I’ll be honest with you: definitions sections are not most people’s idea of a compelling read. They sit at the front of every regulation like a polite but insistent gatekeeper, and most of us walk past them on our way to the substantive requirements.
But here’s what I’ve learned about §820.3: the definitions are where a lot of compliance problems are quietly born. A company operates for years with a perfectly sincere but subtly incorrect understanding of what “manufacturer” means, or what qualifies as a “design history file,” and nobody notices until an investigator from FDA asks a very specific question and gets a very unexpected answer.
So let’s spend a few minutes here. It’s worth it.
What Changed Under the QMSR
The QMSR’s definitions section reflects its broader alignment with ISO 13485:2016. Some terms carried over from the old QSR essentially unchanged. Others were revised. And because ISO 13485 is now incorporated by reference, ISO’s own terminology — and the definitions in ISO 9000, which ISO 13485 draws on — also become relevant. That layering is new, and it’s worth being aware of.
Here are the definitions I’d flag for particular attention:
“Manufacturer” — broader than you might think. The QMSR defines manufacturer to include any person who designs, fabricates, assembles, processes, packs, labels, or installs a finished device. Critically, this includes specification developers — organizations that design a device and contract out the actual manufacturing. If your name is on the 510(k) or PMA, you are the manufacturer in FDA’s eyes, regardless of where the physical production happens. This has been true under the old QSR as well, but the QMSR’s alignment with ISO 13485 reinforces it. I’ve seen companies genuinely surprised by this. Don’t be one of them.
“Design history file” (DHF) — now more explicitly aligned with ISO 13485’s “design and development file.” The substance is similar, but the QMSR’s framing makes clearer that the DHF is a living record of the entire design and development process — not just the final outputs. If your DHF is more of a design output archive than a true development record, this is a good time to revisit that.
“Established” — a quiet but meaningful word. Throughout the QMSR, you’ll see requirements to have “established” procedures, processes, and systems. Under FDA’s interpretation, “established” means documented, implemented, and maintained — not just written down and filed away. A procedure that exists on paper but isn’t followed is not, in the regulatory sense, established. I mention this because it comes up in observations more often than you’d expect.
“Risk” and risk-related terminology — newly prominent. The old QSR used the word “risk” sparingly. The QMSR, through its incorporation of ISO 13485, uses it throughout. ISO 13485’s risk-based approach to quality management is now woven into the fabric of the regulation. If your QMS treats risk management as a standalone activity confined to design controls, the QMSR is asking you to broaden that lens.
A Note on ISO 9000 Terminology
Because the QMSR incorporates ISO 13485 by reference, and ISO 13485 itself references ISO 9000 for certain foundational terms, you may find yourself consulting ISO 9000’s definitions when interpreting some QMSR requirements. This is a new layer of complexity that didn’t exist under the old QSR. In practice, it rarely causes problems — but it’s worth knowing that the terminological foundation now has more depth than it used to.
What to Do Right Now
I’d suggest a focused, one-hour exercise: pull your SOPs, your Quality Manual, and any training materials that define key terms for your team. Compare how you’re using words like “manufacturer,” “design history file,” “established,” and “risk” against the QMSR’s definitions. Flag any places where your internal language has drifted from the regulatory meaning. These aren’t usually major corrections — but they’re the kind of thing that makes an inspection go smoothly rather than sideways.
You’re not looking for problems. You’re looking for alignment. There’s a difference, and it makes the work a lot less stressful.
Up Next
Next time we move into the substance of the QMSR with §820.10 — Quality Management System General Requirements. This is where the regulation starts asking you to demonstrate, not just describe, that your QMS is real. See you then.
This series is a plain-English walkthrough of the QMSR — written for the people who actually have to implement it.