ISO 13485:2016 Appreciation and Interpretation
You need this course if ...
- you want an overview and an understanding of the intent and requirements of ISO 13485 Medical Devices quality management systems (QMS)
- you want to know which version of ISO 13485 you need to implement within your organisation
- you need to understand ISO 13485 compatibility with other management systems
- you want to convert from ISO 9001 to ISO 13485
- if you want to create a single quality system that meets global regulations
You will learn ...
- the scope and application of the ISO 13485 standard
- the differences between ISO 13485:2003 and EN ISO 13485:2012
- essential definitions and terminology to help you interpret and apply ISO 13485 requirements
- the key requirements of ISO 13485 Medical Devices and how they relate to each other to form a robust effective system
- how ISO 13485 forms the basis of worldwide Medical Device Regulation with particular emphasis on Canadian Regulation CMDCAS
- the relationship and differences between ISO 13485 and ISO 9001 requirements
- the relationship between ISO 13485 and risk management standard ISO 14971 and ISO/TR 14969
You will need …
- no previous training
|04 Dec 2017||London||
|05 Mar 2018||LRQA Birmingham - LRQA Birmingham - Birmingham West Midlands||
|04 Jun 2018||London||
We also recommend these related courses to deepen your knowledge of this subject and take your skills up to the next level. Feel free to get in touch with our Client Service Team on 0800 328 6543 if you’d like more advice about which course is right for you or your team.