User:Shawndouglas/sandbox/sublevel14

Sandbox begins below

Title: What is the importance of ISO/IEC 17025 to society?

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: TBD

History of ISO/IEC 17025

ISO/IEC 17025's origins go back to the mid-1970s, when a conference on cross-border acceptance of 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, after turning the work 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. 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. 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 it too didn't address calibration labs. 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. It also added notice that by meeting the requirements of ISO/IEC Guide 25, labs would also comply with the ISO 9000 standard. 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 90001.

Since then, the standard has seen two additional revisions, one in 2005 and another in 2017. With the ISO 9001 standard in revision at the same time as ISO/IEC 17025:1999, the standard's take on ISO 9001 when published was antiquated, requiring the 2005 update. The 2017 version included new requirements for competency, impartiality, and consistent laboratory operation and took on a revised structure from it 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." (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.) As of December 2022, ISO/IEC 17025:2017 remains the latest version of the standard, putting a focus on labs developing a more efficient management system (i.e., a quality management system or QMS).

ISO/IEC 17025 vs. ISO 9001: Supporting quality management in the lab

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, including the eight management principles on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill. In turn, third-party certification bodies provide independent confirmation that organizations 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.

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."

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 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." 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."

From this, we may conclude that—at least for the laboratory—ISO/IEC 17025 is the 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 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. 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. (For more about how the laboratory benefits from ISO/IEC 17025:2017, see How does ISO/IEC 17025 impact laboratories?.)

How supporting laboratory quality management improves society

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?

"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. While the medical laboratory is better covered by ISO 15189, the WHO's statement highlights that all laboratories can benefit from implementing quality management principles.