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…
Risk-Based Thinking in ISO 13485 (and How It’s Different from ISO 9001)
Risk-based thinking is one of those phrases that is mentioned frequently within the ISO standards, but it’s often left…
Duality of Posterity: A Review of AS9100’s “Documented Information”
The Paper Trails of QMS Made Simple If a strong process exists without any documentation, is it really a strong…
What is NADCAP Chemical Processing and Why Should it Matter?
Why Nearly Every Aerospace Supplier and Manufacturer Has Adopted a Standard Despite It Not Being Mandatory In…