The revision of ISO 15189 Medical laboratories – Requirements for quality and competence commenced in 2019 under the direction of the ISO technical committee TC 212 Clinical laboratory testing and in vitro diagnostic test systems.
Vote outcomes:
The international ballot of the Draft International Standard (DIS) for ISO/DIS 15189 Medical Laboratories – Requirement for Quality and Competence has received a 97% positive vote from eligible participating countries. This follows positive comments and feedback from NATA members which led to Standard Australia’s affirmative vote as part of the process. It is now probable that once ISO TC 212 have addressed comments the document will be sent for Final Draft International Standard (FDIS) ballot in mid-2022.
