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Risk and the new standard

Dr David Ricketts, Head of Laboratory Process at Health Service Laboratory, and Alyson Bryant, UKAS Healthcare Accreditation Specialist, give an update on ISO 15189:2022.

ISO 15189:2022 was released in December 2022 and the transition period has begun. There are three significant changes mentioned in the foreword of the new version. The first being that the format of the document has changed to mirror that of ISO 17025:2017, so the document’s structure now complies with the parent documents. The next significant change is the inclusion of point-of-care testing (POCT) in the main standard and the removal of ISO 22870:2016. The last change was the increased importance of risk management and its relation to patient welfare.

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