Guide
ISO 15189:2022 and POCT: what actually changed
ISO 22870, the separate POCT standard, was withdrawn and its requirements absorbed into ISO 15189:2022, mainly via Annex A. Services were expected to complete the transition by the end of 2025. POCT is now assessed as part of the laboratory's single management system, with a stronger emphasis on risk based thinking. If your documents still reference ISO 22870, you are overdue an update.
The short history
For years, point of care testing had its own standard, ISO 22870, used alongside ISO 15189. The 2022 revision of ISO 15189 ended that: POCT requirements were folded into the main standard, and ISO 22870 was withdrawn. Accredited services were expected to transition to ISO 15189:2022 by the end of 2025.
What changed in practice
- One management system. POCT is no longer a bolt on with its own standard. It sits inside the laboratory's single quality management system and is assessed with it.
- Annex A. The POCT specific requirements now live in an annex: governance, agreements with clinical areas, training and competency of non laboratory staff, and the laboratory's responsibility for results generated outside its walls.
- Risk based thinking. The 2022 revision expects services to identify and manage risk proportionately rather than generate paperwork uniformly. For POCT, that means QC plans, competency depth and verification effort matched to the clinical risk of each device.
- Impartiality and structure. Clearer expectations about accountability, which for POCT means the committee, the agreements and the named responsibilities need to be real, not organisational fiction.
What assessors look for now
Assessment of POCT under 15189:2022 tends to probe the same pressure points: does the service know its whole estate, can it evidence competency for the operators actually testing today, does QC design reflect risk rather than habit, are EQA failures investigated to closure, and do results reach the record safely. Witnessing of device sessions on wards and in clinics remains standard.
What to do if you are behind
- Update document references and stop citing ISO 22870 as current.
- Run a gap analysis against 15189:2022 with POCT in scope. Do it honestly, with evidence links.
- Prioritise the gaps by risk, not by ease.
- Prepare the humans: assessors interview coordinators and operators, not just documents.
Our ISO 15189:2022 POCT Readiness course walks you through the standard clause by clause with a gap analysis template, and our readiness consultancy runs the whole exercise with you.
Questions, answered
Is ISO 22870 still valid?
No. ISO 22870 was withdrawn and its requirements were incorporated into ISO 15189:2022, primarily via Annex A. Documents should reference ISO 15189:2022.
When did services have to transition?
Accredited services were expected to complete the transition to ISO 15189:2022 by the end of 2025.
Does a private clinic doing POCT need ISO 15189 accreditation?
Usually not by law, but the standard defines what good looks like, and inspection and commissioning conversations increasingly reference it. Readiness is valuable even without formal accreditation.