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This International Standard promotes the adoption of a process approach […]

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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 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.

Burbank Dental Lab ISO processesThe 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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