The first cleanroom standard, U.S. Federal Standard 209E(FS209E), was introduced in 1963 by the U.S. government. Because FS209E was strictly a U.S.-mandated standard, industries elsewhere had to either adopt or modify the U.S. standard or create new ones.

In response to this challenge, standardization bodies such as the European Committee for Standardization (CEN) and the Institute of Environmental Science and Technology (IEST) developed additional environmental requirements applicable to cleanrooms. It wasn’t until 1996, however, that a new set of environmental standards was born: ISO 14000. Set forth by the International Organization for Standardization (ISO), the ISO 14000 standards clearly define the global requirements for establishing an Environmental Management System (EMS).

The keystone of cleanroom technology in the ISO 14000 series, ISO 14644-1, became mandatory in the European Union on November 1, 1999. Since then, other parts of the world have adopted ISO 14644-1 as their baseline cleanroom (or “clean space”) classification document. All organizations that have earned ISO 9000 certification (the quality counterpart of ISO 14000) are required to use ISO 14644-1 to define their clean space. ISO 14001, the actual standard against which the EMS audit is conducted, provides a compatible management system framework for dealing with the specialized environmental concerns in the management of cleanrooms and other clean manufacturing spaces.

ISO 14000’s Popularity Grows

According to the ISO, as of 2000 there were a total of 22,897 organizations around the world that had earned ISO 14000 certification—8,791 more than the previous year. In the U.S. alone, certification has increased from 636 in 1999 to 1042 in 2000. The Global Environment & Technology Foundation predicts that by year-end 2002 there will be at least 150,000 companies compliant to ISO 14001 (the actual standard in the ISO 14000 system).

Companies have many reasons to establish an ISO 14000 EMS. The most convincing is the promise of increased sales and profits in competitive global markets.