Standards knowledge framework · Medical devices, pharma & cosmetics
ISO 13485
Quality-management system for medical devices.
Applicability
For medical devices, pharma and cosmetics, requiring tight quality, hygiene and batch-record controls.
Core focus areas
- Document, change and training control
- Hygiene, production conditions and process validation
- Traceability, complaints and nonconforming-product handling
Common audit watchpoints
- Batch records are incomplete or changes are not traceable
- Training is not tied to job roles
- Hygiene and environmental controls lack trend records
Practical checklist
Review baseline evidence and site conditions before working through customer or assessor requirements.
Open checklistRelated documents
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