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Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

How Implementing Both ISO9001:2015 & ISO13485:2016 Benefits Your Organization

Matt Pawluk (Director of Quality & Manufacturing, Evolve Manufacturing Technologies, Inc.)

Location: 210D

Date: Wednesday, February 6

Time: 9:15am - 10:00am

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

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