Six tips to prepare for the ISO 15189:2022 transition
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
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 or visit the knowledge hub below.
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