ISO 15189:2022 Medical Laboratories — Requirements for Quality and Competence

An overview of a critical update December 2022

ISO 15189 is applicable to medical laboratories in developing their management systems and assessing their competence.  It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

In December 2022, a critical update for the ISO 15189 standard was released following user feedback from a 2017 survey.  This survey indicated that many lab personnel found the existing standard difficult to interpret and implement, while new technological and medical developments have since emerged, following the previous 2012 release.

This “critical update” now aligns the standard with the principles of a number of standards, namely the application of risk management; safety in your work environment; the collection and transport of patient samples; point-of-care testing (POCT); and the exchange of information between laboratories. 

There’s so much more to the 2022 updates than just the alignment of these standards alone and navigating your way through them all can be a challenge in itself.  But this is where we can help!  

We partnered with Professor Folker Spitzenberger - who is the Professor for Regulatory Affairs for medical devices at the University of Applied Sciences in Lübeck, Germany. Folker, who is also the convener of the German mirror committee of ISO TC 212 that most recently developed the revised version of the standard ISO 15189, presented a webinar titled ‘A Critical Update on the New ISO 15189:2022 Edition’, where he talked through these updates in more detail.

This webinar, hosted by Sten Westgard of Westgard QC is now available for you watch on demand.  Simply CLICK HERE, or on the button below, and start your journey towards ISO 15189:2022 compliance today.