TESTING AND CALIBRATION LABS
Preparing for Change
Steps for labs to take to transition to ISO/IEC 17025:2017
by Bill Hirt
ISO/IEC 17025—General requirements for the competence of testing and calibration laboratories is the global standard for testing and calibration labs. Accreditation of a lab to this standard by an internationally recognized accreditation body provides a global confidence for the tests or calibrations that the lab offers.
Many in the world of international standards welcome the publication of the 2017 revision because it’s been 12 years since the previous version was published, and many of the documents referenced in the 2005 version are now obsolete. Change was clearly needed.
Now with the recently published ISO/IEC 17025:2017, tens of thousands of labs must learn what is new and different. This column will outline some key changes in content, format and style in the new revision.
For accredited labs and accreditation body members of the International Laboratory Accreditation Cooperation (ILAC)—which provides oversight for bodies offering accreditation for labs—there will be a three-year period for implementation of the revised standard. The standard will need to be translated for non- English-speaking nations.
ILAC will not recognize any accreditations to the 2005 version of the standard after the three-year transition period. If a lab chooses not to conform to the new standard, it will no longer be accredited.
What has changed?
ISO/IEC 17025:2017 has limited changes affecting the technical operations of the lab. There are new subclauses and new emphasis on several items.
The numbering format changed, with clauses 4 through 8 in the new version replacing clauses 4 and 5 in the 2005 standard (see Table 1). This format aligns ISO 9001, ISO 17020 and many other ISO conformity assessment standards.
The addition of "risks and opportunities" in clause 8.5 encompasses the concept of preventive action from the 2005 standard. Requirements are less prescriptive and, as in ISO 9001, it outlines the need for accredited labs to identify risks, prioritize them, plan and implement action related to them, and control and monitor them over time.
Clause 4 now has only two considerations: impartiality and confidentiality. Impartiality (now found in the terms and definitions section) is synonymous with objectivity. Any reference to independence has been deleted so labs can have more flexibility—as long as they ensure impartiality. Additionally, detail concerning the concept of confidentiality has been expanded. Confidentiality now also relates to information about the customer obtained from lab activities or other sources.
Sampling has an increased visibility. While few new requirements have been added, consideration of sampling appears in several clauses including 6.6.1 (externally-provided services), 18.104.22.168 (validation of methods including uncertainty), 7.3 (sampling), 7.6.1 (measurement uncertainty) and 7.8.1 through 7.8.5 (reporting requirements).
In general, there is less prescription on how concepts are implemented. There is a greater emphasis on processes, but many documented procedures are still required. Clauses 5.5.c and 22.214.171.124 are included to ensure that all processes are documented to the level necessary to ensure validity of testing and calibration results.
The new version of the standard reflects the increasing attention to statements of conformity and consideration of measurement uncertainty. The new term "decision rule" is referred to multiple times in the standard. It involves factoring the impact of measurement uncertainty into statement of conformity decisions.
Some clauses of the standard’s previous version were combined in the new one, including subcontracting of services (previously 4.5) and purchasing (previously 4.6), which are combined in Clause 6.6—Externally Provided Products and Services. Lab-developed methods and nonstandard methods are no longer listed uniquely and are mentioned only in a list of potential method validation candidates.
Metrological traceability has less visibility in the requirements, but instead is clarified in Annex A, which is devoted to establishing and demonstrating metrological traceability. A key new consideration is to refer to metrological traceability of the measurement results. Formerly, the reference was simply to a measurement. While metrological traceability and the evaluation of uncertainty remain in different sections, Annex A defines the evaluation of measurement uncertainty as one of the necessary components to establish metrological traceability.
Many have wondered whether ISO/IEC 17025:2017 would finally define the expectation of accredited labs to perform proficiency testing/interlaboratory comparisons as a requirement. The answer is yes. It is now in clause 7.7, and many additional considerations, including expanding the quality assurance focus, have been added.
Many quality assurance practices are highlighted and noted for review during assessments. The standard addresses interlaboratory comparisons and intralaboratory comparisons in separate clauses—denoting the value of both approaches. Performance comparison as a separate clause may provide the impetus for externally provided tests.
The new standard acknowledges that information management accompanies the control of data. Several new references are made to computer systems, electronic records and reporting results, communication technologies and sample management with lab information management systems.
The new standard outlines a seven-element set of requirements for complaint processing. It requires increased documented communication between the accredited lab and the complainant.
Much of what is different in the 2017 standard is a matter of focus rather than additional requirements. It is less prescriptive and more focused on the outcomes of processes. While it may appear during the initial review of ISO/IEC 17025:2017 that several requirements are no longer present, the reader may find that the concepts remain.
The effect of the process approach of ISO/IEC 17025:2017 can be seen by the fact that it contains about 20 fewer instances of "shall"—the term indicating a requirement in an ISO document—than in the 2005 version.
What changes for accreditation bodies and assessments?
Accreditation bodies must create an implementation timeline for their employees, assessors, technical experts, customers and applicants for accreditation. They must train their assessors. In addition, they must update assessment checklists for the 2017 standard and define how soon they can be used on assessments.
How can labs prepare?
Online training is available at www.anab.org/training/iso17025/2017. This is the only self-paced web course available in the world, but there are a few traditional classroom courses offered in some parts of the United States.
The first step for labs to take in their transition to the 2017 standard is to purchase the standard. The second step is to provide training to employees. Next, labs must establish or evaluate their management system documentation to identify any gaps in conformance.
If the lab already has documentation based on the 2005 version, it may help to have a crosswalk document, which the accreditation body may be able to provide. The document will help with the new numbering system and ensure all clauses are covered. Many currently accredited labs will find there are few deficiencies in their systems to address, but more opportunity for flexibility in addressing requirements.
Key to the timing of the lab’s preparation is receiving the transition plan from the accreditation body so timing and required practices are understood.
One area accreditation bodies will need to define for their own processes is the approach to assessing management system requirements for the new standard. Labs can now maintain a management system in accordance with option A or option B requirements, which include credit for several ISO 9001 elements. Option A requirements define the management system requirements formally in clause 8 of the standard. Option B requirements are less defined but allow for credit that will reduce those needing to be audited, as long as the organization can verify ISO 9001 conformity.
ISO/IEC 17025:2017 requires that labs selecting option B maintain a management system that fulfills the intent of the requirements listed in option A, which are appropriate for the lab’s calibration and testing activity. Labs pursuing option B should contact their accreditation body to confirm the assessment approach defined.
Assisting each other
While ISO/IEC 17025:2017 will require process and implementation changes for labs and accreditation bodies, the two groups will surely assist each other and maintain contact to ensure that quality of services is maintained.
The 2017 version is likely to be well received. It is hoped that all will embrace and contribute to the implementation of the new standard for the betterment of the global technical community.
Bill Hirt is the global technical advisor for ANAB/ANSI-ASQ National Accreditation Board in Alexandria, VA. He holds a doctorate in microbiology from the University of Cincinnati. Hirt is a member of ASQ.