Let CLSI help you navigate the pathway to laboratory accreditation with these easy-to-use crosswalks. Our crosswalks take the guesswork out of understanding accreditation requirements. We tell you exactly which CLSI standards will give you the step-by-step guidance you need to fulfill requirements set forth by the International Organization for Standardization (ISO), College of American Pathologists (CAP), US Food & Drug Administration (FDA), and The Joint Commission.
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.
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.
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.
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.”
The Joint Commission laboratory accreditation requirements are set forth in the Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing (CAMLAB). These standards focus on the results a laboratory should achieve, rather than specific methods to use. This crosswalk easily explains which CLSI documents give stepwise guidance to achieve those results.
CLSI subscribes to a quality management system (QMS) approach in the development of standards and guidelines that facilitates project management, defines a document structure using a template, and provides a process to identify needed documents. The QMS approach applies a core set of “quality system essentials” (QSEs), basic to any organization, to all operations in any health care service’s path of workflow (ie, operational aspects that define how a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or service, serving as a manager’s guide.