UNI EN ISO 15189 : 2013
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
Superseded date
09-07-2024
Superseded by
Published date
14-05-2013
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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 15189:2012
Bibliography
Describes requirements for quality and competence in medical laboratories.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 15189 : 2014 | Identical |
| EN ISO 15189:2012 | Identical |
| BS EN ISO 15189:2012 | Identical |
| NF EN ISO 15189 : 2012 | Identical |
| DIN EN ISO 15189:2014-11 | Identical |
| I.S. EN ISO 15189:2012 | Identical |
| NEN EN ISO 15189 : 2015 | Identical |
| NS EN ISO 15189 : 2012 | Identical |
| ISO 15189:2012 | Identical |
| NBN EN ISO 15189 : 2013 | Identical |
| UNE-EN ISO 15189:2013 | Identical |
| SN EN ISO 15189 : 2013 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO/IEC 17000:2004 | Conformity assessment Vocabulary and general principles |
| 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 19011:2011 | Guidelines for auditing management systems |
| 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 |
| ISO/IEC 27001:2013 | Information technology — Security techniques — Information security management systems — Requirements |
| ISO 22870:2016 | Point-of-care testing (POCT) — Requirements for quality and competence |
| CLSI QMS13 A : 1ED 2011 | QUALITY MANAGEMENT SYSTEM: EQUIPMENT |
| 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 |
| 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 |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| 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 |
| CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
| 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 |
| ISO/IEC Guide 2:2004 | Standardization and related activities — General 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 |
| 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 GP2 A5 : 5ED 2006 | LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL |
| CLSI H26 A2 : 2ED 2010 | VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS |
| ISO 27799:2016 | Health informatics Information security management in health using ISO/IEC 27002 |
| ISO 3534-1:2006 | Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |
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