This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directives and US FDA’s Quality System Regulation. The relationship with ISO 14971 ‘Application of Risk Management to Medical Devices’ is also explored during the course.
Delegates gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.
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.se@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 Introduction learning path is modular. You can follow training courses in all combinations. We recommend the following order:
In addition to this introduction training, the following training courses are part of the ISO 13485 learning path:
1. Introduction ISO 13485:2016 - € 740,-
2. Implementation ISO 13485:2016 - € 1.425,-
3. Internal Auditor ISO 13485:2016 - € 1.425,-
4. Lead Auditor ISO 13485:2016 - € 3.355,-
When you choose a combination of training courses, you benefit from a price advantage:
| 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 07 80 or send an email to training.se@bsigroup.com.
Who should attend?
Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.
Prerequisites:
There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course.
Delegates will be able to:
- explain the use of ISO 13485:2016 as the basis for a QMS for medical device manufacturers
- identify the relationship between ISO 13485:2016 and European Medical Device Directives
- recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide
Practical Information
- It's a 1-day course.
- The training and materials will be provided in English
- Lunch and drinks are included
- On completion, you'll be awarded an internationally recognized BSI Training Academy certificate.
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.
