Environmental Monitoring 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 monthly environmental monitoring of controlled area CA-1, where sterile drapes (REF 1001, 1002, 1003) are assembled, welded, folded and packed before EO sterilization. ISO 13485:2016 clause 6.4.1 requires your organisation to document requirements for the work environment and to monitor and control it where it can affect product quality.
What's Inside
- Purpose and Summary
- Monitoring Plan and Limits
- Temperature, Humidity and Pressure
- Non-Viable Particle Counts (In Operation)
- Viable Monitoring
- Excursions and Alerts
- Trend — Last Six Months
- Review and Approval
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 6.4.1 and 6.4.2. 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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