Accreditation of medical laboratories: What is new in ISO 15189:2022

Abstract

In this paper, the main changes in ISO 15189:2022 in comparison with the 2012 version are discussed. They affect, directly or indirectly, the actions of medical laboratories towards ensuring validity and accuracy of examination results. A main change refers to the structure that is now aligned with ISO/IEC 17025 and recent editions of other standards in the ISO 17000 series. Further to this, requirements for medical laboratories to plan and implement actions addressing risks and opportunities are introduced in the new standard. This is part of the overall philosophy of the Standard and is reflected in almost all its clauses, mainly those dealing with the pre-examination, the examination and the post-examination processes. Great emphasis is given to sampling and the pre-examination process. Contrary to ISO/IEC 17025, uncertainty arising from sampling is not referred to; this seems to be related to inherent difficulties for such an evaluation. Requirements for equipment calibration and metrological traceability of measurement results are more detailed; similarly, the specific clause on ensuring the validity of examination results, specifying requirements for the internal quality control (IQC), the external quality assessment (EQA) and the comparability of examination results is also more detailed. A new important clause refers to continuity and emergency. The new standard includes requirements for point-of-care testing (POCT) activities, previously included in ISO 22870. Some flexibility on how to meet management requirements is given. Reference is made to a number of additional supporting standards.