a documented description of the procedures in place to fulfil the obligations arising from the quality management system and required under this Regulation and the undertaking by the manufacturer in question to apply those procedures,
tuairisc dhoiciméadaithe ar na nósanna imeachta atá ar bun chun na hoibleagáidí a fhorchuirtear leis an gcóras bainistithe cáilíochta agus a cheanglaítear leis an Rialachán seo agus ar ghealltanas an mhonaróra atá i gceist na nósanna imeachta sin a chur i bhfeidhm,