ISO 15189:2022 Medical Laboratories – Requirements for quality and competence has been published

As with all new standards, there is a three-year transition period, at the end of which, the previous version (2012) will cease to exist. All medical laboratories will need to adapt to the new requirements within this period.  IAS will provide a transition plan to all its accredited entities to ensure a smooth transition and will be informing the public for the time of acceptance of new applications for this new version.

Background information: There were two key reasons for this revision. Firstly, because the parent standard – ISO/IEC 17025:2017 – had been updated to comply with the structure of the normative ISO 9001:2015, and secondly, as ISO/IEC 17025:2017 is a normative reference of ISO 15189, there was a requirement for the documents to be aligned. Also ISO 15189:2012 had reached its periodic review date (5 years after publication).

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