Complaint Investigation Form - ISO 13485

ISO 13485:2016 QMS Template - Complaint Investigation Form (QMS.8.2.2.2 - QR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Complaint Investigation Form 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 investigation process, demonstrating robust customer complaint management as required by ISO 13485:2016.

Why Include a Complaint Investigation Form in Your QMS?

The ISO 13485 standard mandates documenting the complaint investigation process and results, including any corrections or corrective actions. Including a complaint investigation form 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 complaint investigations productively.

Benefits of the Complaint Investigation Form Template

• Detailed Record Keeping: Record all necessary information to show compliance with ISO 13485:2016, including unique complaint reference numbers, dates, descriptions, and root causes.
• Process Transparency: Clearly outline the steps taken during the complaint investigation process, from initiation to resolution.
• Audit Facilitation: Enable auditors to review your complaint investigation 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 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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