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QMS and Standards
ISO 9001:2026 Transition Gaps That Quality Managers Should Address Now
Eric Franco-Velez
ISO 9001:2026 is in its final development stage. The final draft international standard (FDIS) has been submitted for ballot, and publication is expected in September 2026. That gives certified organizations approximately three years to make the transition—with a deadline that currently points to September 2029. Three years sounds comfortable. It isn’t. The ISO 9001:2015 transition taught the…
QMS and Standards
What the Purolea Warning Letter Really Means for AI in Medtech
Etienne Nichols

The U.S. Food and Drug Administration’s April 2, 2026, warning letter to Purolea Cosmetics Lab is making the rounds, mostly under some version of “FDA cracks down on AI in manufacturing.”

That’s the wrong way to read this. If you build medical devices, treating this issue as an AI story will cause you to miss the part that actually applies to you.

Purolea wasn’t a story…

Statistics
Exponentially Weighted Moving Average Charts
Donald J. Wheeler

Many erroneously think of a process behavior chart as a technique for monitoring a process. Consequently, they consider other monitoring techniques as alternatives to a process behavior chart. One of these proposed alternatives is an exponentially weighted moving average (EWMA). While an EWMA may be used to monitor a process and to make adjustments to the process aim, it is, at best, a poor…

Improvement Tools
3Q: Why Science Is Curiosity on a Mission
MIT News

MIT launched a new initiative—titled Science Is Curiosity on a Mission—to make the case for the long-horizon, curiosity-driven science that has powered generations of American innovation. Through stories of scientists pursuing open-ended questions, the project highlights how fundamental discovery research sparks advances in medicine, technology, national security, and economic growth.

…

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What’s a 150-Year-Old Meat Chopper Have to Do With America’s Favorite Sports Car?

Videos

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Features
Shaping Future Management Systems
CANEA
Rapid changes in the global business environment require developing and adapting management systems…
When the Code Your AI Wrote Fails a Patient
Pramin Pradeep
Here’s a scenario that should make any quality leader in pharma or medical devices uncomfortable: A…
My Research Is Working Toward a Pain-Free Mammogram Alternative
Kathryn Keenan
At some point during my teenage years, I became aware that when I grew up, I’d have to get a…
Quality Manufacturing Corporation Turns 3D Inspection Data Into Practical Insights
Ray Chalmers
Established in 1995, Quality Manufacturing Corporation is a fabricator that offers services from…
The Steam Controller and an Industrial Robot: An Unexpected Intersection
Ilnar Galiullin
Valve’s new Steam gaming controller is here—10 years after the original model. It sold out quickly…
AI and Jobs: Are Companies Prepared for the Workforce Revolution?
Andy J. Yap, Phanish Puranam, Victoria Sevcenko
Away from the dire headlines of Big Tech layoffs, the real picture of how organizations are dealing…
The Problem Isn’t the Problem
Akhilesh Gulati
The hardest problems are often not the ones we fail to understand. They’re the ones that resist…
More Features
News
Massimo Group Launches AI Intelligent Patrol Platform Initiative
(Massimo Group: Garland, TX) -- Massimo Group, a U.S.-based power sports and utility vehicle…
TRIMEDX Introduces Agentic AI Capabilities as Part of TRIMEDX-AIQ
(TRIMEDX: Indianapolis) -- TRIMEDX has announced the launch of its technician agent, a…
Hexagon Boosts Large-Volume Inspection Productivity
(Hexagon Portable Metrology Division: North Kingstown, RI) -- Hexagon’s Portable Metrology Division…
Nikon Launches ECLIPSE LV100AMS
(Nikon: Brighton, MI) -- Nikon Corp. has launched the ECLIPSE LV100AMS, a new one‑click automated…
90% of Manufacturers Say Digital Transformation Is Now Essential
(Rockwell Automation: Milwaukee) -- Rockwell Automation, the world’s largest company dedicated to…
Zimmermann Displays Addition to Its Portal Milling Line at IMTS 2026
(Zimmermann: Wixom, MI) -- Zimmermann, a global high-tech supplier of portal milling machines, will…
Continuously Measure Live Fluid Temperatures of Constant-Fill Fluid Couplings
(Voith: York, PA) -- Because constant-fill fluid couplings typically operate in demanding…
Boeing Plans $1 Billion Investment in Kansas Facilities
(ManufacturingDive: Washington, D.C.) -- Boeing CEO and president Kelly Ortberg announced that the…
More News

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