Equipment Maintenance 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 production, test and facility equipment that can affect product conformity, its maintenance requirements and intervals, and the maintenance carried out. ISO 13485:2016 clause 6.3 requires your organisation to document requirements for maintenance activities, including their intervals, when such activities or lack thereof can affect product quality, and to maintain records of such maintenance.
What's Inside
- Scope and Responsibilities
- Criticality Classification
- Equipment and PM Schedule
- Corrective Maintenance — Impact Assessment
- Overdue and Deferred Maintenance
- Critical Spare Parts
- Return-to-Service and Hygiene Rules
- Register Review
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 6.3, 6.4 and 7.6. 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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