FREE for Members! 2022-2023 series/September webinar: Implementing Quality Management Program
This session will cover the following:
Why Quality Management
Systems
§ May
2018 FDA Report on the Quality, Safety, and Effectiveness of Servicing of
Medical Devices
§
Improve & focus a critical eye on our processes
§ Drive
our process towards being metric measured
§
Continuous Improvement
§ High
Quality Service, and better patient outcomes
Formal Quality Management per ISO13485 vs ISO9001
§
Continuous improvement – JC & 9001
§ The
Definition of Risk 9001 - risk is the “effect of uncertainty on an expected
result.”
§ The
Definition of Risk 13485 - anything which could impact the safety or
performance of the device, or the device's ability to achieve market approval.
§
Choosing 9001 allows us to incorporate KPIs around Project Management, Parts
Ordering, and not just Device Service.
Pre-registration is required!
ACCE Members & Collaborators
members: register
for free here.
Non-members, pay and register
here