A key project for our SBU for the last year and a half has been the Integrated Management System (IMS) harmonization across all our sites and departments.
This implied:
the creation of a unique, shared SBU set of policies and procedures
the integration of this entire documentation into one common system, in alignment with the sites’ practices
The reason why we launched ourselves into this gigantic project was to gain efficiency, speed and consistency across the entire SBU by having 1 common process and way of working. Equally important, through this project we aim to obtain 1 BSI certification for the US, Germany, Italy and Swiss sites by the end of 2018. This is a mandatory certification for us to be allowed to continue to sell our products.
As you look at the below timeline of the project, know that we have completed the first 11 steps, and in 2017 we are concentrating our efforts on finalizing the remaining documentation, processes and metrics (for Customer Service, Marketing and EHS) and the Swiss site audit transfer to BSI.
Planning
Note that the platform on which all the IMS documentation is centralized is SmartSolve and all the ENDO SBU employees have access to it.
If you have questions or need further information about the IMS or any of the integrated processes, please refer to the team hereunder:
ENDO IMS - Processes & Coordinators
DS ENDODONTICS PROCESS
SBU COORDINATOR
1. IMS Management
Marie-Charbel Cavignaux
2. Document control
Marie-Charbel Cavignaux
3. Change control
Terri Stanton
4. Global Risk Management
Marie-Charbel Cavignaux
5. Human Resources
Laurence Verdet
6. Infrastructure Building Workspace
Fabien Vilbert
7. EHS
Mathieu Dubail
8. IT
Daniel Kaiser
9. Calibration
Marcie Littleton
10. New Product development
Brian Atkinson
11. Labeling
Janine Conde
12. Regulatory compliance
Perrine Roche
13. Process Validation
Dan Dixon
14. Planning, Delivery, Returns
Chris Gladson
15. Procurement (Sourcing, Purchasing)
Brian Pilon
16. Supplier control
Randy Steed
17. Manufacturing
Chris Gladson
18. Customer Related Process
TBD
19. Servicing activities
Torben Volz
20. Vigilance HHE Market Action
Petra Altmann-Peichl
21. Complaint Management
Petra Altmann-Peichl
22. Post Market Surveillance
Marina Le Pommelec
23. Corrective Action Preventive Action
Juan Gaudiano
24. Internal audit
Steve Matlock
25. NC - Material Review Board
Jean Profeta
26. Measurement and monitoring
Marcie Littelton
27. Quality control
Jonathan Hess
I would also like to take advantage of this occasion to thank each and every single project coordinator for their diligence and professionalism in this journey towards our new common IMS.
Marie-Charbel Cavignaux, IMS Manager, Quality and Regulatory Affairs