Medical Laboratories: ISO 15189:2022 – What’s new?
The ISO 15189 standard was revised and published in December 2022 as the international standard ISO 15189:2022 Medical laboratories – Requirements for quality and competence. Now it is also available in the German version as DIN or OENORM EN ISO 15189:2023. The revised ISO 15189:2022 is the basis for the accreditation of medical laboratories and replaces the previous version from 2012.
Experts of BBMRI.at contributed to the development of this new standard by commenting the draft versions during ISO ballots. BBMRI.at hospital based biobank members often collaborate with partners who work in 15189 accredited laboratories. For them, the new ISO 15189 will become relevant.
What’s new / different?
The chapters of ISO 15189 have been restructured, the previous sections and the regulatory requirements described have been completely revised, and the requirements for quality and competence for patient-near examinations (point-of-care testing, POCT) are now also included. The requirements for the processes of quality management systems (QMS) in Appendix C have also been significantly revised. The standard also focuses on risk management, which is based on the regulatory requirements of ISO 22367:2020 (“Medical laboratories – Application of risk management to medical laboratories”). Another focus the new ISO 15189 places is on the competence of management and staff.
Transition period
In November 2022, the International Laboratory Accreditation Cooperation (ILAC) set a transition period until December 5, 2025, during which accredited medical laboratories must demonstrate that they have switched to the revised standard. After that, the accreditations based on the old ISO 15189:2012 will no longer be recognized internationally under the ILAC arrangement.