Internal Audit Plan Template - ISO 13485

Effectively plan, schedule, and manage internal audits with our ISO 13485:2016 Clause 8.2 Internal Audit Plan Template. Regular internal audits are critical for ensuring the Quality Management System (QMS) is compliant, effective, and continuously improving. This structured audit planning template provides a clear framework for organizing audit activities, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

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

✔ Audit Schedule & Timeline Tracker – Plan audits monthly, quarterly, or annually.

✔ Audit Scope & Objectives Section – Define audit areas, processes, and compliance criteria.

✔ Auditor Assignments & Responsibilities – Assign internal auditors for specific audits.

✔ Risk-Based Approach & Priority Assessment – Focus on high-risk areas within the QMS.

✔ Corrective Action & Follow-Up Planning – Ensure CAPA implementation and process improvements.

✔ Audit-Ready Documentation – Maintain structured records for regulatory inspections.

✔ Editable Digital Format – Fully customizable for different business models and QMS requirements.

This ready-to-use audit planning template is essential for quality managers, regulatory teams, and internal auditors, ensuring a structured, compliant, and effective internal audit program.

Download the ISO 13485:2016 Internal Audit Plan Template today and enhance your audit readiness and QMS compliance!