ISO 9000 / ISO 9001:2008 Process Control
If you are doing high volume production, then you should be doing statistical process control in all parts of your process to assure that your process is under control and to catch your problems early in the process before you generate high volume scrap.
If you are a low-volume or custom product manufacturer, then you can tabulate more global information to demonstrate that your process are under control. Some of the best sources for low-volume process control are:
- Customer Survey Information
- Generation of Nonconforming Materials
- In-process or Final Test Data
Any negative trends should be entered into the corrective and preventive actions system. This should trigger an ECO to fix the problem. This keeps your process loop closed and allow for continuous improvement.
In most cases, this is enough to fulfill the requirements. The creation of customer feedback program is a great way to fulfill many of the ISO 9001 requirements.