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Taking Steps, Making Strides

Evolving the CLSI Standards Development Process for Greater Efficiency, Focus, and Impact

Through standards development, CLSI sees its mission realized in practice. In order to better serve the volunteers that create these needed standards, and deliver them to users with greater speed, we have taken steps to improve the standards development process to benefit all involved.


What Is Changing?

Through this new process, we will unlock parallel efficiencies between process and technical oversight, so we can better prioritize and streamline standards development.

Unified Process Oversight
Instead of multiple Consensus Committees, we will have a single Consensus Council to oversee process-driven aspects for all developed standards. This allows us to prioritize across specialty areas and ensure consensus process requirements are upheld.

Creation of Expert Panels
Expert Panels support the technical quality of documents developed in their specialty area. The Consensus Council and document development committees can look to these experts for input on a standard’s technical accuracy.

One Voting Period
We have consolidated voting to a single period to create greater efficiency. At this time, CLSI Delegates and Document Development Committees are invited to vote on the standard.

More Convenient Collaboration
In addition to online collaboration forums like Workspace, CLSI has developed tools to aid volunteers, including templates, checklists, writer’s instructions, and more.

A New Standard of Benefits

Now CLSI can speed time to knowledge by getting meaningful standards into practice, faster. The needs of our users evolve every day—and so must our standards to remain timely and relevant.

Optimizes Volunteer Time and Talents
Volunteers can focus their contributions where they will make the greatest impact—in areas well aligned with their individual expertise and strengths.

Improves Timeliness and Efficiency
By flattening review processes and adding online tools for volunteer collaboration, we will shorten total development time to help ensure published standards meet timely needs.

Elevates Standards Quality
With one body providing process-driven oversight of all CLSI-developed documents, we can align standard consistency and quality across each of our specialty areas.

Supports and Sustains CLSI’s Mission
This evolved structure enables CLSI to prioritize precious resources to those standards most needed by the market.

The evolved standards development structure is scheduled for full implementation by January 1, 2016.


All of Our Volunteers Have an Equally Important Role to Play.

By delineating volunteer responsibilities between technical and process oversight, we unlock parallel efficiencies to streamline document creation. This empowers our volunteers to accomplish even more with less time demands.

What role is right for you?

The Consensus Council: Providing Process-Driven Oversight

The Consensus Council, composed of approximately 10 CLSI-selected member volunteers, will provide holistic, process-focused oversight of standards developed across specialty areas. The Consensus Council will prioritize these development projects based on greatest market need, and ensure they uphold consensus requirements.

Expert Panels: Upholding Technical Excellence

Expert Panel members will provide discipline-specific expertise as needed to ensure that the standards CLSI develops are of the highest technical and scientific quality. They will also help fill the pipeline for timely document development by proposing new standards to champion through the process.

Document Development Committees, Subcommittees, and Working Groups: Speeding Time to Knowledge

The new structure flattens operational processes to drive efficiency and streamline document review cycles for these document development groups. These modifications, and the addition of helpful collaboration tools, will help us achieve consensus in a shorter timeframe, so committees can get their valuable documents in the hands of the users that need them, faster.

From Start to Market Impact: Creating a CLSI Standard

Use this map to navigate the more efficient and focused path to standards development.

Consensus Council

Members will be selected based on project management capabilities and experience with and/or deep understanding of consensus-based process demands.

As a Consensus Council member, you will play a key role in fostering collaboration between specialty areas to properly prioritize projects across disciplines and fast track documents with the greatest market impact.

Key Responsibilities:

  • Determine priority and resource allocation across documents in all specialty areas.
  • Approve project proposals before the Call for Volunteers, and render final approval for development, including committee rosters.
  • Interface with Document Development Groups, overseeing due process throughout document development (not related to technical quality).
  • Look to Expert Panels for input and validation on technical accuracy and quality of documents in each topical specialty.
  • Provide final consensus approvals of documents developed for publication.

Expert Panel

Members will be selected based on their experience in a technical area. The expert panels serve in an advisory capacity to the Consensus Council, advising on new project proposals, document development issues as they arise, and documents ready for final approval for publication.

Expert Panels exist for the following technical areas: Automation and Informatics, Clinical Chemistry and Toxicology, Evaluation Protocols, Hematology and Immunology and Ligand Assay. Microbiology, Molecular Methods, Newborn Screening, Point-of-Care Testing, Quality Management Systems and General Practices.

Key Responsibilities:

  • Prepares new project proposals and advises the Consensus Council on the technical validity of project proposals submitted by other stakeholders.
  • Recommends chairholders, vice-chairholders, and rosters for document writing groups within the technical area.
  • Serves as technical advisors to the Consensus Council for document development issues, as needed.
  • Serves as technical advisors to document writing groups in their technical areas, as needed.
  • Reviews and comments on Proposed Draft documents within the technical area.
  • Serves as technical advisors to the Consensus Council for documents ready for final approval for publication, as needed.

Still Have Questions?

Tap additional helpful resources that explain process updates, volunteer roles, and resulting benefits in more detail.

FAQ Fact Sheet

If you are a current volunteer and wondering how your role will evolve, check out this helpful Q&A.

Process Changes Quick Guide

If you’d like to learn more about the meaningful changes made to step up standards development, click here.

Ask CLSI Staff

If you have a specific question and don’t see the answer here, please contact CLSI for more information.