Complaints/Feedback and Reporting to Authorities Document ISO 13485 Bundle

Ensure a compliant and efficient process for managing complaints, feedback, and regulatory reporting with our ISO 13485:2016 Clause 8 Bundle of Templates. This comprehensive set of templates helps your organization address customer complaints, gather feedback, and ensure proper reporting to regulatory authorities, in full compliance with ISO 13485:2016 requirements.

✔ Pre-Formatted Complaints Management Procedure – Define steps for logging, investigating, and resolving complaints.
✔ Complaint Investigation Form – Document complaint details, root cause analysis, and corrective actions.
✔ Customer Feedback Log Template – Track feedback from customers and stakeholders to improve product quality.
✔ Feedback Evaluation Template – Assess feedback for trends and areas of improvement.
✔ Regulatory Reporting Procedure Template – Outline steps for reporting serious incidents and safety concerns to regulatory bodies.
✔ Corrective and Preventive Action (CAPA) Integration – Ensure feedback and complaints lead to corrective and preventive actions.
✔ Audit-Ready Documentation & Compliance Tracking – Maintain structured records for audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various industries and compliance needs.

This bundle is ideal for quality managers, regulatory affairs teams, and compliance officers, ensuring a structured, compliant, and efficient approach to complaint handling, feedback analysis, and regulatory reporting.

Download the ISO 13485:2016 Complaints, Feedback & Reporting to Regulatory Authorities Bundle of Templates today and streamline your compliance and quality improvement efforts!