ISO 15189
International
ISO standards
ISO 15189 medical laboratories
Competence and quality for medical laboratories. An assessor asks for the internal quality control record, the competency of the person who validated the result, and the calibration state of the analyser that produced it.
Set by ISO
What we claim, precisely
The platform holds this standard down to the measurable element, with an owner, a control and live-linked evidence for each one, and reports readiness and gaps. It does not assert that a facility is compliant. A person signs that off.
Preparing for ISO 15189
Open the sandbox and look at the readiness view, or ask us to walk it against your own standard set.