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.

What is incorporated

ISO 9000:2015, clause 3

Terms and definitions, fourth edition, September 15, 2015. Incorporated for Section 820.3.

ISO 13485:2016

Third edition, March 1, 2016. Incorporated for Sections 820.1, 820.3, 820.10, 820.35, and 820.45.

Where it is written

21 CFR 820.7

Also called

21 CFR 820.7, 820.7

Related terms