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Internal Audit Plan Template - ISO 13485

Internal Audit Plan Template - ISO 13485

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ISO 13485:2016 QMS Template - Internal Audit Plan & Checklist (QMS. - QR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Internal Audit Plan & Checklist 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 an effective internal audit plan, 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 Internal Audit Plan & Checklist Help My Organisation?

The Internal Audit Plan helps your organization:

  • Organize Audits: Set a detailed plan when performing internal quality audits.
  • Define Objectives: Establish the objectives for the audit and reference the relevant sections of regulation you will assess your QMS against.
  • 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.
  • Considers Risk and Importance: Plans an audit program based on the risk and importance of processes and outcomes of previous audits.

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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