Complaint & Feedback Handling Kit

Complaint and feedback records often exist, but the process around intake, classification, escalation, and trend review is inconsistent and difficult to defend. This kit gives you a tighter complaint-handling structure so data is captured consistently and can flow cleanly into CAPA, PMS, and vigilance decisions. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.

What's included

• Feedback and Complaint Handling SOP.docx
• Complaint Intake Form.xlsx
• Complaint Trend Sheet.xlsx
• Escalation Flowchart.pdf
• Implementation Guide.pdf
• Audit Checklist.pdf

Best suited to: Quality manager, Customer service lead, Distributor, and Regulatory consultant.

Useful in audit situations where you need to:

• Show a structured complaint handling process during ISO 13485 certification, surveillance, supplier, or internal audits.
• Support FDA inspections with controlled records, traceability, and process evidence related to complaint handling.
• Support EU MDR technical documentation or quality-system reviews where complaint handling records need to be complete, controlled, and consistent.

Use this toolkit to move faster, create cleaner evidence, and reduce the time it takes to stand up or repair this part of your ISO 13485 system.