ISO 9001

International Standard: Quality management systems—Requirements

Published by International Organization for Standardization (ISO)

The CFR incorporates ISO 9001 by reference, which makes the edition it names part of the regulation. The CFR requires the edition it names, which may not be the newest. To enforce any other edition, the agency must publish the change in the Federal Register.

The edition the CFR requires

ISO 9001:2008, Fourth edition, dated November 15, 2008 (corrected version dated July 15, 2009)

As the CFR lists it: “ISO 9001:2008(E)—International Standard: Quality management systems—Requirements, Fourth edition, dated November 15, 2008 (corrected version dated July 15, 2009)”

How to read it

A free or purchased copy may not be the edition the CFR names; check it against the edition above. Every incorporated standard can also be inspected at the National Archives (NARA) and at the agency named in the section that lists it.

ISO 9001 is copyrighted by its publisher; RegKnot shows its title and the editions the CFR names, not its text. Read from the eCFR's incorporation-by-reference sections, current as of October 26, 2026. The regulation text governs. All standards the CFR requires.