ISO 13485: QMS Requirements of Medical Devices for Regulatory Purposes
By IJ Arora, Ph.D. ISO 13485:2016 is a standard that addresses quality management system…
One-Off or Systemic: The Search for Root Causes
By Julius DeSilva Accidents and failures, whether in maritime, aviation, healthcare, or nuclear settings,…
The Role of Management Systems in the Tragic Collision Over the Potomac
By IJ Arora, Ph.D. A significant tragedy occurred in Washington D.C. on January 29, 2025,…
The Baltimore Bridge Collapse—Another Case of a Failed Management System
By IJ Arora, Ph.D. Can good management systems make organizations immune to disasters? The…
Webinar Preview—Staying Compliant: Considering Climate Change in ISO Management Systems
Mitigating climate change is one of the most pressing issues confronting organizations today, and the…
Quality Is Not Just a Word We Use, Part Two: Defining Quality
By Tom Taormina Editor’s note: This is the second of three articles in a series…
Can Boeing Deliver a Long-Term Solution to their 737 MAX Problems?
By IJ Arora, Ph.D. Boeing is in the spotlight again with its 737 MAX planes,…
Risk and the 10th Edition of API Q1
By Bud Weightman Have you ever thought a revision to API Spec Q1 could…
The Sinking of the Titan: A Management System Lesson
By IJ Arora, Ph.D. On June 18, 2023, the Titan submersible imploded near the bottom…
Why stakeholders play a key role in your ISMS?
By Chinmay Kulkarni Are you tired of hearing the same old story about IT audit,…