WHEN EVALUATING MANUFACTURERS of cleanroom equipment and supplies, many companies are confused about “ISO certification” of the manufacturers and the meaning behind certification. The intent of this article is to demystify ISO certification and to summarize the key differences between ISO 9000 and ISO 13485 quality standards.

ISO 9001:2000 can be viewed as a general quality standard that is applicable to virtually any industry. It has been used for companies ranging from semiconductor manufacturers to home construction companies and retail automobile dealerships. ISO 13485:2003 is much more comprehensive and detailed, and stresses aspects (documentation of activities, traceability, product cleanliness, personnel requirements, sterilization, etc.) that are of acute importance to medicaldevice companies, the agencies that regulate them, and end users.

History of Quality Standards
The concept of quality standards emerged during the first half of the twentieth century. The first known use of any document resembling a quality standard was during World War II. At that time, the British were experiencing problems with their bombs detonating while still in the factory. Procedures were written describing how the bombs were to be assembled and inspected on-site by the government.

As technology rapidly advanced during the 1950s similar types of problems developed in various industries. The United States military became involved, and by the early 1960s had issued MIL-Q-9858A Quality Program Requirements and MIL-I-45208A Inspection System Requirements to be used for military procurement. Following the lead of the U.S. military, NASA developed a quality system standard forits suppliers.

Concurrent with technological advances, an increase in international trade stimulated interest in the development of standards that would be universally recognized and applicable to various types of industries. Accordingly, in 1980 the International Standards Organization (commonly known as ISO) organized the Technical Committee 176 to develop such a standard.

The first issuance of the ISO standards was in 1987, followed by revisions in 1994 and 2000. In the 1987 and 1994 versions, there were two levels of standards:w 9001: Design/Development, Production, Installation, and Servicing

• 9002: Production, Installation, and Servicing

With the 2000 revision, the 9001 and 9002 structure was eliminated, and all requirements were captured in one document: ISO 9001:2000. Certifications to ISO 9001:1994 and ISO 9002:1994 were no longer valid as of December 14, 2003.