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June 3, 2026
International Standards: Advancing Laboratory Practice Through Translation
CLSI standards are developed with every medical laboratory in mind, whether in South America or the United States. The goal of the guidance is always the same: to deliver safe and reliable practices that ensure the highest quality patient care. Laboratories around the world rely on international standards to support their work, but their success depends on their ability to understand and implement this guidance. While English is generally considered the undisputed lingua franca in the scientific realm, these dense standards documents can still prove challenging for those whose first language is not English.
CLSI standards are developed with every medical laboratory in mind, whether in South America or the United States. The goal of the guidance is always the same: to deliver safe and reliable practices that ensure the highest quality patient care. Laboratories around the world rely on international standards to support their work, but their success depends on their ability to understand and implement this guidance. While English is generally considered the undisputed lingua franca in the scientific realm, these dense standards documents can still prove challenging for those whose first language is not English.
Building on a longstanding partnership with Sysmex, CLSI is expanding access to its guidelines in Japan through a new collaboration with the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the Japan Association of Clinical Reagents Industries (JACRI). While Sysmex has supported Japanese translation efforts for internal use for many years, this broader collaboration is focused on developing validated Japanese Language versions of CLSI guidelines for broader public use, helping laboratory professionals across Japan continue their life-saving work.
Conventionally, it was necessary to read and interpret the CLSI guidelines, which contain extensive information, in their original text. However, by using the Japanese translation corresponding to the CLSI guidelines, it becomes possible to easily and deeply understand the global performance evaluation methods related to performance assessment. This makes it easier to understand “research papers on global performance evaluation” and “regulatory submission information in Europe and the United States” that need to be input into the design and development process, allowing the performance status of products under development to be evaluated from a global perspective. 
Kick-off Meeting of the 'CLSI-JCCLS-JACRI-SYSMEX Japanese Translation Project' in Marunouchi, Tokyo (September 30, 2024)
A United Approach for Global Standards Adoption
CLSI guidelines and their use are not limited to geography. These consensus guidelines are built on data and best practices from subject-matter experts from around the world. CLSI standards are used globally by lab professionals, students, manufacturers, notified bodies, and many other stakeholders that play a role in patient care and have a vested interest in quality laboratory practices.
Ensuring that these standards are understood and applied consistently requires collaboration across the entire clinical laboratory ecosystem. From education and training to research, development, and implementation, multiple stakeholders must work together to align practices and maximize impact.
“CLSI guidelines are considered important documents for all those involved in clinical testing,” said JCCLS Terminology Committee Chairman Professor Masato Maekawa, “These documents are useful not only for education and training [of laboratory professionals], but also as reference materials that diagnostic companies must consider when conducting research and development, manufacturing, and sales.”
Masato Maekawa, Chairman, JCCLS Terminology Committee (Hamamatsu University School of Medicine, Professor Emeritus)
Navigating Differences in Evaluation Practices
For in vitro diagnostics (IVD) manufacturers in Japan, entering the global market presents a unique challenge. International markets require evaluations based on CLSI guidelines while domestic regulations often mandate separate, more narrowly defined assessments. As a result, manufacturers often must duplicate testing efforts.
The repetition is costly, takes more time, and can create inconsistencies, according to JACARI
Managing Director Mr. Mochizuki. Even though products may meet domestic standards and requirements, they may not satisfy CLSI international standards, introducing additional risk when trying to enter the global market. Improving access to the CLSI guidelines plays a vital role in aligning practices and supporting more efficient, globally competitive development.
“It is important for stakeholders, including regulatory authorities, to understand proper evaluation methods for in vitro diagnostics,” explains Mr. Katsuhiko Mochizuki.
Katsuhiko Mochizuki, MANAGING DIRECTOR (JACRI)
CLSI’s global partnership with JACRI WG, JCCLS, and Sysmex is empowering various stakeholders in Japan by making CLSI guidance available in Japanese. By improving accessibility, this effort supports more consistent application of best practices, reduces inefficiencies in evaluation processes, and helps streamline the path to global market approval for in vitro diagnostics.
Supporting Quality and Future Laboratory Needs
One recently translated guideline, CLSI EP05 | Evaluation of Precision of Quantitative Measurement Procedures, is a key document for in vitro diagnostic manufacturers recognized by the US Food and Drug Administration (FDA). This recognition simplifies the process for international manufacturers seeking approval in the US market. (See the US FDA Recognized Standards Database for more information)
With the CLSI EP05 guideline now available in Japanese, manufacturers not only gain a more streamlined pathway to US market entry but also benefit from a more consistent interpretation of its requirements.
Aligning With Global Quality Frameworks
Clinical laboratory practices continue to evolve rapidly, and with that comes a growing need for standardized evaluation methods. International frameworks such as ISO 15189 emphasize the importance of validation and verification processes to ensure the quality and competence of laboratory testing.
And CLSI guidelines play a critical role in supporting those requirements. Aligning with ISO 15189 processes, CLSI quality standards provide laboratories with structured approaches to evaluating testing procedures, particularly as laboratory-developed tests (LDTs) become more common.
“By translating the CLSI guidelines, laboratory technicians are provided with the opportunity to thoroughly read and study them, to understand a systematic and organized approach to clinical testing,” said Professor Maekawa.
Now with translated guidance, laboratory professionals in Japan have greater access to these standards, helping strengthen quality systems and prepare for the future of clinical training.
Advancing Global Alignment
The real significance of this collaboration is global alignment through expanded access to CLSI guidelines. The adoption of CLSI international standards helps reduce inefficiencies, supports more consistent evaluation practices, and contributes to ongoing efforts toward regulatory harmonization.
We believe that products that have undergone performance evaluation based on this standardization will bring clinical tests with guaranteed accuracy and create value by providing reliable, safe, and secure medical care to patients around the world.
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The number of submissions to international academic journals by Japanese engineers increases, diversifying scientific knowledge regarding performance evaluation.
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The number of expert panels for CLSI guideline development composed of Japanese engineers is increasing, and a foundation for more coordinated guideline development is being established.
As stakeholders across Japan gain a clearer understanding of globally recognized evaluation methods, laboratories and manufacturers are better positioned to operate within an increasingly interconnected healthcare landscape.
This effort also reflects CLSI’s mission to advance laboratory excellence worldwide by developing and promoting standards that improve quality, safety, and consistency in patient care across the global laboratory community.
Furthermore, through the following opportunities, by having Japanese manufacturers participate in the standardization of performance evaluation, diversity is brought to the common understanding of performance evaluation, requiring greater coordination to maintain interrelationships, and it is believed that this can lead to a well-balanced, “robust standardization” between theory and practice.
SYSMEX - Test Standards Management Team