Work Instruction 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 all controlled work instructions (WIs) — the Level 3 documents that tell personnel exactly how to perform a task. ISO 13485:2016 clause 7.5.1 requires production to be planned, carried out, monitored and controlled, including, as appropriate, the documentation of procedures and methods for the control of production, and qualification of infrastructure.
What's Inside
- Numbering and Structure
- Register of Work Instructions
- Related Instructions, Plans and Test Methods
- Training Requirements
- Special Process Work Instructions
- Review Schedule
- Superseded and Withdrawn Instructions
- Register Change Log
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 4.2.1, 4.2.4 and 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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