Introduction
0.1 General
The adoption of a
quality management system should be a strategic decision of an
organization. The design and implementation of an organization’s quality
management system is influenced by
a) its organizational environment, changes in that environment, and the risks associated with that
environment,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size and organizational structure.
It
is not the intent of this International Standard to imply uniformity in
the structure of quality management systems or uniformity of
documentation.
The quality management system requirements
specified in this International Standard are complementary to
requirements for products. Information marked “NOTE” is for guidance in
understanding or clarifying the associated requirement.
This
International Standard can be used by internal and external parties,
including certification bodies, to assess the organization’s ability to
meet customer, statutory and regulatory requirements applicable to the
product, and the organization’s own requirements.
The quality
management principles stated in ISO 9000 and ISO 9004 have been taken
into consideration during the development of this International
Standard.
0.2 Process approach
This International Standard promotes the adoption of a process approach
when developing, implementing and improving the effectiveness of a
quality management system, to enhance customer satisfaction by meeting
customer requirements.
For an organization of function
effectively, it has to determine and manage numerous linked activities.
An activity or set of activities using resources, and managed in order
to enable the transformation of inputs into outputs, can be considered
as a process. Often the output from one process directly forms the input
to the next.
The application of a system of processes within an
organization, together with the identification and interactions of these
processes, and their management to produce the desired outcome, can be
referred to as the “process approach”.
An advantage of the
process approach is the ongoing control that it provides over the
linkage between the individual processes within the system of processes,
as well as over their combination and interaction.
When used within a quality management system, such an approach emphasizes the importance of
a) understanding and meeting requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
The
model of a process-based quality management system shown in Figure 1
illustrates the process linkages presented in Clauses 4 to 8. This
illustration shows that customers play a significant role in defining
requirements as inputs. Monitoring of customer satisfaction requires the
evaluation of information relating to customer perception as to whether
the organization has met the customer requirements. The model shown in
Figure 1 covers all the requirements of this International Standard, but
does not show processes at a detailed level.
NOTE: In
addition, the methodology known as “Plan-Do-Check-Act”(PDCA) can be
applied to all processes. PDCA can be briefly described as follows.
Plan:
establish the objectives and processes necessary to deliver results in
accordance with customer requirements and the organization’s policies.
Do: Implement the processes.
Check:
monitor and measure processes and product against policies, objectives
and requirements for the product and report the results.
Act: take actions to continually improve process performance.
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