Standards

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…

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…

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…

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…

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.

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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…