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.