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…
The Who and Why of Manufacturing and QA
Learn How you Might be Right for Opportunities Sweeping Across the Nation For decades now, manufacturing has…
I Received An FDA Form 483 – What Next?
The Whats, Whys, Dos, and Do-Nots Following an FDA Audit Today, we’re taking a look at the role an FDA Form 483…
Auditing the Instruction: Answering FAQ’s From Students
The world of Quality Management can be dizzying. You’ve slogged through brochures, waited through webinars, and sat on…