Further information and resources to help customers and applicant bodies transition to ISO 15189:2022
ISO 15189:2022 Medical Laboratories – Requirements for quality and competence was published on 6th December 2022. 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).
UKAS has worked with The Institute of Biomedical Science (IBMS), Royal College of Pathologists (RCPath) and the Association for Clinical Biochemistry & Laboratory Medicine (ACB) to produce a Position Statement, available here.
The ISO 15189:2022 standard is available from BSI here
Useful information for customers:
Information about timeframes for the transition to the new version of the standard can be found here.
Full information about the transition process can be found here, including a link to the gap analysis template that applicant and transitioning customers will be required to submit to UKAS.