anx_II__cpt_1__cpt_3__cpt_5__item_5__text_2
The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.5.2 or whether reassessment is necessary.
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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.