Definition
What is the ISO 15189 standard?
The ISO 15189 standard sets out the requirements for quality and competence of medical laboratories. Published in 2003 and revised in 2022, it is the global benchmark for accrediting clinical and medical laboratories.
The standard covers the full medical examination process: pre-analytical phase (request, collection, transport), analytical phase (testing, interpretation, validation), and post-analytical phase (reporting, archiving, critical result communication). It integrates ethics, patient confidentiality, and clinical responsibility.
In the US, ISO 15189 accreditation is offered by CAP, A2LA, and COLA, often alongside CLIA certification (which is a separate regulatory requirement). The 2022 version strengthens requirements around risk management, patient safety, and point-of-care testing (POCT).
Who is ISO 15189 for?
The standard targets medical (clinical) laboratories, both public and private, hospital and reference labs, and point-of-care testing (POCT) services in hospital departments.
Why get certified?
ISO 15189 accreditation strengthens clinical credibility, complements CLIA certification in the US, conditions participation in regulated programs and large payer networks, provides international recognition, and improves examination quality for patients and clinicians.
Certified
CAP, A2LA, COLA accreditation in the US
Validity
Varies by accreditation
Avg. timeline
12 to 24 months
