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 varying needs, particular objectives, the
products provided, the processes employed and the size and structure of the organization. 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, regulatory 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 to function effectively, it has to identify and manage numerous linked activities. An activity 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, 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.