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Consensus Process
Building Consensus for Standards
The strength of CLSI’s consensus standards development process begins with our extensive network of subject matter experts who bring a diversity of skill sets, depth of expertise, and vast knowledge to help lead the development of globally-applicable clinical laboratory standards.
CLSI’s collaborative approach ensures representation from all constituents and stakeholders in the laboratory community to yield unbiased guidance that can be confidently adopted by laboratories, clinicians, patients, regulatory agencies, accreditation organizations, and manufacturers throughout the world.
The CLSI Standards Development Process
Ideation
New project ideas can be proposed by anyone, including individuals from our vast member base, subject matter experts serving on committees, or the public at large.
Groups/Committees Involved:
CLSI Members
General Public
CLSI Committees
Evaluation
The Consensus Council evaluates and authorizes document proposals across specialty areas, focusing resources on those projects that meet the greatest need.
Groups/Committees Involved:
CLSI Consensus Council
Recruitment
Recruitment of development committee members is a collaborative effort between the Expert Panel, the Consensus Council, and CLSI Program Managers.
Groups/Committees Involved:
CLSI Expert Panels
CLSI Staff
CLSI Consensus Council
Kickoff
Once a development committee is formed, development begins.
Groups/Committees Involved:
CLSI Development Committees
Development
The project’s development committee works to draft the standard, looking to CLSI Expert Panels as needed.
Groups/Committees Involved:
CLSI Expert Panels
CLSI Development Committees
Voting
CLSI Member Delegates, Expert Panels, and development committees are encouraged to vote and comment on the draft document.
Groups/Committees Involved:
CLSI Expert Panels
CLSI Development Committees
CLSI Member Delegates
Public Commenting
The General Public is invited to provide comments and feedback on the draft document for further development and refinement.
Groups/Committees Involved:
General Public
Resolution
CLSI development committees work to refine the document, resolving all comments and feedback that arises during the voting and commenting period.
Groups/Committees Involved:
CLSI Development Committees
CLSI Staff
Approval
The revised document is presented to the Consensus Council to confirm that the consensus process was followed, and the document is approved for publication.
Groups/Committees Involved:
CLSI Consensus Council
Publication
The document goes into production and is made available to the public.
