Non-conformance Procedure Template - ISO 13485

ISO 13485:2016 QMS Template - Non-Conformance Procedure (QMS.8.3.2 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Non-Conformance 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 an effective non-conformance procedure, 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.

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.
• Control Non-Conforming Products: Prevent non-conforming products from unintended use, sale, or distribution.
• Document Procedures: Define a process for the detection, documentation, exclusion, appraisal, and disposal of non-conforming products.

How Will a Non-Conformance Procedure Help My Organisation?

The Non-Conformance Procedure template helps your organization:

• Document Processes: Clearly document a process for handling products that do not conform to specified requirements.
• Ensure Compliance: Maintain compliance by preventing unintended use, sale, or distribution of non-conforming products.
• Improve Quality Management: Strengthen your Quality Management System by effectively managing and addressing non-conformances.

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.

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