After three years of work by the ISO CASCO Working Group 44, ISO released the third edition of ISO 15189:2022 on December 6th, 2022.
The ILAC Resolution GA 26.08, also adopted by the European co-operation for Accreditation (EA Resolution 2022 (52) 16), specifies that the transition period for implementing the new version of the standard is three years from the date of its publication.
The news regarding the publication of the new standard edition and information about the transition period were posted on the Accreditation Body of Serbia's website on December 21, 2022. This is the first of several pieces of information that will be communicated to laboratories.
On February 28th, 2023, the Institute for Standardization published information that the Serbian standard SRPS EN ISO 15189:2023 is now in effect. The first page of the standard has been translated, with the remainder in English. This new standard replaces SRPS EN ISO 15189:2014 and SRPS EN ISO 22870:2017 starting from February 28th, 2023.
Accredited medical laboratories will need to demonstrate compliance with the new standard during their regular surveillance assessments or reassessment. In exceptional cases, and upon a laboratory's request, a transition to the new standard edition may be facilitated through a special assessment. However, this is contingent on the Accreditation Body of Serbia having the necessary resources available for such an assessment, and it must not compromise the transition plan's set deadlines.
Laboratories are obligated to submit their transition plan for accreditation according to the SRPS EN ISO 15189:2023 standard to the Accreditation Body of Serbia by November 1st, 2023.
Recognizing the three-year transitional period from the standard's publication date, and in collaboration with the Accreditation Council, a sequence of activities has been established to enable necessary adjustments for transitioning to the new standard edition. The goal is to ensure that as of December 6th, 2025, only accreditations according to the new edition of the standard will be valid.