ISO 15189 standard 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.

ISO 15189 Medical Laboratories-Requirements for Quality and Qualification Standard is “ISO/TC 212 Clinical Laboratory Testing” in order to make the structure and content similar to other recently reviewed ISO standards, to reflect changes in current practices and technologies, and to integrate revisions in other supporting documents related to the standard. and In vitro Diagnostic Test Systems” working group and ISO 15189:2022 version was published on 6 December 2022.

The transition to ISO 15189: 2022 of laboratories accredited by our Agency and laboratories that will make or have applied for accreditation as the Turkish Accreditation Agency will be ensured as follows:

• New applications to be made according to the ISO 15189:2013 standard will be accepted until 1 July 2023, and applications after this date will be received according to the ISO 15189:2022 standard.
• If the laboratories that have applied to our Institution according to the ISO 15189:2013 standard until 1 July 2023 request an audit before 1 January 2024, the first accreditation audits will be carried out according to the ISO 15189:2013 standard. The first surveillance and/or scope expansion audits to be made in these laboratories will be carried out in accordance with the ISO 150189:2022 standard, and their transition to the new revision will be ensured.
• Medical Laboratories accredited by our institution are required to complete their preparations for the new revision until January 1, 2024. All surveillance, scope expansion or accreditation renewal audits to be made after this date will be carried out in accordance with the ISO 150189:2022 standard and standard transitions will be ensured. For medical laboratories that have not passed their accreditation to ISO 15189:2022 until 06 December 2025, their accreditation under ISO 15189:2013 will be suspended for a maximum of 6 months. If the accredited medical laboratory fails to complete the necessary procedures to complete the transition period, its accreditation under ISO 15189:2013 will be withdrawn and the laboratory will have to reapply for accreditation.

During the transition period, ISO 150189:2013 and ISO 150189:2022 are equally valid and applicable. Accredited organizations that want to be accredited can access the new standard from the Turkish Standards Institute.

The current requirements in the new version of the standard have remained largely unchanged. 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.

Useful Links:

TSE Standard Search: https://intweb.tse.org.tr/standard/standard/standardara.aspx

ISO's Site: https://www.iso.org/standard/76677.html

TURKAK Announcement: https://www.turkak.org.tr/duyurular/iso-151892022-tibbi-laboratuvarlar-kalite-ve-yeterlilik-icin-sartlar-standardi-yayimlandi.html

Information on ISO 15189: 2022 revision trainings will be announced on the TÜRKAK website in the coming days.