Equipment Qualification Record
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
- Records
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Records
This record documents the qualification of production equipment before it is used to make medical devices. ISO 13485:2016 clause 6.3 requires your organisation to document requirements for the infrastructure needed to achieve conformity to product requirements, including maintenance activities and their intervals, and to keep records of maintenance.
What's Inside
- Equipment Identification
- Design Qualification — URS Traceability
- Installation Qualification
- Operational Qualification
- Parameter Accuracy (3 readings per set point)
- Repeatability
- Functional, Alarm and Software Tests
- Measuring Equipment Used
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 6.3, 7.5.6 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
Reviews
There are no reviews yet.