1.3 The processes required by this Schedule, which are applicable to the medical device and in-vitro diagnostic medical device, but which are not performed by the manufacturer are the responsibility of the manufacturer and are accounted for in the manufacturer's quality management system. 1.4 If a manufacturer engages in only some operations subject to the requirements of this Part, and not in others, that manufacturer need only to comply with those requirements which are applicable to the operations in which it is engaged.