Articles Tagged with ''ISO 9001''

Some of the most disruptive quality failures in medical manufacturing are not found on the production floor. They are built into the handoff between the supplier and manufacturer early in the process. 

I have over the past couple of years presented the journey that ISO 10012 has followed to reach the time for release as the latest revision.

Bob Ferrone specializes in integrating industrial design, engineering, quality, manufacturing and environmental management systems for improving environmental and economic performance. 

Previously, I discussed my concerns about organizations not properly managing corrective actions or process variation. While corrective actions were covered before, this piece focuses on variation.

Ever since the announcement that ISO 9001 would be revised, the internet has been alive with speculation about what will change.

The next few years mark a major convergence in quality and compliance standards. ISO 9001, the foundational global quality management system (QMS) standard, is being revised for 2026. In aerospace and defense, AS9100 is evolving into IA9100, aligning with ISO’s revisions, and incorporating tighter supply-chain and digital assurance practices.

The most popular standard of the 27,000 standards produced by the International Organization for Standardization (often referred to as “ISO”) is ISO 9001 the standard for quality management systems – and it’s going through changes right now.

Michael Byrnes is the executive director of certification operations at ASQ and talks with Quality about certifications, and in particular, how certifications enhance people's careers, benefit the collective community, and really add value to society as a whole.

Syed Ahmed, a senior member of ASQ, shares his thoughts on the future of quality.

There will be more information about potential upcoming changes to the ISO Management System Standards (MSS). One topic of note is that of Continual Improvement (CI).