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.
Delegates develop knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.
ISO 13485:2016 learning path and combination discount
The ISO 13485:2016 Implementation learning path is modular. You can follow the training in all combinations. We recommend the following order:
Besides this introduction course, are the following training courses also part of the ISO 13485 learning path:
1. ISO 13485 Introduction - € 770,-
2. ISO 13485 Implementation - € 1.485,-
3. ISO 13485 Internal Auditor - € 1.485,-
4. ISO 13485 Lead Auditor - € 3.490,-
Attending several training courses of a learning path is associated with special discounts.
| Training course | Investment | Discount |
| Combination training 1 + 2 | € 2.155 | € 100 |
| Combination training 1 + 3 | € 2.155 | € 100 |
| Combination training 1 + 4 | € 4.085 | € 175 |
| Combination training 1 + 2 + 3 | € 3.515 | € 225 |
| Combination training 1 + 2 + 3 + 4 | € 6.830 | € 400 |
In-house training course
For more information about the learning path or in-house training courses, please contact our training team via +31 20 346 0780 or send an email to training.nl@bsigroup.com.
Who should attend?
Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.
Prerequisites:
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 training course.
Delegates will be able to:
- 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
- It's a 2-day course
- The training and materials will be provided in English
- Lunch and drinks are included
For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or 0031-(0)20-346 0780.
