Feedback Procedure - ISO 13485

Effectively collect, analyze, and respond to customer feedback with our ISO 13485:2016 Clause 8.2 Feedback Procedure Template. A structured feedback management system is essential for improving product quality, ensuring regulatory compliance, and enhancing customer satisfaction in medical device manufacturing. This ready-to-use procedure template provides a systematic approach for gathering, evaluating, and acting on feedback, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Feedback Procedure – Covers key ISO 13485:2016 Clause 8.2 requirements.

✔ Feedback Collection Methods – Define structured approaches for gathering feedback from customers, users, and stakeholders.

✔ Evaluation & Categorization Process – Classify feedback based on risk, impact, and relevance to product quality.

✔ Integration with CAPA & Risk Management – Ensure feedback leads to corrective actions and continuous improvement.

✔ Regulatory Compliance & Reporting – Align with MDR post-market surveillance and FDA reporting requirements.

✔ Tracking & Follow-Up Section – Monitor the status of feedback-related actions and improvements.

✔ Approval & Sign-Off Workflow – Assign responsibilities for feedback review and implementation.

✔ Editable Digital Format – Fully customizable for various business needs and product lines.

This feedback procedure template is ideal for quality managers, regulatory teams, and customer service professionals, ensuring a structured, compliant, and efficient feedback management process.

Download the ISO 13485:2016 Feedback Procedure Template today and improve your customer satisfaction and regulatory compliance efforts!