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Top management of the manufacturer shall ensure that responsibilities and authorities are defined, documented and communicated within the manufacturing organisation. Top management of the manufacturer shall establish the inter-relation of all personnel who manage, perform and verify work affecting quality, and shall ensure the independence and authority necessary to perform these tasks. 5.5.2 Management representative: Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes— (a) ensuring that processes needed for the quality management system are established, implemented and maintained; (b) reporting to top management on the performance of the quality management system and any need for improvement; and (c) ensuring the promotion of awareness of regulatory and customer requirements throughout the manufacturing organization.
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