Revision of ISO 15189 – 2022 Edition now released

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.

Masterclass – ISO/IEC 17025: 2017 for Laboratories

This video course provides in-depth training in the requirements of ISO/IEC 17025: 2017 ‘General requirements for the competence of testing and calibration laboratories’.   It commences with an overview of the principles of Quality Management and improvement in the context of a laboratory, provides an overview of ISO/IEC 17025 followed by a detailed discussion on each requirement.  The course also provides an overview of typical quality management system structures and on the steps required to implement the standard and to obtain accreditation.

Click to go to Downloads/Videos page where you will find the link to relevant Udemy resource.