ISO 10012:2003 Measurement management systems
sbickley said:
Hi Everyone,
We currently use many measuring instruments in our First Article and repeat inspection processes. This equipment is currently calibrated by an outside part once per year and we do not conduct GRR studies. We also do not conduct daily tool checks when they are checked out, etc.
Is this acceptable or should we be doing more to ensure conformance with the standard?
Please give me some ammunition if we need to do more so I can sell this to management.
Thanks,
Scott
Scott,
(A short answer

is that if it meets your needs then it's OK.

But it may not really be fully suitable, which is probably your concern.)
I can't directly answer your question, but I can point you to a standard that may help. In ISO 9001:2000, at the end of clause
7.6 Control of measuring and monitoring devices there is a note that specifies ISO 10012-1 and 10012-2 as guidance. Those standards have since been superseded by
ISO 10012:2003 Measurement management systems - requirements for measurement processes and measuring equipment. This can be purchased from
ASQ or
ANSI.
ISO 10012 provides guidance for management of an organization's complete measurement system. (For some reason, many people believe it is only for the calibration/inspection/test areas, but that is not correct.) As stated in the scope, the standard provides guidance for
- management of measurement processes, and
- metrological confirmation of of measuring equipment used to support and demonstrate compliance with metrological requirements.
The "measurement processes" are not restricted by location or function. If a measurement is made that affects product quality, in a core or support process, then is can be managed using this guidance.
Metrology is the science of measurement, so "metrological confirmation" is calibration and "metrological requirements" are the measurement requirements of a product or process.
According to the standard, the measurement requirements are based on the product, customer requirements, legal and regulatory requirements, and so on. All measurement process in production or evaluation have to be managed. All measurements relating to conformance to requirements must be made with calibrated measuring instruments. ISO 10012 is the guidance standard for applying these and other principles to ISO 9001:2000.
As for testing the random number routines, I think NIST has something on that - a search in the
Information Technology Laboratory area for "random number" turned up almost 150 links including
this one. I think they have routines for testing the randomness according to the expected distribution, algorithms for generating specific distributions, and lots of stuff that is way above my understanding level.