Product Quality Trend Report
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
- Report
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Report
This report analyses trends in product quality characteristics to detect adverse trends early. ISO 13485:2016 clause 8.4 requires analysis of data on conformity to product requirements and on characteristics and trends of processes and product, including opportunities for preventive action, using appropriate statistical techniques.
What's Inside
- Purpose and Method
- Seal Channel Rejects (Sterile Barrier)
- Seal Strength Capability
- Incoming Adhesive Peel Strength
- Bioburden
- Signals and Actions
- Review and sign-off section
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 7.1 and 8.4. 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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