Book:LIMS Selection Guide for ISO/IEC 17025 Laboratories/How ISO/IEC 17025 affects and benefits laboratories/What ISO/IEC 17025 asks of laboratories

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2.2 What ISO/IEC 17025 asks of laboratories

After discussing what types of labs are adopting the ISO/IEC 17025 standard, it's now time to get into the details of what the standard asks of adopting labs. Implementing a standard within a regulated business is rarely a straightforward process and has many challenges for all but the most well-organized and -resourced entities. ISO/IEC 17025 is no exception. At its core, the standard has a focus on quality, but that focus is stated through the lens of a lab's ability to demonstrate its competence, impartiality, and consistency across its operations. This section expands on these three characteristics, as well as the specific demands the standard places on the lab. It will also address a handful of gaps ISO/IEC 17025 has when compared to similar standards, as well as possible means towards filling those gaps.

2.2.1 Competence, impartiality, and consistent operations

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, remaining 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" (i.e., the actual output of conduct or practice matches a stated expectation). 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.

2.2.2 Demands on the laboratory

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

• Section 4: General requirements,
• Section 5: Structural requirements,
• Section 6: Resource requirements,
• Section 7: Process requirements, and
• Section 8: Management system requirements.

The various components of these five sections impact the laboratory in many ways, placing demands on the lab while providing tangible and intangible benefits. The rest of this section will address the "demand" side and any gaps in support the standard has, while the subsequent section will address the potential benefits.

General requirements

Section 4 of ISO/IEC 17025:2017 addresses two primary concepts: impartiality and confidentiality. We note that right from the start, one of the three top-level points is addressed in impartiality, asking the lab to maintain commitment to and responsibility for impartiality, while identifying and acting upon any risk to impartiality. Additionally, the standard asks the lab to treat "all information obtained or created during the performance of laboratory activities" with confidentiality. This means taking the necessary security precautions to ensure only authorized individuals can have access to laboratory information, and communicating any release of said confidential information in a timely and appropriate fashion should a law or contract mandate its release.

Structural requirements

Section 5 of ISO/IEC 17025:2017 addresses the organizational pillars required of a laboratory in order to meet the three top-level points of competence, impartiality, and consistent operations. It notes that the lab should be a legal entity, held liable by the laws that created it, and that entity should have management that is clearly identified as having responsibility for various operations. That entity must also document its activities, procedures, and methods that fall under the scope of ISO/IEC 17025:2017 and ensure those activities are conducted in a competent, impartial, and consistent manner. Finally, it recognizes the importance of people to meeting those goals, asking the lab to ensure those people have the authority and resources necessary to create, monitor, and act upon deviations from the lab's procedures, methods, and management systems, including the quality management system (QMS).

Resource requirements

Section 6 of ISO/IEC 17025:2017 addresses the importance of resources to the laboratory in meeting its goals and maintaining a high level of standard practice. The standard covers personnel, the facility and working environment, equipment, metrological traceability (through calibration), and third-party products and services. First, personnel must demonstrate competence and impartiality, which must be proven and documented. Those people must also be aware of their duties and responsibilities, while being given the means to perform them. Second, the facility and work environment must be suitable, without negatively impacting analytical results, and the conditions should be monitored, documented, and controlled to prevent and resolve issues with contamination, interference, or other detrimental influences. Third, what is a laboratory without the proper equipment to effectively meet its goals? Here the standard asks labs to provide the necessary in-lab resources to get the job done. Of course, just having that equipment isn't enough, and the standard asks that any measurement equipment be properly calibrated and able to provide accurate and timely results, with documentation concerning the activities of that equipment being recorded. Extending from there is the fourth topic of metrological traceability, defined as "the “property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty.” The standard goes on to explain how this should best be achieved. Finally, third-party or "external" products and services are addressed, asking the lab to ensure those products and services are "suitable," as determined by review and approval within the organization. When working with those third parties, the lab should also be clear in communicating its own requirements to the third party.

Process requirements

Section 7 of ISO/IEC 17025:2017 is a hefty one, directly addressing the actual work conducted in the laboratory. This section looks at 11 different aspects of workflow in the lab; a brief comment is made about each aspect (it's beyond the scope of this article to go into fine detail):

1. Bid opportunities and contracts: Describes how labs and their clients should communicate clearly about and carefully document work requirements, test methods, and conformity to a specification or standard, as well as any deviation from or amendment to those agreed-upon items.
2. Laboratory methods: Details the level of attention to and fitness of "methods and procedures for all laboratory activities," including how to develop, verify, validate, and document methods, as well as how to handle deviations from those methods.
3. Laboratory sampling: Touches upon the importance of quality sampling plans and methods, as well as what they should contain.
4. Test and calibration item management: Touches upon how test and calibration items should be handled, from beginning to end of the lab's workflow, as well as how those items should be identified and stored.
5. Record management: Briefly addresses the management of technical records and what they should contain.
6. Measurement uncertainty: Touches upon the topic of evaluating measurement uncertainty.
7. Result validation: Describes the importance of result validation, including how results should be monitored and validated, while also addressing proficiency testing, inter-laboratory comparison, and continual improvement for further quality.
8. Result reporting: Describes how results should be reported (including statements of conformity, opinions and interpretations, and amendments), as well as what the report should contain in regards to testing, calibration, and sampling.
9. Complaint management: Describes how the lab should approach internal and external complaints surrounding its activities and services, emphasizing transparency and proper communication.
10. Nonconformity management: Emphasizes the procedures required to effectively handle and mitigate nonconforming work.
11. Data and information management: Recognizes that data and information represent the most critical output of the lab and states how that data and information should be effectively managed to ensure optimal laboratory operations and success.

Management system requirements

Section 8 of ISO/IEC 17025:2017 addresses the laboratory's management system. While the standard never directly calls it a "quality management system" or QMS—in fact, the word "quality" only appears once in this section—the implication in the opening paragraph is that the standard is addressing quality with its requirements for a management system, i.e., a QMS:

The laboratory shall establish, document, implement, and maintain a management system that is capable of supporting and demonstrating the consistent achievement of the requirements of this document and assuring the quality of the laboratory results.

This section breaks the management system down into two options: Option A for a lab needing a built-from-scratch management system, or Option B should a lab already have an ISO 9001-driven management system in place. Most of the section is dedicated to addressing Option A and its requirements for proper documentation, document management, risk management, process improvement, corrective action, internal audits, and management review and buy-in.

2.2.3 Addressing 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 examine and adopt components of 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 laboratorians, 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 17025:2017 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.