ISO 13485:2016 - Webinar CD/Transcript
ISO 13485:2016 – Preparing for Implementation
ISO 13485:2016 will have a direct impact on your quality system including:
- Corrective and preventative action
- Design control
- Risk management
- Supplier management
What do you need to know — and do — to remain compliant?
Industry expert Dan O’Leary — President of Ombu Enterprises, LLC — illustrates the revisions and explains the transition plans for the certificates from the current versions (ISO 13485:2003 and EN ISO 13485:2012) to the corresponding new versions(ISO 13485:2016 and EN ISO 13485:2016). Additionally, he’ll point out potential conflicts with the QSR.
In 90 minutes, you will learn:
- The transition plan for certificates
- The transition plan for the EU Harmonized Standard
- The role of ISO 13485:2016 in the MDSAP and Canada’s plan to adopt it
- The major differences between ISO 13485:2003 and ISO 13485:2016
- The status of supporting documents such as ISO 9000:2015 and ISO/TR 14969:2004
- The status of EN ISO 13485:2016 and issues related to the product directives
- Some potential concerns related to ISO 13485:2016 and the FDA’s QSR
Order today and begin preparing for implementation of ISO 13485:2016.