ISO 15189 Medical Laboratories-Requirements for Quality and Competence Standard; It is the basic document used for the accreditation of medical laboratories such as public and university hospitals laboratories, private hospital and clinical laboratories, private medical analysis laboratories, genetic diseases diagnosis centers, IVF laboratories, pathology laboratories, tissue typing laboratories.
After a certain period of time, the 3rd version of ISO 15189 was published in November 2012; The “ISO/TC 212 Clinical Laboratory Testing and In vitro Diagnostic Test Systems” working group, in which TÜRKAK also takes part, aims to make the structure and content similar to other recently reviewed ISO standards, to reflect the changes in current practices and technologies, and to provide other support services related to the standard. In order to integrate the revisions in the documents, the review meetings started, but due to the Covid-19 pandemic in the world, the studies could not progress at the desired speed. The face-to-face meetings continued online and finally, version 4 of the ISO 15189 standard was published on December 6, 2022.
The current requirements have remained largely unchanged in the new version of the standard. Basically, a similar structure is followed with ISO 9001:2015 and ISO 17025:2017. In addition, a risk-based, patient-focused system that encourages continuous improvement is emphasized. Another significant change is the repeal of the ISO 22870:2016 Standard, which was used together with ISO 15189 in the accreditation of Point-of-Charge Tests (POCT). The requirements of the ISO 22870 standard are discussed in ISO 15189: 2022 and medical laboratories that want to be accredited from bedside tests are expected to fulfill the additional requirements in the standard together with the ISO 15189: 2022 standard.
A transition period of 3 years has been determined by the International Laboratory Accreditation Cooperation (ILAC) for Medical Laboratories to comply with this standard. At the end of this period, the transition of all medical laboratories accredited according to TS EN ISO 15189: 2013 to the ISO 15189: 2022 version must be completed. The Turkish Accreditation Agency's transition policy, application, audit and training calendars will be shared with you in the coming days.
