ISO 9001 - Understanding ISO 9001 Requirements

0.2 Process Approach
This 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. Any activity, using resources and managed in order to enable the transformation of inputs into outputs, can be considered 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 Standard, but does not show processes at a detailed level.

Process Approach:   Key Explanation Points and Tips:

ÞThe process approach is the foundation upon which your QMS must be developed. Let’s understand some basics about processes.

ÞFigure 1 - All work generally involves a process - things go in (inputs); get worked upon (conversion); and come out differently (output). The value-adding conversion activity within a process transforms inputs into outputs, e.g. takes raw materials (the input) and manufactures (the value-adding conversion activity using various resources) a product (the output).

ÞProcess inputs and outputs can be tangible (raw materials or finished product) or intangible (information - e.g. computerized drawing or specification).

ÞFigure 2 - All processes have a supplier and a customer. These suppliers and customers may be internal processes or external to your organization. Each process must have an accountable owner, i.e., having defined responsibility and authority to operate, control and improve their process.

ÞAll processes require the use of resources, e.g. - people, equipment, materials, technology etc. These resources can be used as inputs (raw materials or information such as a customer specification) as well as for the value-adding conversion activity (e.g. use of machinery, equipment, computers, technology, people, etc.) to transform raw material (input) into finished product (output).

ÞAll processes must meet (customer, organizational and applicable regulatory) requirements. The performance of all processes can be monitored and measured. Gather performance data that can be analyzed to determine process effectiveness and whether any corrective action or improvement is needed.



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