Zavedení systému managementu kvality dle ISO 13485 u výrobce zdravotnických prostředků

Abstract

The thesis deals with a practical case study for implementation of quality management system in according with ČSN EN ISO 13485:2016 for surface treatment production line. Main goal is to implement norm, to complete its requirements and to make out the documents of systematic quality management for the producer of medical devices which will be serve as a subsupplier of surface finalizing of the medical devices made of titanium and aluminium alloys.