ISO 15189:2022: what changed for medical laboratories
Accreditation to the 2012 edition of ISO 15189 is no longer valid. Here is what the 2022 edition changed and where to start.
ISO 15189 is the standard most medical laboratories get accredited against. It covers what a laboratory needs for quality and competence. A new edition came out in December 2022, and accreditation bodies gave laboratories three years to move across. That window closed in December 2025, so accreditation to the 2012 edition is no longer valid.
As an EQA provider, we pay closest attention to the parts of the new edition that touch EQA. Here's what changed overall, and where to start if your laboratory is accredited or working towards it.
More focus on risk to patients
The 2022 edition puts more weight on clinical risk and on how a laboratory's work affects patients. You're expected to find the risks across your processes, from receiving a sample to reporting a result, decide which ones matter most, and act on them. Plenty of laboratories already did this informally. Now it has to be planned and written down.
Point-of-care testing moved in
Point-of-care testing used to have its own standard, ISO 22870:2016. Those requirements are now part of ISO 15189:2022, and ISO 22870 has been withdrawn. If your laboratory oversees testing at the bedside or in clinics, that testing now sits inside the same quality management system as everything else you do.
A new structure
The standard was reorganised to match the rest of the ISO 17000 series, like ISO/IEC 17025:2017 for testing and calibration laboratories. The management system requirements moved to the end. You don't have to rewrite every procedure, but the cross-references in your quality manual will probably need updating.
What it means for EQA
EQA is still a core requirement. Accreditation bodies assessing against the 2022 edition check that a laboratory:
- has a documented procedure for enrolling in and taking part in EQA for its examinations, where programs exist;
- takes part in programs that suit its examinations, from providers that meet ISO/IEC 17043, with samples that resemble patient samples;
- reviews its EQA results regularly against set acceptability criteria;
- investigates results that fall outside those criteria and takes corrective action, including judging whether patient results were affected.
HuQAS is accredited to ISO/IEC 17043:2023 as a proficiency testing provider, so our programs cover the second point.
Where to start
- Do a gap assessment of your current system against the 2022 edition.
- Set up a documented risk management process if you don't have one.
- Bring any point-of-care testing you oversee into your quality management system.
- Check your EQA procedure against the list above.
HuQAS can help with each of these. Our ISO 15189 mentorship program starts with a gap assessment and works with your team all the way to accreditation. We also run training on ISO 15189:2022 transition and implementation, and for ISO 15189 internal auditors. Talk to us if you'd like to know more.