ISO stands for the International Organization for Standardization which is a specialized international agency founded in 1948 to promote the development of international standards. Its goal is to facilitate the exchange of goods and services worldwide. The U.S. member body is the American National Standards Institute (ANSI).

All standards developed by the ISO are voluntary -- no legal requirements force countries to adopt them. However, countries and industries often adopt ISO standards thereby making them mandatory. ISO 9000 is a set of generic standards that provide quality assurance requirements and quality management guidance. ISO 9001:2000 is the latest and most detailed model within ISO as it includes product design and development.

Essentially ISO 9001:2000 requires a company to document what it does and then do what it documents. Growing demand for ISO 9001 conforming products, both by buyers and regulators within the U.S. and European communities has made these standards and their usage a matter of considerable importance and concern to U.S. companies who do not yet meet those requirements.

The ISO premise is simple: Consistency breeds reliability, which in turn leads to excellence – excellence when the product is designed, when it is made, and when it is used. This level of consistency minimizes the probability that a defective product will reach the marketplace.