ISO published the new ISO 15189. The standard specifies requirements for quality and competence in medical laboratories¹ and includes now also the requirements for point-of-care testing. Point-of-care testing (POCT) is a form of examination in which the analysis is performed near or at the site of a patient.

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 recognised under the EA Multilateral Agreement (EA MLA).

37 National Accreditation Bodies are signatories to the EA MLA for medical examinations, and they have accredited over 3,800 medical laboratories in total. The list of signatories for the scope medical examinations is available in the document EA-INF/03 Signatories to the EA Multilateral Agreement and more information can be found on each signatory on the page Directory of EA members and MLA signatories.

During the 52^nd General Assembly on 23^rd November 2022, members decided that the preferred standard for the accreditation of medical laboratories is EN ISO 15189 – Medical laboratories — Requirements for quality and competence. EN ISO/IEC 17025 can also be used for activities that are not directly patient-related. That also applies to the case that a national regulator requires the accreditation of a medical laboratory according to EN ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories.

¹A medical laboratory is an entity for the examination of materials derived from the human body for the purpose of providing information for the diagnosis, monitoring, management, prevention, and treatment of disease, or assessment of health.