Management responsibility of ISO 13485
Management responsibility of ISO 13485
Clause 5.0
5.1 Management commitment
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and
e) ensuring the availability of resources.
NOTE For the purposes of this International Standard, statutory requirements are limited to the safety and
performance of the medical device only.
5.2 Customer focus
Top management shall ensure that customer requirements are determined and are met (see 7.2.1 and 8.2.1).
5.3 Quality policy
Top management shall ensure that the quality policy
a) is appropriate to the purpose of the organization,
b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality
management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the organization, and
e) is reviewed for continuing suitability.
5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
5.4.2 Quality management system planning
Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
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 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).
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 (see 8.5), and
c) ensuring the promotion of awareness of regulatory and customer requirements throughout the
organization.
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
5.5.3 Internal communication
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
5.6 Management review
5.6.1 General
Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
Records from management reviews shall be maintained (see 4.2.4).
5.6.2 Review input
The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system,
g) recommendations for improvement, and
h) new or revised regulatory requirements
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