ISO13485 - Responsibility and authority
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Responsibility and authority
Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.
Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality, and shall ensure the 'independence and authority necessary to perform these tasks.
NOTE National or regional regulations might require the nomination of specific persons as responsible for activities related to monitoring experience from the post-production stage and reporting adverse events (see 8.2.1 and 8.5.1).
