ISO 15189:2022 Medical Laboratories – Requirements for quality and competence has now been published. ILAC has agreed a three-year transition period, at the end of which all providers accredited to ISO 15189:2012 worldwide must have been assessed and accredited to the new version.

AAA welcomes the revision of the new ISO 15189:2022 standard which underlines the importance of continually improving quality standards. The added flexibility to allow for clinically justifiable variation to these standards is important to ensure that medical laboratories can strive towards and meet the needs of patients and users within a fully accredited framework, wherever they receive laboratory services.

The new standard is risk based, patient focused and encourages continuous improvement within medical laboratories. The introduction in the standard makes it clear that this is a patient centred standard. Throughout the document there are requirements that are designed to ensure that the risk to patients is central to the ethos of the laboratory’s quality management design and processes.

The existing requirements of the standard are largely unchanged, meaning that most (if not all) the existing quality management systems implemented in laboratories remain valid. The standard contains the minimum requirements for quality and competence and services are encouraged to view this as such, and that continuous improvement should always be sought. The new International Standard will be used as criteria to award accreditation.

The standard is aligned to the revised ISO 9001:2015 which in turn led to a revision of ISO17025:2017 and now follows a similar structure in how it is organised. There are annexes comparing both ISO 9001:2015 to this version and the new standard to the 2012 version.

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 recognised as a Level 4 standard for POCT for the duration of the transition period.