Publication of the new ISO 15189

Publication of the new ISO 15189

According to the report of the ISO Organization in the link:, the fourth edition of the ISO15189 standard was published in December 2022.

This document specifies requirements for quality and competence in medical laboratories. Also, the current document also includes testing requirements in POCT. Point-of-care testing (POCT) is a form of examination in which the analysis is performed near or at the site of a patient.

This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities, and accreditation bodies.

NOTE: International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

Until December 2025, accredited medical laboratories shall comply with this new standard. At the end of the transition period, the accreditation of a medical laboratory to ISO 15189:2012 and the accreditation of POCT to ISO 22870:2016 in conjunction with ISO15189:2012 will not be recognized.