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.
Déanfar na heilimintí, na ceanglais agus na forálacha uile a ghlac an monaróir a dhoiciméadú ar bhealach córasach, ordúil i bhfoirm beartais, nósanna imeachta agus treoracha scríofa.