Change: New Requirements
Procedure Required: NO
Record(s) Required: None
Comments:
This section requires the organization to apply suitable
methods for monitoring and, where applicable, measurement of the quality
management system processes. These methods must demonstrate the ability
of the processes to achieve planned results. When planned results are
not achieved, correction and corrective action must be taken, as
appropriate, to ensure conformity of the product.
Guidance:
I suggest paraphrasing the wording of the standard in your Quality
Manual.
Previous versions of ISO 9001 had addressed the use of statistical techniques. If you use statistical techniques, this is the section that is most appropriate for discussing their use with your ISO 9000 auditor.
Note:
Many ISO 9000 auditors are easily confused with differentiating "quality system monitoring" from "process efficiency monitoring". Many ISO 9000 auditors will argue that the two concepts are the same.
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Copyright © 2003 by Richard C. Randall This Page Last Revised: |
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