ISO 13485:2016 Transition & Auditor Refresher
The new ISO 13485:2016 standard is expected to be published in March 2016. To inform you about the changes within the new standard, we developed a training course in which these changes are explained.
With greater attention on the organization’s ability to meet applicable customer and regulatory requirements, the new ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management. Discover the latest requirements and explore the changes since ISO 13485:2003 and EN 13485:2012. You’ll refresh your auditing techniques and be able to identify the gaps in your current Quality Management System (QMS).
Who should attend?
Anyone involved in planning, implementing, auditing or supervising an ISO 13485:2016 QMS transition.
You should have good knowledge of ISO 13485.
By the end of this course delegates will be able to learn about:
- Key changes and auditing techniques
- How these changes may impact your current QMS
- Revised terms, definitions and audit principles
- Impact of changes from an auditing perspective
- Developing an internal audit schedule and plan
- Relationship between ISO 9001:2015 high level structure and ISO 13485:2016
- Transition timelines and what resources may be required
- It's a 1-day course
- The training and materials will be provided in English
- Lunch and drinks are included
* If required, you could attend the whole day of only the morning.
- € 650 whole day, € 350 only the morning
The training is also available in Dutch.