• Shopping Cart
    There are no items in your cart

CLSI QMS01 A4 : 4ED 2011

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by

QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES

Withdrawn date

23-07-2013

Superseded by

CLSI QMS01 : 5ED 2019

Published date

24-08-2018

Sorry this product is not available in your region.

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Terminology
4 The Quality Management System Model
5 The Quality System Essentials
6 The Path of Workflow Concept
7 Establishing the Quality Management System
8 Applying Quality Management Systems Beyond the
  Laboratory to a Health Care Organisation's Services
9 Conclusion
References
Appendix A - QSEs With ISO 1725, ISO 9001, and ISO 15189
Appendix B - Sample QSE Policy: Documents and Records
Appendix C - QSE Processes
Appendix D - Example Table of Contents for a Quality Manual
Appendix E - Example Quality Report Form
Appendix F - Excerpt From a Position Description Showing
             Duties in the Path of Workflow
Appendix G - Example Orientation Program
Appendix H - Laboratory Training Program Contents
Appendix I - Sample Outline for a Validation Plan
Appendix J - Sample Document Master Index Form
Appendix K - Sample Document Change Request Form
Appendix L - Example Record Retention Schedule Form
Appendix M - Sample Laboratory Information System
             Software Validation Worksheet
Appendix N - Example of a Formula Verification Worksheet
Appendix O - Sample Nonconforming Event Report Form
Appendix P - Example Audit Report Form
Appendix Q - Examples of Laboratory Quality Indicators
Appendix R - Published studies on Laboratory Performance
             Indicators Grouped by QSE and Path of Workflow
Appendix S - Indicators Development Form
Appendix T - Example of a Sample Retention Form
The Quality Management System Approach
Related CLSI Reference Materials

Gives a model for medical laboratories that will assist with implementation and maintenance of an effective quality management system.

DevelopmentNote
Supersedes NCCLS GP26 A3. (07/2011) Formerly CLSI GP26 A4. (07/2013)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Withdrawn
SupersededBy
Supersedes

CLSI M54 A : 2012 PRINCIPLES AND PROCEDURES FOR DETECTION OF FUNGI IN CLINICAL SPECIMENS - DIRECT EXAMINATION AND CULTURE
CLSI EP19 : 2ED 2015 A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES
CLSI MM7 A2 : 2ED 2013 FLUORESCENCE IN SITU HYBRIDIZATION METHODS FOR CLINICAL LABORATORIES
CLSI QMS16 : 2015 LABORATORY PERSONNEL MANAGEMENT
CLSI MM9 A2 : 2ED 2014 NUCLEIC ACID SEQUENCING METHODS IN DIAGNOSTIC LABORATORY MEDICINE
CLSI QMS25 : 1ED 2016 HANDBOOK FOR DEVELOPING A LABORATORY QUALITY MANUAL
CLSI QMS20 R : 1ED 2014 UNDERSTANDING THE COST OF QUALITY IN THE LABORATORY
CLSI M52:2010(R2020) Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
CLSI MM22 A : 1ED 2014 MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES
CLSI QMS15 A : 1ED 2013 ASSESSMENTS: LABORATORY INTERNAL AUDIT PROGRAM
CLSI QMS19 : 2017 CUSTOMER FOCUS IN A QUALITY MANAGEMENT SYSTEM
CLSI MM3 A3 : 3ED 2015 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
CLSI QMS17 : 2017 EXTERNAL ASSESSMENTS, AUDITS, AND INSPECTIONS OF THE LABORATORY
CLSI QMS11 : 2ED 2015 NONCONFORMING EVENT MANAGEMENT
CLSI GP36-A : 2014 PLANNING FOR LABORATORY OPERATIONS DURING A DISASTER
UNE-EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
CLSI QMS04 : 2016 LABORATORY DESIGN
CLSI QMS06 A3 : 3ED 2011 QUALITY MANAGEMENT SYSTEM: CONTINUAL IMPROVEMENT
CLSI QMS18 : 1ED 2015 PROCESS MANAGEMENT
CLSI M52 : 1ED 2015 Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems, 1st Edition
DIN EN ISO 15189:2014-11 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
CLSI M29 A4 : 4ED 2014 Protection of Laboratory Workers From Occupationally Acquired Infections<br>
CLSI C57 : 1ED 2015 MASS SPECTROMETRY FOR ANDROGEN AND ESTROGEN MEASUREMENTS IN SERUM
CLSI QMS24 : 3ED 2016 USING PROFICIENCY TESTING AND ALTERNATIVE ASSESSMENT TO IMPROVE MEDICAL LABORATORY QUALITY
CLSI POCT4 : 3ED 2016 ESSENTIAL TOOLS FOR IMPLEMENTATION AND MANAGEMENT OF A POINT-OF-CARE TESTING PROGRAM
CLSI MM21 : 1ED 2015 GENOMIC COPY NUMBER MICROARRAYS FOR CONSTITUTIONAL GENETIC AND ONCOLOGY APPLICATIONS
CLSI GP23 A2 : 2ED 2014 NONGYNECOLOGICAL CYTOLOGY SPECIMENS: PREEXAMINATION, EXAMINATION, AND POSTEXAMINATION PROCESSES
CLSI QMS02 A6 : 6ED 2013 QUALITY MANAGEMENT SYSTEM: DEVELOPMENT AND MANAGEMENT OF LABORATORY DOCUMENTS
CLSI GP47 : 1ED 2015 MANAGEMENT OF CRITICAL- AND SIGNIFICANT-RISK RESULTS
CLSI QMS05 A2 : 2ED 2012 QUALITY MANAGEMENT SYSTEM: QUALIFYING, SELECTING, AND EVALUATING A REFERRAL LABORATORY
CLSI QMS13 A : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
CLSI GP48 : 1ED 2017 ESSENTIAL ELEMENTS OF A PHLEBOTOMY TRAINING PROGRAM
CLSI GP41 : 7ED 2017 COLLECTION OF DIAGNOSTIC VENOUS BLOOD SPECIMENS
CLSI QMS21 : 1ED 2016 PURCHASING AND INVENTORY MANAGEMENT

CLSI I/LA20 A2 : 2ED 2009 ANALYTICAL PERFORMANCE CHARACTERISTICS AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E (IGE) ANTIBODIES AND DEFINED ALLERGEN SPECIFICITIES
CLSI GP27 A2 : 2ED 2007 USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY
CLSI EP14 A2 : 2ED 2005 EVALUATION OF MATRIX EFFECTS
CLSI C44 A : 1ED 2002 HARMONIZATION OF GLYCOHEMOGLOBIN MEASUREMENTS
CLSI C46 A2 : 2ED 2009 BLOOD GAS AND PH ANALYSIS AND RELATED MEASUREMENTS
CLSI C37 A : 1ED 99 PREPARATION AND VALIDATION OF COMMUTABLE FROZEN HUMAN SERUM POOLS AS SECONDARY REFERENCE MATERIALS FOR CHOLESTEROL MEASUREMENT PROCEDURES
CLSI QMS12 A : 1ED 2010 DEVELOPMENT AND USE OF QUALITY INDICATORS FOR PROCESS IMPROVEMENT AND MONITORING OF LABORATORY QUALITY
CLSI MM17 A : 1ED 2008 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
CLSI EP21 A : 1ED 2003 ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
CLSI QMS04 A2 : 2ED 2007 LABORATORY DESIGN
CLSI GP33 A : 1ED 2010 ACCURACY IN PATIENT AND SAMPLE IDENTIFICATION
CLSI EP12 A2 : 2ED 2008 USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
CLSI GP10 A : 1ED 95(R2001) ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS
CLSI GP17 A2 : 2ED 2004 CLINICAL LABORATORY SAFETY
CLSI EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
CLSI GP29 A2 : 2ED 2008 ASSESSMENT OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE
CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI GP31 A : 1ED 2009 LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE
CLSI QMS10 A : 1ED 2006 A MODEL FOR MANAGING MEDICAL DEVICE ALERTS (HAZARDS AND RECALLS) FOR HEALTHCARE ORGANIZATIONS
CLSI GP40 A4 : 4ED 2006 PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY
CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
CLSI GP5 A3 : 3ED 2011 CLINICAL LABORATORY WASTE MANAGEMENT
CLSI QMS11 A : 1ED 2007 MANAGEMENT OF NONCONFORMING LABORATORY EVENTS
CLSI C43 A2 : 2ED 2010 GAS CHROMATOGRAPHY/MASS SPECTROMETRY CONFIRMATION OF DRUGS
CLSI EP17 A : 1ED 2004 PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
CLSI MM13 A : 1ED 2006 COLLECTION, TRANSPORT, PREPARATION, AND STORAGE OF SPECIMENS FOR MOLECULAR METHODS
CLSI C42 A : 1ED 96(R2001) ERYTHROCYTE PROTOPORPHYRIN TESTING
CLSI GP46 R : 1ED 2003 PLANNING FOR CHALLENGES TO CLINICAL LABORATORY OPERATIONS DURING A DISASTER
CLSI EP25 A : 1ED 2009 EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
CLSI GP9 A : 1ED 98 SELECTING AND EVALUATING A REFERRAL LABORATORY
CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
CLSI X3 R : 1ED 2002 IMPLEMENTING A NEEDLESTICK AND SHARPS INJURY PREVENTION PROGRAM IN THE CLINICAL LABORATORY
CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
CLSI EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
CLSI EP10 A3 : 2006 + A1 2014 PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES
CLSI QMS06 A3 : 3ED 2011 QUALITY MANAGEMENT SYSTEM: CONTINUAL IMPROVEMENT
CLSI C50 A : 1ED 2007 MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE
CLSI QMS03 A3 : 3ED 2009 TRAINING AND COMPETENCE ASSESSMENT
CLSI GP2 A5 : 5ED 2006 LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL
CLSI H26 A2 : 2ED 2010 VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
CLSI EP30 A : 1ED 2010 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
CLSI EP18 A2 : 2ED 2009 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
CLSI C29 A2 : 2ED 2000 STANDARDIZATION OF SODIUM AND POTASSIUM ION-SELECTIVE ELECTRODE SYSTEMS TO THE FLAME PHOTOMETRIC REFERENCE METHOD

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.