JSW05 said:
jrcook5 seems to be promoting a pedantic, legalistic interpretation of the standard that narrowly defines "product" conformance as applicable only to finished products, or products being manufactured.
PEDANTIC...I had to look that one up. We are talking about conforming to the requirements aren't we? ISO 9001 and 13485 are the standards that apply. The auditors, that come in here including the FDA, are very often "pedantic" in there enforcement of the standards and regulations. By the way, I am in the metrology department where being "pedantic" is actually a huge complement. I am not advocating not calibrating R&D devices, all I'm saying is, do you want to include devices in your calibration system that when found out of tolerance require corrective action per ISO that may be overkill based on the usage of the device. The final products are not affected because they are inspected downstream with the controlled calibrated devices.
You might be right, but I think we are missing the greater point. ISO is not here so you can be a slave and be complaint. You are supposed to be compliant because these are GOOD requirements!
Therefore, why do we calibrate gages? Only so final product can be correct? Or, do we do it to ensure that when we go to the trouble of taking a measurement, that we can rely on the results as being accurate? If that is the case, then the only gages that have to be calibrated are those we wish to ensure are accurate. Then they can be calibrated to an accuracy level that is accurate, at a frequency that meets our needs.
If we are going to be pedantic, let's be pedantic to that objective!
We don't do this stuff for ISO or the auditor, we do it for us.