ISO 13485
Monitoring and Measuring Equipment 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 determines the monitoring and measurement to be undertaken, and controls the monitoring and measuring equipment needed to provide evidence that product conforms to the determined requirements. It meets ISO 13485:2016 clause 7.6.
What's Inside
- Determining Measurement Needs and Selecting Equipment
- Equipment Register and Identification
- Equipment Classification
- Calibration and Verification
- Adjustment
- Identification of Calibration Status
- Safeguarding from Adjustments
- Protection from Damage and Deterioration
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 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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