration (GSA) adopted policies permitting procurement officers to accept ISO 9000 registration in lieu of equivalent military and federal quality system standards.61 It is not yet clear, however, whether procurement officers will be required to accept such registration in every instance. In addition, federal regulatory agencies have not responded with similar changes in policy.

The growth of ISO 9000 and other quality system registration services worldwide has added substantial new cost and complexity to the conformity assessment framework illustrated in Figure 3-1. Work is now in progress to develop a set of international standards that have the potential, if similarly overused, to impose even greater waste and expense on U.S. firms. The ISO Technical Committee 207 is now developing environmental management system standards. U.S. industrial and government participants in the process are promoting the position that the committee should avoid a key flaw in the ISO 9000 standards—failure to include, within the standards, strict guidance to restrain inappropriate, excessive reliance on third-party registration by government and private parties.62

Accreditation And Recognition

As this chapter has outlined, the U.S. conformity assessment system has expanded from declaration of conformity by the manufacturer to include third-party testing, certification, and quality system registration. These activities are illustrated in the first level of Figure 3-1. The system has grown, however, not only in the range of activities included, but also through the addition of new layers of assessment. The second level of the system framework is accreditation.

Accreditation Services

Accreditation is a procedure by which an independent party, the accreditor, evaluates and formally acknowledges the competence of a first-level conformity assessment body, such as a testing laboratory, product certifier, or quality system registrar. Accreditation activities arose in the United States in response to both private and public demands for assurance that conformity assessment organizations were competent.63 Just as the cost of third-party activities such as certification must be weighed against the need for formal product assessment, the cost of accreditation systems must be weighed against their particular benefits.

The need for accreditation is greatest when the user—a purchaser or regulator—of a conformity assessment service is not able to assess for itself the competence of that service's provider. A trusted accreditor can assist users in selecting testing laboratories, certifiers, and registrars. 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'

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

products. Rather than assess their suppliers' laboratories themselves, some manufacturers accept accreditation of these laboratories by a third party. In this case, achieving a single, third-party accreditation relieves suppliers of the burden of audits by each of their customers.

The National Aerospace and Defense Contractors Accreditation Program (NADCAP) is one example of a private assessment program established to reduce costs for an industry sector by streamlining the accreditation process. NADCAP was established by the Performance Review Institute, an affiliate of the Society of Automotive Engineers, to accredit laboratories and quality systems of suppliers to prime contractors in the aerospace and defense industry.65

Regulatory authorities rely on third-party accreditation to judge the validity of tests performed on such items as building materials and electrical equipment. For example, OSHA's NRTL program accredits laboratories as competent to test and certify products used in the workplace. Only certifications from accredited laboratories are accepted by OSHA as proving product compliance to its regulations.

Companies seeking registration of their quality assurance systems choose registrars, in part, on the basis of the registrars' accreditation. In the United States, the only nationwide system for accrediting ISO 9000 quality system registrars is operated by the Registrar Accreditation Board, under a joint venture with ANSI. For many independent laboratories and quality system registrars, third-party accreditation has become a basic requirement to attract customers.

Accreditation of a laboratory's or certifier's competence in a particular field typically involves review of the following elements, among others: technical procedures; staff qualifications; product sample handling; test equipment calibration and maintenance; quality control; independence; and financial stability. Teams of accreditors make on-site inspections of facilities and conduct interviews. A laboratory may be required to show its proficiency by measuring known test samples. To maintain accredited status, periodic reassessment, with follow-up testing and site visits, is required.66

In comparison to most of its trading partners, the United States has a decentralized system of accreditation. More than 100 public and private-sector accreditation programs are listed in Tables 3-2, 3-3, and 3-4. Accreditation programs exist at all levels of government and in many private organizations, such as trade and professional associations. Directories of laboratory accreditation programs compiled by NIST's Office of Standards Services, list 31 federal, 21 state, 11 local, and 40 private laboratory accreditation programs. These figures understate the number of state, local, and private programs, as a result of low survey response rates by these organizations during the compilation of directories.

The two largest programs in the United States both focus on testing laboratory accreditation. (Many certifiers are also testing laboratories, however, and are eligible for accreditation of their testing services.) The National Voluntary Laboratory Accreditation Program (NVLAP) is a fee-for-service program operated

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

TABLE 3-2 —U.S. Federal Accreditation Programs

AGENCY

TITLE OF PROGRAM

PURPOSE

Department of Agriculture

 

 

Animal and Plant Health Inspection Service

Accreditation of Lab Facilities for Contagious Equine Metritis

To approve labs to conduct diagnostic procedures for CEM, a highly transmissible venereal disease of horses

Federal Grain Inspection Service

Grain and Commodity Inspection and Weighing

To approve federal and state government and private-sector agents to inspect and weigh grains and test equipment and weights

Food Safety and Inspection Service

Accredited Laboratory Program

To accredit domestic nonfederal analytical chemistry laboratories to analyze meat and poultry food products

Office of Transportation

Agreement on the International Carriage of Perishable Foodstuffs and on the Special Equipment to Be Used for such Carriage (ATP)

ATP sets standards for testing and uses of equipment that carries perishable foodstuffs

Department of Commerce

 

 

National Institute of Standards and Technology / Office of Weights and Measures

State Laboratory Program

To provide system for certifying state weights-and-measures laboratories by specific measurement areas

NIST / National Voluntary Laboratory Accreditation Program

National Voluntary Laboratory Accreditation Program

To accredit public and private testing laboratories

Department of Defense

 

 

Army Corps of Engineers

CE District, Project and Commercial Laboratories Assurance Inspection Program

Each district requests assurance inspections of their testing laboratories by the division materials laboratory

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

Defense Electronics Supply Center

No title

To determine that commercial laboratories are equipped to perform testing for manufacturers listed on Qualified Product/Manufacturer Lists

Defense Logistics Agency / Defense Personnel Support Center

Qualified Laboratory List

To list laboratories capable of performing types of specification tests for clothing, textiles, footwear, and equipage-type items

Environmental Protection Agency

Office of Drinking Water

Drinking Water Laboratory Certification Program

To evaluate laboratories that analyze public drinking water supplies for compliance purposes in states without primacy under the Safe Drinking Water Act

Office of Mobile Sources / Emission Control Technology Division

Retrofit Device Evaluation Program

To recognize independent laboratories performing preliminary screening tests on vehicles for assessing the emission and fuel economy of devices

Office of Air Quality Planning and Standards / Technical Support Division

Wood Stoves New Source Performance Standards Laboratory Accreditation

Manufacturers must use accredited laboratories to certify that their stoves meet air emission limits

Federal Communications Commission

Office of Engineering and Technology / Authorization and Evaluation Division / Equipment Authorization Branch

Description of Measurement Facilities

Laboratories making measurements of devices that are included in applications for FCC equipment authorization provide a description of their facilities

Department of Health and Human Services

Alcohol, Drug Abuse, and Mental Health Administration / National Institute on Drug Abuse / Division of Applied Research

National Laboratory Certification Program

To establish appropriate standards and procedures for periodic review of laboratories and criteria for laboratory certification for urine drug testing for federal agencies

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

AGENCY

TITLE OF PROGRAM

PURPOSE

Food and Drug Administration / Bioresearch Program

Toxicology Laboratory Monitoring Program

To ensure the quality and integrity of data collected in order to support regulatory decisionmaking

FDA / Center for Food Safety and Applied Nutrition

Evaluation of Milk Laboratories

To evaluate and endorse laboratory sample collection surveillance procedures to provide a national base for the uniform collection and examination of milk

Health Care Financing Administration / Health Standards and Quality Bureau

Clinical Laboratories Improvement Act of 1967 and Medicare

Licenser program required for laboratories in interstate commerce

Department of Housing and Urban Development

Federal Housing Administration / Office of Architecture and Engineering / Materials Acceptance Division

Technical Suitability of Building Products Program

To accredit third-party organizations that validate manufacturers' certifications that building materials meet applicable requirements

Department of the Interior

Office of Surface Mining Reclamation and Enforcement / Division of Technical Services

Small Operator Assistance Program

Laboratories prepare data for eligible small coal operators that are used for the operator's small coal mine permit application

Department of Labor

Mine Safety and Health Administration / Approval and Certification Center

No title

Accreditation of inspection/test laboratories as a function of manufacturer quality control maintenance for component parts made and assembled for MSHA approval or certification

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

MSHA / A&CC

Testing and Evaluation of Illumination Systems

Evaluation to determine if light lab meets criteria

MSHA / A&CC

Testing by Applicant or Third Party

Product testing at manufacturer or at third-party lab

Occupational Safety and Health Administration / Office of Variance Determination

Nationally Recognized Testing Laboratories Program

Applicant for recognition as a NRTL shall have administrative and technical capability to conduct product testing activities

OSHA / Blood Lead Program

Blood Lead Program

To evaluate proficiency testing data and approve labs that meet OSHA requirements and standards

OSHA / Office of Construction and Maritime Compliance Assistance

Maritime Cargo Gear Accreditation and Certification Program

Third-party providing impartial inspection of certain maritime cargo gear handling devices

Department of Transportation

United States Coast Guard / Merchant Vessel Inspection Division

Lifesaving, Engineering, Fire Protection, and Pollution Prevention Equipment for Recreational Boats and Commercial Vessels

Laboratories test equipment to standards identified by the Coast Guard. Equipment is either certified by the lab or approved by the Coast Guard

USCG / Marine Technical and Hazardous Materials Division

Approval of Equipment for Use in Hazardous Areas Aboard Commercial Vessels

USCG requires electrical equipment in hazardous areas on certified vessels to be ''listed" by an independent lab recognized by the Commandant

USCG / Merchant Vessel Inspection and Documentation Division

Delegated Approval Authorities for Safety Approval of Cargo Containers

To delegate to qualified persons or organizations authority to approve cargo containers used in international transport

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

AGENCY

TITLE OF PROGRAM

PURPOSE

Department of the Treasury

United States Customs Service / Office of Labs and Scientific Services

Petroleum Gaugers and Commercial Laboratory Programs

To accredit commercial labs to test petroleum, petroleum products, and organic chemicals in bulk and liquid form

Bureau of Alcohol, Tobacco and Firearms / Office of Laboratory Services

Certification of U.S. Laboratories for the Analysis of Wines and Distilled Spirits for Export

To certify labs qualified for analysis of wines and distilled spirits beverages to meet requirements of certain countries that require a chemical analysis

Department of Veterans Affairs

Veterans Health Services and Research Administration / Pathology Service

College of American Pathologists Inspection and Accreditation Program and Related Quality Control Programs

Centralized contract through VA Marketing Center to provide quality control, inspection, and accreditation of clinical labs, special function, and nuclear medicine labs

 

SOURCE: Breitenberg, Maureen ed. Directory of Federal Government Laboratory Accreditation/Designation Programs. NIST Special Publication 808. U.S. Department of Commerce. Gaithersburg, Md.: NIST, 1991.

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

by NIST since 1976.67 NVLAP accredits testing laboratory competence in a range of fields of testing. These include, among others, testing and analysis of asbestos fibers; construction materials; lighting, insulation, and paint products; carpeting; electromagnetic interference; measuring device calibration; personal radiation dosimetry; computer software compatibility; and fasteners. Accreditation fees vary by field, with an initial application fee ranging from $500 to $1,500; annual administrative and technical support fees from $2,600 to $5,600; and fees for on-site assessment of $1,500 to $2,300.68 The 1994 NVLAP directory lists 670 accredited laboratories. The largest areas of accreditation, by number of laboratories, is asbestos analysis. Although NVLAP accreditation is voluntary in most fields, federal asbestos regulations, for example, require testing by a NVLAP-accredited laboratory.

The largest private-sector accrediting organization is the American Association for Laboratory Accreditation (A2LA). Established in 1986, A2LA accredited 603 laboratories as of January 31, 1994.69 Mechanical, chemical, environmental, and construction materials are the predominant testing fields accredited by A2LA. Like NVLAP, A2LA accredits according to guidelines developed by the ISO Council Committee on Conformity Assessment for competence of testing laboratories. Accreditation fees charged by A2LA are typically somewhat lower than those of NVLAP, starting at $1,000 for a single field of testing, plus expenses for on-site inspection of the laboratory by independent assessors.70

Costs of Redundancy in U.S. Accreditation

The decentralized and complex nature of the U.S. system has arisen in an uncoordinated fashion through case-by-case response to specific demands such as those described above.71 As a result, many of the programs listed in Tables 3-2 through 3-4 overlap. This imposes an unnecessary burden on laboratories and certifiers, which must obtain multiple accreditations for each of their areas of competence. For example, a laboratory seeking nationwide acceptance to conduct electrical safety-related materials testing must gain accreditation from at least 43 states; more than 100 local jurisdictions; 3 independent building code organizations; several federal agencies, including OSHA and NVLAP; and several large manufacturers. 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. Although NVLAP operates a program in the field of electromagnetic interference—measurement of interference emitted by electronic devices—the Federal Communications Commission (FCC) does not recognize NVLAP accreditation. Instead, FCC requires laboratories that test products for compliance to its regulations to obtain a redundant accreditation from FCC.73

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

TABLE 3-3 —State and Local Government Accreditation Programs

AGENCY

TITLE OF PROGRAM

PURPOSE

Alabama

Department of Environmental Management

Safe Drinking Water Act Certification

To require certification of all laboratories performing analyses under the Safe Drinking Water Act

California

Department of Housing and Community Development

Approval or Listing of Testing and Inspection Agencies

Approval of standards plan for accessory structures or buildings, etc., that must be tested, inspected, certified by listed agency

State and Consumer Services Agency

Approval of Inspection and Labeling Agency

Approval of inspection and labeling agencies for California State Fire Marshal Listed Products

Connecticut

State Department of Public Health Laboratory Approval and Registration Program

Connecticut State Department of Public Health Laboratory Approval and Registration Program

Approval and registration of private and municipal laboratories in the state as public health laboratories

Department of Public Safety

Approval of Testing Laboratories

For testing and listing of electrical equipment and apparatus and for gas-fired appliances

Florida

Board of Professional Engineers / Department of Professional Regulations

Testing Laboratory Registration Rules

To register and regulate all activities of testing laboratories concerning engineering documents and reports so they meet standards of quality set forth in statutes and rules governing the practice of engineering

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

Office of State Fire Marshal

Listing as a Nationally Recognized Testing Laboratory

To accept products listed by nationally recognized testing laboratories meeting standards accepted by the Florida State Fire Marshal

State Solar Collector Certification Program

Florida State Solar Collector Certification Program

Approval of solar collector ratings as a mandatory program with laboratory accreditation of firms that provide necessary test services

Kentucky

Cabinet for Natural Resources and Environmental Protection

Certification of Laboratories for Water Contaminants and Analysis

Accreditation of labs for inorganic and organic contaminant groups and microbiological analysis of public water supplies

Massachusetts

Department of Public Safety / Board of Fire Prevention Regulations

Recognition for Testing Facilities and Listing of Electrical Equipment and Apparatus

Recognition of testing labs capable of testing and listing products called out in the applicable sections and provisions of the Massachusetts Electrical Code

State Building Code Commission Concrete Materials Testing Laboratory Accreditation

Accreditation of Concrete Materials Testing Laboratories

Licensing of all labs defined by the regulations and engaged in the testing of concrete or concrete materials for use in buildings and structures subject to control

New Hampshire

Office of Fire Marshal, Electrician Board

Acceptance of Product Safety Testing

Acceptance of testing labs for the purpose of identifying product conforming to state code

New Jersey

Department of Environmental Protection

Water Testing Laboratories Accreditation, Quality Assurance Program

Accreditation and licensing of laboratories that test water quality for residue and radiological contamination

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

AGENCY

TITLE OF PROGRAM

PURPOSE

New York

Health Department Environmental Laboratory Approval Program

Environmental Laboratory Approval Program

To approve labs to test samples from public water supplies where the data are to be used to show compliance with the state sanitary code

Department of State Office of Fire Prevention & Control

Fire Gas Toxicity Data File

Determination of testing agencies, acceptable to the Secretary of State, to perform combustion toxicity testing of building materials mandated by the state

North Carolina

Department of Insurance

Acceptance of Laboratories Qualified to Provide Evidence of Safety of Electrical and Mechanical Goods

Acceptance of electrical products tested by laboratories accredited by the North Carolina Building Code Council

Ohio

Board of Building Standards

Accreditation of Testing/Inspection Agencies

Accreditation of agencies for classification of materials or products and of labs for on-site and job-order construction testing of building construction material

Oregon

Building Codes Agency

Testing Laboratory Accreditation

To establish labs whose tests, standards, and approvals are acceptable on electrical products

Pennsylvania

Department of Agriculture / Division of Milk Sanitation

Division of Milk Sanitation

Approval of milk and dairy products testing facilities, sample collection, analysts' evaluation, and operations

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

Vermont

Department of Labor and Industry

Electrical Testing and Labeling Laboratory Recognition

Recognition of testing laboratories to test and label products conforming to requirements of adopted codes and standards

Washington

Department of Labor and Industries

Accreditation as an Electrical Testing Laboratory

Acceptance of labs as nationally recognized to approve controlled devices to meet the adopted code

LOCAL AGENCIES

City of Los Angeles, Calif.

Department of Building and Safety

Testing Agency Approval

Approval of all labs testing electrical and mechanical products whose published listings are recognized by the department

City of Oakland, Calif.

Department of Public Works, Electrical Inspection

Approval of Electrical Safety Testing Laboratories

Approval of testing laboratories to label or list products as conforming to the requirements of the Superintendent of the Electrical Department

City and County of San Francisco, Calif.

Bureau of Building Inspection

Approved Listing Agencies

Approval of listing agencies to test and list materials and methods of construction

Metropolitan Date County, Fla.

Product Control Section

Determination of Laboratories Acceptable

Approval of all products that are a permanent part of a building, tested to appropriate standards, and approval of labs that provide such data

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

AGENCY

TITLE OF PROGRAM

PURPOSE

City of Atlanta, Ga.

Department of Planning and Development

Code Compliance Office

To approve agencies that provide an identification symbol or label as a recognized testing laboratory

City of Chicago, III.

Electrical Inspection Section

Accreditation as a Recognized, Independent Electrical Testing Laboratory

To accredit as nationally recognized standards testing laboratories, organizations whose testing and listing services are acceptable

City of New Orleans, La.

Department of Safety and Permits

Recognized Safety Testing Laboratory

Evaluation of laboratories for recognition as safety testing laboratory

City of New York, N.Y.

Department of Buildings

Acceptance of Testing Service or Laboratory

Determination of acceptability of testing and inspection laboratories and firms to provide data on compliance of products on installation

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

City of Cleveland, Oh.

Board of Building Standards and Building Appeals

Approved Testing Laboratory Listing

To list approved testing laboratories for energy, electrical safety, and gas-fired appliances

City of Portland, Oreg.

Bureau of Buildings

Electrical Testing Laboratory Approval Program

Approval of laboratories that are permitted to test and certify or label electrical equipment for sale or use in the city

City of Richmond, Va.

Electrical Department

Laboratory Acceptance Program

Acceptance of laboratory judged to be a recognized testing lab for the inspection and approval of appliance, devices, or materials in accordance with the National Electrical Code

 

SOURCE: Hyer, Charles W. ed. Directory of State and Local Government Laboratory Accreditation/Designation Programs. NIST Special Publication 815. U.S. Department of Commerce. Gaithersburg, Md.: NIST, 1991.

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

TABLE 3-4 —U.S. Private Sector Testing Laboratory Accreditors

ORGANIZATION

FIELDS OF TESTING

Air Movement and Control Association

Acoustic/vibration measurement, construction materials, electrical, mechanical, and thermal

American Architectural Manufacturers Association

Construction materials, mechanical, and thermal

American Association for Laboratory Accreditation

Acoustic/vibration, biological, chemical, construction materials, electrical, geotechnical, mechanical, medical, metrology, nondestructive, optics and photometry, and thermal

American Association of Motor Vehicle Administration

Acoustic/vibration, chemical, electrical, mechanical, and optics and photometry

American Association of State Highway and Transportation Officials

Construction materials

American Institute of Steel Construction

Chemical, construction materials, and mechanical

American Society for Testing and Materials

Chemical and mechanical

ASTM and NIST Cement and Concrete Reference Laboratory

Construction materials

American Society of Mechanical Engineers

Biological, chemical, electrical, mechanical, metrology, and thermal

American Wood Preservers Bureau

Chemical, construction materials, and mechanical

Associated Laboratories, Inc.

Chemical and construction materials

Association of American Railroads

Acoustic/vibration measurement, chemical, mechanical, nondestructive

Board of Accreditation of Concrete Testing Laboratories, Inc. of North Carolina

Chemical, construction materials, mechanical

Building Officials and Code Administrations International

Chemical, construction materials, electrical, mechanical, nondestructive, and thermal

Cellulose Industry Standards Enforcement Program

Construction materials

Corporation for Open Systems International

Electrical, mechanical, and ionizing radiation

Council of American Building Officials / National Evaluation Service

Chemical, construction materials, electrical, mechanical, nondestructive, and thermal

ETL Testing Laboratories, Inc.

Mechanical and thermal

Insulating Glass Certification Council

Chemical and mechanical

International Association of Plumbing and Mechanical Officials

Chemical, construction materials, mechanical, and thermal

International Conference of Building Officials

Chemical, construction materials, electrical, mechanical, nondestructive, and thermal

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

ORGANIZATION

FIELDS OF TESTING

International Electrotechnical Commission Quality Assessment System for Electronic Components

Acoustic/vibration measurement, electrical, mechanical, metrology, and thermal

Kitchen Cabinet Manufacturers Association

Mechanical

MET Electrical Testing Company, Inc.

Acoustic/vibration measurement, chemical, construction, electrical, mechanical, metrology, and thermal

MTL Certification Services Co., Inc.

Mechanical

National Association of Independent Laboratories for Protective Equipment Testing

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

Acoustic/vibration, chemical, electrical, mechanical, metrology, nondestructive, optics and photometry, and thermal

Precast/Prestressed Concrete Institute

Construction materials

Safety Glazing Certification Council

Chemical and mechanical

Solar Rating and Certification Program

Construction materials, electrical, mechanical, optics and photometry, and thermal

Southern Building Code Congress International

Acoustic/vibration, chemical, construction materials, mechanical, nondestructive, and thermal

U.S. National Electronic Components Quality Assessment System

Acoustic/vibration measurement, electrical, mechanical, metrology, and thermal

 

SOURCE: Hyer, Charles W. ed. Directory of Professional/Trade Organization Laboratory Accreditation/Designation Programs. NIST Special Publication 831. U.S. Department of Commerce. Gaithersburg, Md.: NIST, 1992.

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

Another example of multiple accreditation requirements imposed at the federal level is associated with American Society for Testing and Materials (ASTM) standard testing methods in many product sectors. For example, the standard test method for radiant panels used in lighting is ASTM E648. NVLAP accredits labs for testing to E648. The NRTL program operated by OSHA, however, does not accept NVLAP accreditation in this area, requiring laboratories to obtain a second accreditation. In fact, the GSA Furniture Center; DoD's Defense Electronics Supply Center and Defense Logistics Agency; the U.S. Coast Guard; and the Federal Aviation Administration also require E648 accreditation. In addition, state and local governments may impose their own requirements and are under no obligation to accept any of these federal accreditations—with the exception of NRTL accreditation, which states are required to accept as a result of regulatory preemption by the Department of Labor. 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. Accreditation costs for these laboratories, all of which have average annual revenues from testing of less than $1 million, range from $12,900 to $87,000 per year.75 To meet multiple accreditation requirements, one laboratory is accredited in a single area of testing, electromagnetic interference, by all of the following: NVLAP; the FCC; the U.S. Coast Guard Laboratory Approval Program; DoD's Defense Electronics Supply Center; and a European organization, Interference Technology International. The president of a second laboratory reports that accreditation costs ''could double or triple within the next 3-5 years" because of "unnecessary duplicative costs."

Economic data on the aggregate costs to the U.S. economy of multiple accreditation in product testing are unavailable. A 1993 study in a related area, however, provides compelling evidence of potential savings from consolidating redundant accreditation programs. The EPA commissioned a study in 1992 by a special advisory Committee on National Accreditation of Environmental Laboratories (CNAEL).76 Among other key findings, CNAEL concluded that environmental laboratories operating in multiple states face accreditation for the same tests by each state, often with arbitrarily differing criteria. CNAEL performed a detailed cost analysis and identified accreditation costs of $1,400 for small laboratories and between $10,773 and $21,546 for large laboratories. These costs include on-site audit costs, accrediting fees, and performance evaluation sample testing.

Aggregating these costs over the environmental testing industry, the CNAEL study found that replacing multiple state accreditation programs with a single, national program would significantly reduce costs. From a current, total cost estimated at between $17 million and $28 million per year, a streamlined system would reduce costs to between $13.5 million and $15.5 million, including a significant administrative fee charged by the national program.77 This reduction

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
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of approximately 28 percent in national economic costs of accreditation would be highly significant if they could be replicated in the much larger sphere of product testing and certification. Accreditation costs and patterns of redundant accreditation requirements, of course, may vary considerably between environmental testing and the wide range of product testing fields. Nevertheless, the findings of the CNAEL study provide important guidance—particularly, in the absence of similar, detailed estimates for the product testing sphere.

Government Recognition of Accreditation Services

Recognition is the most recent layer to be added to the U.S. conformity assessment system. Recognition involves assessment of the competence of programs that accredit conformity assessment organizations, such as laboratories, certifiers, and quality system registrars.78 Government recognition has the effect of conferring official acceptance, for example, of testing and certification performed by any laboratory accredited by a government-recognized accreditor. 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. Two U.S. government programs, both operated by NIST, currently involve recognition-level activities. These are the National Voluntary Conformity Assessment System Evaluation (NVCASE) program and NIST conformity assessment activities mandated by Congress under the Fastener Quality Act (P.L. 101-592).

The NVCASE program was established by NIST in early 1994. Its goal is to provide for increased access of U.S. products to foreign markets. NVCASE provides a basis for the U.S. government to give assurance to foreign governments of the technical competence of U.S. conformity assessment organizations. This assurance is intended to encourage foreign government acceptance of conformity assessment services performed by U.S. organizations—such as product testing and certification—as meeting foreign regulatory requirements.79 In the absence of foreign government acceptance, U.S. products must be retested for conformity with product regulations in export markets, even when they have been tested and certified within the United States. Issues related to international acceptance of conformity assessment procedures are examined in detail in Chapter 4.

NVCASE is a voluntary program. U.S. conformity assessment organizations are not required to seek recognition. Once fully implemented, NVCASE will evaluate U.S. conformity assessment organizations at their request, on a fee-for-service basis, in accordance with internationally accepted standards for conformity

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
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assessment procedures.80 NIST will list approved organizations in a register of recognized U.S. conformity assessment programs. NIST has stated that in order to limit expansion of the government's role in conformity assessment, NVCASE will operate principally at the level of recognition of accreditors and will recognize laboratories and product certifiers in a given product sector or field of testing only if no accreditation program exists in that area.81

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. This program creates a new precedent for U.S. government reliance on recognition of private accreditors to meet the needs of federal regulatory enforcement. As NIST identifies and recognizes private-sector accreditors, NIST-operated accreditation programs in this area will become duplicative and unnecessary. To the extent that recognized, competitive private-sector accreditation services take the place of government-operated programs, such as those under the Fastener Quality Act and others identified in Table 3-2, there is the potential for significant reduction in government costs.

Recognition-level activities are likely to increase in importance, for three reasons. First, government recognition has the potential to promote U.S. exports by enabling negotiation of government-to-government agreements for mutual recognition of conformity assessment systems. It was for this purpose that NVCASE was created. Prospects for mutual recognition agreement negotiations with U.S. trading partners, as well as the role of NVCASE in such agreements, are discussed in detail in the next chapter.

Second, recognition can support streamlining of the U.S. domestic conformity assessment system. Government recognition of private-sector accreditors will enable both regulatory and procurement agencies to eliminate the costs associated with operating federal accreditation, certification, and other conformity assessment programs while maintaining responsible oversight of regulatory and procurement enforcement. NIST recognition of private accreditors under the Fastener Quality Act provides a clear precedent for reliance on private-sector accreditors in regulatory enforcement. Transferring federal conformity assessment activities to the private sector will eliminate duplication between public and private programs and will increase the efficiency of the U.S. conformity assessment system. Specific mechanisms by which these goals may be achieved are elaborated in Chapter 5.

Finally, federal government recognition of private-sector conformity assessment programs has the strong potential to promote acceptance of conformity assessment among states and cities within the United States. As this chapter has noted, redundancy in testing and certification requirements is an acute problem at

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
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these levels. Federal recognition will increase the acceptability of conformity assessment procedures throughout the United States, reducing inefficiency and raising the level of competition in product testing and certification services.

Summary And Conclusions

This chapter has examined the growing size and complexity of the U.S. system for ensuring that products conform to standards. 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. conformity assessment system. Testing and certification services provided by independent laboratories represent a $10.5 billion industry in the United States. Evaluation and registration of manufacturers' quality management systems is a new, rapidly expanding component of the system. A growing number of public and private programs independently accredit testing laboratories, certifiers, and quality system registrars.

This chapter documents serious waste and inefficiency in the U.S. conformity assessment system. The system's growing complexity, as well as the lack of coordination among federal, state, and local authorities, have serious, adverse consequences for U.S. economic performance. Measures must be taken in both the public and the private sectors to address these problems, including the gathering and analysis of additional data on the economic costs of redundant certification, registration, and accreditation, and other sources of inefficiency in the system. Raising the efficiency of the U.S. conformity assessment system will lower costs for private firms, government agencies, and consumers. It will increase the competitiveness of U.S. firms in both domestic and foreign markets. Chapter 5 presents specific recommendations to achieve these goals.

The next chapter places issues concerning standards development and conformity assessment systems into the context of international trade. It examines the increasingly close links between domestic and international standards, testing, and certification and the performance of U.S. manufacturers in global markets. Recent developments in U.S. multilateral and bilateral trade relationships are assessed, as well as U.S. policy measures that have the potential to improve U.S. export performance.

Notes

1.  

International Organization for Standardization (ISO), Certification and Related Activities, 22-23.

2.  

Breitenberg, The ABC's of Certification Activities in the United States, 15.

3.  

For internationally accepted definitions of conformity assessment terms, see International Organization for Standardization, Compendium of Conformity Assessment Documents, 153-160. See also Breitenberg, The ABC's of Certification Activities in the United States.

4.  

ISO, Certification and Related Activities, 14.

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

5.  

See Breitenberg, The ABC's of Certification Activities in the United States, 2; and Robert B. Toth, ed., Standards Activities of Organizations in the United States, 597-598.

6.  

For a discussion stressing the impact of product liability on corporate decisions regarding product safety, see George Eads and Peter Reuter, Designing Safer Products.

7.  

ISO, Certification and Related Activities, 141-145.

8.  

For an overview of the evolution of the U.S. conformity assessment system framework, and its link to changes in manufacturing and business practices, see Locke, Conformity Assessment—At What Level?

9.  

For discussion, see ISO, Certification and Related Activities, 41-50.

10.  

For discussion, see Locke, Conformity Assessment—At What Level?

11.  

For an overview of areas regulated through federal conformity assessment programs, see Breitenberg, ed., Directory of Federal Government Certification Programs.

12.  

Breitenberg, Directory of Federal Government Certification Programs, 145-148.

13.  

Cheit, Setting Safety Standards, 9.

14.  

Eads and Reuter, Designing Safer Products, 41.

15.  

For a discussion of circumstances in which third-party conformity assessment in place of second-party is justified, Keith Mowry, Conformity Assessment: An Extra Benefit from Standards.

16.  

U.S. Bureau of the Census, Current Business Reports BS/92, Service Annual Survey: 1992, 18.

17.  

U.S. Bureau of the Census, 1987 Census of Service Industries: Miscellaneous Subjects, Summary 4-9, 4-11.

18.  

In 1994, ACIL changed its name to reflect more accurately the range of services provided by its members. It is now known formally as ACIL: The Association of Independent Scientific, Engineering and Testing Firms. ACIL Newsletter (June 1994), p. 1.

19.  

Personal communication with Jack Moody, Chief, Service Census Branch, U.S. Bureau of the Census, June 6, 1994.

20.  

U.S. Bureau of the Census, Current Business Reports BS/92, Service Annual Survey: 1992, 18.

21.  

ISO, Compendium of Conformity Assessment Documents, 154.

22.  

Breitenberg, ed., Directory of Federal government Laboratory Accreditation/Designation Programs, 52-53.

23.  

ISO, Compendium of Conformity Assessment Documents, 155.

24.  

ANSI, American National Standards for Certification Z34.1.

25.  

Breitenberg, The ABC's of Certification Activities in the United States, 4-5, 12-13.

26.  

For a discussion of types of product certification programs and factors influencing choice of methods to be used, see ISO, Certification and Related Activities, 21-50.

27.  

Breitenberg, The ABC's of Certification Activities in the United States, 7.

28.  

ISO, Certification and Related Activities, 21-36.

29.  

American Council of Independent Laboratories, Inc., Directory (22nd ed., 1992-1993), 1992.

30.  

Underwriters Laboratories, An Overview of Underwriters Laboratories: Testing for Public Safety, brochure, 1993.

31.  

Breitenberg, ed., Directory of U.S. Private Sector Certification Programs, 75.

32.  

Nina I. McClelland, David A. Gregorka, and Betsy D. Carlton, "The Drinking Water Additives Program," Environmental Science & Technology 23, no. 1 (1989), 14-18; and NSF International, "NSF International," brochure, n.d.

33.  

Breitenberg, The ABC's of Certification Activities in the United States, 6.

34.  

Breitenberg, The ABC's of Certification Activities in the United States, 7.

35.  

Breitenberg, The ABC's of Certification Activities in the United States, 7.

36.  

See Breitenberg, ed., Directory of Private-Sector Certification Programs, 46, 167; and Cheit, Setting Safety Standards, 22, 27-28.

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
×

37.  

Breitenberg, Index of Products Regulated by Each State.

38.  

NIST, "Weights and Measures," in Guide to NIST, November 1993, available through Internet at gopher://gopher-server.nist.gov.

39.  

Breitenberg, The ABC's of Certification Activities in the United States, 8.

40.  

Breitenberg, The ABC's of Certification Activities in the United States, 8.

41.  

Cheit, Setting Safety Standards, 14; and Charles Hyer, Publisher, TMO Update, personal communication, June 22, 1994.

42.  

For the most recent available directory, see Breitenberg, Directory of Federal Government Certification Programs.

43.  

U.S. Department of Defense, pamphlet, Qualified Manufacturers List (QML): Capturing Commercial Technology for Microelectronics.

44.  

Information provided by staff of Office of Standards Services, NIST, May 1994.

45.  

Deloitte & Touche Management Consulting, ISO 9000 Survey.

46.  

Quality Systems Update: Special Supplement 4, no. 5 (May 1994): 4.

47.  

See Breitenberg, More Questions and Answers about the ISO 9000 Standard Series and Related Issues.

48.  

See, for example, Reimann and Hertz, The Malcolm Baldrige National Quality Award and ISO 9000 Registration, 42-53.

49.  

Michael Barrier and Amy Zuckerman, Quality Standards the World Agrees On, 71-73.

50.  

Because the ISO 9000 standards are relevant only to the manufacturing process and not the product itself, a poor product design could be produced with a high degree of consistency by a high-quality, ISO 9000-compliant manufacturing plant. A ridiculous example that serves to illustrate the concept is a hypothetical, ISO 9000-registered manufacturing plant producing "high-quality" concrete life preservers. For further discussion, see Barrier and Zuckerman, Quality Standards the World Agrees On.

51.  

Unlike ISO 9000, the Malcolm Baldrige National Quality Award (MBNQA) criteria include measures of customer satisfaction. Although very few firms can win the MBNQA in a given year, widespread dissemination of information about the award criteria for firms to follow voluntarily can be an effective means of promoting quality in U.S. industry. See Reimann and Hertz, The Malcolm Baldrige National Quality Award and ISO 9000 Registration.

52.  

ISO, Certification and Related Activities, 65-75.

53.  

For a discussion of the role of quality system registration as part of a comprehensive conformity assessment scheme, see ISO, Certification and Related Activities, 24-26, 77-80.

54.  

Breitenberg, Q&A on ISO 9000; and Performance Review Institute, National Aerospace and Defense Contractors Accreditation Program, brochure, n.d.

55.  

Greg Saunders, et al. Working Group on Military Specifications and Standards, Road Map for Milspec Reform, 32-33.

56.  

This standard overlaps closely with ISO 9000 and other quality management system standards. The lack of a mechanism for the Nuclear Regulatory Commission to accept ISO 9000 registration as a substitute for 10 C.F.R. 50, Appendix B, forces parts suppliers to the nuclear industry to undergo duplicate registration procedures. As a result, the supplier base in the industry has been reduced in size and competitiveness. Electric Power Research Institute, "Comparison of ISO 9000 Requirements to Those of 10 C.F.R. 50 Appendix B: Task Sheet", April 8, 1992; and data provided by Lonnie Dunn, Procurement Quality Assurance Office, Illinois Power Company, 1994.

57.  

"Big Three Standards to be Rolled Out This Month," Quality Systems Update, CEEM Information Services newsletter July 1994): 1.

58.  

Data provided by Lawrence L. Wills, IBM Director of Standards, October, 1993.

59.  

The survey was sent to all 1,679 U.S. and Canadian firms registered as of the date of the survey. 37 percent of the survey population responded, representing a statistically valid sample of firms in all major industry sectors and a wide range of firm sizes. Foster Finley and Don Swann, ISO 9000 Survey Results, Deloitte & Touche Management Consulting, January 1994.

Suggested Citation:"3 Conformity Asses." National Research Council. 1995. Standards, Conformity Assessment, and Trade: Into the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/4921.
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60.  

The survey found that companies with comprehensive quality management systems already in place in advance of seeking ISO 9000 registration were no more or less likely than other firms to anticipate recovering the expense of registration through cost savings. Foster Finley, Deloitte & Touche Management Consulting, ISO 9000: Investment or Expense?, 1993.

61.  

"GSA Clarifies Stance on ISO 9000 Registration", Quality Systems Update 4, no. 5 (May 1994), 9; and "DoD, NASA Officials: Thumbs Up on ISO 9000," Quality Systems Update 4, no. 2 (February 1994), 1.

62.  

Joe Cascio, presentation at 1994 ANSI Annual Public Conference.

63.  

See Locke, Conformity Assessment—At What Level?

64.  

Locke, Conformity Assessment—At What Level?, 5-6.

65.  

Performance Review Institute, National Aerospace and Defense Contractors Accreditation Program; and Charles Hyer, "Performance Review Institute," TMO Update, May 20, 1994, 6.

66.  

Breitenberg, Laboratory Accreditation in the United States 5-8; and Charles Hyer ed., Directory of Professional/Trade Organization Laboratory Accreditation/Designation Programs, 3-5.

67.  

See NIST, National Voluntary Laboratory Accreditation Program: Procedures and General Requirements.

68.  

NIST, National Voluntary Laboratory Accreditation Program: Fee Schedule and Worksheets.

69.  

A2LA, 1993 Annual Report.

70.  

A2LA, "Application for Accreditation", 1994.

71.  

See Locke, Conformity Assessment—At What Level?, 1-4.

72.  

Breitenberg, Laboratory Accreditation in the United States, 15.

73.  

U.S. General Accounting Office, Laboratory Accreditation: Requirements Vary Throughout the Federal Government, 26-28.

74.  

Data supplied by Charles Hyer, Executive Vice President, The Marley Organization, August 1994.

75.  

Kim Phillipi, Entela, Inc. to Joseph O'Neil, ACIL, memorandum, 19 August 1994, Accreditation Costs (Grand Rapids, Mich., 1994); David Krashes, MMR, Inc. to Joseph O'Neil, ACIL, West Boylston, Mass., 11 August 1994, letter; and Walter Poggi, Retlif Testing Laboratories to Joseph O'Neil, ACIL, memorandum, n.d., Retlif Testing Laboratories' Yearly Accreditation Costs.

76.  

See U.S. Environmental Protection Agency, Jeanne Hankins, ed., Final Report of the Committee on National Accreditation of Environmental Laboratories.

77.  

For details of results and methodology, see U.S. Environmental Protection Agency, Final Report of the Committee on National Accreditation of Environmental Laboratories.

78.  

NIST, "Establishment of the National Voluntary Conformity Assessment System Evaluation Program." In Federal Register, 19129-19133.

79.  

See NIST, Establishment of the National Voluntary Conformity Assessment System Evaluation Program.

80.  

Internationally accepted standards for conformity assessment services, such as testing, certification, and accreditation, are outlined in a series of guides published by the ISO Council Committee on Conformity Assessment (CASCO). See ISO, Information on CASCO.

81.  

NIST, "Establishment of the National Voluntary Conformity Assessment System Evaluation Program," 19131-19132.

82.  

Fastener Quality Act, 101st Congress, 2nd session, H.R. 3000.

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Mandated standards used for vehicle airbags, International Organization for Standards (ISO) standards adopted for photographic film, de facto standards for computer software--however they arise, standards play a fundamental role in the global marketplace.

Standards, Conformity Assessment, and Trade provides a comprehensive, up-to-date analysis of the link between standards, product testing and certification, and U.S. economic performance. The book includes recommendations for streamlining standards development, increasing the efficiency of product testing and certification, and promoting the success of U.S. exports in world markets.

The volume offers a critical examination of organizations involved in standards and identifies the urgent improvements needed in the U.S. system for conformity assessment, in which adherence to standards is assessed and certified. Among other key issues, the book explores the role of government regulation, laboratory accreditation, and the overlapping of multiple quality standards in product development and manufacturing.

In one of the first treatments of this subject, Standards, Conformity Assessment, and Trade offers a unique and highly valuable analysis of the impact of standards and conformity assessment on global trade.

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