Wednesday, December 13, 2006

ISO 9001:2000 requirements - Part 2

5 Management responsibility

5.1 Management commitment

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving 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.

5.2 Customer focus

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 & 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 continually improve 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
Top management shall ensure that 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 and communicated within the organization.

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, and
c) ensuring the promotion of awareness of 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, and
g) recommendations for improvement.

5.6.3 Review output

The output from the management review shall include any decisions and actions related to

a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.

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