ISO 13485:2016 is the first major revision to the global quality system standard since 2003. In this one hour recorded webinar we cover the major changes that have been made and tell you what needs to be done before you seek recertification by your Notified Body.
- Timeline for certification transition for current certificate holders and new ISO 13485 certifications
- Comparison with other management standards and global regulatory expectations
- Brief overview of the significant changes made between the 2003 and 2016 versions
- Review of emphasized areas for the quality system that are expected moving forward
- Planning methods for certification transition and new certification
Who Should Watch:
This recorded webinar is appropriate for anyone responsible for QA compliance. It is expected that attendees will have knowledge of ISO 13485 already as we will not cover the basic concepts of the existing standard and will focus on the changes instead.
Recorded December 2016
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