ISO 13485
Product Realization Planning 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 plans and develops the processes needed for product realization, as required by ISO 13485:2016 clause 7.1.
What's Inside
- Product Realization Process Overview
- When Planning Is Initiated
- Consistency with QMS Processes
- Risk Management in Product Realization
- Determining Planning Requirements
- Documenting the Planning Output
- Stage-Gate Reviews
- Production Readiness Review
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 7.1. 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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