SOP Internal Audit
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Use this SOP Internal Audit template to establish a consistent, compliant process for planning, conducting, and documenting internal audits of your quality management system, including required auditor qualifications and handling of findings such as nonconformities and opportunities for improvement. This document is essential for demonstrating ongoing compliance with ISO 13485, FDA QSR, and EU MDR/IVDR requirements, and should be completed whenever you plan or perform internal audits to ensure your processes meet regulatory and organizational standards. Filling out this template helps you identify gaps, drive continuous improvement, and prepare for external audits or inspections.