Are you ready for audits? ISO? FDA? Is your quality management system working the way you want it to? Is it still just a checkbox activity? Or, are you ready to elevate yourself to be a true quality professional?

A quality management system should help us run our business better and produce safer medical devices. It should be built well and run well - effective and efficient.

On today’s episode, we have Larry Mager, a senior advisor for UL EHS Sustainability. He shares a tool he developed called the Quality System Performance Assessment that determines the operational quality of a quality system.


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Some of the highlights of the show include:

● The Quality System Performance Assessment is built upon three foundational aspects: 1) Stakeholders require compliance with regulations and standards; 2) Processes must be effective in attaining expected results; 3) Business stakeholders expect those processes are efficient in operational execution.

● The three parts of a performance assessment are an :1) Audit for the compliance; 2) Appraisal of the management system; and 3) Analysis of the data.

● A compliance audit focuses on the identification and verification of the policies, processes, and procedures that a company developed to satisfy regulations and standards - what should be done.

● Companies do not need to wait for audits from ISO or FDA. They can initiate internal audits to determine the effectiveness of their quality system.

● An appraisal is focused on the management of a quality system, and the goal is to understand the results of the management processes - how they do it.

● It takes five integrated components, 17 key principles around those components, and three primary objectives to appraise what works and what doesn’t with a quality management system.

● Data has become very important. Gather data to look at the quality of the output and the adherence of quality processes. UL EHS has a method that helps companies how to measure each process within a quality system for effectiveness of required results. Also, measure the efficiency of operational execution.

● A company’s products are evaluated with similar items on the market to determine if its products are behaving differently and if they are being identified for malfunction, injury, or death.

● The FDA is coming! The FDA is coming! Companies can have a competitor that has issues with its products. If your company has similar products, then the FDA may just walk through your door one day to review your products, as well. What’s the benefit risk?

● Take information from the compliance audit, appraisal of the management, and the analysis of the data to process it as a performance report to identify concerns and plan for improving quality.



Larry Mager

UL EHS Sustainability

Quality Management System Performance Assessment for Medical Device Industry

Greenlight Guru

U.S. Food and Drug Administration (FDA)

Manufacturer and User Facility Device Experience (MAUDE)

International Organization for Standardization (ISO)


Quotes by Larry:

The last 12-15 years of my career have been primarily focused on an understanding of how best to transform a quality system.”

(Companies) They don’t look at their quality system as the thing that helps them out operationally...or something that needs to be assessed...

A lot of times, these systems are created and they’re not known or followed.



The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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