ISO 13485
Customer Requirements and Contract Review Procedure
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
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- Standard
- ISO 13485
- Document Type
- Procedure
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Procedure
This procedure defines how your organisation determines and reviews the requirements related to its medical devices before committing to supply them, and how it communicates with customers. It meets the requirements of ISO 13485:2016 clause 7.2.
What's Inside
- Determining Requirements Related to Product
- Review Levels
- Review Before Commitment
- Standard Order Processing (Level 1)
- Tenders and Quotations
- Special Contracts: OEM, Private Label and Quality Agreements
- Amendments to Contracts and Orders
- Delivery and Post-Delivery Commitments
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 7.2. 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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