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 review: At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements— (a) to evaluate the ability of the results of design and development to meet requirements; and (b) to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with th ...

Design and development validation: Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches or their equivalence. Design v ...

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.