Internal Audit Procedure Template - ISO 13485

Internal Audit Procedure Template - ISO 13485

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ISO 13485:2016 QMS Template - Internal Audit Procedure (QMS.8.2.4 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Internal Audit Procedure 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 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 Internal Audit Procedure Help My Organisation?

The Internal Audit Procedure template helps your organization:

  • Establish Audit Processes: Define a clear process for performing internal quality audits.
  • Monitor Results: Set methods for monitoring audit results and taking timely, effective action to address identified deficiencies.
  • Ensure Compliance: Regularly check that your QMS conforms to planned arrangements, ISO 13485 requirements, and any applicable regulatory requirements.

What Does the Standard Say About Internal Audits?

The ISO 13485 standard requires organizations to perform regular internal audits at planned intervals. These audits must 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 Procedures: Clearly describes the internal audit process, ensuring auditors do not audit their own work.

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

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

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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