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

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)