Q: I am updating the instrumentation section of a product fabrication specification to replace a cancelled military specification (MIL-STD 45662) that specified calibration systems requirements. I am looking for an industry standard that provides requirements/guidance for documentation of our established schedules and procedures for all of our measuring and test equipment and measurement standards.
I am looking into ANSI/ISO/ASQ Q10012-2003: Measurement management systems — Requirements for measurement processes and measuring equipment and ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories, and I would like guidance on usage and application of these standards.
A: The two standards in question, ISO 10012 and ISO 17025 have different scopes.
While the scope of both documents includes language that can perhaps cause confusion, what follows is the salient text from both that illuminates the difference between the two.
From the scope of ISO 10012:
“It specifies the quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met.”
From scope of ISO 17025:
“This International Standard is for use by laboratories in developing their management system for quality, administrative and technical operations.”
ISO 10012 focuses on the requirements of the measurement management system. You can consider it a system within the quality management system. It defines requirements relevant to the measurement management system in language that may illustrate interrelations to other parts of an overall quality management system.
ISO 10012 is a guidance document and not intended for certification. An organization, for example, could have a quality management systems that is certified to ISO 9001:2008. Even if the organization chooses to adhere to the requirements of ISO 10012, the certification to ISO 9001 does not imply certification to the requirements of ISO 10012.
ISO 17025 describes the requirements for a quality management system that can be accredited (a process comparable but different from certification). It encompasses all aspects of the laboratory.
The competence referred to in the title of the standard relates to the competence of the entire system – not just training of personnel. It addresses such factors as contracts with customers, purchasing, internal auditing, and management review of the entire quality management system – ISO 10012 does not.
In summary, ISO 10012 is a guidance document that addresses one element (namely management of a measurement system) of a quality management system. ISO 17025 defines requirements for entire quality management system that can be accredited.
Denise Robitaille
Vice Chair, U.S. TAG to ISO/TC 176 on Quality Management and Assurance
SC3 Expert – Supporting Technologies
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ANSI/Z-540-1 would be a better answer.
John Dalrymple, CQE
NGC, QA
Actually, ANSI/NCSL Z540-1-1994 is a precursor to the 17025:2005 QMS requirements. There were revisions that include Z540-2 that still aren’t as thorough as 17025. However if you would like to use Z540, I recommend reviewing ANSI/NCSL Z540.3-2006. There it relates to your PFA (Pass Fail Accept) criteria, meaning uncertainty of measurement. Everything in Z540.3 is in 17025. If you want to generate true confidence of measurement that your customers and AB appreciate, then of all of those standards, I recommend Z540.3. It also depends on the focus of your business. If calibrations are just a subsidiary aspect of your business, then spending the money to get accredited may not be necessary, especially if its for internal use only. However if you are performing calibrations for other companies, and you are not accredited yet, I strongly recommend Z540.3 over all of the other international standards. Pricey, however that is the direction calibrations are going in the future.