ISO 15189:2022 – How do the changes impact point-of-care testing?

ISO 15189:2022 arrived in November 2022 although its impact is not fully understood with individual organisations looking to conduct a full gap analysis against the ISO 15189:2012 and 22870:2016. Lead biomedical scientist Tony Cambridge looks at what the changes mean for those involved in point-of-care testing.

The new ISO 15189:2022 standard was published in November 2022, and replaces both the 2012 version, and ISO 22870:2016 (Requirements for Point of Care Testing) with the point-of-care elements of ISO 22870:2016 now incorporated.1

Alignment with ISO/IEC 17025:2017 has resulted in the management requirements appearing at the end of the document. The document is written with an overall change of emphasis on risk management and impact on patient care. The risk focus and incorporation of POCT have been anticipated following a number of national presentations and updates.

David Ricketts observed that: “ISO15189 (2022) is less prescriptive than the previous iteration and now has many supporting standards available to help laboratories implement the changes, but also requires some significant changes to the thought process of the laboratory to comply.”

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