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Audit Report

Use this Audit Report template to systematically document and summarize the outcomes of your internal or external quality management system audits, including identified nonconformities and recommendations. Completing this report is essential after each audit to ensure regulatory compliance, facilitate corrective actions, and provide clear evidence of ongoing process monitoring for ISO 13485, EU MDR, or FDA QSR requirements. This template helps you track audit findings, support continuous improvement, and demonstrate due diligence during inspections or certification reviews.
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Audit Report

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1. Audit Information

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2. Audit Results

The audit was conducted on the processes identified in the table below. The number of major nonconformities (NC), minor nonconformities, and recommendations (REC) are provided as well. A description of the findings, if any, are described in the later sections.

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2.1 Major Nonconformities

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2.2 Minor Nonconformities

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2.3 Recommendations

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3. Conclusion

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