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About CLSI

 

Developing Standards Through a Unique Consensus Process

Led by dedicated volunteers, our committees create the standards that CLSI sets forth.

The strength of CLSI’s consensus process begins with our volunteers, who bring a diversity of skill sets, depth of expertise, and vast knowledge of regulatory requirements to lead the development of globally applicable clinical laboratory standards.

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

About the Development Process

Similar to many organizations, CLSI has a hierarchy of committees that overlook the development of our consensus standards and guidelines. What’s different about CLSI is that all of our committees have a balanced consensus body, which means that government, industry, and professional representatives have an equal say when approving documents for publication.

The consensus committees are divided into nine subject areas. The responsibility of managing the development of CLSI standards and guidelines falls onto these consensus committees. The consensus committees are divided into nine subject areas. The responsibility of creating and revising the standards and guidelines falls onto the document development committees and subcommittees.

Before CLSI publishes a document, the drafts pass through a series of review, comment, and voting cycles to ensure that consensus has been met. At different voting stages, different committees, as well as the public, have the ability to review and vote on the draft.

In-depth information on the consensus process for document development and the voting stages can be found in the Document Development Committee (DDC) Orientation Program, and in CLSI’s Standards Development Policies and Processes


Get Involved—Volunteer Today!

Maximize your voice in the global laboratory health care community as you work alongside colleagues from diverse sectors to develop CLSI’s consensus-based standards and guidelines.

To find the latest opportunities to participate on our standards development committees, visit our Opportunities page. If you have a new project you’d like to propose, you can submit your idea here.

 

Luann Ochs video

Luann Ochs, Senior VP of CLSI, elaborates on the benefits and significance of volunteering.

CLSI Standards by the Numbers

1,800+
active volunteers creating our standards

12
standards and guidelines specialty areas

9
standards development consensus committees

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