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Internal Audit Report Template - ISO 13485

Internal Audit Report Template - ISO 13485

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ISO 13485:2016 QMS Template - Internal Audit Report (QMS.8.2.4.3 - QR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Internal Audit Report template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

  • Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
  • Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
  • Compliance Assurance: Utilizing our template helps you maintain effective internal audit procedures, demonstrating robust quality management as required by ISO 13485:2016.

What is an Audit?

An audit is an independent examination of your Quality Management System (QMS) to ensure it meets the requirements of ISO 13485. The assigned auditor will review your QMS documents, records, and procedures to check for compliance with the standard. Your organization must schedule regular assessments by both internal and external auditors.

How Will Having an Audit Findings Report Help My Organisation?

The Audit Findings Report template helps your organization:

  • Record Findings: Document the findings of your internal quality audits.
  • Track Non-Conformances: Record any non-conformances found and plan corrective actions.

What Does the Standard Say About Internal Audits?

The ISO 13485 standard requires organizations to perform regular internal audits at planned intervals to ensure that the QMS:

  • Conforms to Planned Arrangements: Aligns with documented plans and procedures.
  • Meets ISO 13485 Requirements: Complies with the standard and any applicable regulatory requirements.
  • Documents Results: Records the results and conclusions of audits and ensures necessary corrections and corrective actions are taken where appropriate.

This template helps your organization meet these requirements and maintain an effective internal audit process.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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