The ISO 15189:2022 Medical Laboratories – Requirements for Quality and Competence Standard is the fundamental document used to accredit medical laboratories, including public and university hospital laboratories, private hospital and clinic laboratories, private medical analysis laboratories, genetic disease diagnosis centers, IVF laboratories, and pathology and tissue typing laboratories.

ISO re-published the ISO 15189:2022 version on December 6, 2022. As per the announcement by the Turkish Accreditation Agency, new applications must adhere to the ISO 15189:2022 standard, and applications according to ISO 15189:2013 standard will be accepted until July 1, 2023.

Accredited Medical Laboratories are required to complete their preparations for the new revision by January 1, 2024. Any surveillance, scope expansion, or accreditation renewal audits scheduled after this date will follow the ISO 150189:2022 standard, and provide standard transitions.

Accreditation of medical laboratories that fail to transition to ISO 15189:2022 by 06 December 2025 will be suspended for up to 6 months under ISO 15189:2013. If a laboratory fails to complete the necessary procedures within this period, its accreditation under ISO 15189:2013 will be withdrawn, and the laboratory will have to reapply for accreditation.

For training and consultancy services, 10K provides the required assistance.

The ISO 15189:2022 Medical Laboratories – Requirements for Quality and Competence Update training for the new standard version is planned as a one-day session

ISO 15189:2022 Medical Laboratories – Requirements for Quality and Competence Basic training according to the new version of the standard is a two-day session.