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Difference Between ISO/IEC 17025

and ISO 10012

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