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)