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

Most discussions about One QMS focus on harmonization.

But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organizations structure a QMS.

In this episode, I compare centralized, decentralized, and federated (hybrid) Quality Management System models, including the trade-offs of each in terms of ownership, standardization, flexibility, governance, and decision-making.

We also walk through how the document hierarchy typically differs across each model—from the Quality Policy and Quality Manual to standards, SOPs, work instructions, and records—and discuss why governance often has a greater impact on success than the operating model itself.

Timestamps

00:00 Why "One QMS" Is Trending

01:33 The Three Primary QMS Models

01:50 Centralized QMS

02:01 Decentralized QMS

02:28 Federated (Hybrid) QMS

03:50 Comparing the Document Hierarchy

04:14 Centralized Document Structure

05:04 Decentralized Document Structure

05:22 Federated Standards, SOPs, and Governance

06:50 The QMS Tree: Philosophy, Governance, and Execution

08:20 Why Governance Matters More Than the Model

Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.