EN ISO 13485:2016 – Quality Management System (QMS)

by | Sep 1, 2023 | Past Training

This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned.


Training Objectives:

  • Understand the QMS principles and the links between the different QMS processes 
  • Define a QMS architecture 
  • Establish a roll-out plan for leading the implementation of a QMS 
  • Dive into the details of each process during dedicated sections 


Training Content:

  • Introduction to ISO 13485:2016: the importance of implementing a QMS, QMS benefits, the certification process 
  • Implementation Phases of the ISO 13485  
  • Visit the architecture of a QMS 
  • Diving into the requirements of the sections on Management responsibility, Resource management, Product realization and Measurement, analysis and improvement 
  • Building and reviewing concrete examples of key QMS documents (quality manual, standard operating procedures…) 


Training Format:

  • Presentation with interactive discussions
  • Exercises during the training
  • End of training assessment (participants will receive a training certificate)