Internal audit

An internal audit is a systematic, independent examination of the quality management system against planned arrangements, the standard, and the organization's own procedures.

ISO 13485 clause 8.2.4 requires audits at planned intervals, by auditors who do not audit their own work, with records of the results and of the follow-up. The program has to cover the QMS, including outsourced processes, over time. It does not require every clause every month. It does require a plan you can explain.

A useful internal audit produces findings the process owner recognizes, graded honestly, with corrective action where the cause is systemic. A report that says 'no findings' in a young QMS is often a weak audit, not a strong system. The follow-up is part of the audit, not a favor the auditor does later.

HAVGATE is built around this activity: criteria, notes, a generated report, approval, and a link into nonconformance and CAPA. The audit management page and the sample report show the output. MDSAP-style audits use the same engine with the seven-chapter checklist.