ISO certificate
ISO 15189 Accreditation (Medical Laboratories)
A practical guide to quality and competence for medical labs — built around traceability, validation, and patient-impact evidence.
What ISO 15189 is (in operational terms)
ISO 15189 is an accreditation standard for medical laboratories combining quality management with technical competence. Audits focus on the end-to-end lab path: pre‑examination controls, method validation, result integrity, and traceability to ensure reliable patient-impact decisions.
Typical scope choices that affect the audit
- Departments/tests in scope (chemistry, hematology, microbiology, pathology, etc.).
- Sample collection responsibilities and pre‑examination controls.
- Reference ranges, critical values, and reporting rules.
- External quality assessment and proficiency testing participation.
Key ISO 15189 expectations
- Method validation: evidence that methods are fit for purpose.
- Quality control: internal QC, EQA/PT, and trend analysis.
- Traceability: sample identification, chain, and result integrity.
- Competence: training, authorization, and ongoing evaluation.
- Nonconformities: incidents, corrective actions, and effectiveness checks.
Next step
Want a clear path to certification?
Send your scope and target date and we’ll reply with an implementation path and quotation.