November 4, 2025
How ISO 13485 Interacts with ISO 9001 (and Why It Matters)
Introduction ISO 9001 is the bread and butter of manufacturers all across the globe. Simple as. However, in…
November 4, 2025
How AS9101 and AS9104 Changed AS9100 Audits: A Retrospective
With the new revisions in effect for AS9101 and AS9104 by the International Aerospace Quality Group (IAQG), the world…
October 9, 2025
The Cost of Waiting: What Nonconformance to the FDA Final Rule and ISO 13485 Spells for Manufacturers
The FDA’s two-year transition window ends in February 2026. Learn the consequences of nonconformance and why ISO 14971…
October 1, 2025
ISO 9001:2026 Timeline – A Comprehensive Look
Introduction It’s human nature to procrastinate when a deadline feels far off. With the release of the ISO 9001 Draft…
September 29, 2025
The Most Overlooked Clauses in ISO 13485 (and How to Avoid Trouble)
Introduction Details make or break your margins in ISO 13495. A single overlooked clause can spell catastrophe for…
September 29, 2025
QMSR Final Rule Explained: What Manufacturers Need to Know
Are you as ready as you think? When the FDA announced they were updating the bastion of Quality System Regulation (QSR)…
September 29, 2025
What You Need to Know About Getting Certified in AS9100: Timelines, Salaries, and the Future
"AS9100 is as lucrative as it is regulated." Introduction When prospecting quality assurance in the aerospace and…
September 3, 2025
ISO 9001 DIS: What Quality Professionals Should Know About the Draft Standard
"The Draft International Standard for ISO 9001 is the first messenger of the new era of quality management." Recently,…
August 18, 2025
When and How to Justify Exclusions in ISO 13485
What you leave out of your QMS can matter just as much as what you include. ISO 13485 isn’t designed to be a…
August 1, 2025
Breaking Down the Latest IA9100 Updates- What You Need to Know Now
What’s Going On with AS9100? If you've been scrambling to learn more about the next update to AS9100 and what it might…