Understanding Leadership -Section 5 of ISO 9001/AS9100/AS9120 Standard
The latest revision of the ISO 9001/AS9100/AS9120 standard brings greater clarification on the elements that make up a process. Clause 4.4 of this standard requires an organization not only to identify necessary processes, but to also define the key details about each one. By considering all various elements of a process, the organization develops a deeper understanding of what it takes for their quality management system to be effective.
As defined by the ISO 9001 standard, these various elements include:
- Inputs and outputs
- Sequence
- Criteria and method
- Resources
- Responsibility
- Risk evaluation
- Improvement
Typically, the input of a process is a physical or informational resource given from the process that precedes it. On the other hand, the output is the product or the resource that was produced as a result of the process. The input and output can be seen as the two ends of any given process.
When it comes to sequence, the standard is simply asking the organization to list interaction of the processes in the order in which they are executed.
As for criteria and method, the organization needs to define the requirements that the process is intended to meet and the procedures that are being utilized to achieve these results. It is also required to define the resources needed to complete the process. Resources may include raw materials and supplies, but also specifications or utilities. It is important to thoroughly define the necessary resources and prepare them for the process in order to avoid having to restart in the event a key resource is missed.
Responsibility and authority is another element in which the purpose is to ensure that there is always someone responsible for any given process.
Next, it is important to address the risks and opportunities that affect the process. Risks can drive from several areas such as internal and external issues, or interested parties and their needs and expectations. In contrast, opportunity can come from the organization’s strengths and uniqueness.
By the end of the process, it is critical to conduct an evaluation and identify areas that may benefit from improvement. The organization should compare the actual results to the intended results of the process. Additionally, improvement of a process can result in increased efficiency, cost reductions, or preventative action to help fill the gap between the actual and intended process results.