ISO 15189 revision – what’s changed in the 2022 updated standard?

It’s official: ISO 15189:2012 – Medical Laboratories, is being updated. At the time of writing, the standard is with ISO for final editing and translation and is due to be published in late November or December 2022.

The authors of the new standard are keen to emphasize that the ISO 15189 update is a refinement and a clarification of the standard, rather than a significant overhaul. This means there are a number of broad changes to the scope and tone of the document, but there should be no major surprises for labs that currently meet the ISO 15189 standard.

In short, there really aren’t significant fundamental changes. With a few exceptions, the changes are there to further refine and clarify the standard for the shifts and changes to the medical laboratory landscape since 2012. That’s not to say that you won’t have to make changes and that you should let complacency creep in. You will still need to be aware of what is changing and be prepared for the transition.

So, download the whitepaper to begin your preparations for the ISO 15189 transition today.