Introduction ISO 13485:2016 Training Course
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 email@example.com if you have any questions in regards to the online exam and your training course.