''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).
bag
quality_public
created
Thu, 19 Mar 2015 22:15:24 GMT
creator
dirkjan
modified
Thu, 19 Mar 2015 22:15:24 GMT
modifier
dirkjan
tags
ISO13485