Episode 324

#324 Management Responsibility: The most important part of a QMS

Management responsibility is crucial to the success of a QMS… but what is it? What’s covered by the topic of management responsibility and who’s the responsible party? In today’s episode, you’ll hear from Sara Adams, Lead Auditor, Quality Engineer, and now Medical Device guru, on the subject of management responsibility and all that entails. 

Listen to the episode to learn what Sara is thinking about when she thinks about the topic of management responsibility. She shares her thoughts on quality policy, organizational structure, management review, and quality systems procedures. 

Some of the highlights of today’s show include:

  • Whether a summary statement is enough, or whether the policy needs to be a paragraph
  • Who the management representative is and what they are supposed to do
  • Why you need management review even if you’re not selling products
  • Getting executive management on board with a culture of quality
  • Making management review meaningful



“The quality policy should be the battle cry, the rally cry, the thing that pumps us up that we remember, not just words on a page.”

“It is really important to have enough resources in the right roles to be able to meet the requirements of this regulation.”

“Don’t just gloss over it. It is something that you have to do, but make it meaningful.”

About the Podcast

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Global Medical Device Podcast powered by Greenlight Guru
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 ...

About your host

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Etienne Nichols

Mechanical Engineer, Medical Device Guru, and host of the Global Medical Device Podcast