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



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