Adopts ISO 15189:2012 to specify requirements for quality and competence particular to medical laboratories.

Identically adopts ISO 22367:2020, which specifies a process for a medical laboratory to identify and manage the risks associated with medical laboratory examinations. The process...

AS ISO 13131:2022 identically adopts ISO 13131:2021, which provides processes that can be used to analyse the risks to the quality and safety of healthcare...

This Amendment applies to the Title and Preface only.

Identically adopts ISO/TS 22583:2019, which gives guidance for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision...