Complaints/Feedback and Reporting to Authorities Document ISO 13485 Bundle

ISO 13485:2016 QMS Templates - Complaints/Feedback and Reporting to Regulatory Authorities Bundle

Enhance your Quality Management System with our ISO 13485:2016 compliant Complaint Handling, Feedback and Reporting to Regulatory Authority templates, 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.

This bundle contains:

• ISO 13485 Complaints Handling Procedure
• ISO 13485 Feedback Procedure
• ISO 13485 Reporting to Regulatory Authorities Procedure
• ISO 13485 Feedback and Complaints Spreadsheet
• ISO 13485 Complaint Investigation Form

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 complaint handling procedure, demonstrating robust customer complaint management as required by ISO 13485:2016.

Why Include a Complaints/feedback and reporting to authorities documents in Your QMS?

The ISO 13485 standard mandates documenting procedures for complaint handling, feedback and reporting to regulatory authorities. Including these documents in your QMS is essential for:

• Customer Satisfaction: Properly addressing complaints to prevent escalation and avoid brand damage or loss of revenue.
• Continuous Improvement: Leveraging customer feedback to improve your medical devices and Quality Management System.
• Consistent Handling: Ensuring a structured and consistent approach to managing customer complaints productively, and reportable incidents are well managed.

Benefits of the Complaint Handling, Feedback and Reporting to Authorities Templates

• Defined Process: Clearly outlines how customer complaints, feedback and reporting to regulatory authorities related to your medical device products are handled.
• Focused Coverage: Specifically addresses complaints and feedback about medical device products and related activities.
• Audit Facilitation: Enables auditors to review your complaint handling, feedback and reporting processes demonstrating compliance and good practice.

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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