The revision of ISO 15189 Medical laboratories – Requirements for quality and competence has now been released as ISO 15189:2022. Qualimetric has developed a Video-based training course taking you through the additional requirements and development of an action plan to implement them. This is now available – click on this link to access the Udemy page.
The revision of the standard commenced in 2019 under the direction of the ISO technical committee TC 212 Clinical laboratory testing and in vitro diagnostic test systems. The revised standard has now been released as ISO 15189: 2022. The changes include re-alignment of the clause structuring to bring it broadly 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.
We have also created a full gap assessment of the changes available to download as a free pdf. Please click this link to open the pdf.