LII:LIMS Selection Guide for ISO/IEC 17025 Laboratories/Introduction to ISO/IEC 17025

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1. Introduction to ISO/IEC 17025

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ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories is an internationally recognized standard that places requirements on testing, calibration, and sampling laboratories to demonstrate "the competence, impartiality, and consistent operation" of their business activities.[1] At its core, the standard places a strong focus on implementing procedural and quality management mechanisms as a means towards meeting those goals. ISO/IEC 17025 has a long history that dates back to a time when international trade in the 1970s saw Japan leading the charge with its total quality efforts, driven by the desire to rebuild shattered industries after World War II. Japanese products just couldn't compete with the quality of other industrialized nations, and the Japanese clamored for something better. That focus on total quality eventually spread Westward in the 1980s.[2][3] To this day, this desire for higher-quality goods and services by customers, clients, and other stakeholders continues to drive innovation and expansion in industry. Such is the path with quality, a trait demanded by and benefiting society in many ways.

The ISO/IEC 17025 standard is one of a few standards that focuses on managing quality in the organization, yet it goes beyond standards like ISO 9001 by not only encouraging use of a quality system (i.e., a quality management system or QMS) but also setting standards of unbiased operational competence and consistency. The standard also is clear in its audience: testing, calibration, and sapling labs. Not all labs choose to adopt the standard, but those that do tend to find it rewarding, if not also a bit challenging.

The rest of this chapter will examine the ISO/IEC 17025 standard and its origins, and how it compares to standards like ISO 9001. It will also address how those labs choosing to embrace the standard provide a net benefit to society as a whole.

1.1 History of ISO/IEC 17025

ISO/IEC 17025's origins go back to the mid-1970s, when a conference on cross-border acceptance of laboratory test data led to the International Laboratory Accreditation Cooperation (ILAC) beginning work on what would eventually become ISO Guide 25 Guidelines for assessing the technical competence of testing laboratories, with that work ultimately getting turned over to the International Organization for Standardization (ISO). The intent of developing the guide, published in 1978, was to gain international cooperation towards improving the world's laboratory services by promoting a scheme for accredited laboratory test results, such that the results could be more readily accepted across national borders.[4][5][6] That first guide didn't address the activities of calibration labs, however, and it would require further revisions, as the general guidelines towards proving a lab's technical competence were also inadequate.[5] For the next version—released in 1982 as ISO/IEC Guide 25: General requirements for the technical competence of testing laboratories—the International Electrotechnical Commission (IEC) became involved. That version saw upgrades in proving technical competence, as well as the addition of the requirement for a quality system, though this revision also didn't address calibration labs.[5] The next version, released in 1990 as ISO/IEC Guide 25 General requirements for the competence of calibration and testing laboratories, finally addressed calibration labs and, with the help of the Council Committee on Conformity Assessment (CASCO), lent "support for national systems, thus easing bilateral agreements" associated with laboratory testing.[4][5][6] It also added notice that by meeting the requirements of ISO/IEC Guide 25, labs would also comply with the ISO 9000 standard, which also focused on quality. Four years later, CASCO pushed to turn ISO/IEC Guide 25 into a full standard, and by 1999, ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories was born, which also met the requirements of ISO 9001.[4][5][6]

Since then, the standard has seen two additional revisions, one in 2005 and another in 2017.[4][5][6] With the ISO 9001 standard being in revision at the same time ISO/IEC 17025:1999 was ready to release, the standard's views on ISO 9001 when published were antiquated, requiring the 2005 update.[5] The 2017 version included new requirements for competency, impartiality, and consistent laboratory operation and took on a revised structure from its 2005 predecessor, with the 2005 division between technical management and quality management being replaced by "a more unified focus on a laboratory's general responsibility management."[5] (For more on the differences between the 2005 and 2017 version, see the National Association of Testing Authorities' (NATA's) gap analysis document comparing the two.[7]) As of January 2023, ISO/IEC 17025:2017 remains the latest version of the standard, putting a focus on labs seeking competent, impartial, and consistent results, with a focus on an efficient management system (i.e., a QMS).

1.2 ISO/IEC 17025 vs. ISO 9001

Given the history of ISO/IEC 17025, the uninformed individual may wonder what the difference is between that and the ISO 9000 series of standards. While it is true that ISO 9001 is mentioned in the context of complying with ISO/IEC 17025, there are several differences, though the critical concept of quality management is found in both. Let's first talk about what ISO 9001 and the 9000 series are geared to do and how they address quality management.

The ISO 9000 family of standards addresses the fundamentals of QMSs for an organization[8], including the eight management principles on which the family of standards is based.[8][9] ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.[10] In turn, third-party certification bodies provide independent confirmation that organizations wishing to adhere to the standard meet the requirements of the standard.

Quality management is defined by ISO 9000 as a set of "coordinated activities to direct and control an organization with regard to quality." By extension, those coordinated activities require sufficient "organizational structure, resources, processes and procedures" in order to implement quality management throughout the enterprise, otherwise known as a quality system.[11]

Note that the discussion so far has focused on how the standard addresses the "organization" seeking to improve quality. That's because ISO 9001 is directed at all kinds of organizations operating in any type of industry and sector, whereas ISO/IEC 17025 specifically targets testing, calibration, and sampling laboratories. There are other differences from ISO/IEC 17025 as well, the most significant being that ISO 9001 deals strictly with deploying a QMS in the organization, whereas ISO/IEC 17025 expands into a toolbox of requirements for ensuring not only quality but also the "competence, impartiality, and consistent operation of laboratories."[1]

Finally, accrediting to either of the two standards is also a different process, which highlights the inherent differences between the two standards. As laboratory consultancy Perry Johnson Consulting notes, the difference between the ISO/IEC 17025:2017 and ISO 9001:2015 standards can be found in comparing the accreditation process: "ISO/IEC 17025:2017 accreditation is recognition of a laboratory’s competence to produce technically valid results, while ISO 9001:2015 registration of a laboratory is limited to QMS conformance."[12] They add that ISO/IEC 17025:2017's "technical competency requirements go beyond QMS registration and relate specifically to the qualifications needed with regard to personnel, equipment, facilities, and laboratory methods."[12]

From this, we may be tempted to conclude that—at least for the non-clinical laboratory (non-clinical because the clinical lab usually turns to ISO 15189:2022 Medical laboratories — Requirements for quality and competence)—ISO/IEC 17025 is the quality management standard to comply with, end of story. However, the utility of ISO 9001 to the laboratory should not be completely dismissed. For those struggling with implementing the management system portion of ISO/IEC 17025, additional inspiration and guidance may be found in ISO 9001. For example, ISO 9001:2015 provides additional scope in establishing a QMS, particularly through identifying problematic issues and important stakeholders. It also expands discussion about the importance of organizational leadership establishing quality policy and the organization developing quality objectives, as well as the greater need for identifying organizational knowledge and fully implementing monitoring and measurement mechanisms.[13] From this, the laboratory may gain additional benefits by supplementing their ISO/IEC 17025:2017 compliance with some aspects of ISO 9001:2015, further enabling a more risk-based approach to managing quality in the lab.[13] (For more about how the laboratory benefits from ISO/IEC 17025:2017, see section 2.3 of the next chapter.)

1.3 How we benefit from ISO/IEC 17025 laboratories

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The discussion so far has been useful in giving background about standards bodies giving organizations—including laboratories—a framework for improving operational quality, but how does this all relate to the primary question about ISO/IEC 17025 benefiting society? From here, it's useful to examine the importance of the laboratory itself to society. In the guide The Laboratories of Our Lives: Labs, Labs Everywhere!, the first chapter emphasizes the ubiquity of the laboratory in the fabric of society, despite the lab being largely invisible to the average individual[14]:

Laboratories play an integral role in modern life, ubiquitous and often unseen by the average person. They improve quality of life, act as hotbeds of discovery, and help us make sense of our universe, particularly in the capable hands of the tens of thousands of professionals who work in them. But the laboratory as we know it today is actually a relatively new concept. It wasn't always as sectionally organized, well-staffed, and well-equipped. To gain a better sense of how common the laboratory is to our lives, we must first briefly look at the past history of laboratory research and how it developed from a philosophical and more selfish endeavor to one more focused on analysis and the benefits to society.

Labs can be a hotbed of economic activity, as found with the United States' Argonne National Laboratory in Illinois, which claimed in 2021 to employ more than 3,400 people and have an approximately $168 million total economic impact on the state.[15] Labs can also be a significant source of innovation to society, with the old Bell Telephone Laboratories at its peak employing some 1,200 PhDs and being responsible for the creation of vital technologies such as solid state components, wireless telephony technology, the C programming language, and the Unix operating system (thanks to Bell researchers like Ken Thompson and Dennis Ritchie).[16] In fact, laboratories are often at the heart of a company's R&D efforts towards bringing people new products. Vehicle[17] and makeup[18] users alike are affected by manufacturing laboratories that research, design, test, and quality control their products. Clinical labs help keep current and future generations healthy, and forensic labs help bring justice to the wronged. Of course, calibration laboratories are vital to ensuring the precise measurement and production values of any equipment those other laboratories strongly depend on.

However, labs can and do fail (completely, or at their tasks)[19][20][21], like any other business. This can happen for a number of reasons[19][20], though insufficient attention to risk and quality management is usually a major contributor.[21][22][23] In fact, data and quality management are arguably at the heart of aiding not only in reducing errors in laboratory processes but also more rapidly recovering from errors in and strengthening the quality of processes.

Labs of all types should be addressing quality within their operations, particularly when those operations affect human and animal health. "Quality management is as applicable for the medical laboratory as it is for manufacturing and industry," states the World Health Organization (WHO) in its 2011 Laboratory Quality Management System: Handbook.[11] While the medical laboratory is better covered by ISO 15189 for its quality needs, the WHO's statement highlights that all laboratories can benefit from implementing quality management principles. This includes food and beverage laboratories, water and wastewater laboratories, and calibration laboratories, among many others.

Past research has shown that a well-implemented quality plan, paired with quality indicators, is significantly associated with improving laboratory services and client satisfaction.[24] In particular, the customer or client is increasingly seen as the most important element driving laboratory quality, supported by effective QMS implementation and improvement. "A QMS with customer focus as its heart is the core foundation for a business striving to attain distinction irrespective of technology, commercial strategy or organizational philosophy," notes Udoh and Eluwole, adding that "at the end of the day, the quality of a product will be determined by whether or not it fulfills customer requirements."[25] By extension, the end user of a product or service will be not only more satisfied but also safer for it.

One can look to the Galaxy Note 7 battery explosion issue from Samsung in 2016 as an example, with 13 people known to have been injured and 47 reports of property damage having been filed.[26] Later analysis by Counterpoint Research noted of the Galaxy Note 7 situation that “very often, laboratory times and testing periods are shrunk to expedite approval and release-to-market of key devices; it is possible all charging scenarios were not thoroughly tested."[25] The end result is injuries, property loss, and dissatisfied customers who begin to look elsewhere for a safer, more reliable product. The clinical and public health lab offers another example, with the World Health Organization (WHO) noting the negative consequences of laboratory error include unnecessary treatment, treatment complications, failure to provide the proper treatment, a delay in a correct diagnosis, greater costs, and poor patient outcomes. The cure, they add, is effectively implementing the QMS and adopting internationally recognized laboratory standards.[27] Finally, the food supply chain can become adulterated by lack of quality and regulation (i.e., food fraud); however, laboratories focused of fighting food fraud and ensuring manufacturer quality help reduce public health threats, improve customer confidence and satisfaction, and improve economic output.[28]

Quality management also improves overall costs and efficiency for not only the laboratory but also society.[29][30][31][32] Raiborn and Payne noted this in the mid-1990s while discussing the topic of "total quality management"[32]:

Who benefits from prompt, reasonable-cost throughput? The answer is easy: everyone. Customers benefit because they get what they want, when they want it, and at a reasonable price. Satisfied customers are repeat customers, which means that employees benefit because production and, therefore, jobs will continue. The company benefits because shortened lead time means lowered investment and faster cash flow; satisfied, repeat customers and efficient processes also mean higher profits and, thus, happy stockholders. Society benefits because there is greater availability of resources for alternative purposes since prices have fallen (or greater value is being provided for the same price) and companies will continue in business, providing numerous positive societal effects from their existence (tax payments, employment, charitable contributions, etc.).

While Raiborn and Payne's quote specifically refers to improvements in costs and efficiency within the organization due to proper quality management, their words sum up quite well the overall benefits to society laboratory quality management brings. A product or service—whether it be the analytical results of the laboratory itself or the larger macro view of safer, more high-quality products and services via laboratory testing—that meets customer requirements is the end result of quality laboratory work, and society benefits from it thanks in part to well-implemented quality management mechanisms. Without them, products and services are more risky to use, more apt to have health-impeding impurities and contaminates, less beneficial, and more expensive.


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Citation information for this chapter

Chapter: 1. Introduction to ISO/IEC 17025

Title: LIMS Selection Guide for ISO/IEC 17025 Laboratories

Edition: First Edition

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: February 2023