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Audit Plan

Use this Audit Plan Template to systematically organize and document your internal or supplier audit activities, participants, and audit scope for medical device quality management systems. This template ensures all required audit criteria and responsibilities are clearly defined and should be completed before each scheduled audit to comply with ISO 13485, EU MDR, or FDA QSR requirements. Properly filling out this template supports effective audit preparation, traceability, and regulatory compliance.
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Audit Plan Template

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1. Information and Participants

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2. Planned Audit Participants

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3. Audit Criteria

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4. Audit Activities

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Medical Device Certification Made Easy.