ISO 13485
Production and Process Control 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, carries out, monitors and controls production and service provision so that product conforms to specification, as required by ISO 13485:2016 clause 7.5.1.
What's Inside
- Production Process Overview
- Production Planning and Work Order Release
- Documented Procedures and Methods
- Qualification of Infrastructure
- Line Clearance and Pre-Production Checks
- Material Issue and Control
- Monitoring Process Parameters and Product Characteristics
- Monitoring and Measuring Equipment
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 7.5.1. 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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