CLSI QMS06 PDF

CLSI QMS06 includes written and graphic descriptions of the fundamental processes and common supporting elements in a continual improvement (CI) program. It provides the user with definitions, concepts, methods, and tools for implementing an effective program and meeting applicable requirements. The CI fundamental processes include:
• Identifying opportunities for improvement (OFIs)
• Selecting an opportunity
• Generating solution(s)
• Implementing solution(s)
• Evaluating the effect of the solution(s)
• Integrating and sustaining improvement(s)

The CI common supporting elements include but are not limited to:
• Management review
• Teamwork
• Improvement models and tools
• Documents and records
• Change management
• Risk management
• Communication

Although quality professionals might differ on various CI definitions, concepts, models, and tools, CLSI QMS06 attempts to consolidate the vast amount of information available while remaining nonprescriptive. CLSI QMS06 encourages using an organized systematic approach to CI, so that optimal outcomes are achieved for the efforts expended.

CLSI QMS06 is intended for use by all organizations and individuals involved in the management or implementation of preexamination, examination, and postexamination phases of medical laboratory examinations. CLSI QMS06 may also be applicable to other laboratories and nonlaboratory settings.

CLSI QMS06 is not meant to be prescriptive, nor a comprehensive instructional manual for using the tools described. It does not cover content and detail covered in other CLSI documents or requirements specific to any regulatory or accreditation organization.

CLSI MM14Ed3E PDF

This document provides guidelines for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports.

CLSI EP21 PDF

CLSIEP21provides developers and endusers with an understanding of concepts related to total analytical error (TAE) for quantitative measurement procedures. An experimental protocol and analytical method are provided to estimate TAE based on a comparison of results between the candidate method and a comparator method using patient specimens. Each paired difference is compared with a pre-established specification for acceptability, ie, the allowable total error (ATE). Guidance for determining the ATE is provided in CLSIEP46.

CLSI EP46 PDF

CLSI EP46 provides developers and end users with an understanding of concepts related to setting allowable total error (ATE) goals and limits for quantitative measurement procedures. CLSI EP46 provides an overview of concepts related to total error, considerations for applying total error concepts (such as setting acceptance criteria for analytical performance characteristics), and models to inform the determination of ATE goals and limits.

CLSI POCT16 PDF

Emergency and Disaster Point-of-Care Testing, 1st Edition, Approved Guideline, POCT16Ed1

CLSI EP32 PDF

CLSI EP32 provides guidance on establishing, validating, and documenting metrological traceability for end-user calibrators and results for human samples measured using in vitro diagnostic medical devices (IVD MDs) in medical laboratories based on the metrological traceability requirements for IVD MDs in ISO 17511.

CLSI NBS13 PDF

CLSI NBS13 describes a newborn screening system for detecting spinal muscular atrophy (SMA). It discusses bothSMN1exon 7 deletion testing andSMN2copy number analysis performed on newborn dried blood spot specimens, as well as screening strategies for identifying newborns at increased risk for SMA.

CLSI EP35 PDF

CLSI EP35 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 CLSI EP35 apply to both quantitative measurement procedures and qualitative examinations.

CLSI GP40-Ed5 PDF

CLSI GP40 provides guidelines on water purified for medical laboratory use, methods for monitoring water quality and testing for specific contaminants, and water system design considerations.

CLSI PRE02 PDF

CLSI PRE02 provides procedures for the collection of diagnostic venous blood specimens, including line draws, blood culture collection, and venipuncture in children.