Hello and welcome to the module "ISO 13485 readiness version 2016"

Goal of the module

Readiness for implementation, certification, maintenance and improvement of your medical devices quality management system so as to be able to:

With this module you will learn about the ISO 13485 standard and

You will become familiar with

At the end of the module you will know how to

  • interpret the requirements of the ISO 13485 standard
  • take part in the development of the quality policy and quality objectives
  • take part in the implementation of the document system
  • implement the 7 quality management principles
  • evaluate the ISO 13485 certification project
  • use the steps and tools for implementation of your QMS

How to be more effective during e-learning

  • choose the hours of the day (or night) when you feel best ready to learn
  • ask people around you not to disturb you during your training
  • stay focused during the training
  • take notes

Where to start?

it is best to start from the beginning. The multiple choice test (MCT) at the beginning will help you to understand where you are in relation to the module.

To access the final MCT, you must have passed the 7 MCT's with success (note: 15 or more out of 20). Take your time and do not be afraid to go back and start the MCT again. The certification audits are based on clauses 4 to 8, but the first three clauses will help you easily acquire the material.

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