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…
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)…
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…
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,…
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…
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…
CAPA vs. Nonconformance in ISO 13485: Teammates- Not Twins
In the arena of ISO 13485, as long as you're treating every nonconformance like a CAPA, you’re wasting time. When…
What AS9100 Means by “Critical Items” and Why You Need to Define Them
Have you ever scanned through AS9100 Clause 8.1.1 and scratched your head at the mention of “critical items”? If so,…
ISO 13485 Lead Auditor vs. ISO 13485 MDSAP Lead Auditor
What's the Difference? Which One Fits My Role? No two lead auditor courses are built for the same job, and when you…
Product Safety in AS9100: What It Actually Means, and What You’ll Need to Show
A Comprehensive Walkthrough of One of The Most Important Facets of Aerospace Manufacturing Product safety isn’t a new…