Does my organization need to be a member before I can volunteer?
Your organization does not need to be a member of CLSI for you to become a volunteer; however, if your organization is not a member, you must join CLSI as an Individual Member. CLSI has 2,000 volunteers, who work together to develop CLSI documents through CLSI’s consensus process. Learn more about CLSI membership opportunities here.
Why types of documents and products does CLSI offer?
CLSI offers voluntary consensus standards and guidelines, reports, and a number of companion products.
Standards are documents developed through the consensus process that clearly identify specific, essential requirements for materials, methods, or practices for use in an unmodified form. Standards may, in addition, contain discretionary elements, which are clearly identified.
Guidelines are documents developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. Guidelines may be used as written or modified by the user to fit specific needs.
Reports are documents that have not been subjected to consensus review.
Companion products include any item provided or sold that is intended to be used in conjunction with a CLSI standard or guideline. Examples include, but are not limited to, Quick Guides, Wall Charts, software, and templates. Companion products typically contain or refer to technical content taken directly from standards and guidelines.
What does "consensus" mean in the context of the CLSI consensus process?
CLSI voluntary consensus is the agreement among materially affected, competent, and interested parties. Voluntary consensus does not always connote unanimous agreement, but it does mean that the participants have considered and resolved all relevant objections.
I have an idea for a project. How do I suggest it?
Any person or organization may propose a new CLSI project by submitting a completed Project Proposal Form. Project proposals are evaluated through a progressive project assessment/authorization process that includes:
Following project assessment, the completed proposal, the approved document development committee roster, and a project business plan are presented to the Consensus Council for authorization.
Member selection for a document development committee is primarily based on expertise and/or practical experience as defined in the project proposal.
Consensus Council—The Consensus Council is the authority over all CLSI standards development activities, including project approval, prioritization, status assessment, and consensus approval for document publication. The Consensus Council serves as the consensus body for CLSI, and ensures that CLSI’s standards development activities are in alignment with Board-directed organizational priorities, CLSI’s mission and vision, budget, and resource availability.
What are the roles and responsibilities of Expert Panel participants?
Expert Panel—Expert panels are authorized by the CLSI Board of Directors. An Expert Panel serves as the expert body for CLSI standards development activities within a technical area. This includes developing and endorsing project proposals; recommending document chairholders, vice-chairholders, and roster members; and reviewing and commenting on documents in development, with the purpose of ensuring the technical quality of documents. The Expert Panels also serve in an advisory capacity to the Consensus Council, advising on new project proposals, document development issues, and documents ready for final approval for publication.
What are the roles and responsibilities of members of a document development group?
Document Development Group—The Document Development Committee (DDC) creates new and revises existing CLSI standards, guidelines, reports, or companion products, upon approval and appointment by the Consensus Council. The Working Group (WG) prepares specific document sections, data, or other information intended to be part of a standard, guideline, report, or companion product developed by a DDC or Subcommittee.
Chairholder—reports to the consensus council, develops and implements project budget and schedule, plans and conducts committee meetings, manages development or revision of the document, and monitors participation of committee members and contributors.
Vice-Chairholder—serves as leader and representative in the chairholder’s absence.
Member—develops a table of contents, identifies primary references, participates as a contributing author and subject matter expert, completes and votes on the document development group’s draft document, addresses all comments submitted during the voting stages, and revises drafts as appropriate.
Contributor (formerly Advisor or Observer)—reviews and comments on draft documents. These individuals, who are knowledgeable and experienced in the topic area, provide valuable input on the draft documents.
Committee Secretary—supports the consensus process by providing accurate, technically oriented meeting summaries. The secretary is knowledgeable in the subject area and is able to prepare meeting summaries that include details supporting the rationale for decisions and changes made during the meeting.
Who is eligible for reimbursement of meeting expenses?
CLSI has a volunteer reimbursement policy here.
What is the CLSI process for developing a consensus standard or guideline?
See the full process here.
How do I review or comment on a CLSI document in development?
Anyone is eligible to review or comment on a CLSI draft document. At specific points in the document development process, the draft is reviewed by the document development committee and the appropriate consensus committee. During the proposed draft voting period, the document is reviewed by the CLSI delegates and the Board of Directors. At this time, it is also available for public review. Requests for copies of draft documents should be submitted via email to email@example.com or via fax to +1.610.688.0700. All comments are addressed by the CLSI committee that developed the document. Comments may be submitted using our comment form, via email at firstname.lastname@example.org, via fax at +1.610.688.0700, or via mail to:
950 West Valley Road, Suite 2500
Wayne, PA 19087 USA
How are minority opinions handled in the CLSI consensus process?
Unresolved objections (ie, “reject” votes) and substantive changes after balloting are reported to the committee, and committee members have the opportunity to respond, reaffirm, or change their votes based on the stated objection(s).
Unchanged reject votes or unresolved comments are appended to the document as minority opinions, with a notification and request for user input.
Does CLSI have an appeals process?
The CLSI Standards Development Policies and Processes Document provides for appeal by persons or organizations that have been or will be materially or adversely affected by substantive and procedural actions or inactions with regard to the development, revision, reaffirmation, or withdrawal of a CLSI consensus document. The appeals procedures shall provide for participation by all parties concerned without imposing an undue burden on them. Consideration of appeals shall be fair and unbiased and shall fully address the concerns expressed.
These appeals procedures are consistent with the requirements of the American National Standards Institute Essential Requirements. Each objector shall be informed that an appeals process exists within the procedures used by CLSI. The burden of proof to show adverse effect shall be on the appellant.
The CLSI consensus procedure incorporates two avenues of appeal: appeal of substantive issues and appeal of procedural issues. Procedural appeals include whether a technical issue was afforded due process. Notice of this process will be incorporated in the comment/response summary published in CLSI consensus documents.
Appeal of substantive issues related to the contents of CLSI documents is incorporated in the consensus development process by requiring all relevant objections to be satisfactorily addressed by the respective committee.
What is CLSI's policy on harmonization of terms and methods?
Terms and definitions are fundamental parts of documents; therefore, it is necessary to standardize their use.
Toward that end, CLSI:
- Identifies harmonization issues as early as possible in the consensus process.
- Fully implements the protocol for use of terms and definitions that recognizes International Organization for Standardization (ISO) terms as the preferred terms and identifies terms from other sources and applies them as appropriate.
- Maintains an up-to-date database of nomenclature and definitions used in CLSI, ISO, and European Committee for Standardization standards, and ensures access to the database by committee participants.
- Is proactive in educating volunteers, committees, and constituents on the importance of harmonization.
- Staff and volunteers are responsible for implementation of the harmonization policy.
What are the differences between the Consensus Council, Expert Panels, and document development groups?
See the differences here.
Is CLSI an accredited standards development organization?
Yes, CLSI is accredited by the American National Standards Institute.
How is voting conducted on CLSI documents? Who is eligible to vote?
Voting can be accomplished at a committee meeting, during a conference call, or electronically via e-mail. Only document development group participants designated as members, Consensus Council members, CLSI Board of Directors, and CLSI delegates and alternate delegates are eligible to vote on documents.