doc__table__166
— The use of quality assurance systems for the purpose of conformity assessment in the Union harmonisation legislation is described in modules D, E and H and their variants. — For the purpose of complying with the applicable legislation the manufacturer must ensure that the quality system is implemented and applied in such a way that it ensures full compliance of the products with the legislative requirements in question. — Compliance of the manufacturer with standards EN ISO 9000, EN ISO 9001, gives a presumption of conformity with the corresponding quality assurance modules as regards the legislative provisions covered by these standards. — In addition the quality system must take into consideration the specificities of the concerned products.
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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.