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