ISO 15189:2022 – A new task for medical laboratories


2022 saw the publication of a new version of ISO 15189 - Medical laboratories - Requirements for quality and competence. One of the main changes in the new version of the standard is the is the introduction of a risk-based philosophy. It has also been significantly restructured to follow the format of standards in the ISO 17000 series. In addition, requirements for point-of-care testing, previously addressed in ISO 22870, have been incorporated in the standard.

This brief Information Leaflet, prepared by the Eurachem Education and Training Working Group gives a quick overview of the main changes in the 2022 edition of the Standard.


The leaflet is currently available in English.


Translation into other languages is encouraged for members of Eurachem. Other offers of translation should be directed to the Eurachem Secretariat for permission. The Eurachem policy on maintenance and development of Eurachem guidance, available on the Policies page, gives further information on translation.


1. Dates show date of publication of the linked file on this website.

2. English edition first published 2024-06-18