Accreditation of medical laboratories only according to the ISO 15189 standard

In its Resolution 2022 (52) 12 of 23.11.2022, the European co-operation for Accreditation (EA) announces that medical laboratories now have to be accredited according to ISO 15189. 

The only exceptions: If national regulations require a medical laboratory to be accredited according to the international standard ISO/IEC 17025, this will be tolerated by the EA as the European umbrella organisation of the national accreditation bodies. And for activities that are not directly patient-related, the ISO 15189:2022 standard cannot be used.

Based on the above-mentioned resolutions of the EA General Assembly, the SAS specifies below the details for the transition of the accreditation of medical laboratories, which were previously accredited according to the standard ISO/IEC 17025:2017, to the standard ISO 15189:2022.

Detailed letter of information (German version):

Request form:

Reference document (German version):

Last modification 05.12.2023

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