Feedback & Complaints Spreadsheet - ISO 13485

ISO 13485:2016 QMS Template - Feedback & Complaints Spreadsheet (QMS.8.2.2.1 - QR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Feedback & Complaints Spreadsheet 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 feedback and complaint handling procedures, demonstrating robust quality management as required by ISO 13485:2016.

Why Do You Need a Feedback & Complaints Spreadsheet?

The ISO 13485 standard mandates that organizations document procedures for feedback and complaint handling and maintain records of these activities. Including a Feedback & Complaints Spreadsheet 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 and documenting feedback and complaints.

What Information Do You Need to Fill in the Spreadsheet?

To effectively use the Feedback & Complaints Spreadsheet, you need to record:

• Complaint Identification: Assign unique complaint reference numbers.
• Complaint Details: Record details such as the date the complaint was made, the dates of any investigations, descriptions of the complaint, and the nature of any injury or harm caused.

Our template helps you capture all necessary information to ensure compliance with ISO 13485 requirements.

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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