You need this course if you want to know how to design and implement an effective QMS based on ISO 13485:2016, prepare for ISO 13485 certification or you want to improve the effectiveness of your current system.
You will learn how to implement a QMS based on ISO 13485:2016 and the importance and relevance of legislation surrounding medical devices.
As well gathering knowledge surrounding documenting systems, processes and typical methods, this course covers core topics such as:
- how to develop a quality policy and objectives
- how to implement processes for improving the effectiveness of the system
- how develop an appropriate management review process
- how to plan and manage your internal quality auditing activities
- how to eliminate the causes of problems through effective corrective action
And… you will also have the opportunity to understand a few hot topics such as:
- the significance of process and environmental controls (e.g. clean rooms, sterilisation, personnel controls)
- the requirements surrounding software validation
- understand the key features of risk assessment as defined in ISO 13485
- the design and development requirements in ISO 13485
The course duration will be 2 days and encompasses a class room style, relevant and engaging exercises supported by comprehensive notes.