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Questions and Answers on Quality

Product quality depends on many process variables, such as the caliber of the components or materials used; type of equipment used in design, production, handling, installation, testing and shipping; the equipment calibration and maintenance procedures; the training and experience of production and supervisory personnel; the level of “workmanship”; and sometimes the environmental conditions (temperature, humidity, level of dust particles) in the area where the product is produced. The process, organizational structure, procedures, and resources that manufacturers and suppliers use to control these variables to produce a product or service of consistent quality to meet defined specifications is called a quality system. In 1979, the International Organization for Standardization (ISO), a worldwide federation of over 90 countries founded in 1946 to promote the development of international standards to facilitate the exchange of goods and services worldwide, formed Technical Committee (TC) 176 on Quality Management and Quality Assurance. The Committee’s purpose was to address the worldwide trend towards increasingly stringent customer demands with regard to quality. This committee was tasked with addressing the growing confusion in the conduct of international trade resulting from differing quality system requirements at national and lower jurisdictional levels. As a result of TC 176’s work, ISO released a series of five standards in 1987, the ISO 9000 Standard Series. These standards provided guidance on selection of and requirements for a basic quality management system. Soon compliance with the standards became recognized and required by many foreign and domestic buyers and by some governmental regulators. In addition, quality system registration was seen and used by manufacturers as a competitive marketing tool. Quality system registration or approval entails the assessment and periodic audit of the adequacy of a supplier’s quality system by a third party, known as a quality system registrar. When a supplier’s system conforms to the registrar’s interpretation of an ISO 9000 standard, the registrar issues the supplier a “certificate of registration.” It should be noted that it is the supplier’s quality system that is registered, not an individual product. This increasing demand for compliance with or registration to the ISO 9000 standards, combined with the lack of adequate and accurate information on the topic, created significant problems for both U.S. industry and government agencies. To fill this void, NIST published two basic primers on the ISO 9000 Series and the usage of the ISO standards. The two reports, Questions and Answers on Quality, the ISO 9000 Standard Series, Quality System Registration, and Related Issues [1] and More Questions and Answers on the ISO 9000 Standard Series and Related Issues [2], addressed such issues as: the types of requirements included in the standards; how the U.S. registration system operates; how the ISO 9000 standards were being used in the European Union’s new regulatory scheme; mutual recognition efforts at the international level; how federal agencies were using the standards within their regulatory and procurement programs; and information on other ISO 9000 based standards, such as the QS 9000 Standard—a standard published by the auto industry to define a set of quality system requirements for suppliers to the “Big Three” and other auto companies. The ISO 9000 Standards increased the visibility of and U.S. concerns over the impact of international standards on U.S. competitiveness to a degree never encountered before. The NIST reports provided timely and accurate information that was sorely needed by both the private and government sectors to formulate adequate responses to these issues— information not being provided by the private sector at that time. The reports were written in an easy-to-read question-and-answer format, providing information in a way managers could use to make informed decisions regarding the application of the ISO 9000 Standard Series within company and governmental operations. The use of the ISO 9000 standards is now a key domestic and international business strategy for many U.S. companies—one that is becoming increasingly necessary for survival. U.S. industry has become acutely aware that information on these and other national and international standards and related conformity assessment activities is vital to ensure continued competitiveness in the U.S. and global marketplaces. The Questions and Answers on Quality reports have been and continue to be widely distributed by NIST and by private sector companies and educational institutions. The popularity of and demand for these reports far exceeded anything that the Office of Standards Services had anticipated or had ever experienced.