April 23, 2026
How ISO 9001:2026 Is Taking Shape: Where the Revision Stands and What Manufacturers Need to Know
The ISO 9001 standard is getting its first major revision since 2015, and the process is moving faster than most…
April 15, 2026
How Regulatory Changes in Medical Devices Are Reshaping What Quality Professionals Need to Know
Regulatory changes in medical device quality are accelerating, and quality professionals who aren't keeping pace are…
April 1, 2026
Ishikawa Diagrams in 8D: When and How to Use Them for Root Cause Analysis
In the 8D methodology, an Ishikawa diagram, also known as a fishbone diagram, is one of the most commonly utilized…
March 5, 2026
Sampling: How One Bad Document Can Derail Your Audit
If you’ve lived through an AS9100, you know the dread that can come with sampling. An auditor’s fingers trembling mere…
March 5, 2026
An AS9100 Audit: A Practical Map of the Aerospace Quality System
For quality professionals not involved in aerospace AS9100 is “ISO 9001 but aerospace.” In many ways, it’s true. ISO…
March 4, 2026
Configuration Control in AS9100: What You Need to Know Now
Configuration control in AS9100 ensures that aerospace organizations maintain accurate, approved product definitions…
January 27, 2026
ISO 13485: The Things That Will Matter Most After February 2026
Introduction When the Final Rule takes effect in less than a month, changes won’t show up as a new, shiny checklist or…
January 27, 2026
‘Checkbox’ Training and Why AS9100 Pushes Back On It
Introduction We get it. Between CPD hours and new standards, any veteran auditor worth their salt has taken more…
January 27, 2026
The Engineering vs. Quality Standoff: The Path to Collaboration With AS9100
Engineering Changes in AS9100: Getting Engineers and Quality on the Same Page It’s a tale as old as the standard.…
January 27, 2026
The Eyes of an ISO 13485 Auditor: The Hidden Risks Between the Lines
Introduction When standards are structured in a way that you need classes to begin to interpret them, pitfalls are a…