Q: In ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements, clause 7.6, there is a requirement which states: “When used in the monitoring and measurement of specified measurements, the ability of computer software to satisfy the intended application shall be confirmed.”
Do you have any guidance on how this can be established in an analytical laboratory?
A: To answer your question, I would first refer you to the note at the end of 7.6. It reads:
“NOTE: Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.”
Now, that can sound confusing to some folks. So, let me offer you some direction. To “confirm” (verify) your software’s abilities, you need a known standard. I’m not referring to a standard that is traceable to national standards. I’m referring to data you know should be revealed as a failure by your software.
For example: You have samples from 10 subgroups and, you know that one sample, when analyzed, will be found to be nonconforming. You can use a separate source to determine what the Cpk is, or you can simply identify which sample is out of tolerance and by how much. When you use this known standard to test your analytical software, the results will tell you if it is suitable for use.
Most software is designed with some sort of pass/fail testing option. Nonetheless, using a proven standard to verify your software brings it down to earth and more applicable to your needs.
ASQ Senior Member, CQT, CQI
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