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For many organizations, environmental management starts as a compliance exercise. A regulation requires certain controls, a customer requests certain assurances, and a company puts a program in place to meet the minimum requirement. That approach works, but it treats environmental management as a box to check rather than a source of business value. ISO 14001 […]

Since the Quality Management System Regulation (QMSR) took effect on February 2, 2026, FDA inspectors have been evaluating device manufacturers directly against ISO 13485:2016 rather than the legacy 21 CFR Part 820 framework. That shift means the standard’s clause structure is no longer just a certification requirement. It is now the roadmap FDA investigators use

Aerospace, space, and defense organizations have relied on AS9100 for decades to demonstrate a rigorous, sector-specific quality management system. That standard is now heading toward a significant evolution. It’s being renamed IA9100, and its structure and requirements are being shaped directly by the ongoing revision of its parent standard, ISO 9001. For organizations certified to

Manufacturers who rely on ISO 9001 to run their quality management systems have a new deadline on the calendar. The Final Draft International Standard for ISO 9001:2026 has been submitted for its final ballot, and publication is expected in September 2026. If your organization is certified to ISO 9001:2015, or working toward certification, now is

The Quality Management System Regulation officially took effect on February 2, 2026, replacing the Quality System Regulation that governed medical device manufacturers for decades. The QMSR incorporates ISO 13485:2016 by reference, aligning the FDA’s manufacturing requirements with the international standard used by regulators around the world. Alongside that shift, the FDA replaced its long-standing Quality

The ISO 9001 standard—an essential framework for quality management systems worldwide—is undergoing a major overhaul. Its upcoming revision, commonly referred to as ISO 9001:2026, aims to address modern business realities while preserving the proven high-level structure that practitioners have come to rely on. If you’re keen to stay ahead, here’s an in-depth update on the

If you’re part of the aerospace, defense, or space industry, you already know the name AS9100. But starting in 2026, this standard is getting a major overhaul—and a new name. It’ll be known as IA9100, reflecting its truly international scope. These changes aren’t just cosmetic. They’re rewriting how aerospace organizations approach quality—making systems more predictive,

🌐 The ongoing revision of ISO 9001, the international standard for quality management systems (QMS), continues to move forward with some key updates from August to October 2024.

🌐 FDA will mesh their existing Quality System Regulation (QSR) with ISO 13485.