CLSI at the 21st Annual HuQAS Scientific Conference
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About CLSI
Globally Recognized Standards Documents
Developed by our members for use by the global laboratory community, CLSI’s consensus-based medical laboratory standards are the most widely recognized resources for continually improving testing quality, safety, and efficiency. Organizations use CLSI standards to improve their testing outcomes, maintain accreditation, bring products to market faster, and navigate regulatory hurdles.
Global Training and Partnerships
Through our Partnerships program, CLSI provides international outreach services and hands-on support to laboratories around the world, helping them achieve sustainable quality with systems to better diagnose and treat patients with infectious diseases.
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What We Offer
Free COVID-19 Resources
We have compiled a list of helpful documents for the lab community’s use during the COVID-19 pandemic. You can view these documents, learn how they help with COVID-19 testing, and access sample pages. Plus, some CLSI documents are free for a limited time.
A Committed Membership Base
Our members help support volunteer committee work and encourage their staff to participate on document development committees. Members are also asked to review, comment, and vote on CLSI documents before they are published—ensuring that the document development process is fair and unbiased, and that everyone has a seat at the table.
An Unmatched Volunteering Experience
Through a consensus-based process, CLSI’s standards are developed and written by volunteer committees of leading experts in the field of laboratory medicine. Our volunteer committees share information from their own laboratory work to create documents used by the medical laboratory community to improve processes, pass and maintain accreditation, meet regulatory requirements, and more.
Featured Products | View our recently published products.
CLSI QMS15
Laboratory Internal Audit Program, 2nd Edition
This guideline provides recommendations for establishing a laboratory internal audit program to enhance the quality of laboratory services through continual improvement. An audit program defines the “who,” “what,” “when,” “where,” and “how” of meeting requirements for internal auditing, and the audit process describes the details of conducting individual laboratory internal audits.
CLSI QMS15OL
Laboratory Internal Auditing Course
This self-paced online learning course is based on CLSI document QMS15, Laboratory Internal Audit Program, 2nd Edition.
CLSI QMS01
A Quality Management System Model for Laboratory Services, 5th Edition
This guideline provides a model for medical laboratories to organize the implementation and management of an effective quality management system.
CLSI Subscription Product
Gap Analysis Tool
Gap Analysis is an online subscription product that provides users with performing a quick and easy gap analysis and can track progress toward achieving complete compliance.
CLSI New Derivative Products
Implementation Guides
Help your laboratory scientists learn to use CLSI's Evaluation Protocols standards. Properly implementing our EP standards ensures quality test results, regulatory requirements readiness, and preparedness for accreditation.
CLSI LQMS Online Package
LQMS - Laboratory Quality Management System Certificate Program PKG
Earn P.A.C.E.® credits with this self-paced online learning program that will give you the knowledge and skills necessary for successful implementation and sustainment of a quality management system in your lab.