ISO 13485
Infrastructure and Work Environment 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, provides, qualifies, maintains and controls the infrastructure and work environment needed to achieve conformity to product requirements. It covers the requirements of ISO 13485:2016 clauses 6.3 and 6.4.
What's Inside
- Infrastructure
- Determining Infrastructure Requirements
- Facility Layout and Segregation
- Equipment Register and Identification
- Acquisition, Installation and Qualification
- Maintenance
- Breakdowns and Impact on Product
- Changes, Relocation and Decommissioning
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 6.3 and 6.4. 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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