Calling all experienced auditors!
FDA’s Case for Quality seeks to elevate the focus of the medical device industry from compliance to practices that support medical device quality and safety.
How can your organization become “quality mature”?
By fusing decades of auditing expertise and performance improvement consulting experience, Oriel STAT A MATRIX has developed Performance-Based Auditing for Medical Devices, a methodology designed to move your audits beyond compliance.
Participants in this class learn how to analyze process performance data and document the:
-
Effectiveness of the management system in achieving business results.
-
Efficiency of the management system processes toward achieving business results with the least amount of resources.
Armed with this information, you will have the skills and knowledge to analyze data and identify opportunities to improve process performance, product quality, and customer satisfaction. This information allows you to speak the language of the boardroom: dollars and cents. As well, it is key to FDA’s Case for Quality and its focus on the use of critical-to-quality design and production practices that support higher-quality results.
NOTE: This course uses Minitab statistical software. Students must bring personal laptops to class loaded with the latest version of Minitab. A free 30-day trial version of Minitab 17 can be found at www.minitab.com.