ISO/IEC 17025:2005 - An Innovative Standard for Laboratory Quality Systems
ISO/IEC 17025:2005 has been revised to align the ISO 17025:1999 version with ISO 9001:2008. Thus, ISO harmonized lab system accreditation by recognizing the ISO 9001:2008 standard as the basis for sound management of lab systems. This is now
found in Clause 4 of ISO/IEC 17025. The technical part, in Clause 5 contains all
of the requirements that testing and calibration labs have to meet if the wish to
demonstrate that they operate a management system, are technically competent and
are able to generate technically valid results.
ISO/IEC 17025:1999 replaced ISO/IEC Guide 25:1990 & EN 45001:1989 as the contemporary
standard to be adhered to by all testing & calibration laboratories. It integrated
the requirements of ISO 9001 & 9002(1994) & embodied the extensive experience gained
over a time span of 10 years of lab systems implementation.
Provided the accreditation bodies of various countries negotiate mutual agreements,
the acceptance of testing & calibration results among these nations will be the
mutually beneficial outcome. The global nature of the present standard enables any
laboratory to comply with it.
A methodical perusal of the industries & service practices that exist in the global
economy reveals that companies improve and stay competitive when they employ the
best business practices from around the world. The new standards are benchmarks,
gathering & sharing these best-in-class systems. They reflect the progression of
organizations from compliance with standards to the adoption of a continuous improvement
strategy for customer satisfaction. The new standards serve as implementation guides
but also as the basis for accreditation.
The comparative advantage
of ISO/IEC 17025:2005
ISO/IEC 17025 promotes cooperation between laboratories and other bodies to assist
in the exchange of information & experience and the harmonization of standards &
procedural goals. As a rule, within an organization any technology should be subjected
to calibration & testing and measured by a sampling scheme that results in data
collection and analysis. It is then possible to gauge the effect on the activities
or goods produced and plan appropriately for improvement. Essentially, this is the
goal of all standards introduced in the business environment.
Companies that have already begun to implement ISO/IEC 17025 have noticed some definite
differences. The need for international standards in law and commerce manifests
itself in the first sentence in Clause 4.1.1, under the Management Requirements
& Organization stipulation, "The laboratory or the organization of which it is part
shall be an entity that can be held legally responsible."
Subsequently, the various potential conflicts of interest that may influence individuals,
departments or the company itself are noted in 4.1.3 and cautioned against in other
areas of the standard where they might be of concern.
- The collection, use & protection of electronic data are emphasized frequently.
- The definition of a laboratory has been expanded to encompass permanent facilities,
sites away from the permanent facilities and associated temporary facilities in
- Definition, calculation, documentation & analysis of best measurement capability
& uncertainty of measurement are part of the requirements of the standard for the
laboratory in 5.4.6, 5.4.7
- Requirements for Reports and Certificates in 5.10.3 through 5.10.8 should put to
rest exactly what a legitimate report or certificate must contain & accompany what
a customer is paying for.
A good number of labs and companies are closing in on compliance or certification
in response to these needs and their customers' requirements.