What is the ISO 9000 Process Approach?

ISO 9001 uses a process-oriented approach. ISO 9001:2008 examines about 21 processes in its scope, one of which is the entire Quality Management System. The process approach is the elemental core of ISO’s view of a Quality Management System. Thus, a QMS can be thought of as a single large process that avails many inputs to generate many outputs. ISO 9001 promotes the process approach to managing an organization, and requires the QMS to consider the organization as a series of interlinked processes. The description of the process approach in the ‘Introduction’ to ISO 9001 is informational and does add requirements. However, Clause 4.1 specifies the steps necessary to implement a process approach in the QMS processes, and the Notes to clause 4.1 providing examples of required QMS processes.

What are processes, inputs and outputs?

Every organization is made up of a series of interacting processes. A process is a set of activities that uses resources (people, machines, etc.) to transform inputs into outputs. The process approach considers the interaction between these processes, and the inputs and outputs that tie these processes together. The output of one process becomes the input of another.

The ISO 9001 Standard is designed to manage and improve those processes.

1. First, you identify your key processes.
2. Second, you define quality standards for those processes.
3. Third, you decide how process quality will be measured.
4. Fourth, you document your approach to achieving the desired quality, as determined by your measurements.
5. Fifth, you evaluate your quality and continuously improve.

Once these are identified, an organization can ensure its processes are effective (the right process is followed the first time), and efficient (continually improved to ensure processes use the least amount of resources). The effectiveness of the entire system is determined by the effectiveness of each process and the interactivity of these processes within the system. By establishing quality objectives and auditing how effectively the processes fulfill those objectives, an organization can determine whether the processes add value.

Using the Process Approach while designing and developing a quality management system enables this to happen. A QMS using the process approach (guided by standards) can meet their customers’ (internal or external) requirements and continual improvement in:

• The organizations’ overall function- the series of processes
• Processes – the conversion of inputs into output
• Results – Products and services resulting from processes
• Quality – fulfilling requirements/objectives
• Environment – preventing pollution and waste to improve the new bottom-line
• Safety removing unacceptable risks for the people supporting the processes

The Process Approach enables the organization to meet customer requirements and deliver continual improvement.