Feedback Procedure - ISO 13485

ISO 13485:2016 QMS Template - Feedback Procedure (QMS.8.2.1 - QP)

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

What is a Feedback Procedure?

A Feedback Procedure defines how feedback is handled by your organization. This includes all feedback received from customers, stakeholders, and other relevant sources related to your medical device products and associated services. Feedback can be:

• Negative
• Neutral
• Positive

Negative feedback may also constitute a complaint, for which you can refer to our template QMS.8.2.2 - QP - Complaints Procedure. This template helps you establish a clear Feedback Procedure and outline your organization’s response to different types of feedback.

What Does ISO 13485 Say About Customer Feedback?

The ISO 13485 standard requires that organizations:

• Gather and Monitor Information: Measure the effectiveness of the quality management system by collecting and monitoring customer feedback.
• Document Methods: Clearly document the methods for acquiring and using this information.
• Establish Procedures: Maintain documented procedures for the feedback process.

Benefits of Using This Template

• Structured Process: Define and streamline how feedback is handled and responded to within your organization.
• Compliance: Ensure full compliance with ISO 13485 requirements for feedback management.
• Customer Satisfaction: Improve customer satisfaction by systematically addressing and acting on feedback.

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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