CLSI EP32 R : 1ED 2006
Current
The latest, up-to-date edition.
METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
Hardcopy , PDF
English
17-02-2006
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Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
2.1 Quality in Laboratory Medicine
2.2 External Environment
3 Definitions
4 Traceability
4.1 Overview of the Process for Establishing Traceability
4.2 Process to Establish Traceability
4.3 Reporting Traceability in Product Literature
References
Appendix A - Traceability and Calculating Uncertainty of
Calibrator Levels for hCG
Appendix B - XYZ Glucose Analytical System Glucose Calibrator
Traceability Summary
Appendix C - System X Glucose Calibrator Traceability Example
Related CLSI/NCCLS Publications
Gives guidance on establishing traceability of the chemical calibration step in clinical laboratory measurements, based on the traceability requirements for in vitro diagnostic (IVD) medical devices as given in ISO 17511 and ISO 18153 and in accordance with the requirements for traceability as stated in the IVD Directive.
| DevelopmentNote |
Formerly CLSI X5 R. (07/2013)
|
| DocumentType |
Report
|
| ISBN |
1-56238-598-4
|
| Pages |
56
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Current
|
| BIS IS/ISO 15189 : 2012 | MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE |
| I.S. EN ISO 15189:2012 | MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15) |
| CLSI EP14 A3 : 2014 | EVALUATION OF COMMUTABILITY OF PROCESSED SAMPLES |
| PREN ISO 15189 : DRAFT 2011 | MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE |
| UNE-EN ISO 18113-1:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| UNE-EN ISO 15189:2013 | Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) |
| CLSI EP30 A : 1ED 2010 | CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE |
| PD ISO Guide 34:2009 | General requirements for the competence of reference material producers |
| ISO Guide 34:2009 | General requirements for the competence of reference material producers |
| EN ISO 18113-1:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| UNI EN ISO 15189 : 2013 | MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE |
| CLSI EP31 A : 1ED 2008 | VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM |
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| CLSI I/LA21 A2 : 2ED 2008 | CLINICAL EVALUATION OF IMMUNOASSAYS |
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| 11/30173018 DC : 0 | BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE |
| I.S. EN ISO 18113-1:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
| CLSI C53 P : 1ED 2008 | CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE |
| CLSI EP28 A3 : 3ED 2010 | DEFINING, ESTABLISHING, AND VERIFYING REFERENCE INTERVALS IN THE CLINICAL LABORATORY |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| BS EN ISO 15189:2012 | Medical laboratories. Requirements for quality and competence |
| CLSI C49 A : 1ED 2007 | ANALYSIS OF BODY FLUIDS IN CLINICAL CHEMISTRY |
| DIN EN ISO 18113-1:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| BS EN ISO 18113-1:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| CLSI C24 A2 : 2ED 99 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENTS: PRINCIPLES AND DEFINITIONS |
| CLSI EP14 A2 : 2ED 2005 | EVALUATION OF MATRIX EFFECTS |
| CLSI C37 A : 1ED 99 | PREPARATION AND VALIDATION OF COMMUTABLE FROZEN HUMAN SERUM POOLS AS SECONDARY REFERENCE MATERIALS FOR CHOLESTEROL MEASUREMENT PROCEDURES |
| CLSI EP12 A : 1ED 2002 | USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE |
| 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 EP10 A2 : 2ED 2002 | PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY METHODS |
| CLSI EP6 A : 1ED 2003 | EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH |
| CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
| CLSI EP9 A2 : 2ED 2002 | METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
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