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ISO 9001:2008: Continual improvement 8.5.1
One of the driving goals of ISO 9001 is the principle of continual improvement. You must be able to demonstrate continual improvement. Distinction must be made between ‘continual’ and ‘continuous’ improvement.
Unlike continuous improvement (which must be constant, steady and always positive), continual improvement may show signs of dwells, momentary setbacks, delays or slight reversal, shows process variation, provided the overall trend is positive or improving.
Auditors will expect to see a process method, techniques, formats, etc. is in place for establishing and implementing continual improvement. The impetus for continual improvement must come from the use of (as a minimum):
- Quality policies
- Quality objectives
- Audit results
- Analysis of data
- Corrective actions
- Preventive actions
- Management review
There is no requirement that the organization should set objectives for improvement of all its processes at any one time. It would be unrealistic to expect an organization to make progress in all potential improvements simultaneously.
Each improvement will require the commitment of resources, which should be prioritized by top management, especially if investment is required. It is the responsibility of the company to demonstrate improvement rather than the auditor to look for it. Accordingly, it is a useful audit practice to ask management to identify any improvement initiatives taken since the previous visit, and also any planned for the future.
Processes can always be made more efficient and effective, even when they are producing conforming products. The aim of a continual improvement programme is to increase the odds of satisfying customers by identifying areas that need improvement. It requires the organization to plan improvement systems and to take into account many other activities that can be used in the improvement process.
Auditors should look for evidence that your organization is analyzing data from process monitoring and is then taking the results forward for evaluating process efficiency and/or improving process output. One point that should be specifically examined is the consistency of the way in which the improvement of any one process contributes to meeting the overall objectives, so as to ensure that this will not conflict with the achievement of other objectives.