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 through several exercises
  • End of training assessment


EUR 625 incl. course material and certificate


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