Internal Audit Schedule Template - ISO 13485

Streamline your internal audit planning and scheduling with our ISO 13485:2016 Clause 8.2 Internal Audit Schedule Template. Regular internal audits are essential for evaluating the effectiveness of your Quality Management System (QMS) and ensuring ongoing compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820. This structured audit scheduling template provides a systematic approach to planning and tracking audit activities throughout the year.

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

✔ Annual & Periodic Audit Planning Section – Schedule audits monthly, quarterly, or annually.

✔ Audit Scope & Focus Areas – Define which processes, departments, and QMS elements will be audited.

✔ Assigned Auditors & Responsibilities – Track auditor assignments and team roles.

✔ Risk-Based Prioritization – Ensure audits focus on high-risk and critical processes.

✔ Corrective Action & Follow-Up Tracking – Monitor audit findings and CAPA implementation.

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

✔ Editable Digital Format – Fully customizable for different medical device businesses.

This ready-to-use audit schedule template is ideal for quality managers, regulatory teams, and internal auditors, ensuring a structured, organized, and compliant audit process.

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