Quality Management Systems
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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 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.
This interactive an engaging online course has been designed to provide an in depth understanding of ISO 13485:2016. On completion of this training, participants will be able to apply their knowledge to the development of a ISO 13485:2016 compliant quality management system and help maintain on going certification for their organisation. Explore the requirements of ISO 13485:2016 and how the standard interacts with ISO 9001:2015, the European Medical Device Directive and the US FDA’s Quality System Regulation.
Finally an online learning platform thats 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 users 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.
Chapter 1 - Introduction to IS0 13485:2016
What is ISO 13485:2016?
What is a medical device?
What is a Quality Management System?
What does ISO 13485:2016 enable organisations to do?
Chapter 2 - Key Improvements of ISO 13485:2016
Key benefits, especially in compliance
Chapter 3 - Scope of ISO 3485:2016
- Structure of the revised ISO 13485
- Key areas of change between the 2003 and 2016 versions of ISO 13485.
- Regulatory requirements in ISO 13485:2016
Chapter 4 - Quality Management Systems (QMS)
What are they and why have one?
Chapter 5 - Resource Management
Expectations of ISO 13485:2016 with regard to resource management
Ensuring conformity with ISO 13485:2016
Significant revisions to resource management in ISO 13485
Chapter 6 - Product Realisation
Implications for organisations
Chapter 7 - Measurement, analysis and improvement
Measurement, analysis and improvement processes
Control of non-conforming products
Analysis of data
Compliance with ISO 13485:2016 Clause 8
Chapter 8 - ISO 13485:2016 and FDA regulations
How does ISO 13485:2016 help with FDA conformity?
Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
Chapter 9 - Summary
Steps for implementation
Ewelina Testoni, PhD
Fiona Duthie, PhD
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