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