ISO & management systems

ISO 15189 Medical Laboratory Accreditation Readiness

Help a medical laboratory prepare evidence for an accreditation assessment of its quality system and technical competence.

Laboratory staff discuss a specimen handoff
Illustrative imagery

Where it helps

ISO 15189 addresses quality and competence in medical laboratories. Preparation covers medical laboratory workflows from collecting or receiving specimens through examination and reporting, depending on the assessment scope.

How the work takes shape

NexSar reviews sampled records and the documented system with the lab’s technical owners. The engagement identifies where evidence needs improvement and who will verify the technical work before an accreditation body assesses the laboratory.

Workflow stages include Examination scope, then Review lab evidence, then Assessment readiness.
Illustrative workflow

Example engagement

A medical laboratory preparing to add an examination discipline could map records for specimen acceptance, instrument checks, staff authorizations, and the release of results using de-identified examples.