sec_5_1_6__para
Some modules and their variants are based on quality assurance techniques and are derived from the EN ISO 9000 (244), EN ISO 9001 (245) standards. The modules based on quality assurance techniques (modules D, E, H and their variants) describe the elements a manufacturer must implement in his organisation in order to demonstrate that the product fulfils the essential requirements of the applicable legislation.
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Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.