Stronger laboratories.
Safer, more reliable testing.

CLSI ensures your laboratory delivers quality results every time with international standards, training, and tools.

Spotlight on Essential Standards

Explore important standards that drive quality and compliance in laboratories.

View All

CLSI M07
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That...
Twelfth Edition
Microbiology
$180.00
CLSI MM26
Cancer Molecular Testing: Principles of Oncology Test Interpretation,...
First Edition
Molecular Diagnostics
$180.00
CLSI EP10
Preliminary Evaluation of Quantitative Medical Laboratory Measurement...
Fourth Edition
Method Evaluation
$180.00
CLSI AUTO11
Information Technology Security of In Vitro Diagnostic Instruments and...
Third Edition
Automation and Informatics
$180.00
Woman with Baby
Microorganisms
Global Representation

The Global Leader
for Clinical
Laboratory Standards

International laboratory standards assure patients and providers that the tests they rely on are safe and accurate. Anywhere, every time. Quality practices allow for innovation and improvements in diagnostic testing, setting the course for better health care today and tomorrow. CLSI is committed to developing and promoting the use of international standards to support better patient outcomes and global public health.

CLSI is also a member-based nonprofit organization representing more than 26,000 laboratory professionals and almost 2,000 subject matter experts participating in standards development.

Standards Development

Setting the Standard
Together

CLSI’s collaborative approach ensures balanced representation from the global laboratory community to yield unbiased consensus standards and best practices that can be confidently adopted by laboratories, clinicians, agencies, and industry leaders around the world.

Empower Your Organization,
Elevate Your Career

CLSI members have access to the foremost industry, health care, and regulatory experts around the world, whose deep knowledge and practical expertise inform every piece of guidance CLSI issues.

Standards Implementation

Ensuring Quality
Testing

As the recognized leader facilitating the development of global consensus standards and guidance, CLSI sets your lab, your team, and your organization up for success.

Share Your Expertise

Join our community of industry leaders who volunteer their experience and knowledge to drive innovation and excellence in laboratory practices.

New Product

Method Navigator

Method Navigator enables users to easily reference and access resources for the establishment and implementation of laboratory-developed tests (LDTs) or other regulatory-approved commercial test methods.

Latest Insights

Newborn Screening
We spoke with Dr. Bradford Therrell, an expert in newborn screening and an author for CLSI NBS01 about the importance of newborn screening and it's global impact.
Article
CLSI is excited to celebrate Dr. Michael Loeffelholz for receiving the 2026 ASM Service Award from the American Society of Microbiology.
Method Evaluation
The table provided maps specific Clinical and Laboratory Standards Institute (CLSI) Evaluation Protocol (EP) documents that cover the Verification Phase of the Test Life Phases Model to assist medical laboratories verifying performance claims for both laboratory-developed tests and regulatory cleared or approved test methods.