anx_XII__para_3__continuation__2
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.
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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.