Re: Validation of A Procedure
I'm not the ISO expert (more broad technical issues). So ISO folks, please correct me if needed.
My understanding that a procedure used in an ISO17025 context must be adequate. That is, there must be some basis that it correctly checks an instrument's specifications. If you use one developed by an OEM, military (GIDEP/MIDAS), ANSI, ASTM or other nationally or internationally recognized organization with their approval process, it is assumed that it was validated to assure it correctly and completely checked the instrument.
When you develop one yourself, you must somehow verify that it fully and correctly checks specifications.
For example, if verifying a high accuracy digital indicator with a 12 inch gage block, temperature is a significant source of error. If you wrote a procedure that did not include a proper method to deal with temperature implications, although the tolerance limits and other instructions may be correct, that missing detail (temperature correction) could invalidate the procedure. I don't imply that is a problem with yours, or that your procedure has any deficiencies that would invalidate it. Your procedure may be fully correct and complete. What I believe the assessor wants to know is what method you used to assure that it was complete and correct.
What constitutes adequate validation? I have numerous thoughts, but I'll leave that level of detail to more qualified folks.
One alternative may be to locate a published procedure for your mfr/model or it's equivalent. There are definitely GIDEP procedures to cover it (if you are eligible to participate). There may also be other acceptable published procedures.