Developing Standards Through a Unique Consensus Process
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.
Whether working on new guidelines for point-of-care-testing or revising quality system procedures, CLSI’s collaborative approach ensures balanced representation from each constituency—government, industry, and professions—and yields an unbiased consensus standard that can be confidently adopted by laboratories, clinicians, regulatory agencies, and industry throughout the world.
Learn More About the CLSI Standards 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 Administrative Procedures.