INFORMATION ABOUT TRANSITION PERIOD FOR IMPLEMENTATION OF ISO 15189:2022 – Medical laboratories – requirements for Quality and competence

In December 2022, ISO published the fourth new edition of ISO 15189:2022 – Medical Laboratories – Requirements for Quality and Competence. At the end of December 2022, Institute for standardization of the Republic of North Macedonia, ISRNM, published МКС EN ISO 15189:2022.

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.

As prescribed in PR 04-01, Procedure for changes of accreditation requirements, IARNM prepared action plan for implementation of the requirements of the new edition. According to the plan, on the 1st of January 2024, IARNM will start with assessment of МКС EN ISO 15189:2022 based on the client’s request, and starting on the 1st of June 2024, all assessments will be performed according to the new edition of the standard. For those transitions, which will be held together with the regular surveillance visits, the medical laboratories are obliged to submit updated Application Form.