UKAS ISO15189:2022 Transition Update

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Throughout 2023, UKAS have been hard at work training Assessment Managers and Technical Assessors on the new requirements of the updated ISO15189 guidelines, sharing information about the updated standard and developing the UKAS 15189:2022 Transition Hub providing a one-stop-shop for information on the ISO15189:2022 update.

Recently, UKAS have published a Transition update to remind laboratories of where they stand in seeking their updated accreditation. In this update, UKAS state “As per the UKAS transition plan, all assessments due to take place from the 1st January 2024 will be to ISO15189:2022.”

A gap analysis will be required one month prior to transition assessments, detailing the gaps and the actions which have been taken to remedy these gaps. This should include evidence, such as updated documents and records, embedded in the gap analysis document, showing what action has been taken to bring a laboratory’s practices in line with the updated standard.

An important note included in this transition update is , “UKAS cannot grant accreditation on intent; organisations shall make the necessary changes and have implemented these prior to the transition assessment.” So if your accreditation assessment is due soon, you might want to make use of our ISO15189:2022 Accreditation Guide to assist you in your gap analysis to ensure you don’t miss out.

This is crucial for laboratories because failure to align with the 2022 version of the standard before the deadline of 6th December 2025 will result in a suspension of ISO15189 accreditation for up to 6 months.

Some of the key accreditation updates include:

You can find more information to assist in your gap analysis and achieving ISO15189:2022 accreditation our ISO15189:2022 Accreditation Guide – a free PDF is available below.

Randox Quality Control’s Acusera range provides true third part quality controls designed to help you achieve all aspects of ISO15189:2022 accreditation including commutable matrices containing consistent, clinically relevant concentrations with unrivalled consolidation of analytes. To learn more about our range of quality control products, visit our website or, get in touch today at marketing@randox.com

Posted on 10th January 2024 at 1:18 pm.

Written by Jason Armstrong

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