Accreditation Crosswalks

This table identifies CLSI international standards recognized by the US Food and Drug Administration (FDA). Implementation of these standards can help accelerate regulatory approval. More than 100 CLSI standards and guidelines have been recognized.

CLSI Documents and ISO Quality Standards

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.

Crosswalk of Documents Referenced Within CAP Accreditation Checklists

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.

Crosswalk of FDA Recognized Consensus Standards

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. This table identifies CLSI international standards recognized by the US Food and Drug Administration (FDA). Implementation of these standards can help accelerate regulatory approval. More than 100 CLSI standards and guidelines have been recognized.

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.”

Crosswalk of Documents Referenced Within The Joint Commission Accreditation Standards

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.

Quality System Essentials

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.