Standards
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 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.…
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…
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…
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…
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…