CLSI and International Standards Development

Founded in 1947, the International Organization for Standardization (ISO) is an international body composed of representatives from various global standards organizations. CLSI serves as the American National Standards Institute (ANSI)-appointed Secretariat for the International Organization for Standardization (ISO) Technical Committee 212 (ISO/TC 212), Clinical laboratory testing and in vitro diagnostic test systems. ISO/TC 212 is responsible for international standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems.

Visit the ISO website for information on ISO/TC 212 and the ISO standards development process.

CLSI also serves as the administrator for the US Technical Advisory Group (TAG) for ISO/TC 212. This committee is accredited by the ANSI and operates in compliance with applicable ANSI requirements

Through an agreement with the American National Standards Institute, CLSI is able to offer ISO Technical Committee 212 approved and draft standards.

Questions? View our ISO FAQs.