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.
