Feedback & Complaints Spreadsheet - ISO 13485
Feedback & Complaints Spreadsheet - ISO 13485
Template Overview
Template Overview
Ensure structured tracking and resolution of customer feedback and complaints with our ISO 13485:2016 Clause 8.2 Feedback & Complaints Spreadsheet Template. A well-documented feedback and complaint management system is essential for ensuring product quality, regulatory compliance, and continuous improvement in medical device manufacturing. This easy-to-use spreadsheet helps organizations log, analyze, and track customer feedback, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR.
Key Features
Key Features
✔ Pre-Formatted Feedback & Complaints Tracking Spreadsheet – Covers key ISO 13485:2016 Clause 8.2 requirements.
✔ Customer & Product Information Section – Log customer details, product name, batch number, and issue description.
✔ Complaint Categorization & Root Cause Analysis – Track feedback types, risk levels, and potential regulatory impact.
✔ Corrective & Preventive Action (CAPA) Integration – Ensure resolution and prevent recurrence.
✔ Status & Resolution Tracking – Monitor complaint progress from open to closure.
✔ Regulatory Compliance & Post-Market Surveillance (PMS) Section – Ensure adherence to vigilance reporting requirements.
✔ Automated Filters & Sorting Features – Easily manage open, pending, and resolved cases.
✔ Editable Digital Format – Fully customizable for different medical device business models.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use feedback and complaints tracking tool is ideal for quality managers, customer service teams, and regulatory professionals, ensuring efficient, compliant, and structured complaint management.
Download the ISO 13485:2016 Feedback & Complaints Spreadsheet Template today and enhance your customer satisfaction and compliance process!
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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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