Professional Documents
Culture Documents
Lesson # 23
ISO 9001(2000) QMS
MANAGEMENT RESPONSIBILITY
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.
General guidance
Top management should establish policies and strategic objectives consistent with the purpose of the
organization. Leadership, commitment and the involvement of the top management are essential for
developing and maintaining an effective and efficient quality management system to achieve benefits for
all interested parties.
The key to achieving benefits for interested parties is to sustain and increase customer satisfaction. The
deployment of the policies and implementation of plans to achieve the objectives are the responsibility of
management. Management should involve everyone in the organization in these actions.
Top management should define an approach for measurement of the organization's performance in order
to verify that strategic objectives are achieved.
• financial measures,
• measures of process performance, and
• assessment of satisfaction level of customers and other interested parties.
This performance information should be used as input to management review in order to ensure that
continual improvement is the driver for organizational development.
Issues to be considered
Issues to consider when developing, implementing and managing the organization's quality management
system include the use of the quality management principles outlined in 4.3.
• promoting policies and objectives to increase awareness, motivation and involvement of people,
identifying realization processes which add value for the organization,
• planning for the future of the organization and management of change,
• setting and communicating directions related to achieving satisfaction of interested parties.
The quality management system should be appropriate for the organization's size and structure. It should
be focused on the achievement of the organization’s quality objectives.
Top management should consider its approach to performance improvement through both continual
improvement and radical change. It should consider the resources and communication needed to ensure
that the quality management system is maintained and developed as the organization structure changes.
Top management should identify the organization's rea1ization processes, as these are directly related to
the success of the organization. Top management should also identify those support processes that affect
the efficiency of the realization processes or the needs of other interested parties.
To ensure all processes operate as an efficient network, the organization should analyze how all the
processes interact.
• To ensuring that the sequence and interaction of processes are designed to achieve the desired
results,
• To ensuring inputs, activities and outputs are dearly defined and controlled,
• To managing risks and opportunities.
• To monitoring inputs and outputs to verify that individual processes are linked and operate
effectively and efficiently. and
• To establishing data analysis that facilitates continual improvement across ail processes.
It is useful to define a process owner with full responsibility and authority to manage each process, and to
achieve process objectives.
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 and 8.2.1)
NOTE When determining customer needs and expectations, it is important to consider obligations
related to product, including regulatory and legal requirements.
General
Every organization has several categories of interested parties, each with needs and expectations.
T o meet the needs and expectations of all interested parties, organizations should consider
The success of the organization depends on understanding and satisfying current and future needs and
expectations of customers (including end-users), and other interested parties. The management should
endeavor to exceed the expectations of all interested parties.
• conformance,
• dependability,
• availability,
• delivery,
• post-realization activities, and
• price and life-cycle costs.
The organization should also identify people's needs and expectations for recognition, work satisfaction,
competencies and development of knowledge. Such attention helps to ensure that the involvement and
motivation of people are as strong as possible.
The organization should also define financial and other results which satisfy the identified needs and
expectations of owners and investors.
Management should consider the potential benefits of establishing partnerships with suppliers to the
organization, in order to create value for both parties. A partnership should be based on the definition of a
joint strategy, sharing knowledge, risks and profits.
In considering its relationships with society, the organization should .demonstrate responsibility for health
and safety,
Management should ensure that the organization has knowledge of the statutory and regulatory
requirements that apply to its products, processes and activities.
The response to relevant statutory and regulatory requirements should not prohibit the organization from
meeting its quality objectives.
Quality policy
An organization's quality policy should be consistent witl1 the organization's overall business policies.
Planning
Quality objectives
The organization's objectives should be established during the planning process. They should be
consistent with the quality policy and capable of being measured.
When establishing these objectives, management should consider the current and future needs of the
organization and the markets served. Consideration should also be given to output from management
reviews, current product and process performance, and to the levels of satisfaction of all interested parties.
Objectives should be deployed throughout the organization with defined responsibility for their
achievement and be clearly communicated to all relevant people. People should be able to translate these
objectives into their individual contributions.
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.
Quality management system planning
Management should implement quality planning for the activities and resources needed to satisfy the
quality policy, objectives and requirements. Quality planning is an integral part of the quality
management system.
Top management shall ensure that responsibilities and authorities are defined and communicated within
the organization.
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
maters relating to the quality management system.
Management should define and implement a quality management system in order to provide confidence
that the organization can satisfy the needs and expectations of interested parties. The quality management
system should be consistent with the organization's size, culture and products.
Quality planning outputs should be reviewed regularly (as changes in the organization's situation occur}
and revised as necessary.
Top management should define and communicate responsibility and authority in order to implement and
maintain the quality management system effectively and efficiently.
All people should be given authority and responsibilities to enable them to assist in the achievement of
the quality objectives. This assignment of authority and responsibility helps to establish involvement and
commitment of people throughout the organization.
Management representative
Management representative(s) should be appointed and given authority by top management to manage,
monitor, evaluate and coordinate the quality management system processes. The goal of the appointment
is to enhance effective and efficient operation of the quality management system.
The representative(s) should report to top management and communicate with customers and other
interested parties on matters pertaining to the quality management system.
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.
Internal communication
Management should define and implement processes for the communication of quality requirements,
objectives and accomplishments. Providing this information becomes a resource for improvement and the
involvement of people in achieving quality objectives.
Management Revie w
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.
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.
Review input
Management review
Top management should establish a process to review the quality management system at periodic
intervals to evaluate its effectiveness and efficiency and verify that quality policy and objectives are being
satisfied. In addition, the management review process should analyze current activities that may require
change and consider opportunities for improvement of the quality management system.
• results from audits of the quality management system including internal, customer and third party
audits,
• measurements of satisfaction of the needs and expectations of interested parties,
• performance of processes,
• analysis of product conformance,
• status of corrective and preventive actions,
• status of action items from previous reviews, and
• changes in original assumptions (for example, those arising from new technologies, outputs of
research and development, quality concepts, financial, social, environmental conditions and
relevant statutory and regulatory changes).
The outputs 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.
Results of management reviews shall be recorded. ]
Review output
Management review activity should be set in a context of the organization's strategic planning cycle. This
placement helps to ensure quality objectives and requirements are integral to the organization’s overall
objectives and requirements.
Observations, recommendations, conclusions and decisions for actions should be recorded to facilitate
monitoring of progress, and used as input to subsequent reviews.
The management review process should be evaluated for effectiveness and improved when necessary.