Special Processes Made Simple: What Aerospace and Medical Device Standards Are Actually Asking For
Introduction In the aerospace and medical device manufacturing industries, there exist select processes that cannot be…
The Deadline Ledger: The Coming Wave of Quality Standard Transitions
Introduction Change doesn’t come overnight in quality management systems. The material that shepherds auditors and…
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…
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…
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…
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…
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…