The original ISO 9000 standards were a series of five international standards (ISO 9000, 9001, 9002, 9003, and 9004), developed by ISO Technical Committee (TC) 176 and published in 1987 to provide guidance on selection of an appropriate quality management program (system) for a supplier's operations. The Series is generic in scope covering both service and manufacturing industries. The 1994 and 2000 edition of ISO 9001 contain requirements in twenty areas covering: management responsibility; quality system requirements; contract review; design control; document and data control; purchasing; requirements for customer-supplied product; product identification and traceability; process control; inspection and testing; control of inspection, measuring and test equipment; inspection and test status; control of nonconforming product; corrective and preventative action; handling, storage, packaging, preservation and delivery; control of quality records; internal quality audits; training; servicing; and the use of statistical techniques. ISO 9002 covers all elements except design control. ISO 9003 (which is not used to any extent in the United States) covers significantly fewer elements. The titles and content of the 1994 edition of the series are as listed in Appendix I.

The United States has been an active participant in ISO TC 176 since 1987, and the 1994 and 2000 edition of the ISO 9000 Standard Series have been adopted in the United States as the ANSI/ASQC Q 9000 Standard Series. The ISO 9000 standards, which were initially intended to be advisory in nature and which were developed primarily for use in two- party contractual situations or for internal auditing, are currently being applied under a much broader range of conditions and circumstances.

The reader should also note that some national and regional standards bodies are developing supplemental guidance for the application of the ISO 9000 series to specific industries. For example, CEN and CENELEC are developing more specific requirements for the application of the ISO 9001 to the medical device industry; and the U.S. Food and Drug Administration (FDA) is revising its Good Manufacturing Practice (GMP) regulations for medical devices to follow ISO 9001 with appropriate additional requirements.