ISO 13485:2016 Implementation Training Course

You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.

Develop your knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.

Who should attend?

Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.


You should have a good knowledge of ISO I3485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction course.

By the end of this course delegates will be able to define the:

  • Define a quality management system
  • Identify the steps for defining, planning, organizing and scheduling necessary activities
  • Implement an effective quality management system
  • Conduct a base line review of an organization's current position with regard to ISO 13485:2016

Practical Information

This two day training course includes lunch and drinks. The training and the materials will be provided in English. For further information regarding reduced rates at the hotel where the training is being conducted please contact or 0031-(0)20-3460780.

Modular training course

The course ISO 13485:2016 Implementation Training Course is modular. This means you can follow the training in all combinations. We recomment the following order:


Attending several training courses of a learning path is associated with special discounts. 



Price 2017



ISO 13485:2016 Introduction Training course

 €          675



ISO 13485:2016 Implementation Training Course

 €         1325



ISO 13485:2016 Internal Auditor Training Course

 €         1325


4 ISO 13485:2016 Lead Auditor Training Course  €        3.150  



 €        6.475











 Combination training 1 + 2 

 €       1.850

 €         150


 Combination training 1 + 3

 €       1.850

 €         150


 Combination training 1 + 2 + 3

 €       3.025

 €         300

   Combination training 1 + 2 + 3 + 4   €       5.975  €         500

When there are more employees who need to understand, implement or audit your management system, a training could be delivered at your location as well. Based on your learning needs we could deliver a customized in-house training course for your team.  

For more information  about the learning path or in-house training courses, please contact Mark Leenaers via +31 20 346 07 83 or send an email to


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Head + Heart + Hands: practical and effective learning

To retain your ability and enhance knowledge to effectively apply the skills our training concept Head, Heart and Hands becomes more and more important. Having a business perspective is essential from a performance point of view.

Head: knowledge - know what is in the standard (background), acquire knowledge

Heart: attitude - why use the standard, what is the use of the standard for my organization, get motivated and continue to use the standard

Hands: behaviour - doing, practicing, making concrete and put into practice

Recognizable examples and assignments which can be made individually or in groups are used extensively in our courses. The course takes place on the basis of activities and has proven to have a positive effect on work performance while saving time and money because the first steps for the organization were already taken during the course.