# 246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-07-15
- Length: 8m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-15-246-the-3-ways-to-structure-a-quality-management-system-centralized-vs-federated
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/246---The-3-Ways-to-Structure-a-Quality-Management-System-Centralized-vs--Federated-vs--Decentralized-e3m3g06

## Summary

Subhi Saadeh, a quality consultant specializing in drug-device combination products, explains the three primary structures for Quality Management Systems: centralized, decentralized, and federated. He details how document hierarchies differ across these models, noting that centralized systems rely on global SOPs while decentralized ones allow local autonomy. Saadeh argues that governance and clear decision rights are more critical to success than the specific operating model chosen, as this is where systems often fail.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-15-246-the-3-ways-to-structure-a-quality-management-system-centralized-vs-federated#t=0) Introduction: The Trend of One QMS

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

large enterprises

## Related episodes from other shows

- [#360: Is It Possible to "Buy" a QMS?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-11-360-is-it-possible-to-buy-a-qms) (Global Medical Device Podcast)
- [#329 The Right Way to Start a QMS: When, How, & What](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what) (Global Medical Device Podcast)
- [Understanding the 'Compliance Manager' Role](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role) (Global Medical Device Podcast)
- [#324 Management Responsibility: The most important part of a QMS](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-22-324-management-responsibility-the-most-important-part-of-a-qms) (Global Medical Device Podcast)
- [Common QMS Mistakes SaMD Companies Make](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-21-common-qms-mistakes-samd-companies-make) (Global Medical Device Podcast)

## Citing this page

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