Understanding ISO/IEC 17025
Knowing the principles behind ISO/IEC 17025 can help lab managers and assessors understand the individual requirements of the standard.
ISO/IEC 17025 is a standard that sets out the specific requirements to be met by laboratories wishing to achieve the production of competent results as a matter of course. These requirements were developed by groups of laboratory experts from around the world over the course of 30 years. From the first, laboratory competence has been the paramount consideration.
In today’s world, recognition of such competence generally requires that laboratories which have implemented the requirements of the standard also work to obtain accreditation. Accreditation involves assessment and, like all auditassociated activities, assessment of technical competence requires trained assessors to deliver these assessments. Assessors must be fully cognizant of each of the requirements in the standard.
During the course of their work, assessors will often encounter situations where they are forced to defend particular requirements to a laboratory seeking accreditation and, while they understand the specific requirement under discussion, they may not be able to clearly articulate why such a requirement exists in the first place. That is to say — they may not be able to identify the principles which underlie the stated requirement.
At the same time, a laboratory’s blind adherence to each of the requirements of the standard, while better than no system at all, is not an approach which instills confidence in their ability to produce competent results. Nor is it the best approach to use in acquiring recognition of such competence.
ISO 9000:2000 is now well-known and respected around the world as a standard which aims at having conforming organizations implement a “model for excellence.” While some may see this aim as a very ambitious one for any organization, the standard effectively breaks down the elements which an organization can readily achieve in their implementation of such a model. One of the great strengths of ISO 9000:2000 is its clear basis on principles which can be easily articulated and understood.
Those who live and work in the world of laboratories also adhere to specific principles, but these have not been articulated in one collection. Such principles would provide a clearly understood basis for the requirements of the standard which most directly impacts laboratory operations.
The objective of this article is to provide a listing of the principles behind ISO/IEC 17025. These can be used by laboratories to better appreciate individual requirements of the standard. The article can also be used by assessors in understanding how or why a specific requirement can help (or perhaps hinder) a laboratory to implement the processes required for the recognition of their competence.
From study of the standard and its impact on laboratory operations over the course of the last twelve years, the following principles are considered to be the main forces behind all of the requirements of ISO/IEC 17025:
- Capacity
- Exercise of Responsibility
- Scientific Method
- Objectivity of Results
- Impartiality of Conduct
- Traceability of Measurement
- Repeatability of Test
- Transparency of Process
Capacity
Laboratories must have the resources (people with the required skills and knowledge, the environment with the required facilities and equipment, the quality control, and the procedures) in order to undertake the work and produce technically valid results.
Exercise of responsibility
Persons in the laboratory organization must be allocated the authority to execute specific functions within the overall scope of work — and the organization must be able to demonstrate accountability for the results of their work.
Scientific method
Work carried out by the laboratory must be based on accepted scientific approaches, preferably consensus-based, and any deviations from accepted scientific approaches must be substantiated in a manner considered generally acceptable by experts in that field.
Objectivity of results
Results produced within the scope of work of the laboratory must be mainly based on measurable or derived quantities. Subjective test results should be produced only by persons deemed qualified to do so and such results should be noted as being subjective, or known by experts in that field of testing to be mainly subjective.
Impartiality of conduct
The pursuit of technically valid results through the use of generally accepted scientific approaches is the primary and overriding influence on the work of persons executing laboratory tests and calibrations — all other influences should be considered secondary and not permitted to take precedence.
Traceability of measurement
The results produced, within the scope of work of the laboratory, must be based on a recognized system of measurement that derives from accepted, known quantities (SI system) or other intrinsic or well-characterized devices or quantities.
The chain of comparison of measurement between these accepted, known quantities or intrinsic devices or quantities, and the device providing objective results, must be unbroken for the competent transfer of measurement characteristics, including uncertainty, for the whole of the measurement chain.
Repeatability of test
The test which produced the objective results will produce the same results within accepted deviations during subsequent testing, and within the constraints of using the same procedures, equipment, and persons used during a previous execution of the test.
Transparency of process
The processes existent within the laboratory producing the objective results should be open to internal and external scrutiny. This is to identify and mitigate factors that may adversely affect the laboratory's ability to produce technically valid results, primarily objective and based on scientific method.
Conclusion
These eight principles may not cover every aspect of every requirement in the standard, but they are broad enough to allow persons working in laboratories to appreciate the reasons behind most of the individual requirements. They may also allow assessors to use their professional judgement in assessing the conformance of a laboratory to each of the requirements within the standard.
J.E.J. (Ned) Gravel is the Manager, Quality and Training at the Canadian Association for Environmental Analytical Laboratories (CAEAL). The association is a public-private partnership which provides services to over 400 member laboratories including PT services, accreditation, and training. Ned represented Canada on ISO/CASCO Working Group 10 — the group which developed ISO/IEC 17025, and Working Group 25 — the group which was assigned the task of aligning ISO/IEC 17025 with ISO 9000:2000.
Canadian Association for Environmental Analytical Laboratories Suite 310, 1565 Carling Avenue, Ottawa, ON K1Z 8R1, Canada; (613) 233-5300; www.caeal.ca.