Internal Audit Report Template - ISO 13485
Internal Audit Report Template - ISO 13485
Template Overview
Template Overview
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.
Key Features
Key Features
✔ 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.
Why choose a QMS Template?
Why choose a QMS Template?
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!
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Additional information
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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