In large enterprises, Quality Management Systems (QMS) and ISO 9001 are often perceived as "anchors" that slow down Agile development due to heavy documentation and rigid waterfall-based approvals. However, quality assurance is not about "zero bugs"?it is about "providing confidence to stakeholders."

In this session, I will share Mitsubishi Electric’s strategic journey in rebuilding its QMS from the ground up to support Agile. We will explore:

The Layered QMS Architecture: How we decoupled "Abstract Processes" (the 'What') from "Team Implementations" (the 'How') to allow organizational flexibility.

Defining "What NOT to Do": The transition from centralized gatekeeping to decentralized empowerment, transferring release authority to Product Owners (PO) to enhance decision-making agility.

The Rise of the Quality Engineer (QE): Moving away from third-party testing toward a "companion" model, where QEs participate in sprints to ensure the "Definition of Done" (DoD) is met from within.

Attendees will learn a proven blueprint for achieving ISO 9001 certification without sacrificing the agility required in the modern DX era.

Audience gain：

Strategic QMS Design: Learn how to architect a layered QMS that separates compliance requirements from specific development methodologies to maintain organizational agility.

Governance Modernization: Understand how to redefine "Release Approval" and "Metrics" to empower Agile teams while maintaining accountability.

The Companion QE Model: Discover how to integrate Quality Engineers into the DevOps lifecycle to automate and accelerate "confidence building."

Practical ISO 9001 Navigation: Gain insights on how to interpret international standards in a way that naturally fits Agile events and artifacts (PBI, DoD, Sprints).