Duration: 6 hours
Speaker: Dr Lydie Moreau

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: why implementing a QMS, QMS benefits, the certification process
- Implementation Phases of the ISO 13485
- Visit of 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: 

Presentations with interactive discussions
End of training assessment