Internal Audit Report Template - ISO 13485

Ensure effective and audit-ready internal quality assessments with our ISO 13485:2016 Clause 8.2 Internal Audit Report Template. Conducting regular internal audits is essential for evaluating the effectiveness of the Quality Management System (QMS) and ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820. This structured audit report template provides a clear and systematic approach for documenting audit findings, identifying non-conformities, and tracking corrective actions.

✔ Pre-Formatted Internal Audit Report Template – Covers key ISO 13485:2016 Clause 8.2 requirements.

✔ Audit Scope & Objectives Section – Define the purpose, areas, and processes being audited.

✔ Compliance Checklist & Assessment Criteria – Ensure alignment with QMS and regulatory requirements.

✔ Findings & Non-Conformance Documentation – Log observations, deviations, and potential risks.

✔ Corrective & Preventive Action (CAPA) Tracking – Assign responsibility for resolving issues effectively.

✔ Audit Summary & Sign-Off Section – Ensure accountability and final approval.

✔ Audit-Ready Record Keeping – Maintain structured documentation for regulatory inspections.

✔ Editable Digital Format – Fully customizable for various medical device business models.

This ready-to-use internal audit report template is ideal for quality managers, regulatory teams, and compliance officers, ensuring structured, consistent, and effective internal auditing.

Download the ISO 13485:2016 Internal Audit Report Template today and enhance your QMS compliance and continuous improvement efforts!