Normative References — You Will Need to Buy More Documents
Ah, Clause 2. The normative references section. In virtually every ISO management system standard ever published, this is the page
Artificial Intelligence, ISO 42001, Standards
Standards
Artificial Intelligence, FDA 21 CFR 820 QMSR, ISO 13485, ISO 42001
AI Tools in Medical Device Manufacturing: A Roundtable with Art Meta, Norma Tive, and Clara Fication
We pulled three of our resident experts into one (virtual) room to tackle the five AI questions medical device manufacturers are wrestling with right now. There was banter. There were citations. Norma kept her composure.
ISO 13485, Standards
Document Control: Because ‘Pretty Sure That’s the Current Version’ Is Not a QMS Strategy
§4.2.4 requires you to actually control your documents — not just own them. Norma explains what that means in practice, what changed from the 2003 version, and why ‘it’s in a shared drive somewhere’ is the document control equivalent of hiding under a blanket.
FDA 21 CFR 820 QMSR, ISO 13485, Regulations, Standards
The Section of QMSR That Makes ISO 13485 the Law (Also, You Need to Buy It)
Section 820.7 is three short paragraphs, and most people skim right past it. Don’t. It’s the provision that turns ISO 13485:2016 from a helpful standard into a legal requirement — and it fundamentally changes how you read the entire QMSR.
Artificial Intelligence, ISO 42001, Standards
Yes, This Applies to You
Welcome to the first installment of what I have grandly titled The ISO 42001 Annotated Companion for People Who Will
ISO 13485, Standards
The Medical Device File — One Document, Four Names, Zero Excuses for Not Having It
The Medical Device File goes by many names — Technical File, Design History File, Device Master Record — but §4.2.3 has one clear message: for every device you make, there must be a file that proves you know what you’re doing. Norma explains what goes in it and why “it’s all in various folders” is not an answer.
ISO 13485, Standards
The Quality Manual — Yes, It Still Exists, and No, It Doesn’t Need to Be a Novel
The Quality Manual is one of those requirements that makes people either write 200 pages or one page of pure abstraction. Norma explains what §4.2.2 actually asks for — and how to get it right without losing your mind or your auditor.
ISO 13485, Standards
If It Isn’t Documented, It Didn’t Happen
Clause 4.2.1 establishes the documentation framework your entire QMS depends on. Here’s why ‘we know how to do it’ is not the same as ‘it’s documented’ — and why that distinction will matter enormously at your next audit.
ISO 13485, Standards
Yes, You Actually Need a Quality Management System (No, a Folder Called ‘Quality Stuff’ Doesn’t Count)
Let’s be honest. When someone first hands you ISO 13485 and says “we need to comply with this,” you flip