Standards

As food companies stand up digital traceability platforms to meet FSMA 204 requirements—now due by July 2028 after the compliance date extension—a quieter problem is showing up behind the deadline itself.

Most of these platforms are being deployed alongside existing quality…

ISO 9001:2026, the sixth edition of the quality management systems standard, was published on Sept. 16, 2026, replacing ISO 9001:2015. ISO lists the new edition as Edition 6, 2026-09. ISO/TC 176 confirmed that the Final Draft International Standard (FDIS) was approved ahead of publication.

On March 3, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Tentamus India Private Limited. The inspection it describes started the way most do, with one difference. At the initiation of the inspection, the agency’s investigator observed the firm attempting to remove…

At first glance, the next version of RC14001, the management standard for the chemical industry, looks like a simplification. In practice, it gives organizations more flexibility but also more responsibility. The revised standard no longer hands organizations a predefined list of stakeholder…

On April 2, 2026, the U.S. Food and Drug Administration issued a warning letter to Purolea Cosmetics Lab, reference 722591-04022026. By now, most of you have heard the story. The company had used AI agents to write drug product specifications, procedures, and master production records. No…

Consider an AI tool that delivers consistently accurate results and demonstrates impressive capabilities. If the people who are expected to rely on it can’t understand how decisions are reached or challenge outcomes that appear wrong, why would they trust it with an important decision? Would an…