Overview
The ISO 13485 Ascelon eLearning course is a detail non-tutor lead program for learners’ understanding of ISO 13485: 2016 Quality Management System standards requirements. This online course will discuss and share key QMS principals’ knowledge that facilitate global alignments for medical device quality management systems and support busy learners to gain knowledge of applying the principles of QMS to be implemented their workplace. The training course is developed by qualified experts who have several years of quality assurance experience in healthcare products.
What you will learn
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Principles of ISO 13485 Risk based approach Quality Management System
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Understanding on how to meet regulatory requirements ensuring patient safety.
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Clause by Clause guidance of each requirement with details explanations with interfaces and link between each clause requirements.
Content
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ISO 13485 Standards Requirements (Basic module)
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ISO 13485 Standards Design and Development Requirements
What is included
This is a self-paced online learning that allows learners to view instructional online materials on their own schedule. Learners can access and complete the learning topics and attempt course quizzes of course for a month upon date of signing up. The whole course will take about 14 to 16 hours to complete.
On completion, learners will be awarded certificate of completion issued by Ascelon qualified facilitator.
Target Audience
Anyone who is involved with medical devices and who has responsibility for developing or working or involved with the implementation of the standard.
This training module is design to suit both ISO 13485 standard awareness induction for new employees as well as refresher course that should be completed annually to keep employees QMS compliance knowledge up to date.
How will I benefit?
Through this course, learners will gain knowledge on how to establish and implement ISO 13485 QMS to meet the standards requirements, and successfully achieve or maintain certification.