Medical Devices

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 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.

HOW LONG
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.

COURSE CONTENTS

 

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 improvements

  • 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?

  • Documentation requirements

  • Management responsibilities

Chapter 5 - Resource Management
  • Current regulations

  • 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
  • Main changes

  • Implications for organisations

Chapter 7 - Measurement, analysis and improvement
  • Measurement, analysis and improvement processes

  • Control of non-conforming products

  • Analysis of data

  • Improvement 

  • Compliance with ISO 13485:2016 Clause 8

  • Main changes

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

  • Next steps

  • Knowledge check

"I found the system easy to use and the navigation through various screens was easy too. Varying the way information was accessed and the way the quizzes were done made it more interesting than if it was all the same throughout" 

Veronica
5.0
2017-08-02T14:39:48+00:00
"I found the system easy to use and the navigation through various screens was easy too. Varying the way information was accessed and the way the quizzes were done made it more interesting than if it was all the same throughout"  Veronica

I certainly enjoyed using the course and I thought it was easy to use overall. I thought the interactive part of the course and a little tests at the end of each section were especially useful.

Ewelina Testoni, PhD
5.0
2017-12-11T15:31:09+00:00
I certainly enjoyed using the course and I thought it was easy to use overall. I thought the interactive part of the course and a little tests at the end of each section were especially useful. Ewelina Testoni, PhD

I just wanted you to know that I thought the GCP course was good. The right level and I liked the fact you could read more if you wanted to e.g. articles.

Fiona Duthie, PhD
2018-03-26T10:49:01+00:00
I just wanted you to know that I thought the GCP course was good. The right level and I liked the fact you could read more if you wanted to e.g. articles. Fiona Duthie, PhD
5
2

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Phone

0161 633 4594

Address

82 Lane Head Farm, Lane Head Road, Lees, Oldham, OL45RT

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