Complaint & Feedback Handling Kit

Who This Kit Is For

Organisations needing practical tools and documentation structures to capture, process and trend complaints and feedback.

The Compliance Problem It Solves

• Feedback and complaints managed in email or spreadsheets with no unified system.
• Weak trending and no structured link to CAPA or PMS.
• Audits questioning completeness of complaint records or response timelines.

What You Get In This Kit

• Complaint and feedback handling SOP and workflow.
• Complaint intake form, investigation form and closure templates.
• Feedback and complaint log with basic trending capabilities.

How This Kit Reduces Your Audit Risk

• Consolidates complaint and feedback handling into one controlled process.
• Improves investigation documentation and linkage to CAPA and PMS outputs.
• Provides clear, auditable evidence of complaint processing and trend monitoring.

How To Implement It (Step-by-Step)

1. Download the kit and align the SOP with your regulatory and business context.
2. Introduce standard forms and logs for all complaints and feedback.
3. Train staff on how to capture, escalate and document feedback and complaints.
4. Review trends and outcomes regularly and integrate them into your risk and CAPA processes.

Technical & Regulatory Alignment

• Built for: ISO 13485:2016 clauses 8.2.2 and 8.2.1.
• Typical use: complaint and feedback control, trending and escalation.
• Document type: complaint & feedback system kit.