Complaint Handling Procedure - ISO 13485

Complaint Handling Procedure - ISO 13485

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ISO 13485:2016 QMS Template - Complaint Handling Procedure (QMS.8.2.2 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Complaint Handling 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 complaint handling procedure, demonstrating robust customer complaint management as required by ISO 13485:2016.

Why Include a Complaints Procedure in Your QMS?

The ISO 13485 standard mandates documenting procedures for complaint handling. Including a complaint handling procedure 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.

Benefits of the Complaint Handling Procedure Template

  • Defined Process: Clearly outlines how customer complaints related to your medical device products are handled.
  • Focused Coverage: Specifically addresses complaints about medical device products and related activities.
  • Audit Facilitation: Enables auditors to review your complaint handling process, 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

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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