Quality System setup

Quality system setup and inspection preparedness

Continuous improvement and assessment of the vigilance system performance and setup is one of the main critical responsibilities of the product owner (Quality Assurance). During inspections competent authorities scrupulously check this responsibility and most of the inspection findings are identified in this domain. FGK is offering to its clients:


  • analyze your vigilance system and help you implementing appropriate modifications as part of inspection preparedness
  • set up your company audit plan and we audit the vigilance activities of your third party providers.