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11/30173018 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
Available format(s)

Hardcopy , PDF

Superseded date

30-11-2012

Language(s)

English

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

BS EN ISO 15189

Committee
CH/212
DocumentType
Draft
Pages
70
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
PREN ISO 15189 : DRAFT 2011 Identical

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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