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. Feedback on the proposed new standard has now been gathered and it is likely that the document will be published as a Final Draft International Standard mid 2022 with full publication as an ISO standard shortly after that. The proposed changes include re-alignment of the clause structuring to bring it in line with the latest version of ISO/IEC 17025: 2017 and the incorporation of Point-Of-Care Testing (POCT) standard ISO 22870 which at present is a ‘stand-alone’ add-on standard used in conjunction with the current version of ISO 15189.
Qualimetric will be providing a full gap assessment of the changes as soon as the FDIS is produced and running transition awareness courses as soon as the full standard is published. Please contact us at [email protected] if you wish to register interest and we will update you as soon as the changes occur and notify you of any planned training/awareness sessions.