Projektinformationen

Task

  • Update of the existing QM system certified according to EN ISO 9001:2008 and EN ISO 14001:2009 to EN ISO 9001:2015 and EN ISO 14001:2015
  • Expansion to include all processes and documentation required for the supply of medical technology components that are eligible for approval, as well as support for certification in accordance with EN ISO 13485:2016