The independent platform for news, articles and advice for professionals in laboratory medicine

Publication of ISO 15189:2022

‘ISO 15189:2022 Medical Laboratories – Requirements for quality and competence’ was published on 6 December 2022 by UKAS.

The International Laboratory Accreditation Cooperation (ILAC) has agreed that there shall be a three-year transition period; by the end of this period providers accredited to ISO 15189:2012 worldwide must have been assessed and accredited to ISO 15189:2022.

Key updates to the standard include a greater focus on clinical risk and the impact of services on patients, incorporation of the requirements of ISO 22870:2016 Point-of-care testing (POCT)Requirements for quality and competence, and a structural reorganisation to bring the standard in line with ISO 17000-series standards (the ‘parent' standards of ISO 15189).

As the updated ISO 15189:2022 standard incorporates the requirements of ISO 22870:2016, accredited POCT providers will only be assessed against the requirements of ISO 15189:2022 in future, and ISO 22870:2016 will be made obsolete in due course.

UKAS says in a bulletin that more detail will follow in the next few weeks, of detailed UKAS guidance for transition of customers currently accredited under ISO 15189:2012 and the impact of the new standard on applicant customers.

UKAS has worked with the Institute of Biomedical Science (IBMS), The Royal College of Pathologists (RCPath) and The Association for Clinical Biochemistry & Laboratory Medicine (ACB) to produce a Position Statement, available here

ISO 15189:2022 is available direct from ISO (International Organization for Standardization) here. It will be available from BS Online (BSOL) in due course. 

 

Upcoming Events

POCT: The Power to Disrupt

The Jubilee Hotel and Conferences, Nottingham
28 March 2023

Microbiology Society Annual Conference 2023

Birmingham International Convention Centre.
17-20 April 2023

British Society for Microbial Technology Annual Microbiology Conference

Royal Air Force Museum, Hendon, London
11 May 2023

Microscience Microscopy Congress 2023 (mmc 2023, incorporating EMAG 2023)

Manchester Central Conference Centre
4-6 July 2023

Annual SHOT Symposium 2023

Etihad Stadium, Manchester, M11 3FF
4 July 2023

IBMS Congress 2023

ICC Birmingham
25-28 September 2023

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

Upcoming Events

POCT: The Power to Disrupt

The Jubilee Hotel and Conferences, Nottingham
28 March 2023

Microbiology Society Annual Conference 2023

Birmingham International Convention Centre.
17-20 April 2023

British Society for Microbial Technology Annual Microbiology Conference

Royal Air Force Museum, Hendon, London
11 May 2023

Microscience Microscopy Congress 2023 (mmc 2023, incorporating EMAG 2023)

Manchester Central Conference Centre
4-6 July 2023

Annual SHOT Symposium 2023

Etihad Stadium, Manchester, M11 3FF
4 July 2023

IBMS Congress 2023

ICC Birmingham
25-28 September 2023

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

Step Communications Ltd, Step House, North Farm Road, Tunbridge Wells, Kent TN2 3DR
Tel: 01892 779999 Fax: 01892 616177
www.step-communications.com
© 2023 Step Communications Ltd. Registered in England. Registration Number 3893025