EN ISO 15189:2007
(Main)Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007)
Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007)
ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories.
ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.
Medizinische Laboratorien - Besondere Anforderungen an die Qualität und Kompetenz (ISO 15189:2007)
1.1 Diese Internationale Norm legt Anforderungen an die Qualität und Kompetenz im besonderen Fall medizinischer Laboratorien fest.
1.2 Diese Internationale Norm ist für die Anwendung durch medizinische Laboratorien bei der Entwicklung von deren Qualitätsmanagementsystem und der Beurteilung ihrer eigenen Kompetenz sowie für die Anwen¬dung durch Akkreditierungsstellen bei der Bestätigung oder Anerkennung der Kompetenz von medizinischen Laboratorien bestimmt.
Laboratoires d'analyses de biologie médicale - Exigences particulières concernant la qualité et la compétence (ISO 15189:2007)
L'ISO 15189:2007 spécifie les exigences de qualité et de compétence propres aux laboratoires d'analyses de biologie médicale.
L'ISO 15189:2007 est destinée à être utilisée par les laboratoires d'analyses de biologie médicale qui élaborent leurs systèmes de management de la qualité et évaluent leur propre compétence ainsi que par les organismes d'accréditation engagés dans des activités de confirmation ou de reconnaissance de la compétence des laboratoires d'analyses de biologie médicale.
Medicinski laboratoriji – Posebne zahteve za kakovost in usposobljenost (ISO 15189:2007)
1.1 Ta mednarodni standard opredeljuje zahteve za kakovost in usposobljenost posameznih medicinskih laboratorijev.
1.2 Medicinski laboratoriji naj ta mednarodni standard uporabljajo pri razvijanju sistemov vodenja kakovosti in ocenjevanju lastne usposobljenosti, akreditacijski organi
za potrjevanje ali priznavanje usposobljenosti medicinskih laboratorijev.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15189:2007
01-september-2007
1DGRPHãþD
SIST EN ISO 15189:2003
SIST EN ISO 15189:2003/oprA1:2005
Medicinski laboratoriji – Posebne zahteve za kakovost in usposobljenost (ISO
15189:2007)
Medical laboratories - Particular requirements for quality and competence (ISO
15189:2007)
Medizinische Laboratorien - Besondere Anforderungen an die Qualität und Kompetenz
(ISO 15189:2007)
Laboratoires d'analyses de biologie médicale - Exigences particulieres concernant la
qualité et la compétence (ISO 15189:2007)
Ta slovenski standard je istoveten z: EN ISO 15189:2007
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 15189:2007 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 15189
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2007
ICS 11.100.01; 03.120.10 Supersedes EN ISO 15189:2003
English Version
Medical laboratories - Particular requirements for quality and
competence (ISO 15189:2007)
Laboratoires d'analyses de biologie médicale - Exigences Medizinische Laboratorien - Besondere Anforderungen an
particulières concernant la qualité et la compétence (ISO die Qualität und Kompetenz (ISO 15189:2007)
15189:2007)
This European Standard was approved by CEN on 9 April 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15189:2007: E
worldwide for CEN national Members.
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EN ISO 15189:2007 (E)
Foreword
This document (EN ISO 15189:2007) 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 October 2007, and conflicting national
standards shall be withdrawn at the latest by October 2007.
This document supersedes EN ISO 15189:2003.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Bulgaria, 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.
Endorsement notice
The text of ISO 15189:2007 has been approved by CEN as EN ISO 15189:2007 without any
modifications.
2
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INTERNATIONAL ISO
STANDARD 15189
Second edition
2007-04-15
Medical laboratories — Particular
requirements for quality and competence
Laboratoires d'analyses de biologie médicale — Exigences particulières
concernant la qualité et la compétence
Reference number
ISO 15189:2007(E)
©
ISO 2007
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ISO 15189:2007(E)
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SLOVENSKI SIST EN ISO 15189
STANDARD
september 2007
Medicinski laboratoriji – Posebne zahteve za kakovost in usposobljenost
(ISO 15189:2007)
Medical laboratories – Particular requirements for quality and competence
(ISO 15189:2007)
Laboratoires d'analyses de biologie médicale – Exigences particulières
concernant la qualité et la compétence (ISO 15189:2007)
Medizinische Laboratorien – Besondere Anforderungen an die Qualität und
Kompetenz (ISO 15189:2007)
Referenčna oznaka
ICS 11.100.01; 03.120.10 SIST EN ISO 15189:2007 (sl,en)
Nadaljevanje na straneh II in III ter od 1 do 69
© 2011-04. Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 15189 : 2007
NACIONALNI UVOD
Standard SIST EN ISO 15189 (sl, en), Medicinski laboratoriji – Posebne zahteve za kakovost in
usposobljenost (ISO 15189:2007), 2007, ima status slovenskega standarda in je istoveten
evropskemu standardu EN ISO 15189 (en, de, fr), Medical laboratories – Particular requirements for
quality and competence (ISO 15189:2007), 2007.
NACIONALNI PREDGOVOR
Evropski standard EN ISO 15189:2007 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 15189:2007 je prevod evropskega standarda EN ISO 15189:2007. V primeru spora glede
besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard.
Slovenski prevod SIST EN ISO 15189:2007 je pripravila delovna skupina, ki so jo sestavljali
predstavniki SIST/TC VAZ Varovanje zdravja, SIST/TC VZK Vodenje in zagotavljanje kakovosti ter
SIST/TC UGA Ugotavljanje skladnosti.
Odločitev za izdajo tega standarda je dne 28. avgusta 2007 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 ISO 31 (vsi deli) Veličine in enote
SIST EN ISO 9000:2005 Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2005)
SIST EN ISO 9001:2000 Sistemi vodenja kakovosti – Zahteve (ISO 9001:2000)
SIST EN ISO/IEC 17025:2005 Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih
laboratorijev (ISO/IEC 17025:2005)
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 15189:2007
PREDHODNA IZDAJA
SIST EN ISO 15189:2003 Medicinski laboratoriji – Posebne zahteve za kakovost in
usposobljenost (ISO 15189:2003)
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard” oziroma “mednarodni
standard”, v SIST EN ISO 15189:2007 to pomeni “slovenski standard”.
– Uvod in nacionalni predgovor nista sestavni del standarda.
II
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SIST EN ISO 15189 : 2007
– Ta nacionalni dokument je istoveten EN ISO 15189:2007 in je objavljen z dovoljenjem
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgija
This national document is identical with EN 13108-20:2006 and is published with the permission of
CEN
Rue de Stassart, 36
1050 Bruxelles
Belgium
III
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SIST EN ISO 15189 : 2007
IV
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EVROPSKI STANDARD EN ISO 15189
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM april 2007
ICS 11.100.01; 03.120.10 Nadomešča EN ISO 15189:2003
Slovenska izdaja
Medicinski laboratoriji – Posebne zahteve za kakovost in usposobljenost
(ISO 15189:2007)
Medical laboratories – Particular Laboratoires d'analyses de biologie Medizinische Laboratorien –
requirements for quality and médicale – Exigences particulières Besondere Anforderungen an die
competence (ISO 15189:2007) concernant la qualité et la Qualität und Kompetenz
compétence (ISO 15189:2007) (ISO 15189:2007)
Ta evropski standard je CEN sprejel 9. aprila 2007.
Člani CEN morajo izpolnjevati notranje predpise CEN/CENELEC, s katerim je predpisano, da mora biti
ta standard brez kakršnihkoli sprememb sprejet kot nacionalni standard. Najnovejši seznami teh
nacionalnih standardov z njihovimi bibliografskimi podatki se na zahtevo lahko dobijo pri Upravnem
centru ali 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, veljajo kot uradne izdaje.
Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Fra
...
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