In December 2022, ISO published the fourth new edition of ISO 15189:2022 – Medical Laboratories – Requirements for Quality and Competence. The revision was under the authority of the Technical Committee ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.
This document is also applicable to point-of-care testing (POCT).
According to Resolutions (EA Resolution 2022 (52) 16 and ILAC Resolution GA 26.08), the transition period for the application of the new edition of the standard is three years from the date of publication, i.e., December 2025. In the defined transition period, the two editions of the standard (ISO 15189:2012 and ISO 15189:2022) are valid. Resolutions are available at the following link.
In the coming period, IARNM will publish additional information on the transition period and conducting of the assessments according to the new edition.