Customer Complaint Register
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
- Standard
- ISO 13485
- Document Type
- Register
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Register
This register lists every complaint received and tracks it to closure. ISO 13485:2016 clause 8.2.2 requires complaint handling to be timely and to include recording, evaluation, investigation (or documented justification for not investigating), determination of the need to report to regulatory authorities, handling of complaint-related product, and determination of the need for corrections or corrective actions.
What's Inside
- Purpose and Rules
- Status Summary
- Complaint Register
- Investigation, Actions and Closure
- Reportability Decisions
- Analysis
- Feedback Not Classified as Complaints
- Register Review
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 8.2.2. It fits with the rest of the QEHS Vault ISO 13485 document set.
Format
Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.
Key Benefits
- Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements
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