ISO Has Published a New Edition of ISO 15189—Requirements for Quality and Competence

The International Organization for Standardization (ISO) has published a new edition of ISO 15189—Medical laboratories—Requirements for quality and competence. ISO 15189 is applicable to medical laboratories in developing their quality management systems and assessing their competence and for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities, and accreditation bodies. ISO 15189 is also pertinent to point-of-care testing (POCT).

Founded in 1947, ISO is an international body composed of representatives from global standards organizations. CLSI serves as the American National Standards Institute (ANSI)-appointed Secretariat for the 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 laboratory medicine and in vitro diagnostic test systems. This includes quality management, pre- and postanalytical procedures, analytical performance, laboratory safety, reference systems, and quality assurance. Visit the ISO website for information on ISO/TC 212 and the ISO standards development process. As a convenience to our customers, CLSI offers ISO Technical Committee 212-approved and draft standards on our website.

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

CLSI is planning future educational programs and trainings to discuss the changes in the new edition of ISO 15189 and what they mean for the medical laboratory. Keep an eye on our website later this winter for more information!