We inform accredited medical laboratories and all interested parties that a new edition of the ISO 15189:2022 was published on December 6th, 2022.
In accordance with the resolution of the International Organization for Accreditation of Laboratories (ILAC Resolution GA 26.08), which was also adopted by the European co-operation for accreditation (EA Resolution 2022 (52) 16), it was determined that the transition period for the application of the new edition of the standard is three years from the date of its publication.
By the end of the transition period, laboratories accredited according to ISO 15189:2012 shall be assessed and accredited according to ISO 15189:2022.
Having in mind that the requirements for point-of-care testing (POCT) contained in ISO 22870:2016 have been incorporated into the new edition of ISO15189:2022, ISO 22870:2016 shall continue, during the transition period, alongside ISO 15189:2012 recognized as level 4 of the standard for POCT.
After the transition period, the accreditation of medical laboratories according to ISO 15189:2012 and the accreditation of POCT according to ISO 22870:2016 along with ISO 15189:2012 shall no longer be recognized.
You can see more information about the new edition of ISO 15189:2022 at the following link: HERE
Information regarding the relevant Serbian standard can be found on the website Institute for Standardization of Serbia.
In the coming period, the Accreditation Body of Serbia shall prepare a transition plan in order to enable medical laboratories to transition to accreditation in accordance with the new edition of the standard in a timely manner.