2023-10-11T04:38:35
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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