In December 2022, the International Standards Organisation (ISO) published a new edition of ISO 15189 Medical Laboratories - Requirements for quality and competence, replacing the 2012 version of the same name.
The International Laboratory Accreditation Cooperation (ILAC) has resolved that accredited medical laboratories recognised under the ILAC Mutual Recognition Arrangement (MRA) have three years to transition their ISO 15189 accreditations of the new edition of the Standard; that is, by December 2025. Any medical laboratories that continue to be accredited under the 2012 edition of the Standard at December 2025 will not be recognised under the ILAC MRA.
As a Signatory to the ILAC MRA for the accreditation of medical laboratories, IANZ, and it's accredited medical laboratories, are obliged to comply with the ILAC resolution.
IANZ has released a transition notice the alert our clients with the timelines, assessment process and resolution of issues which can be accessed here: