Internal audit The manufacturer shall conduct internal audits at planned intervals to determine whether the quality management system— (a) conforms to the planned arrangements, to the requirements of this Schedule and to the quality management system requirements established by the manufacturer; and (b) is effectively implemented and maintained. An audit programme shall be planned, taking into con ...

Design and development verification: Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained.