BS EN ISO 15189:2012
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Medical laboratories. Requirements for quality and competence
Hardcopy , PDF
01-06-2023
English
30-11-2012
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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 |
CH/212
|
| DevelopmentNote |
Supersedes 99/562552 DC (03/2003) Supersedes 11/30173018 DC. (11/2012)
|
| DocumentType |
Standard
|
| Pages |
64
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
This International Standard specifies requirements for quality and competence in medical laboratories.
This International Standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
| Standards | Relationship |
| ONORM EN ISO 15189 : 2014 | Identical |
| EN ISO 15189:2012 | Identical |
| UNI EN ISO 15189 : 2013 | 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 |
| BS 70000:2017 | Medical physics, clinical engineering and associated scientific services in healthcare. Requirements for quality, safety and competence |
| 15/30323396 DC : 0 | BS 70000 - MEDICAL PHYSICS, CLINICAL ENGINEERING AND PHYSIOLOGICAL SCIENCE SERVICES IN HEALTHCARE - REQUIREMENTS FOR QUALITY, SAFETY AND COMPETENCE |
| 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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