Quality Management Systems
A professionally developed, interactive and engaging online training course.
Delivering unique, exciting and interactive e-learning technology courses.
ABOUT THE COURSE
The publication of ISO 13485:2016 marks a turning point in Quality Management Systems, for those involved in the lifecycles of medical devices.
ISO 13485:2016 was written to support Medical Device manufacturers in designing Quality Management Systems (QMS) that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of Medical Devices, that are safe for their intended purpose. ISO 13485 was last reviewed in 2020, which maintained that the 2016 version was still current.
This professionally developed, interactive and highly engaging online course has been re-designed in 2020 to provide in-depth understanding of ISO 13485:2016 and its practical implications. Learners will discover new knowledge and skills through a range of interactive learning methods including scenarios and regular knowledge checks.
On completion of this training, participants will be able to apply their knowledge to the development of an ISO 13485:2016 compliant Quality Management System and help maintain ongoing certification for their organisation.
Finally an online learning platform that’s fun, engaging and can be taken on any device, anywhere, anytime.
WlLL THE COURSE TAKE?
This course takes approx. 2-3 hrs to complete. This time will vary depending on the user’s previous knowledge and as the course contains lots of links to more information, it will also depend how many the user choose to access.
At the end of the course the user can download and print their own certificate as a record of their course completion.
Module 1: Introduction to ISO 13485
What is a Medical Device?
Introduction to ISO 13485
Scope of ISO 13485
Key improvements from the 2003 version of the Standard
Module 2: Quality Management Systems (QMS)
QMS general requirements
What is an ISO 13485 compliant QMS?
QMS document requirements
Module 3: ISO 13485 Practical Implications
Measurement, analysis and improvement
Module 4: Summary
Knowledge consolidation: Scenario
Knowledge check: Exam
Fiona Duthie, PhD
Ewelina Testoni, PhD
Stefan Smet, Writingale
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82 Lane Head Farm, Lane Head Road, Lees, Oldham, OL45RT