Section 820.35 is where the QMSR gets specific about records — particularly complaint files and servicing records. It’s not dramatically different from what you were doing under the old QSR, but there are real changes worth knowing, and one of them involves UDI.
Ah, Clause 2. The normative references section. In virtually every ISO management system standard ever published, this is the page
§4.2.5 requires you to control your records — identify them, protect them, store them properly, and retain them for as long as required. Records are proof. Treat them accordingly.
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.
Welcome to the first installment of what I have grandly titled The ISO 42001 Annotated Companion for People Who Will
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.
§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.
Section 820.10 is where the QMSR stops asking whether you have a quality system and starts asking whether it actually works. Clara explains what ‘demonstrate’ really means to FDA, what changed from the old QSR, and how to make sure your QMS can stand up to scrutiny.
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.
Definitions sections rarely get the attention they deserve — until an audit, when suddenly the precise meaning of ‘manufacturer’ or ‘design history file’ matters enormously. Clara walks through the QMSR’s key terminology changes and why they’re worth your time.