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