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Title: How does ISO/IEC 17025 impact laboratories?

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: TBD

What ISO/IEC 17025 asks of laboratories

The "Scope" section of ISO/IEC 17025:2017 indicates the standard "specifies the general requirements for the competence, impartiality, and consistent operation of laboratories." Unfortunately, the document only defines "impartiality," and not "competence" and "consistent operation"; as such, we have to improvise a bit to get to the bottom of the significance of these three terms.

1. Competence: While ISO/IEC 17025 does not define "competence," it does reference ISO 15189 Medical laboratories — Requirements for quality and competence, as well as ISO 17034 General requirements for the competence of reference material producers, in the bibliography. Of them, ISO 15189:2012 defines competence as "demonstrated ability to apply knowledge and skills," while noting that the definition is given in a generic sense, with other ISO documents being more specific. (Note that the latest version is ISO 15189:2022, released in December 2022; however, ISO/IEC 17025:2017 references the 2012 version.)

That said, ISO/IEC 17025:2017 is asking a laboratory to demonstrate an ability to apply its knowledge and skills effectively to all its operations.

2. Impartiality: ISO/IEC 17025:2017 defines "impartiality" as "presence of objectivity," adding several notes to the definition. First, the standard adds that "Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory." It also adds nine other terms that can convey the context of impartiality, including "freedom from conflict of interests, "freedom from bias," and "neutrality."

That said, ISO/IEC 17025:2017 is asking a laboratory to demonstrate objectivity in its operations, free from conflicts of interest, bias, and prejudice, while maintaining a level of neutrality to its primary output: analytical results.

3. Consistent operation: The ISO defines "consistency" in several of its standards (e.g., ISO 9241, ISO/IEC 25000), but the definition is specific to the context of those standards. As such, we have to look elsewhere and make reasonable assumption that the definition of "consistency" applies to ISO/IEC 17025:2017. Merriam-Webster's definition 1b of "consistency" is "harmony of conduct or practice with profession," with "profession" meaning "public proclamation." This definition applies somewhat, but when paired with definition 3a—"firmness of constitution or character: persistency"—we come up with an idea of what the standard intends.

ISO/IEC 17025:2017 is asking a laboratory to conduct its activities in an enduring manner that is consistent with the lab's goals, mission statement, and standard practices.

Of course, that's the top-level view. The rest of the standard elaborates on what a lab preforming sampling, testing, and calibration activities must do to meet the three goals of competence, impartiality, and consistent operation.

Gaps in ISO/IEC 17025

It's important to note that ISO/IEC 17025 does not cover compliance with laboratory safety requirements. Labs implementing the standard may very well want to reach out to other QMS frameworks to fill the gaps, for example, implementing the "Facilities and Safety" quality system essential (QSE) found in Clinical and Laboratory Standards Institute's (CLSI's) QMS01 A Quality Management System Model for Laboratory Services and the World Health Organization's (WHO's) Laboratory Quality Management System: Handbook. (A QSE, as defined by CLSI and WHO, is "a set of coordinated activities that serve as building blocks for quality management," with each needing to be "addressed if overall laboratory quality improvement is to be achieved." Both organizations include 12 QSEs as part of their QMS framework and emphasize that all must be met for overall laboratory quality improvement to be realized.) The "Facilities and Safety" QSE describes those elements that are essential to a laboratory's personnel, its design, and its safety in being able to prevent and control physical, chemical, and biological hazards from impacting operations. The WHO notes that addressing these elements through a laboratory safety program solidifies the lab's ability to provide quality data and services through protecting those in the lab, the facility, its equipment, and the work environment.

Aside from safety, ISO/IEC 17025 has a few more minor gaps in how it addresses laboratory assessment tasks and personnel requirements when compared to the "Assessment" and "Personnel" QSEs of CLSI and WHO. For example, the "Assessment" QSE addresses external audits whereas ISO/IEC 17025 does not, and the topics of proficiency testing and other external quality assessment methods is more rigorous in the "Assessment" QSE. Additionally, while ISO/IEC 17025 speaks of needing to document competence requirements for personnel, the "Personnel" QSE delves into greater detail of competency assessment methods, policy writing, procedure development, training, and performance appraisal. A lab implementing and accrediting to ISO/IEC 17025 may wish to further compare the nuances of these QSEs with the ISO standard as part of an effort to exceed the bare minimums of meeting ISO/IEC 17025 requirements.

Benefits of complying with ISO/IEC 17025

In its 2011 Laboratory Quality Management System: Handbook, the WHO notes the following concerning the QMS model:

Laboratories not implementing a good quality management system are guaranteed that there will be many errors and problems occurring that may go undetected. Implementing a quality management system may not guarantee an error-free laboratory, but it does yield a high-quality laboratory that detects errors and prevents them from recurring.

Complying with and accrediting to ISO/IEC 17025 has numerous benefits, as it:

• demonstrates conformance to an international standard that in turn expands a laboratory's business opportunities
• demonstrates objectively, through accreditation, provision of quality and technically competent services
• enhances the reliability, accuracy, and validity of analytical and calibration results produced by the lab
• enhances the quality of testing, calibration, and sampling methods
• encourages compliance to other standards of practice
• facilitates traceability of measurements and calibrations to appropriate standards
• encourages a proactive, risk-based organizational culture of quality that in turn enables the lab to better identify, assess, and address risk
• encourages professionalism and pride within the organization
• aids in controlling costs, improving measurement accuracy, and reducing waste
• improves productivity and efficiency among lab staff
• improves reputation and performance in the lab's industry
• ensures specific quality levels, compliance requirements, and customer needs are satisfied
• facilitates cooperation between laboratories and other entities internationally, while also accelerating and improving confidence in international trade