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.

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 course.

By the end of this 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)20-3460783.

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:

Leergang

Besides this implementation course, are the following training courses also part of the ISO 13485 learning path: 

1. Introduction

3. Internal Auditor

4. Lead Auditor

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

No.

Training

Price

 

1

ISO 13485:2016 Introduction

 €          675

 

2

ISO 13485:2016 Implementation

 €       1.325

 

3

ISO 13485:2016 Internal auditor 

 €       1.325

 

4

ISO 13485:2016 Lead auditor 

 €       3.150

 

 

Total

 €       6.475

 

 

 

 

 

 

 

Investment

Discount

 

 Combination training 1 + 2 

 €       1.850

 €         150

 

 Combination training 1 + 3

 €       1.850

 €         150

 

 Combination training 1 + 4

 €       3.825

 €         200

 

 Combination training 1 + 2 + 3

 €       3.025

 €         300

 

 Combination training 1 + 2 + 3 + 4 

 €       5.975

 €         500

If more employees need to understand, implement, audit, your management system, training can be delivered at your location. Based on your learning needs we could provide 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 mark.leenaers@bsigroup.com


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In company

We can deliver this training course to your team in-house. Training in-company allows you to save on each individual delegate and also cut out travel and accommodation expenses, which can be significant.With our in-company training, not only can you meet your business needs, but you can also:

  • Refresh your team’s skills and boost their confidence
  • Give your team an overview of your management system(s)
  • Train a group of auditors to the same level, using the same consistent techniques

For more information about the in-company training or to request a quote, please contact Mark Leenaers via +31 (0)20 346 07 83 or send an email to mark.leenaers@bsigroup.com