MIL STD 45662 TO ISO 10012-1?

MY COMPANY WANTS TO COMPLY TO ISO-9002 IN A
YEAR FROM NOW. I'VE BEEN HERE FOR ABOUT A MONTH, I HAVE MY WORK CUT OUT FOR ME, TOSAY THE LEAST. QUESTION IS: DOES ISO 10012-1 REPLACE MIL 45662, DOES IT PROVIDE MORE DETAILED INFO FOR CALIBRATIONS? IF NOT IS THERE ANYTHING ELSE? (BESIDES 17025).
ANY HELP WOULD BE APPRECIATED.
BOB

[Ryan Wilde]

Bob,

ISO 10012-1 is not the official replacement for 45662A, but it is what I would call a parallel document. It is, in my opinion, far less prescriptive than 17025 and 45662A. The direct replacement for 45662A is ANSI/NCSL Z540-1, which is ISO Guide 25 (the predecessor to 17025) with a section at the end to cover points in 45662A not in the ISO document.

My suggestion would be to have a copy of ALL of the documents, and comply with one with an eye toward the others. You can never be too informed or too prepared for what may be required in the future. My guess would be that it won't be long before a lab with unproven traceability (read: unaccredited) will no longer be acceptable, even for internal labs.

Ryan

[Graeme]

Bob,

First, I assume you REALLY mean ISO 9001:2000 as your registration goal, with element 7.3 (Design) excluded.

ANSI/NCSL Z540-1-1994 was issued in August 1994. This standard includes all of the requirements of ISO 9001-1994 and MIL-STD-45662A; and SOME of the requirements of the old ISO Guide 25. It is reorganized and restated to (supposedly) meet the needs of a calibration lab.

Also in August 1994, the Department of Defense cancelled MIL-STD-45662A and replaced it with Z540-1. (Section 18 of Z540-1 IS the old MIL-STD, almost verbatim.) The MIL-STD, and this part of Z540-1, applies to the measurement standards used by a calibration laboratory.

ISO 17025:1999 completely replaces Guide 25. This goes beyond any of the other standards. You have all of the quality management system requirements of an ISO 9000-based system, PLUS the requirement to demonstrate your technical competency in each measurement area being accredited. You also must have a very strong understanding of your measurement uncertainty for each process, as well as good measurement quality assurance processes.

ISO 10012-1:1992 is a useful addition to these standards and ISO 9001:2000, for quality management systems as they apply to a calibration lab. At almost ten years old, though, it is somewhat dated.

I'm going through registration now, and it is a lot of work. I echo the suggestion of Ryan - look at all of them. ISO 9001:2000 will be your main guide as that will be your conformance standard. If you are involved in calibrations, though, then you should ALSO be doing elements from Z540-1 and 10012-1 that are not in 9001:2000. Once you have an effective 9001-based quality management system in place and registered, then you can re-assess your needs to see if laboratory accreditation under 17025 makes sense for you.

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Graeme C. Payne
ASQ Certified Quality Engineer
Graeme@asqnet.org

[This message has been edited by Graeme (edited 05 June 2001).]