Quality Assurance ISO
Support for Designing a Company Quality System according to
- UNI EN ISO 9001
- ISO/IEC 20000-1 Information technology. Service Management. Specification
- UNI CEI ISO/IEC 27001 Information Technology – Security Techniques – Systems for informations security management – Requirements
- UNI EN ISO 14001 Environmental Management systems
- UNI EN ISO 10891 Private Security Agencies
- SA 8000 Ethics Certification
- OHSAS 18001
Support for Company Quality System building up
- Analysis of Company Workflows impacting on Quality System
- Assistance in the Company Quality System certification path
- Training concerned with Quality System implementation
- Support in Company Quality System management and maintainence
Product/Process Requirements
- Software Validation (ISO 62304)
- Risk Management according to UNI CEI ISO 14971:2002 standard (Application of Risk Management to Medical Devices).
- Clinical Studies Verification
QA Management Outsourcing
CE Mark Assistance
Business Continuity System (BS 25999)
System Integrated Certification
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