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ISO 15189:2022 – What does it mean for pathology service delivery?

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of all laboratories to be completed by December 2025, when the old (2012) version, along with ISO 22870, is being withdrawn as a standard.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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Upcoming Events

Pathology Horizons 2024

MacDonald Bath Spa Hotel, Bath
18-20 April, 2024

Diagnostics North East Conference 2024

The Catalyst, Newcastle upon Tyne
19 April, 2024

ECCMID 2024 - European Congress of Clinical Microbiology and Infectious Diseases

Fira Gran Via, 08038 Barcelona, Spain
27-30 April 2024

British Society for Microbial Technology Annual Microbiology Conference

UK Health Security Agency, Colindale, London
2 May 2024

EQA Reports: Interpreting Key Information & Troubleshooting Tips

ONLINE - Zoom
Thursday 16th May 2024

Participants’ Meeting: UK NEQAS Immunology, Immunochemistry & Allergy

Sheffield Hallam University, City Campus, Howard Street, Sheffield
24th May 2024

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

Download the FREE Pathology In Practice app from your device's App store

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