User:Shawndouglas/sandbox/sublevel15

Sandbox begins below

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 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
• Section 8: Quality 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 next section will address the potential benefits.

Demands on the lab

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 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. 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 identfied 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.

Quality management system requirements

Section 8 of ISO/IEC 17025:2017 addresses

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