All Features
Neeta Verma
Product compliance is moving beyond certificates and restricted-substance checks. PFAS restrictions, digital product passports, artificial intelligence, supply-chain transparency, and sustainability increasingly require manufacturers to connect regulatory knowledge with reliable product, material,…
Pascal Terrien
In the electrotechnology sector, we know one thing for certain: Trust can’t be imposed; it must be built. Standardization enables us to build it every day. As the world grapples with climate, digital, and societal challenges, manufacturers, electricity producers, grid operators, conformity…
Stephanie Ojeda
The recent multistate outbreak of cyclosporiasis is a powerful reminder that food quality involves more than appearance, consistency, and shelf life. It requires an integrated approach to food safety, supplier control, traceability, risk management, and continuous improvement.
By mid-July 2026,…
Steve Romig
Quality teams throughout the food manufacturing industry face increasingly difficult obstacles and risks while keeping our food safe. A team can discover a positive Listeria result on a slicer component inside a ready-to-eat production zone after earlier environmental monitoring signals in the area…
Roderick Munro
As this article is being written, the (final draft) FDIS ISO 9001:2026 global vote has concluded, and we should soon see the new published requirements.
If published as drafted, which is widely expected, one of the most significant changes is an increased emphasis on demonstrating the…
Rob Moorey
The healthcare technology management (HTM) industry is facing a looming labor shortage and must attract enough skilled professionals to meet future demand. The industry is grappling with an aging workforce, a shrinking traditional talent pool, and increasingly complex medical equipment. Healthcare…
Vick Vaishnavi
The complexity of today’s manufacturing operations and ever-evolving digital disruptions, including the biggest of all, artificial intelligence (AI), require standards that set the pace and keep organizations around the world aligned with what quality looks like.
ISO 9001 has been the…
Megan Wallin-Kerth
Speaking with experts who love their jobs usually makes you aware of two things simultaneously: 1) how much you don’t know, and 2) how much you’d like to know. My conversations with Prashant Darisi and Vick Vaishnavi were no exception. I walked away with an appreciation for the decades of expertise…
Craig Cochran
With ISO 9001:2026 just around the corner, the topic of internal auditing is likely on the minds of many quality professionals.
This is the perfect time to reexamine your resources and strategies for internal auditing. The single biggest success factor of your audit program is who you select to…
Sai Ranjith
The U.S. Food and Drug Administration scrutiny of AI and machine learning in medical devices is intensifying. Yet most companies still apply failure mode and effects analysis (FMEA) methods designed for deterministic hardware failures. AI failures are probabilistic, context-dependent, and often…
Govind Ramu
Artificial intelligence (AI) workloads are reshaping the scale, speed, and risk profile of data center construction. As AI adoption accelerates, operators need more physical infrastructure, faster deployment cycles, and greater confidence that critical systems will perform as intended after handoff…
Mike King, Julie Larsen
Midtier life sciences companies are spending more than ever on quality and regulatory technology, yet many are paying enterprise prices for capability they never use. The right question isn’t whether to invest in a quality management system (QMS) or regulatory information management (RIM) platform…
QT9 Software
For years, many medical device manufacturers approached U.S. Food and Drug Administration (FDA) inspections through a familiar lens: Prepare documents, review subsystem requirements, rehearse likely questions, and demonstrate compliance against a known framework. That approach was shaped by the…
Tobias Lurk
ISO has set its focus on revising three key management system standards this year. It started with ISO 14001, which covers environmental management and was published on April 15, 2026. ISO 9001 for quality management will follow in the fall. For ISO 45001, the occupational health and safety…
Luca Ziveri
A line operator in a chemical packaging plant notices a torque inconsistency on a capping head. The deviation is within tolerance on the individual reading, but the operator has seen this pattern before; it usually precedes a run of out-of-spec caps over the next two shifts. He would normally flag…
Neerav Singh
Audit week has a way of revealing gaps that stay invisible during normal operations. Your methods are sound, and your data look clean. Then the assessor asks for the calibration certificate on the torque wrench used last Tuesday, and someone heads off to find it.
That small gap, a record that…
Stephanie Ojeda
In the larger organizations I worked for as a quality leader, supplier auditing was almost always calendar-driven. Sometimes supplier audits happened once a year; in other places, they might happen twice. I’d build the schedule to accommodate that, and the system would just run.
Over time, I…
Aity Ritesh Raj
FDA inspectors don’t just check your records. They bring their own thermometer.
And when their reading doesn’t match six months of logged data from the sensor on your cold room wall, the honest explanation is one nobody wants to say: The monitoring system was compliant; the measurement just wasn’t…
Lexi Sharkov
When a training matrix is built and managed correctly, it’s the backbone of compliance. It ensures that every employee knows how to perform their job and creates the traceability auditors love to see.
The problem is that it doesn’t take much for a training matrix to spiral out of control. What…
Takeisha Wright
A CAPA investigator opens an AI-enabled quality management system and asks for potential root causes. The system produces several plausible explanations, summarizes similar historical events, and recommends corrective actions. The investigator reviews the suggestions, selects one, and closes the…
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…
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…
Pramin Pradeep
Here’s a scenario that should make any quality leader in pharma or medical devices uncomfortable: A software team building a diagnostic support tool uses an AI coding assistant to generate a data-processing module. The module looks correct, passes validation testing, and ships. Eighteen months…
Santosh Vasudevan
For more than 30 years I’ve audited management systems in manufacturing, automotive, laboratory, service, and nuclear environments. During that time I’ve watched internal auditing change shape several times. Paper checklists gave way to process-based auditing. Filing cabinets gave way to digital…
Paddy McNamara
The food manufacturing industry has spent the last two years trying to figure out where AI fits: Vision inspection systems? Predictive maintenance? Yield optimization? Contamination detection? The applications are real, but they’re expensive, technically complex, and often require significant…