Standards
Most early-stage medical device companies never decide to skip a quality management system (QMS). They just never decide to buy one. The founding team opens a shared drive, builds a spreadsheet for design inputs and outputs, starts a document register in another tab, and agrees to sort out the…
Leadership responsibility is included in ISO 9001:2026, Clause 5.1.1, to promote quality culture and ethical behavior. A strong argument could be made for adding safety as well.
Ethics has a very wide range of applications, including the need to avoid conflicts of interest (like…
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.
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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…