Hello and welcome to the free demo eLearning course T 42v16
"ISO 13485 internal audit version 2016"
You have access to the first chapters and their multiple-choice tests (MCT's) to get an idea of the content and means used in the PQB online courses.
If you have questions, feel free to ask (go back to the home page via the PQB logo and then click the Contact tab).
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Below is the text for the beginning of the training T 42v16:
Goal of the module
To conduct an audit according to ISO 19011 so as to be able to:
- identify improvement opportunities
- increase the satisfaction of interested parties
- evaluate the performance of the ISO 13485 QMS medical devices
With this module you will learn about the internal audit in an ISO 13485 certified company and
- locate the audit in the quality approach
- identify the stakes
- understand the requirements
- control the tools
You will become familiar with
- best practices
- good behavior
- case studies
- the terminology
- the questionnaire
- the report
At the end of the module you will understand the methods to organize and conduct the audit, including how to
- build the audit plan
- control the test
- avoid conflicts
- analyze the documents
- show the strong points
- detect the improvement opportunities
- make it so that conclusions are accepted
- write the audit report
- initiate the actions
- follow-up the actions
How to be more effective during e-learning
- choose the hours of the day (or night) when you feel best ready to learn
- ask people around you not to disturb you during your training
- stay focused during the training
- take notes
Where to start?
It is best to start from the beginning. The multiple-choice test (MCT) at the beginning will help you to understand where you are in relation to the module.
To access the final MCT, you must have passed the 5 MCTs with success (note: 15 or more out of 20). Take your time and do not be afraid to go back and start the MCT again.