Transition to ISO 15189:2022

The ISO 15189:2022 standard, 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.

All accredited Medical Laboratories must have been assessed and accredited by an Accreditation Body to the ISO 15189:2022 standard by December 6, 2025.

Some of the key updates include a greater focus on clinical risk and the impact of services on patients.  The standard now includes the requirements of ISO 22870:2016 Point-of-care testing (POCT) – Requirements for quality and competence, and a structural reorganization to bring the standard in line with the ISO 17000-series standards.

Here is the ILAC resolution:

ILAC Resolution GA 26.08

• As the revised version of ISO 15189 is scheduled for publication in 2022 or early 2023, the General Assembly endorses the recommendation of the AIC that a transition period of 3 years from the date of publication be adopted. 

• Noting that the requirements for Point of Care Testing (POCT) contained in ISO 22870:2016 have been incorporated into the revised ISO 15189, ISO 22870:2016 in conjunction with ISO15189:2012 will still be recognized as a Level 4 standard for POCT for the duration of the transition period. 

• At the end of the transition period, the accreditation of a medical laboratory to ISO 15189:2012 and accreditation of POCT to ISO 22870:2016 in conjunction with ISO15189:2012 will not be recognized under the ILAC Arrangement.

The IAAC MLA Group will monitor this transition period for ISO 15189:2022 and shall request IAAC member Accreditation Bodies signatories to the ISO 15189 MLA, to submit regular reports to ensure a smooth transition throughout the region.

The ISO 15189:2022 standard is available for online purchase from ISO (International Organization for Standardization).