GLOSSARYUS
QMSR
The FDA's Quality Management System Regulation, 21 CFR Part 820, in effect since February 2, 2026. The regulation requires a documented quality management system that meets ISO 13485:2016 together with the additional requirements Part 820 sets.
Avoid This Mistake
A quality system built only to ISO 13485 can miss the added requirements in 21 CFR 820.35 (record content) and 820.45 (labeling and packaging controls).
Sections
- QMSR Section 820.1 (Scope)The scope section of Part 820. The part covers the methods, facilities, and controls used to design, manufacture, package, label, store, install, and service finished devices for human use. Contract sterilizers, relabelers, repackers, remanufacturers, and initial distributors of foreign entities that perform those functions are included.
- QMSR Section 820.7 (Incorporation by Reference)Incorporates two ISO documents into Part 820 by reference, each at a stated edition: ISO 13485:2016, third edition, and clause 3 of ISO 9000:2015, fourth edition.
- QMSR Section 820.10 (Quality Management System)The core requirement of Part 820. A manufacturer must document a quality management system that meets the applicable requirements of ISO 13485 and the other applicable requirements of the part. It also ties named ISO clauses to other regulations in Title 21.
- QMSR Section 820.35 (Control of Records)Adds record content the FDA requires beyond ISO 13485 clause 4.2.5: required content for complaint, servicing, and UDI records, and a way to mark confidential records to help the FDA decide on disclosure.
- QMSR Section 820.45 (Device Labeling and Packaging Controls)Adds labeling and packaging controls beyond ISO 13485 clause 7.5.1. A manufacturer must document procedures for the integrity, inspection, storage, and operations of labeling and packaging, and examine labeling for accuracy before release or storage.