ISO 13485
Cleanliness / Contamination Control Record
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
- Records
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Records
This record shows that the planned arrangements to prevent contamination of product, the work environment and personnel were carried out in controlled area CA-1 during September 2027.
What's Inside
- Purpose and Summary
- Cleaning Programme
- Cleaning Log Summary
- Disinfectant Preparation and Verification
- Cleaning Effectiveness Verification
- Personnel Hygiene and Gowning
- Gowning Observation Audit
- Health and Gowning Qualification
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 6.4.1, 6.4.2 and 7.5.2. 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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