Current Edition Checked October 24, 2026
The transition from the 2012 edition ended in December 2025; point-of-care testing requirements are now included.
What It Covers
Quality and competence requirements for medical laboratories, including point-of-care testing, with an emphasis on risk to patients.
Who It Applies To
Clinical and medical laboratories seeking accreditation.
Key Requirements
- Risk management focused on patient safety.
- Pre-examination, examination, and post-examination processes controlled.
- Measurement uncertainty and validity of results assured.
- Point-of-care testing brought inside the laboratory’s quality system.
What an Auditor Asks to See
- How risks to patients are identified and controlled across the examination process.
Where Systems Fall Short
- Point-of-care testing managed outside the laboratory’s system.
How QES Helps
Gap assessments and internal audits against the 2022 edition.
Related Standards
Sources. ISO — ISO 15189:2022 (opens in a new tab); de Grandson — ISO management system revisions, 2026–2030 (September 2026) (opens in a new tab). Status checked October 24, 2026. This page summarizes ISO 15189:2022; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.