Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.
ISO 15189:2012 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.

Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO 15189:2012, korrigierte Fassung 2014-08-15)

Diese Internationale Norm legt Anforderungen an die Qualität und Kompetenz in medizinischen Laboratorien fest.
Diese Internationale Norm kann für die Anwendung durch medizinische Laboratorien bei der Entwicklung von deren Qualitätsmanagementsystemen und der Beurteilung ihrer eigenen Kompetenz bestimmt. Auch Kunden des Laboratoriums, Aufsichtsbehörden und Akkreditierungsstellen dürfen die Norm für die Bestätigung oder Anerkennung der Kompetenz medizinischer Laboratorien benutzen.
ANMERKUNG: Internationale, nationale oder regionale Bestimmungen oder Anforderungen können auch für spezifische, in dieser Internationalen Norm enthaltene Themengebiete gelten.

Laboratoires de biologie médicale - Exigences concernant la qualité et la compétence (ISO 15189:2012, Version corrigée 2014-08-15)

L'ISO 15189:2012 spécifie les exigences de qualité et de compétence applicables aux laboratoires de biologie médicale.
L'ISO 15189:2012 peut être utilisée par les laboratoires de biologie médicale qui élaborent leurs systèmes de management de la qualité et évaluent leur propre compétence. Les clients des laboratoires, les autorités règlementaires ainsi que les organismes d'accréditation engagés dans des activités de confirmation ou de reconnaissance de la compétence des laboratoires de biologie médicale peuvent également l'utiliser.

Medicinski laboratoriji - Zahteve za kakovost in kompetentnost (ISO 15189:2012)

Ta mednarodni standard opredeljuje zahteve za kakovost in usposobljenost medicinskih laboratorijev. Ta mednarodni standard lahko uporabljajo laboratoriji pri razvoju sistemov upravljanja kakovosti in vrednotenju lastne kompetentnosti. Uporablja se lahko tudi za potrjevanje ali prepoznavanje kompetentnosti medicinskih laboratorijev s strani laboratorijskih strank, upravnih organov in akreditacijskih organov.

General Information

Status
Withdrawn
Publication Date
31-Oct-2012
Withdrawal Date
13-Dec-2022
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
14-Dec-2022

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SLOVENSKI STANDARD
SIST EN ISO 15189:2013
01-marec-2013
1DGRPHãþD
SIST EN ISO 15189:2007
Medicinski laboratoriji - Zahteve za kakovost in kompetentnost (ISO 15189:2012)
Medical laboratories - Requirements for quality and competence (ISO 15189:2012)
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO
15189:2012)
Laboratoires d'analyses de biologie médicale - Exigences concernant la qualité et la
compétence (ISO 15189:2012)
Ta slovenski standard je istoveten z: EN ISO 15189:2012
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
SIST EN ISO 15189:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15189:2013

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SIST EN ISO 15189:2013


EUROPEAN STANDARD
EN ISO 15189

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2012
ICS 03.120.10; 11.100.01 Supersedes EN ISO 15189:2007
English Version
Medical laboratories - Requirements for quality and competence
(ISO 15189:2012)
Laboratoires de biologie médicale - Exigences concernant Medizinische Laboratorien - Anforderungen an die Qualität
la qualité et la compétence (ISO 15189:2012) und Kompetenz (ISO 15189:2012)
This European Standard was approved by CEN on 31 October 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15189:2012: E
worldwide for CEN national Members.

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SIST EN ISO 15189:2013
EN ISO 15189:2012 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 15189:2013
EN ISO 15189:2012 (E)
Foreword
This document (EN ISO 15189:2012) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee CEN/TC 140
“In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the
latest by November 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15189:2007.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15189:2012 has been approved by CEN as a EN ISO 15189:2012 without any modification.


3

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SIST EN ISO 15189:2013

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SIST EN ISO 15189:2013
INTERNATIONAL ISO
STANDARD 15189
Third edition
2012-11-01
Medical laboratories — Requir
...

SLOVENSKI SIST EN ISO 15189

STANDARD
marec 2013












Medicinski laboratoriji – Zahteve za kakovost in kompetentnost

(ISO 15189:2012)


Medical laboratories – Requirements for quality and competence

(ISO 15189:2012)


Laboratoires d'analyses de biologie médicale – Exigences concernant la qualité

et la compétence (ISO 15189:2012)


Medizinische Laboratorien – Anforderungen an die Qualität und Kompetenz

(ISO 15189:2012)





















Referenčna oznaka

ICS 03.120.10 ; 11.100.01 SIST EN ISO 15189:2013 (sl, en)


Nadaljevanje na straneh II in III ter od 1 do 91



© 2014-11. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15189 : 2013
NACIONALNI UVOD
Standard SIST EN ISO 15189 (sl, en), Medicinski laboratoriji – Zahteve za kakovost in kompetentnost
(ISO 15189:2012), 2013, ima status slovenskega standarda in je istoveten evropskemu standardu
EN ISO 15189 (en, de, fr), Medical laboratories – Requirements for quality and competence
(ISO 15189:2012), 2012.
Ta dokument nadomešča SIST EN ISO 15189:2007.
NACIONALNI PREDGOVOR
Evropski standard EN ISO 15189:2012 je pripravil tehnični odbor ISO/TC 212 Preskušanje kliničnih
laboratorijev ter diagnostični sistemi in vitro v sodelovanju s tehničnim odborom Evropskega komiteja
za standardizacijo CEN/TC 140 Diagnostični medicinski sistemi in vitro. Slovenski standard SIST EN
ISO 15189:2013 je prevod evropskega standarda EN ISO 15189:2012. V primeru spora glede
besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard.
Slovenski prevod standarda SIST EN ISO 15189:2013 je pripravila delovna skupina strokovnjakov iz
naslednjih nacionalnih tehničnih odborov SIST/TC VAZ Varovanje zdravje, SIST/TC VZK Vodenje in
zagotavljenje kakovosti in SIST/TC UGA Ugotavljanje skladnosti.
Odločitev za izdajo tega standarda je dne 7. februarja 2013 sprejel SIST/TC VAZ Varovanje zdravja.
ZVEZA S STANDARDI
S privzemom tega evropskega standarda veljajo za omenjeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo:
SIST EN ISO/IEC 17000 Ugotavljanje skladnosti – Slovar in splošna načela (enakovreden z
ISO/IEC 17000:2004)
SIST EN ISO/IEC 17025:2005 Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih
laboratorijev (ISO/IEC 17025:2005)
SIST-V ISO/IEC Vodilo 99 Mednarodni slovar za meroslovje – Osnovni in splošni koncepti ter z
njimi povezani izrazi (VIM)
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 15189:2012
PREDHODNA IZDAJA
SIST EN ISO 15189:2007, Medicinski laboratoriji – Posebne zahteve za kakovost in usposobljenost
(ISO 15189:2007)
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v
SIST EN ISO 15189:2013 to pomeni “slovenski standard”.
– Uvod in nacionalni predgovor nista sestavni del standarda.
II

---------------------- Page: 2 ----------------------

SIST EN ISO 15189 : 2013
– Ta nacionalni dokument je istoveten EN ISO 15189:2012 in je objavljen z dovoljenjem
CEN Management Centre
Avenue Marnix 17
B-1000 Bruxelles
Belgija

This national document is identical with EN ISO 15189:2012 and is published with the permission of
CEN Management Centre
Avenue Marnix 17
B-1000 Bruxelles
Belgium

III

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SIST EN ISO 15189 : 2013




















(Prazna stran)

IV

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EVROPSKI STANDARD EN ISO 15189
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM november 2012


ICS 03.120.10; 11.100.01 Nadomešča EN ISO 15189:2007




Slovenska izdaja

Medicinski laboratoriji – Zahteve za kakovost in kompetentnost
(ISO 15189:2012)

Medical laboratories – Laboratoires d'analyses de biologie Medizinische Laboratorien –
Requirements for quality and médicale – Exigences concernant Anforderungen an die Qualität und
competence (ISO 15189:2012) la qualité et la compétence (ISO Kompetenz
15189:2012) (ISO 15189:2012)




Ta evropski standard je CEN sprejel 31. oktobra 2012.

Člani CEN morajo izpolnjevati notranje predpise CEN/CENELEC, s katerim je predpisano, da mora biti
ta standard brez kakršnih koli sprememb sprejet kot nacionalni standard. Najnovejši seznami teh
nacionalnih standardov z njihovimi bibliografskimi podatki se na zahtevo lahko dobijo pri Upravnem
centru CEN-CENELEC ali pri katerem koli članu CEN.

Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru
CEN-CENELEC, veljajo kot uradne izdaje.

Člani CEN so nacionalni organi za standarde Avstrije,
...

SLOVENSKI STANDARD
oSIST prEN ISO 15189:2011
01-marec-2011
Medicinski laboratoriji - Posebne zahteve za kakovost in usposobljenost (ISO/DIS
15189:2011)
Medical laboratories - Requirements for quality and competence (ISO/DIS 15189:2011)
Medizinische Laboratorien - Besondere Anforderungen an die Qualität und Kompetenz
(ISO/DIS 15189:2011)
Laboratoires d'analyses de biologie médicale - Exigences concernant la qualité et la
compétence (ISO/DIS 15189:2011)
Ta slovenski standard je istoveten z: prEN ISO 15189
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
oSIST prEN ISO 15189:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 15189:2011

---------------------- Page: 2 ----------------------
oSIST prEN ISO 15189:2011


EUROPEAN STANDARD
DRAFT
prEN ISO 15189
NORME EUROPÉENNE

EUROPÄISCHE NORM

January 2011
ICS 03.120.10; 11.100.01 Will supersede EN ISO 15189:2007
English Version
Medical laboratories - Requirements for quality and competence
(ISO/DIS 15189:2011)
Laboratoires d'analyses de biologie médicale - Exigences Medizinische Laboratorien - Besondere Anforderungen an
concernant la qualité et la compétence (ISO/DIS die Qualität und Kompetenz (ISO/DIS 15189:2011)
15189:2011)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 140.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 15189:2011: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN ISO 15189:2011
prEN ISO 15189:2011 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------
oSIST prEN ISO 15189:2011
prEN ISO 15189:2011 (E)
Foreword
This document (prEN ISO 15189:2011) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee CEN/TC 140
“In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 15189:2007.
Endorsement notice
The text of ISO/DIS 15189:2011 has been approved by CEN as a prEN ISO 15189:2011 without any
modification.

3

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oSIST prEN ISO 15189:2011

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oSIST prEN ISO 15189:2011

DRAFT INTERNATIONAL STANDARD ISO/DIS 15189
ISO/TC 212 Secretariat: ANSI
Voting begins on Voting terminates on

2011-01-06 2011-06-06
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION


Medical laboratories — Particular requirements for quality and
competence
Laboratoires d'analyses de biologie médicale — Exigences particulières concernant la qualité et la
compétence
[Revision of second edition (ISO 15189:2007)]
ICS 03.120.10; 11.100.01


ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organiza
...

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