We offer key resources for your organization or laboratory to leverage when implementing clinical laboratory standards in your environment.
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CLSI has changed some of the document codes and included colors to better classify our document categories. This document includes a full list of the document code changes and their corresponding colors that have been put in place as of March 2013.
Numerous CLSI documents are referenced in the College of American Pathologists (CAP) Accreditation Checklists and serve as key resources in satisfying regulatory requirements. CAP Accreditation Checklists are updated regularly to include CLSI’s standards, guidelines, and other documents as references.
*Updated October 2013!
This crosswalk shows how CLSI documents could help laboratory managers further their professional knowledge across the CLMA Body of Knowledge for Clinical Laboratory Managers. It contains the CLMA Domains, Competencies, and Levels within the competencies, as well as the CLSI documents and products that align with a specific level of competency or the entire competency.
*Updated December 2013!
This crosswalk shows how CLSI quality system essentials (QSE) correspond with clauses in ISO quality documents. The ISO quality documents are listed along with the related CLSI documents under each QSE.
*Updated June 2014!
The US Food and Drug Administration (FDA) maintains a database of recognized consensus standards. Included in the database are over 100 CLSI consensus standards and guidelines.
*Updated July 2013!
Please click here for information regarding FDA Recognized Consensus Standards and access to the FDA Recognized Consensus Standards Database. CLSI standards and guidelines can be located by searching on “CLSI” and/or “NCCLS.”
CLSI Documents Referenced to The Joint Commission Laboratory Accreditation Standards Chapters
*Updated July 2013!
The Harmonized Terminology Database is a compilation of internationally accepted terminology and is a tool for CLSI volunteers, members, and anyone in the laboratory sciences and related health care industries. It has been made publicly available to encourage broad acceptance and usage of internationally accepted terminology.
The CLSI Harmonization Policy outlines the process for using globalized terminology and procedures in CLSI documents.
When statements of fact are presented in CLSI documents, the original source of the fact needs to be provided in a reference citation. References tell readers where to access more information regarding the subject, and they give credit to the original authors.
The CLSI Style Guide provides guidance related to CLSI document structure and style, and is a valuable resource for volunteers drafting CLSI consensus documents.
This section includes corrections for CLSI documents. These minor corrections were identified after the documents were published. Future print and electronic copies of the documents will include the corrected pages.
This document defines due process requirements for development of CLSI consensus documents and related activities. An understanding of these Administrative Procedures enables participants to familiarize themselves with the procedures and principles of the Clinical and Laboratory Standards Institute (CLSI), maximize their level of participation, and appreciate the significance of their individual and collective contributions.
CLSI respects the privacy of all of our members and visitors to our website. To ensure your privacy is protected, we have implemented the following policy.