4.20. Statistical Techniques

4.20.1. Identification of need

You are required to review your process for possible applications of statistical tools. The intended purpose is to ensure that you control and verify your process capability as well as the product characteristics.

Therefore:

• You will review the need for statistical techniques to ensure the capability of your processes and products

4.20.2. Procedures

You may use statistical techniques to validate the product, material, or process. These techniques must be documented and approved. Operators must b trained and demonstrate proficiency.

The ISO 9000 standard is interpretive to accommodate different types of businesses. It is important to ensure that your interpretation is shared by your auditor.

Therefore:

• Where you have statistical techniques employed, they will be accompanied by documented procedures to ensure the proper use.