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ISO 13485
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ORGANISATION
ENVIRONMENTAL SUSTAINABILITY POLICY
Quality Manual
QUALITY POLICY
System Procedures
Change Control
Competence, Awareness and Training
Documentation
Internal & External Communication
Management Review
Projects
Customer Focus, Feedback and Complaints
Regulatory Control
Adverse Incident, Advisory Notices & Recall
Product Realisation
Customer Property
Control of Monitoring and measuring equipment
External Providers (Purchasing & Supplier Management)
Warehousing, Preservation, Identification & Traceability
Validation
Cleanliness (Facility & Personal Hygiene, Waste & Pest Control), Health & Safety
Operational Procedures
INFRASTRUCTURE & ENVIRONMENT
Technical Services
Continual Improvement
Monitoring & Measurement
Data Analysis
Non Conformance Corrective Action
Preventative Action Risk Assessment
QMS Auditing V14
Sales, Customer Related Processes & Returns
ISO 13485
Product Realisation
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