The development of international standards is within the purview of the International Organization for Standardization (ISO).
CLSI serves as the Secretariat of ISO Technical Committee 212 (ISO/TC 212), Clinical laboratory testing and in vitro diagnostic test systems, a responsibility that was delegated by American National Standards Institute (ANSI). ANSI is a member of ISO.
ISO/TC 212 is responsible for international standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems.
The work of ISO/TC 212 is currently supported by five working groups. This includes, for example, quality management, pre- and postanalytical (pre- and postexamination) procedures, analytical performance, laboratory safety, reference systems, and quality assurance.
CLSI also serves as the administrator for the US Technical Advisory Group (TAG) for ISO/TC 212.