This one day, introductory course provides an overview of ISO 13485:2016, and promises to give delegates an understanding of the intent and the requirements for ISO 13485:2016 quality management systems (QMS).
You can choose whether to attend our ISO 13485:2016 Appreciation and Interpretation as a public course or as an in-company event. Our public courses allow delegates to interact and network with other delegates from various medical devices companies and appreciate how other organisations have interpreted and implemented the ISO 13485 standard. As an in-company event, our ISO 13485:2016 experts come to you. Our ISO 13485: 2016 Appreciation and Interpretation course can be tailored to your organisation’s own management system and run at a date and time to suit you.
Who should attend?
This introductory course is relevant to anyone, of any level, involved with an ISO 13485:2016 management system who wishes to learn more about the standard and who:
- wants an overview and an understanding of the intent and requirements of ISO 13485:2016, and its compatibility with other management systems
- wants to convert from ISO 9001 to ISO 13485:2016
- wants to create a single QMS that meets global regulations
What you will learn
What will I learn?
- the scope and application of the ISO 13485:2016 standard
- the differences between ISO 13485:2003, EN ISO 13485:2012 and ISO 13485:2016
- essential definitions and terminology to help you interpret and apply ISO 13485:2016 requirements
- the key requirements of ISO 13485:2016 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 13485:2016 and ISO 9001:2015 requirements
- the relationship between ISO 13485:2016 and the risk management standard ISO 14971