9.1 Is there a written procedure for product recall in case of a quality concern?
9.2 Is the recall procedure regularly reviewed and updated?
9.3 Is there a procedure ensuring all customers and authorities are informed in case of serious or potentially life-threatening situations?
9.4 Do records contain sufficient information to allow a recall?
9.5 Are records readily available to the designated person responsible for recalls?
9.6 Is the effectiveness of the recall system evaluated?