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Non-conformance Report Template - ISO 13485

Non-conformance Report Template - ISO 13485

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ISO 13485:2016 QMS Template - Non-Conformance Report (QMS.8.3.2.2 - QR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Non-Conformance 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 an effective non-conformance report process, demonstrating robust quality management as required by ISO 13485:2016.

What is a Non-Conformance?

A non-conformance is a failure to meet one or more of the requirements specified in the ISO 13485 standard. If your organization identifies or is issued a non-conformance during a routine audit or otherwise, you must take immediate steps to rectify the issue.

How Will Keeping Non-Conformance Reports Help My Organisation?

The Non-Conformance Report template helps your organization:

  • Document Non-Conformances: Record detailed reports of any non-conforming products, including associated investigations and actions taken.
  • Ensure Compliance: Ensure that any non-conformances are corrected, demonstrating compliance with ISO 13485.
  • Track and Resolve Issues: Maintain a log of the nature of any non-conformity and the actions taken to address it.

What Does the Standard Say About Non-Conformances?

The ISO 13485 standard requires organizations to:

  • Identify Non-Conforming Devices: Identify any medical device that does not conform to specified requirements.
  • Maintain Records: Keep records of the nature of any non-conformity discovered and any subsequent actions taken.

This template helps your organization meet these requirements and maintain an effective non-conformance management 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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