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Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality

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. 

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Course Dates

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.
There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

Course Details


  • Recognize the difference between compliance-based auditing and performance-based auditing.
  • Learn how a performance-based audit program connects process metrics to key indicators of business performance.
  • Learn how to apply:
    • Performance-based methodologies for preparing and conducting audits.
    • Statistical tools that assess process performance and product characteristics, including the use of Minitab statistical software.
    • A process performance scoring system (and connecting it with nonconformities).


  • The fundamentals of performance-based auditing:
    • More robust methodologies for preparing and conducting audits
    • Auditor competence
    • Enhanced audit criteria that consider efficiency and effectiveness
    • Applied statistics for auditing
  • Planning, conducting, and reporting a performance-based audit
  • Linkages between the process approach to auditing and key performance indicators (KPIs)
  • Measuring audit program effectiveness

Who Should Attend

Designed for experienced management system auditors who have successfully completed an auditing course and performed actual audits, as well as audit program managers and QMS management representatives.  

  • In-Person Full-Days

  • CEUs


Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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