Name: UNI EN ISO 15189 : 2013
Brand: UNI

MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE

Published date

05-14-2013

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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	Current
Supersedes	UNI EN ISO 15189 : 2007

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