5 Management Responsibility Flashcards
5 Management responsibility
5.1 Management commitment
Top management shall provide evidence of
5.1 Management commitment
Top management shall provide evidence of its commitment to the development and implementation of
the quality management system and maintenance of its effectiveness by:
a) communicating to the organization the importance of meeting customer as well as applicable
regulatory requirements;
b) establishing the quality policy;
c) ensuring that quality objectives are established;
d) conducting management reviews;
e) ensuring the availability of resources.
5.2 Customer focus
Top management shall ensure that:
5.2 Customer focus
Top management shall ensure that customer requirements and applicable regulatory requirements are determined and met.
5.3 Quality policy
Top management shall ensure that the quality policy:
5.3 Quality policy
Top management shall ensure that the quality policy:
a) is applicable 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;
e) is reviewed for continuing suitability.
- 4 Planning
- 4.1 Quality objectives
Top management shall ensure that:
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet applicable
regulatory requirements and requirements for product, 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:
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;
b) the integrity of the quality management system is maintained when changes to the quality
management system are planned and implemented.
- 5 Responsibility, authority and communication
- 5.1 Responsibility and authority
Top management shall ensure that:
- 5 Responsibility, authority and communication
- 5.1 Responsibility and authority
Top management shall ensure that responsibilities and authorities are defined, documented and
communicated within the organization.
Top management shall document 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.
5.5.2 Management representative
Top management shall appoint a member of management who:
5.5.2 Management representative
Top management shall appoint a member of management who, irrespective of other responsibilities,
has responsibility and authority that includes:
a) ensuring that processes needed for the quality management system are documented;
b) reporting to top management on the effectiveness of the quality management system and any need
for improvement;
c) ensuring the promotion of awareness of applicable regulatory requirements and quality
management system requirements throughout the organization.
5.5.3 Internal communication
Top management shall ensure that:
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.
- 6 Management review
- 6.1 General
The organization shall:
5.6.1 General
The organization shall document procedures for management review. Top management shall review
the organization’s quality management system at documented planned intervals to ensure its
continuing suitability, adequacy and effectiveness.
The 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 4.2.5).
5.6.2 Review input
The input to management review shall include,
5.6.2 Review input
The input to management review shall include, but is not limited to, information arising from:
a) feedback;
b) complaint handling;
c) reporting to regulatory authorities;
d) audits;
e) monitoring and measurement of processes;
f) monitoring and measurement of product;
g) corrective action;
h) preventive action;
i) follow-up actions from previous management reviews;
j) changes that could affect the quality management
system;
k) recommendations for improvement;
l) applicable new or revised regulatory requirements.
5.6.3 Review output
The output from management review shall:
5.6.3 Review output
The output from management review shall be recorded (see 4.2.5) and include the input reviewed and
any decisions and actions related to:
a) improvement needed to maintain the suitability, adequacy, and effectiveness of the quality management system and its processes;
b) improvement of product related to customer requirements;
c) changes needed to respond to applicable new or revised regulatory requirements;
d) resource needs.
