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.
Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.
Qualification:This course forms part of our Auditor Qualification programme. To find out more, please visit our training auditor qualification page here.
Gain a Certificate of Achievement for this course
You can now qualify for a Certificate of Achievement, by passing the assessment requirements, including an end-of-course online exam, you’ll improve your professional profile and be able to:
- Provide evidence of your learning
- Demonstrate your competence
We will email your exam log-in details when you’ve finished the course. The exam is done online which means you can choose when and where to complete it. You are strongly advised to choose a time and a place where you will not be disturbed, and where you have access to a reliable internet connection. The exam takes approximately 80 minutes, is comprised with 40 multiple choice questions and you have up to 30 days to complete it – including one opportunity for a re-take.
Upon successful completion of this exam you will be awarded a Certificate of Achievement alongside your Certificate of Attendance. If, however, you decide not to complete the exam, you will still be awarded with a Certificate of Attendance.
Please talk to a member of our training team on +31 (0)20 346 0780 or via training.nl@bsigroup.com if you have any questions in regards to the online exam and your training course.
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 implementation course, the following training courses are also part of the ISO 13485 learning path:
1. Introduction ISO 13485:2016 training course - € 740,-
2. Implementing ISO 13485:2016 training course - € 1.425,-
3. Internal Auditor ISO 13485:2016 training course - € 1.425,-
4. Lead Auditor ISO 13485:2016training course - € 3.355,-
Attending several training courses of a learning path is associated with special discounts.
| Training course | Investment | Discount |
| Combination training 1 + 2 | € 2.065 | € 100 |
| Combination training 1 + 3 | € 2.065 | € 100 |
| Combination training 1 + 4 | € 3.920 | € 175 |
| Combination training 1 + 2 + 3 | € 3.365 | € 225 |
| Combination training 1 + 2 + 3 + 4 | € 6.545 | € 400 |
In-house training course
For more information about this course and/or the possibilities of an in-house training for your organization, please contact our Training Advisors on 0031 (0)20 346 0780 or send an email to training.se@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 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.se@bsigroup.com or 0031-(0)20-346 0780.
