© ISO 2003 — All rights reserved
37 ISO 9001:2000
ISO 13485:2003 5.5 Responsibility, authority and
communication
5.5.1 Responsibility and authority
Top management shall ensure that responsibilities and authorities are defined, documented and
communicated within the organization.
5.5 Responsibility, authority and communication
5.5.1 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 stall ensure the independence and authority necessary to perform these tasks.
NOTE National or regional regulation 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.
5.5.2 Management representative
Top management shall appoint a member of management who, irrespective of other respon-
sibilities, shall have responsibility and authority that includes:
a ensuring that processes needed for the quality management system are established, imple-
mented 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 customer requirements throughout the organ-
ization. NOTE
The responsibility of a management rep- resentative can include liaison with external parties on
matters relating to the quality management system.
5.5.2 Management representative
Top management shall appoint a member of management who, irrespective of other respon-
sibilities, shall have responsibility and authority that includes
a ensuring that processes needed for the quality management system are established, imple-
mented and maintained; b reporting to top management on the performance
of the quality management system and any need for improvement
see 8.5 ; and
c ensuring the promotion of awareness of regulatory and customer requirements through-
out the organization. NOTE
The responsibility of a management rep- resentative can include liaison with external parties on
matters relating to the quality management system.
5.5.3 Internal communication
