ISO 15189 is the international standard for quality and competence in medical laboratories, so it is the standard a buyer should expect of the laboratory that analyses their samples. The current edition is ISO 15189:2022, published on 6 December 2022, and the separate point-of-care standard ISO 22870:2016 is now part of it.
Accreditation is issued for a defined scope, which means named measurands at named laboratory sites, so a claim that a supplier's laboratories are ISO 15189 accredited is not by itself checkable. In Germany the national accreditation body is DAkkS, and a scope annex belongs with every certificate it issues.
Reading that annex takes ten minutes and it answers the only question that matters, which is whether your markers are covered at the site that will run them.
- Ask for the scope annex covering the markers on your own panel.
- Ask which site will run those markers and confirm that it is listed.
- Ask which edition of the standard the current accreditation was issued under.
- Ask how point-of-care testing is handled now that ISO 22870 is inside ISO 15189.
In this glossary, Akkreditiertes Labor explains what an accreditation actually covers, RiliBÄK covers the German quality guideline beside it, and ISO 13485 covers the standard your kit maker works to.
This glossary entry is general information, not medical advice, and it is not intended to diagnose, treat or rule out any condition. Discuss your own results with a clinician who knows your history.
