Join us in celebrating our 50th Anniversary!
Join us in celebrating our 50th Anniversary!

CLSI Standards Documents for Public Review

Comment on New and Revised Standards Drafts

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. Opening the dialogue to CLSI members and nonmembers alike, we encourage your involvement in shaping our documents to ensure all interested parties are given a voice.

General Information

Requests for documents should be submitted via e-mail to or by fax to +1.610.688.0700. Comments related to CLSI draft documents shall be made in writing using the comment table form and shall be submitted no later than the comment deadline indicated below.

CLSI Standards Documents for Public Review and Comment

QMS01 (Proposed Draft)—A Quality Management System Model for Laboratory Services. This guideline provides a model for medical laboratories to organize the implementation and maintenance of an effective quality management system. This draft document is available to the public for review and comment for 60 days (26 June to 24 August 2018).

EP35 (Proposed Draft)—Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures. This guideline provides recommendations for assessing clinically equivalent performance for additional similar-matrix specimen types and suitable performance for dissimilar-matrix specimen types such that the laboratory does not necessarily need to repeat the full measurement procedure validation for each specimen type. The recommendations in this guideline apply to both quantitative measurement procedures and qualitative examinations. This draft document is available to the public for review and comment for 60 days (17 July to 14 September 2018).

QMS23 (Proposed Draft)—General Laboratory Equipment Performance Qualification, Use, and Maintenance. This guideline reflects requirements and provides recommendations and examples for use in planning, recording, and monitoring performance qualification, function checks, calibration verification, and preventive maintenance activities for general laboratory equipment. This draft document is available to the public for review and comment for 60 days (31 July to 28 September 2018).

The review and comment period provides an opportunity for the public to offer input on CLSI draft consensus documents. At the end of the 60-day review and comment period, the committee that developed the document is required to review and provide responses to all comments received and revise the draft document as appropriate.

Please note CLSI draft documents are available only for the purposes of review and comment and are not to be reproduced or circulated for any other reason. Draft documents have not completed the consensus review process and therefore shall not be used for any clinical purposes or to satisfy regulatory or accreditation requirements. They should not be considered either final or published and may not be quoted or referenced.