Six tips to prepare for the ISO 15189:2022 transition

Aaron Hoare Date published: Nov 12, 23

ISO 15189:2012 – Medical Laboratories, is changing to an updated version by 2023. Here are our tips for managing the transition to the updated standard based on our substantial experience with ISO 15189 certified laboratories and our recent webinar discussing the revision.

We are intentionally avoiding giving advice that is too specific, here. After all, one of the major changes in the revision is that it is moving away from being overly prescriptive to being more about labs justifying their own approach. As such, we want to do the same. So, read on for our tips to ensure a clean transition into meeting the updated ISO 15189 standard.

Tips to prepare for the changes to ISO 15189

1 - Read the wording of the document carefully.

The standard isn’t written to catch anyone out, and the majority of questions you might have can probably be answered with careful re-reading. One of the new standard’s authors tells us that there were over 8000 notes on the first draft, so you can rest assured that all the wording has been scrutinised and carefully chosen for clarity.

2 - Begin to think about your processes in relation to the patient.

The new standard places a heavy focus on the patient, so everything you do, or plan to do, in your lab should not be looked at in the context of your laboratory operations in isolation. Ask yourself how any action might impact the patient. Is there a risk you regularly deal with? You should be asking how that risk might affect the patient. Is there a step you’re planning to add into a diagnostic process? Ask how that new step might impact the patient. It will pay, if you’re not already, to get into this patient-centric mindset as soon as possible to aid a smooth transition to the updated ISO 15189 standard.

3 - Remember that the new focus is on being less prescriptive and encourages applying the standard to your lab’s specific circumstances.

If it is not possible or appropriate for your lab to meet part of ISO 15189, you will not need to as long as you can prove it’s appropriate. The new Point of Care Testing (POCT) annex is the clearest example of this. If your lab doesn’t carry out any patient-facing work, then you do not need to meet these requirements. In short, you have the option to justify if parts of the standard aren’t possible or appropriate for your lab. It’s ultimately all about justifying your approach and the risks involved: there is no definitive “right” way to do things.

4 - Don’t panic! Keep in mind that there will be a 3-year transition period from the date of publication.

Although it would be sensible to get everything in order as soon as possible to meet the new standard, you won’t be expected to meet the revised standard in a matter of weeks or months. In fact, the College of American Pathologists (CAP) have indicated that they don’t intend to start the process of transitioning its accreditees until June 2024, to give one example. This delay is to give people time to understand the new standard, start building evidence that they meet it, and to establish a dialogue with their accrediting body.

[Update for 2024] – You should now already be well along the way to transitioning to the new standard, but it remains just as important not to panic. By carrying out a thorough gap analysis and establishing open communication with your accreditation body, you should quickly be able to identify any areas that need rectifying to be compliant with the updated ISO 15189.

5 - Buy a copy of the standard as soon as you can and look at it side by side with the previous version.

This will help you to start mapping the changes you will need to make. There is an annex in the new standard that shows the structure of the previous standard alongside the new one, but this is a very “top-level” view. There will be no substitute for looking at both standards in detail, side-by-side. Think carefully about how you are meeting each part of ISO 15189:2012 and how you might adapt to the changes in the updated version. Alternatively, download our ISO 15189:2022 compliance checklist so you can track what actions you need to carry out in your lab to ensure compliance.

6 - Upgrade to, or make sure you are already using, powerful QMS software.

Perhaps your lab is still largely paper-based, or maybe your current quality management solution causes just as many issues as it resolves. In any case, there is no better way to attain and maintain ISO 15189 certification than using a robust eQMS and, for the same reasons, this software will be crucial for a smooth transition to the updated standard. With new emphasis in the updated standard on data protection, risk management and seeking opportunities for improvement, there is no doubt that a tool like Ideagen Quality Management could be the key to your lab meeting ISO 15189 standards with ease.

Additional ISO 15189 revision resources

If you’re looking for additional resources to help you manage the transition to the updated version of ISO 15189, you can watch the webinar we mentioned at the top of this article on demand.

Alternatively, you can visit our ISO 15189 knowledge hub, where we have plenty of resources on the standard including several specifically about the transition to ISO 15189:2022.

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Browse our full range of resources on ISO 15189, including free downloads and watch on demand webinars.

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