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TJM05
Hello,
A little background first- I am currently at a machine shop with about 20 employees. We are in the process of ISO 9001 certification. Right now we are completing our gap analysis and getting our ducks in a row. I work for a very "can-do" company, that will bend over backwards to do a procedure on its own rather outsource. As you can imagine, we are having a grand ol' time looking at the "measurements and calibrations [sect. 7.6]" section of the ISO 9001 2008 standard.
My question relates to section 7.6 of 9001:2008 It states in the 3rd paragraph (I think), that when necessary, you need to calibrate and/or verify all of the measuring equipment, have traceability, etc.
1) Does that word "traceability" in the standard relate exactly to the NIST's policy on traceability (as found on their website)? I realize it could relate to another institution other than NIST that also has a policy on traceability...
2) For a machine shop with micrometers, calipers, pin gages, thread and ring gages, etc. is it always necessary? (FYI our general tolerances are +/-.005 in most cases though sometimes they get down to +/-.0005
3) If we come up with an in house calibration procedure, I've heard that it needs to be "validated" and the person doing it "trained". What do those terms mean?
4) How particular are ISO auditors on this section? What are they looking for?
How do you other quality people meet this standard?
Sorry for the long post and thank you in advance for everything!
A little background first- I am currently at a machine shop with about 20 employees. We are in the process of ISO 9001 certification. Right now we are completing our gap analysis and getting our ducks in a row. I work for a very "can-do" company, that will bend over backwards to do a procedure on its own rather outsource. As you can imagine, we are having a grand ol' time looking at the "measurements and calibrations [sect. 7.6]" section of the ISO 9001 2008 standard.
My question relates to section 7.6 of 9001:2008 It states in the 3rd paragraph (I think), that when necessary, you need to calibrate and/or verify all of the measuring equipment, have traceability, etc.
1) Does that word "traceability" in the standard relate exactly to the NIST's policy on traceability (as found on their website)? I realize it could relate to another institution other than NIST that also has a policy on traceability...
2) For a machine shop with micrometers, calipers, pin gages, thread and ring gages, etc. is it always necessary? (FYI our general tolerances are +/-.005 in most cases though sometimes they get down to +/-.0005
3) If we come up with an in house calibration procedure, I've heard that it needs to be "validated" and the person doing it "trained". What do those terms mean?
4) How particular are ISO auditors on this section? What are they looking for?
How do you other quality people meet this standard?
Sorry for the long post and thank you in advance for everything!