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. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 131 of 248 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. 1.5 It is emphasized that the quality management system requirements specified in this Schedule are in addition to complementary to technical requirements for products. 1.6 Manufacturers of components or parts of finished devices and in vitro diagnostic medical devices are encouraged to use appropriate provisions of this Schedule as guidance.