Template:LIMS Selection Guide for ISO/IEC 17025 Laboratories/Introduction to ISO/IEC 17025/ISO/IEC 17025 vs. ISO 9001

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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[1], including the eight management principles on which the family of standards is based.[1][2] ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.[3] 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.[4]

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."[5]

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."[6] 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."[6]

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.[7] 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.[7] (For more about how the laboratory benefits from ISO/IEC 17025:2017, see section 2.3 of the next chapter.)

  1. ↑ 1.0 1.1 Tsim, Y.; Yeung, V.; Leung, E. (2002). "An adaptation to ISO 9001:2000 for certified organisations". Managerial Auditing Journal 17 (5): 245–50. doi:10.1108/02686900210429669. 
  2. ↑ Beattie, K.R. (2010). "Implementing ISO 9000: A study of its benefits among Australian organizations". Total Quality Management 10 (1): 95–106. doi:10.1080/0954412998090. 
  3. ↑ "ISO 9001:2015 Quality management systems — Requirements". International Organization for Standardization. September 2015. https://www.iso.org/standard/62085.html. Retrieved 11 February 2023. 
  4. ↑ World Health Organization (2011). "Laboratory Quality Management System: Handbook" (PDF). World Health Organization. ISBN 9789241548274. http://apps.who.int/iris/bitstream/handle/10665/44665/9789241548274_eng.pdf?sequence=1. 
  5. ↑ "ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories". International Organization for Standardization. November 2017. https://www.iso.org/standard/66912.html. Retrieved 11 February 2023. 
  6. ↑ 6.0 6.1 Perry Johnson Consulting, Inc (January 2022). "ISO/IEC 17025:2017 Testing and Calibration Laboratories: An Executive Overview" (PDF). https://www.pjcinc.com/Downloads/ISOIEC17025_exov.pdf. Retrieved 11 February 2023. 
  7. ↑ 7.0 7.1 Hammar, M. (11 July 2019). "ISO 17025 vs. ISO 9001 – Main differences and similarities". Advisera Blog. Advisera. https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities/. Retrieved 11 February 2023. 
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