ISO 15189 Internal Audit Checklist

An ISO 15189 internal audit checklist is used to run an internal audit of a medical laboratory against ISO 15189:2022, the standard for the quality and competence of medical laboratories. Its purpose is to check, through objective evidence, that the laboratory's management system and examination processes conform to the standard and work in practice. It follows the auditing approach of ISO 19011: a planned programme, competent and objective auditors, and findings based on evidence. It is an audit-process tool, distinct from a requirement-by-requirement compliance checklist.

Working through the audit programme, scope and criteria, auditor objectivity, evidence sampling across the laboratory workflow (organization, personnel, facilities and equipment, pre-examination, examination and quality control, and post-examination), and findings, corrective actions and management review, the checklist keeps the audit disciplined and its findings defensible. Because the sample of records, patients and examinations depends on the laboratory's scope and the programme, the checklist covers the audit steps and lets you record what applies rather than prescribing a fixed sample or interval.

Internal audits of a medical laboratory often drift into a paper exercise: the same person reviews their own area, findings are opinions rather than evidence, and nonconformities are raised but never verified as closed. The audit satisfies ISO 15189 on paper but gives management no real assurance about patient results, and the same issues reappear at the accreditation assessment.

An ISO 15189 internal audit checklist fixes that by holding the audit to the discipline of ISO 19011: a programme that covers the whole system over time, competent and objective auditors, evidence sampled across the pre-examination, examination and post-examination workflow, and corrective actions verified to closure. The audit becomes a genuine source of assurance that feeds management review.