The new ISO 15189 standard for medical laboratories was published 12 months ago, and is well into a three-year transition period, with inspections under the new standard set to begin soon. Dr David Ricketts – one of the new standard’s authors – writes for Pathology in Practice on the main changes, and what they mean for the delivery of pathology services.
In December 2022 the latest version, version 4 of ISO 15189 was launched. This standard is used by the United Kingdom Accreditation Service (UKAS) to assess medical laboratories for quality and competence. There is a three-year transition period to move accredited laboratories from the 2012 version of the standard to the new version, with year one almost complete.
Laboratories are required to submit a completed gap analysis to UKAS at least one month before their on-site assessment in 2024, in order for the full transition of all laboratories to be completed by December 2025, when the old (2012) version, along with ISO 22870, is being withdrawn as a standard.
Clinically focused
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