Complaint Investigation Form - ISO 13485
Complaint Investigation Form - ISO 13485
Template Overview
Template Overview
Effectively document, investigate, and resolve customer complaints with our ISO 13485:2016 Clause 8.2 Complaint Investigation Form Template. A structured complaint handling process is essential for ensuring product quality, regulatory compliance, and continuous improvement in medical device manufacturing. This ready-to-use form helps organizations log, track, and analyze complaints, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR.
Key Features
Key Features
✔ Pre-Formatted Complaint Investigation Form – Covers key ISO 13485:2016 Clause 8.2 requirements.
✔ Customer & Product Information Section – Record details of the complaint, device model, and batch/serial number.
✔ Complaint Description & Root Cause Analysis – Log complaint details and conduct a structured investigation.
✔ Risk Assessment & Regulatory Impact Evaluation – Ensure compliance with post-market surveillance (PMS) and vigilance reporting.
✔ Corrective & Preventive Action (CAPA) Link – Implement corrective actions to prevent recurrence.
✔ Disposition & Closure Tracking – Document resolution status, repair, replacement, or further investigation.
✔ Approval & Sign-Off Workflow – Assign responsibility and track investigation progress.
✔ Editable Digital Format – Fully customizable for various complaint handling scenarios.
Why choose a QMS Template?
Why choose a QMS Template?
This user-friendly complaint investigation form is ideal for quality managers, regulatory teams, and customer service personnel, ensuring a structured, compliant, and effective complaint resolution process.
Download the ISO 13485:2016 Complaint Investigation Form Template today and enhance your customer complaint management system!
Couldn't load pickup availability
Share

Additional information
-
About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
-
Secure Payment and Document Download
Our secure system keeps your transaction safe, and the email will be sent promptly to the address you provided. Just click the link to instantly access and download your documents.
-
Contact Us
For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.