How Implementing Both ISO9001:2015 & ISO13485:2016 Benefits Your Organization
Wed. February 6| 9:15 AM - 10:00 AM | 210D
Show: MD&M West 2019
Track: MD&M West: Regulatory & Quality Update
Badge Type: Paid
The requirements in ISO 9001 and ISO 13485 diverged dramatically with the recent revisions. Companies that can implement both standards will find a positive impact to their processes, culture, and leadership decisions. This session will take a closer look at both standards and give you an inside look at how to bridge gaps between quality initiatives and every day business practices.
Topics covered include:
- How existing tools, such as SOPs and management reviews, are written and formed
- Ways internal audits are prioritized
- Case study on how this was successfully accomplished with results of a recent transition audit