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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