PREN ISO 15189 : DRAFT 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
01-11-2012
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
5 Technical requirements
Annex A (informative) - Correlation with ISO 9001:2008
and ISO/IEC 17025:2005
Annex B (informative) - Comparison of ISO 15189:2007
to ISO 15189: 20XX
Annex C (informative) - Ethics in laboratory medicine
Bibliography
Describes the requirements for quality and competence in medical laboratories. Applicable for use by medical laboratories in developing their quality management systems and assessing their own competence. Laboratory customers, regulating authorities, and accreditation bodies may also use it for confirming or recognizing the competence of medical laboratories.
| Committee |
TC 140
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| 11/30173018 DC : 0 | Identical |
| 01/561148 DC : DRAFT MAR 2001 | BS EN 14136 - USE OF EXTERNAL QUALITY ASSESSMENT SCHEMES IN THE ASSESSMENT OF THE PERFORMANCE OF IN VITRO DIAGNOSTIC PROCEDURES |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| CLSI GP27 A2 : 2ED 2007 | USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY |
| ISO 1087-1:2000 | Terminology work Vocabulary Part 1: Theory and application |
| CLSI GP29 A : 1ED 2002 | VALIDATION OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE |
| ISO 15194:2009 | In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation |
| EN 1614:2006 | Health informatics - Representation of dedicated kinds of property in laboratory medicine |
| CLSI I/LA33 P : 1ED 2009 | VALIDATION OF AUTOMATED DEVICES FOR IMMUNOHEMATOLOGIC TESTING PRIOR TO IMPLEMENTATION |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO/IEC Guide 43-1:1997 | Proficiency testing by interlaboratory comparisons Part 1: Development and operation of proficiency testing schemes |
| CLSI QMS04 A2 : 2ED 2007 | LABORATORY DESIGN |
| CLSI GP33 A : 1ED 2010 | ACCURACY IN PATIENT AND SAMPLE IDENTIFICATION |
| CLSI H57 A : 1ED 2008 | PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS |
| CLSI EP31 A : 1ED 2008 | VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM |
| CLSI GP17 A2 : 2ED 2004 | CLINICAL LABORATORY SAFETY |
| CLSI GP29 A2 : 2ED 2008 | ASSESSMENT OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE |
| ISO/IEC 17011:2004 | Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies |
| CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
| CLSI GP44 A4 : 4ED 2010 | PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS FOR COMMON LABORATORY TESTS |
| CLSI GP31 A : 1ED 2009 | LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE |
| CLSI AUTO10 A : 1ED 2006 | AUTOVERIFICATION OF CLINICAL LABORATORY TEST RESULTS |
| CLSI GP40 A4 : 4ED 2006 | PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY |
| ISO 15190:2003 | Medical laboratories Requirements for safety |
| CLSI GP41 A6 : 6ED 2007 | PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE |
| ISO/IEC 17043:2010 | Conformity assessment — General requirements for proficiency testing |
| ISO Guide 30:2015 | Reference materials — Selected terms and definitions |
| CLSI EP32 R : 1ED 2006 | METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION |
| CLSI QMS11 A : 1ED 2007 | MANAGEMENT OF NONCONFORMING LABORATORY EVENTS |
| ISO/TS 22367:2008 | Medical laboratories Reduction of error through risk management and continual improvement |
| ISO 9001:2015 | Quality management systems — Requirements |
| CLSI EP17 A : 1ED 2004 | PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| CLSI GP42 A6 : 6ED 2008 | PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS |
| 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 |
| ISO/IEC Guide 43-2:1997 | Proficiency testing by interlaboratory comparisons Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies |
| CLSI GP16-A3 : 2009 | Urinalysis; Approved Guideline—Third Edition |
| CLSI GP35 P : 1ED 2009 | DEVELOPMENT AND USE OF QUALITY INDICATORS FOR PROCESS IMPROVEMENT AND MONITORING OF LABORATORY QUALITY |
| CLSI AUTO8 A : 1ED 2006 | MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS |
| EN 12435:2006 | Health informatics - Expression of results of measurements in health sciences |
| 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 |
| ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
| ISO 3534-1:2006 | Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |
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