Referred to generically as ISO 9000, this is actually a series of five standards (ISO 9000 - 9004) that provide a model for documenting an organization's quality-management system. Developed in 1987 by the International Organization for Standardization in Geneva, Switzerland, the standards assure that an ISO 9000-registered supplier (a product or service provider) is capable of controlling the processes that determine the acceptability of its product or service. Note: The standards apply to the quality of the process and not the quality of the product or service.

ISO 9000 and ISO 9004 introduce the standards, define terminology and guide a company in selecting to which of the standards—9001, 9002 or 9003—it should register. Additionally, they describe the 20 quality-systems elements against which the company will be audited.

ISO 9001, the most stringent and broadest standard, confirms process conformance for the entire product cycle, from design and development to production, installation and service. A company registering to this standard must meet all 20 quality-system elements.

ISO 9002 applies only to production and installation. Eighteen of the 20 quality-system elements apply to this level. It is normally used by a product manufacturer.

ISO 9003 applies only to final inspection and test. It is not widely used and then primarily by service providers such as distribution companies. Twelve of the 20 quality-system elements apply to this level.

To receive ISO 9000 registration, a company must pass an audit conducted by a third-party organization: the registrar. The registrar sends auditors (sometimes called assessors) to the company to verify that it complies with the standards. If it does, the registrar issues the company a registration certificate. Many customers require that the registrar itself be accredited by a nationally recognized accreditation body. The Registrar Accreditation Board (RAB) provides that function in the United States.

Increasingly, customers (purchasers)—especially European customers—require that their suppliers be ISO 9000 registered. In the case of products sold in Europe that have a health, safety or environmental impact, this requirement comes from the European Union itself, which demands that those products be manufactured under ISO 9000 standards.

ISO 9000 can have a direct impact on facilities planners, particularly if the planner is responsible for specifying capital equipment used in the manufacture of the product. Special facilities considerations such as clean rooms, air or water filtration systems, and secure installations could also be subject to ISO 9000 if those items impact product or process quality.

For more information or to order copies of the standards, contact the American Society for Quality Control: Telephone (414) 272-8575 or fax (414) 272-1734.