Introducing Exemplar Global’s Redesigned Internal Auditor Program
One of the exciting new initiatives that Exemplar Global has recently launched is our redesigned…
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 Secret to Building Real Confidence? It’s a Cycle, Not a Gift
By Jackie Stapleton “But I still don’t feel confident…” This confession comes up time and…
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,…
ISO 14001:2015 Isn’t the Problem— How You’re Pitching It Might Be
By Jackie Stapleton Back in 2010, I was the Quality & Environmental Systems Manager at…
Get Clause 6.1.2 Environmental Aspects Right or Nothing Else Works – ISO 14001:2015
By Jackie Stapleton One of my biggest lightbulb moments with ISO 14001 was realising just…
Don’t Get Left Behind – Get Ahead of the ISO 9001:2026 Changes
By Jackie Stapleton I made a promise to myself back in 2015 when the last…
How to Meet Annual Compliance Requirements Without Overloading Your Team
By LeAnn Chuboff Why Annual Compliance Is Essential for Food Safety Programs Maintaining a robust…
Integrating Human Factors into Compliance Strategies
By Gurpriya Kaur Introduction In the complex world of medical device design, ensuring usability and…