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 oth ...

7.5.1.1 General requirements The manufacturer shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:— (a) the availability of information that describes the characteristics of the product; (b) the availability of documented procedures, documented requirements, work instructions; and reference materials and refere ...