ISO 15189:2022
Medical Laboratories - Requirements for Quality and Competence.
ISO 15189:2022 specifies requirements for quality and competence in medical laboratories. It supports laboratories in demonstrating reliable, patient-focused testing services to users, regulators, and accreditation bodies, and also applies to point-of-care testing (POCT).
Important Note
ISO 15189:2012 has been withdrawn. Following ISO 15189:2022 publication in December 2022, ILAC’s transition period ended in December 2025.
Key Benefits
- Demonstrate technical competence in medical laboratory testing.
- Improve reliability, traceability, and consistency of test results.
- Strengthen patient safety and clinical confidence in laboratory outputs.
- Support accreditation readiness and regulatory recognition.
Who Needs This?
Hospital laboratories, private diagnostic labs, pathology services, and healthcare organizations operating medical laboratory testing services.
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