Feedback & Complaints Spreadsheet - ISO 13485

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.

✔ 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.

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!