The strength of CLSI’s consensus process begins with the contributions of our subject matter experts, who bring a diversity of skill sets, expertise, and experience with regulatory requirements, and the robust protocols for public review that ensure that guidance is inclusive, relevant, and applicable.
Standards Development
Consensus-Based International Standards and Guidance
Developed with subject matter experts and organization leaders from health care, research, industry, and government, CLSI’s consensus standards represent validated international best practice for laboratory testing. CLSI’s collaborative approach ensures balanced representation to yield unbiased consensus standards that can be confidently adopted by laboratories, clinicians, regulatory agencies, and manufacturers throughout the world.
Our Areas of Expertise
CLSI documents cover a variety of specialty areas, from laboratory basics and quality management systems, to verification and validation protocols, information management, and point of care practices. We also develop interactive tools, guides, and other resources designed to assist in implementing these standards.
Share Your Knowledge, Participate in the Process
Developing standards is hard work. And it's important work. It takes a lot of collaboration and many, many participants. Committee members and working groups share their expertise to help develop the guidance. Public comment and voting ensures that consensus is achieved. Expert panels help determine what new standards are needed. There are many ways to be involved and to connect and collaborate with other leaders in the field.
Groups and Committees
Document Development Committees
Comprised of balanced representation from all constituencies, CLSI document development committees have primary responsibility for developing or revising consensus documents. A DDC is a group of technical experts who work together to manage the document content through development and disbands once that work is complete.
Subcommittees
Subcommittees are responsible for individual documents in a particular topic area. These subcommittees draft documents, evaluate and respond to comments on content throughout the development process, conduct periodic document reviews, and may be responsible for continual revision of certain documents.
Expert Panels
Expert panels are responsible for identifying and proposing projects and advising the Consensus Council on the suitability of proposed projects. The focus of the expert panels is on reviewing, commenting on, and voting on documents within their areas of expertise.
Working Groups & Ad Hoc Working Groups
CLSI’s working groups focus on specific tasks that support the work of a committee. A working group’s assignment is usually limited in scope. This work can include drafting a document or a particular section of a document or conducting a technical study. These groups are disbanded upon completion of the assignment.
Consensus Council
The Consensus Council helps define priorities, manage CLSI standards development, and identify continuous improvement opportunities for standards development related processes. The Consensus Council also votes to ratify Final Draft documents and confirm their adherence to process requirements.
Identify a Standards
Opportunity
Have a project idea? Believe there is a need for new guidance? Anyone can propose a project. Suggestions are vetted by our Expert Panels and Consensus Council to prioritize new projects for development.
International Standards Development
CLSI, ISO, and ANSI
The International Organization for Standardization (ISO) was founded in 1947 for the purpose of harmonizing measurement systems and regulatory practices to facilitate trade and collaboration between countries. CLSI was appointed by the American National Standards Institute (ANSI) to serve as Secretariat for the ISO Technical Committee 212 (ISO/TC 212): Medical laboratories and in vitro diagnostic systems. ANSI is an accrediting body that designates standards development organizations to represent the needs and view of US stakeholders in standardization forums around the globe, like ISO.
ISO/TC 212 is responsible for global standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems. CLSI also serves as the administrator for the US Technical Advisory Group (TAG) for ISO/TC 212.
Projects in Progress
Curious about what's in development? View our Projects in Progress to learn more about when to anticipate new publications.
Documents for Public Review
Help shape the standards that affect your day-to-day work. To preserve the integrity of standards developed through the CLSI consensus process, we seek input from the public on our in-process draft documents before they are approved for publication.
We encourage your involvement in shaping our documents to ensure all interested parties are given a voice.
Document Notices
CLSI documents are under constant scrutiny and review to ensure that they meet our standards of excellence. Corrections are appended to future print and electronic copies of the documents, made available to past purchasers, and cataloged here for reference.
A CLSI consensus document may be withdrawn at any point in the consensus process based on information that the consensus document is invalid or obsolete, or otherwise no longer needed in CLSI’s portfolio.
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