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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-06-22
- Length: 42m
- Episode: 324
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-22-324-management-responsibility-the-most-important-part-of-a-qms
- Listen: https://podcast.greenlight.guru/episode/324-management-responsibility-the-most-important-part-of-a-qms

## Summary

Sara Adams, a Lead Auditor and Quality Engineer at Greenlight Guru, explains the critical role of management responsibility in a medical device Quality Management System (QMS). She details how top management must establish a meaningful quality policy, provide adequate resources, and conduct rigorous management reviews to ensure regulatory compliance and a culture of quality. Adams emphasizes that without active executive buy-in and cross-functional engagement, even well-documented systems fail to protect patients or satisfy auditors.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-22-324-management-responsibility-the-most-important-part-of-a-qms#t=0) Introduction and Quality Policy as a Battle Cry
- [15:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-22-324-management-responsibility-the-most-important-part-of-a-qms#t=936) Organizational Structure and Resource Allocation
- [18:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-22-324-management-responsibility-the-most-important-part-of-a-qms#t=1104) The Role of the Management Representative
- [20:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-22-324-management-responsibility-the-most-important-part-of-a-qms#t=1208) Conducting Meaningful Management Reviews
- [32:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-22-324-management-responsibility-the-most-important-part-of-a-qms#t=1963) Quality Planning and Executive Buy-in

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- ISO 13485 (other)
- FDA (other)
- Greenlight Guru Academy (product)

## Related episodes from other shows

- [179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-12-179-quality-is-not-everyones-job-why-thats-a-good-thing) (Let's Combinate)
- [071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols) (Let's Combinate)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)
- [002 - “Seeing David in the Stone: Predictive Quality Management” with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager) (Let's Combinate)
- [215 - Why Aren’t Technical People Leading Drug-Device Audits?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-26-215-why-arent-technical-people-leading-drug-device-audits) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-22-324-management-responsibility-the-most-important-part-of-a-qms. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.