GLOSSARYGlobal

Document Control

Procedures that control the documents a quality management system requires. The controls cover approval, review, change identification, and keeping obsolete versions out of use.

Where it is written: ISO 13485:2016 clause 4.2.4
Old rule: 21 CFR 820.40, in Part 820 before February 2, 2026
Also called: control of documents

Avoid This Mistake

Records are a special type of document, controlled under clause 4.2.5 rather than 4.2.4.

Related terms

Medical Device File Design and Development File

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