QMS Systems

A management system of an organisation can include different management systems, such as a Quality Management System or a Financial Management System.


A Quality Management System ensures that all activities with regard to quality are under control and all activities leading to a product or service are effective and efficient. This way a product or service can be delivered of consistent good quality.



mi-CE consultancy can help you with setting up you QMS system according to your specific wishes with the focus on:


  • ISO 13485:2016
  • MDSAP ISO 13485:2016
  • ISO 9001: 2015
  • Hospital QMS systems


Additionally, compliance to the specific QMS Annexes of the directives is guaranteed as well


  • Annex IX, MDR
  • Annex IX, IVDR
  • 21 CFR 820 (FDA)