ISO 13485 (Clause 8.2) - Feedback, Complaints & Returns Spreadsheet Template
ISO 13485 (Clause 8.2) - Feedback, Complaints & Returns Spreadsheet Template
Template Overview
Template Overview
Ensure compliance with ISO 13485:2016 Clause 8.2 – Monitoring & Measurement by tracking and managing customer enquiries, feedback, and product returns with our Enquiries, Feedback & Returns Spreadsheet Template. This user-friendly, structured tool helps medical device manufacturers, quality teams, and customer service personnel document, analyze, and resolve customer interactions efficiently while maintaining full audit and regulatory compliance.
Key Features
Key Features
✔ Pre-Formatted Spreadsheet – Covers key ISO 13485:2016 Clause 8.2 requirements.
✔ Customer Enquiry Tracking Log – Record queries, response times, and resolutions.
✔ Feedback & Complaint Management Section – Document issues, corrective actions, and regulatory reporting.
✔ Product Returns & Investigation Tracking – Log returned items, reasons, and actions taken.
✔ Escalation & Resolution Status Columns – Monitor open and closed cases.
✔ Automated Date & Status Filters – Easily track trends and response efficiency.
✔ Editable & Customizable Format – Adaptable for different medical device classifications and regulatory needs.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use spreadsheet ensures efficient complaint resolution, traceability, and regulatory compliance, helping your team improve customer satisfaction and meet post-market surveillance obligations.
Download the ISO 13485:2016 Enquiries, Feedback & Returns Spreadsheet Template today and streamline your customer management processes!
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Additional information
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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.
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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.