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Water quality testing in the lab (6f16fede-a75c-4444-af64-a339dff12012).JPG

Title: What types of laboratory testing are affected by ISO/IEC 17025?

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: TBD

Introduction

The International Organization for Standardization (ISO) and its ISO/IEC 17025 standard highlight the importance of "promoting confidence in the operation of laboratories,"[1] which are deeply woven into the fabric of modern society.[2] As the standard notes, that confidence is gained through the laboratory demonstrating "competence, impartiality, and consistent operation" in all of its activities.[1] Those laboratories choosing to conform to ISO/IEC 17025—though facing a number of challenges in implementing that conformity—have much to gain in the way of quality products and services, more rapidly detected and triaged errors, greater customer satisfaction and reputation, and broader access to markets.[3]

But what types of labs are choosing to conform to or are being driven to adopt the ISO/IEC 17025 standard? This brief LIMS FAQ article looks at these laboratories and their activities through the lens of categorization and example.


Laboratories choosing to conform to ISO/IEC 17025

The scope section of ISO/IEC 17025 indicates that the standard "is applicable to all organizations performing laboratory activities, regardless of the number of personnel."[1] Further, in its terms and definitions section, the standard states that a laboratory—for the purposes of the document—is a "body that performs one or more of ... testing, calibration, [and] sampling, associated with subsequent testing or calibration."[1] Of course, when it comes to testing, calibration, and sampling, these types of activities occur in a wide variety of industry contexts, including but not limited to environmental science, forensic science, food and beverage manufacturing, agricultural research, and pharmaceutical manufacturing.

The following subsections provide background on the different laboratory operations affected by ISO/IEC 17025 and give examples of ISO/IEC 17025-accredited activities, research topics, or calibration targets noted in academic literature. These subdivisions of labs are, in part, influenced by the work of Pillai et al. (though they largely fail to address calibration and reference testing labs in their work; these labs are added here).[4]

Analytical and regulatory testing labs

These types of labs conduct analytical tests on a wide variety of substances, materials, and equipment to ensure they are safe, effective, and secure for their application. Often times that testing is being performed due to a regulatory mandate concering safety and efficacy.[4] Manufacturers of all types of consumables and consumer use products (e.g., pharamaceuticals, foods, and cosmetics) will turn to in-house or third-party analytical and regulatory testing laboratories to perform the recommended or mandated analyses on their products to ensure their quality and safety.[4] Additionally, federal, state, and local governments also have to follow regulations concerning frequent testing of municipal infrastructure, including water, wastewater, and construction activities.[5][6] Yet another example can be found with the analytical activities of the forensic laboratory, which provides a diverse array of investigative services.[7] Examples of activities conducted by these and similar labs under ISO/IEC 17025 recommendations and protocols include:

  • analytical chemistry sampling[8];
  • sampling and high-resolution gamma-ray spectrometry of environmental soil, tap water, and aerosol filters[9];
  • radiological testing of food and drinking water[10];
  • individual and environmental dosimetry testing[11];
  • forensic paternity testing[12];
  • forensic anthropology analyses[13]; and
  • forensic toxicology and drug analysis.[14]

Product development and manufacturing labs

These are a subset of the above-mentioned analytical and regulatory testing labs, with a routine focus on pre-market research and development (R&D) and quality control analyses that help bring a product or service to market. That testing is typically conducted early on in a product lifecycle, based upon a set of predetermined limits set by a manufacturer or other criteria that are in turn driven by regulations and/or customer requirements.[4] This sort of testing could occur with sourcing ingredients or components to ensure they are certified to not contain allergens or an acceptable and safe level of contaminants, such as heavy metals. It also occurs during the development phase to ensure that any proposed final recipe or manufacturing specification doesn't have any unexpected toxicology or errors and has a reasonable chance of going to market.[15][16] Examples of activities conducted by these and similar labs under ISO/IEC 17025 recommendations and protocols include:

  • pesticide testing of honey[17];
  • nitrogen, protein, moisture, and ash analysis of foodstuffs[18];
  • toxic and allergenic component/contaminant analysis of consumer cosmetic, personal care, and building products [19];
  • long-range infrared camera development[20]; and
  • veterinary low-dose Cannabis sativa extract development.[21]

Basic and applied research labs

Basic research labs seek to understand and form theories concerning scientific questions, while applied research labs typically follow that basic research, conducting studies to apply that basic research towards solving practical problems. Both "conduct their work to support and inform the understanding of science", as well as drive regulatory support[4], and these lab can benefit from the recommended approach of ISO/IEC 17025. Basica and applied research labs may appear in academia, in government, or in private industry, studying a wide variety of topics. Research topics in ISO/IEC 17025-certified labs include (but is not limited to):

  • veterinary parasitology[22];
  • environmental chemistry[23];
  • diseases and their pathogenesis[4];
  • pharmaceuticals[24]; and
  • contract research projects.[25]

Reference measurement and calibration labs

A reference or calibration laboratory performs reference or calibration measurement procedures, or assigns reference values to test objects, later potentially providing those associated reference values for references or sources of traceability of test results.[26][27][28] ISO/IEC 17025 saw the addition of calibration laboratories to its focus in 1990 through its predecessor document ISO/IEC Guide 25 General requirements for the competence of calibration and testing laboratories as a greater means of lending "support for national systems, thus easing bilateral agreements" associated with laboratory testing.[29][30][31] In other words, with international trade hitting new records[32], it's more important than ever that an internationally recognized standardized approach to analyzing globally traded products is enacted, and the equipment and standards used for those analyses are themselves are properly calibrated and maintained.[33] (After all, when the biggest output of a lab is its analyses, it's best to ensure they are precise, accurate, and timely.) Laboratory equipment isn't all that's getting calibrated, however. These labs also calibrate important equipment in other fields of expertise. Examples of instruments and equipment getting calibrated to a standard in ISO/IEC 17025 calibration labs include:

  • radiation monitoring instruments[10];
  • electronic medical equipment[34];
  • laser and optical communication equipment[35]; and
  • high-accuracy Global Navigation Satellite System-based instruments.[36]


A note about clinical laboratories

You may notice that the clinical laboratory doesn't appear in the above listing. That is because quality management in the clinical lab is best guided by ISO 15189:2022 Medical laboratories — Requirements for quality and competence. (This is not to say that ISO/IEC 17025-compliant environments haven't conducted clinical analyses, as they have[37][38][39][40], but it's not the most ideal standard to be compliant with in the clinical environment, and ISO 15189 is increasingly common in hospital and clinical labs.[41]) The standard, which received an update in December 2022, is described by the ISO as being "applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities, and accreditation bodies."[42] Development of the standard began in the mid-1990s due to the lack of applicability ISO/IEC 17025 and ISO 9001 had to clinical labs. First published in February 2003, the standard was, however, developed with ISO/IEC 17025 and ISO 9001 in mind, taking the technical requirements of the first and the quality management requirements of the latter, while also adding input on professional requirements from the European Communities Confederation of Clinical Chemistry (EC4).[43] All said, ISO 15189 is arguably the best quality management standard for clinical laboratories as it takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to improving patient safety and outcomes.[44]

A potential companion to ISO 15189:2022 is the World Health Organization's Laboratory Quality Management System: Handbook. Though a bit outdated, as it was developed in 2011, the WHO handbook is based off of ISO 15189 and Clinical and Laboratory Standards Institute's (CLSI's) QMS01 A Quality Management System Model for Laboratory Services (or more specifically, its predecessor documents HS1 and GP26[45][46]).[44] The WHO and CLSI tend to go beyond ISO/IEC 17025 by incorporating 12 quality system essentials (QSEs)—"a set of coordinated activities that serve as building blocks for quality management"—as part of their QMS framework and emphasize that all must be met for overall clinical laboratory quality improvement to be realized.[44][47]

For more on this topic, see Plebani and Sciacovelli's "ISO 15189 accreditation: Navigation between quality management and patient safety."


Conclusion

References

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