5.4 Planning 5.4.1 Quality objectives: Top management of the manufacturer shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the manufacturing organization. The quality objectives shall be measurable and consistent with the quality policy. 5.4.2 Quality management system planning: Top management of the manufacturer shall ensure that— (a) the planning of the quality management system is carried out in order to meet the specified requirements, as well as the quality objectives; and (b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 5.5 Responsibility, authority and communication