Internal Audit Procedure SOP template (ISO 15189:2022)

An internal audit procedure describes how the laboratory checks whether its management system and working practices meet defined requirements and operate as intended. It provides a repeatable approach to planning, gathering evidence, reporting findings and following up action. The procedure should support useful examination of real work rather than encourage a paperwork exercise based only on completed checklists.

A good version explains how the audit programme takes account of process importance, previous findings, changes and known risks. It defines audit scope, criteria, responsibilities and expectations for auditor competence and objectivity. Auditors need practical direction on sampling records, observing activities and interviewing staff while protecting patient information and avoiding unnecessary disruption to service delivery.

Describe how evidence is evaluated and how findings are written so that the requirement, observed condition and supporting evidence are distinguishable. Include routes for urgent escalation where an audit identifies an immediate safety concern. After reporting, assign responsibility for corrections, cause evaluation and corrective action where needed. Closure should depend on suitable evidence, with effectiveness checks proportionate to the issue. Programme review should consider coverage and recurring themes as well as whether scheduled audits were completed.