SIST EN ISO 15189:2013
(Main)Medical laboratories - Requirements for quality and competence (ISO 15189:2012)
Medical laboratories - Requirements for quality and competence (ISO 15189:2012)
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)
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 d'analyses de biologie médicale - Exigences concernant la qualité et la compétence (ISO 15189:2012)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
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.
INTERNATIONAL ISO
STANDARD 15189
Third edition
2012-11-01
Medical laboratories — Requirements for
quality and competence
Laboratoires de biologie médicale — Exigences concernant la qualité et
la compétence
Reference number
ISO 15189:2012(E)
©
ISO 2012
ISO 15189:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
ISO 15189:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Management requirements . 5
4.1 Organization and management responsibility . 5
4.2 Quality management system . 8
4.3 Document control . 9
4.4 Service agreements .10
4.5 Examination by referral laboratories . 11
4.6 External services and supplies .12
4.7 Advisory services .12
4.8 Resolution of complaints .12
4.9 Identification and control of nonconformities .12
4.10 Corrective action .13
4.11 Preventive action .13
4.12 Continual improvement .14
4.13 Control of records .14
4.14 Evaluation and audits .15
4.15 Management review .17
5 Technical requirements .18
5.1 Personnel .18
5.2 Accommodation and environmental conditions .20
5.3 Laboratory equipment, reagents, and consumables .22
5.4 Pre-examination processes .25
5.5 Examination processes .28
5.6 Ensuring quality of examination results .31
5.7 Post-examination processes .33
5.8 Reporting of results .33
5.9 Release of results .35
5.10 Laboratory information management .36
Annex A (informative) Correlation with ISO 9001:2008 and ISO/IEC 17025:2005 .38
Annex B (informative) Comparison of ISO 15189:2007 to ISO 15189:2012 .43
Bibliography .47
ISO 15189:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15189 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic
test systems.
This third edition cancels and replaces the second edition (ISO 15189:2007), which has been technically revised.
A correlation between the second and third editions of this International Standard is provided as Annex B. The
third edition continues the alignment established in ISO/IEC 17025:2005.
iv © ISO 2012 – All rights reserved
ISO 15189:2012(E)
Introduction
This International Standard, based upon ISO/IEC 17025 and ISO 9001, specifies requirements for competence
1)
and quality that are particular to medical laboratories . It is acknowledged that a country could have its own
specific regulations or requirements applicable to some or all its professional personnel and their activities and
responsibilities in this domain.
Medical laboratory services are essential to patient care and therefore have to be available to meet the needs
of all patients and the clinical personnel responsible for the care of those patients. Such services include
arrangements for examination requests, patient preparation, patient identification, collection of samples,
transportation, storage, processing and examination of clinical samples, together with subsequent interpretation,
reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work.
Whenever allowed by national, regional or local regulations and requirements, it is desirable that medical
laboratory services include the examination of patients in consultation cases, and that those services actively
participate in the prevention of disease in addition to diagnosis and patient management. Each laboratory
should also provide suitable educational and scientific opportunities for professional staff working with it.
While this International Standard is intended for use throughout the currently recognized disciplines of medical
laboratory services, those work
...
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.
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
– Uvod in nacionalni predgovor nista sestavni del standarda.
II
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
SIST EN ISO 15189 : 2013
(Prazna stran)
IV
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, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Nekdanje jugoslovanske republike Makedonije, Nemčije, Nizozemske, Norveške,
Poljske, Portugalske, Romunije, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in Združenega
kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung
Upravni center: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN. Lastnice avtorskih pravic so vse države članice CEN Ref. oznaka: EN ISO 15189:2012: E
SIST EN ISO 15189 : 2013
VSEBINA StranCONTENTS Page
Predgovor k evropskemu standardu . 3 Foreword to the European standard .3
Predgovor k mednarodnemu standardu. 4 Foreword to the International standard.4
Uvod.5 Introduction.5
1 Področje uporabe . 7 1 Scope .7
2 Zveza s standardi . 7 2 Normative references.7
3 Izrazi in definicije . 7 3 Terms and definitions.7
4 Zahteve za vodenje . 13 4 Management requirements .13
4.1 Organizacija in odgovornost vodstva . 13 4.1 Organization and management
responsibility.13
4.2 Sistem vodenja kakovosti. 18 4.2 Quality management system .18
4.3 Obvladovanje dokumentov. 20 4.3 Document control.20
4.4 Storitvene pogodbe .21 4.4 Service agreements .21
4.5 Preiskava, ki jo opravijo prejemni 4.5 Examination by referral laboratories .23
laboratoriji . 23
4.6 Zunanje storitve in nabava 4.6 External services and supplies .24
materialnih sredstev. 24
4.7 Svetovanje. 24 4.7 Advisory services .24
4.8 Reševanje pritožb. 25 4.8 Resolution of complaints.25
4.9 Identifikacija in obvladovanje 4.9 Identification and control of
neskladnosti.25 nonconformities .25
4.10 Korektivni ukrepi. 26 4.10 Corrective action .26
4.11 Preventivni ukrepi.26 4.11 Preventive action.26
4.12 Nenehno izboljševanje . 27 4.12 Continual improvement .27
4.13 Obvladovanje zapisov . 27 4.13 Control of records.27
4.14 Vrednotenje in presoje . 29 4.14 Evaluation and audits.29
4.15 Vodstveni pregled. 32 4.15 Management review.32
5 Tehnične zahteve . 34 5 Technical requirements.34
5.1 Osebje . 34 5.1 Personnel .34
5.2 Prostori in okoljske razmere. 37 5.2 Accommodation and environmental
conditions .37
5.3 Laboratorijska oprema, reagenti 5.3 Laboratory equipment, reagents, and
in potrošni material . 39 consumables.39
5.4 Predpreiskovalni procesi . 45 5.4 Pre-examination processes .45
5.5 Preiskovalni procesi . 50 5.5 Examination processes.50
5.6 Zagotavljanje kakovosti rezultatov 5.6 Ensuring quality of examination results .55
preiskav. 55
5.7 Popreiskovalni procesi . 58 5.7 Post-examination processes.58
5.8 Poročanje o rezultatih.59 5.8 Reporting of results.59
5.9 Izdajanje rezultatov.61 5.9 Release of results .61
5.10 Vodenje informacij laboratorija. 63 5.10 Laboratory information management.63
Dodatek A (informativni): Primerjava z Annex A (informative): Correlation with
ISO 9001:2008 in ISO/IEC 17025:2005 . 66 ISO 9001:2008 and ISO/IEC 17025:2005.67
Dodatek B (informativni): Primerjava Annex B (informative): Comparison of
ISO 15189:2007 z ISO 15189:2012 . 76 ISO 15189:2007 to ISO 15189:2012.77
Literatura.86 Bibliography.86
SIST EN ISO 15189 : 2013
Predgovor k evropskemu standardu Foreword to the European standard
Ta dokument (EN ISO 15189:2012) je pripravil This document (EN ISO 15189:2012) has been
tehnični odbor ISO/TC 212 "Preskušanje prepared by Technical Committee ISO/TC 212
kliničnih laboratorijev ter diagnostični sistemi in "Clinical laboratory testing and in vitro
vitro" v sodelovanju s tehničnim odborom diagnostic test systems" in collaboration with
CEN/TC 140 "Diagnostični medicinski Technical Committee CEN/TC 140 “In vitro
pripomočki in vitro", katerega sekretariat vodi diagnostic medical devices” the secretariat of
DIN. which is held by DIN.
Ta evropski standard mora dobiti status This European Standard shall be given the
nacionalnega standarda bodisi z objavo status of a national standard, either by
istovetnega besedila ali z razglasitvijo najpozneje publication of an identical text or by
maja 2013, nasprotujoče nacionalne standarde pa endorsement, at the latest by May 2013, and
je treba razveljaviti najpozneje novembra 2015. conflicting national standards shall be
withdrawn at the latest by November 2015.
Ta dokument nadomešča EN ISO 15189:2007. This document supersedes EN ISO 15189: 2007.
V skladu z notranjimi predpisi CEN/CENELEC According to the CEN/CENELEC Internal Regu-
morajo ta evropski standard obvezno uvesti lations, the national standards organisations of the
nacionalne organizacije za standardizacijo following countries are bound to implement this
naslednjih držav: Avstrije, Belgije, Bolgarije, European Standard: Austria, Belgium, Bulgaria,
Cipra, Češke republike, Danske, Estonije, Croatia, Cyprus, Czech Republic, Denmark,
Finske, Francije, Grčije, Hrvaške, Irske, Estonia, Finland, Former Yugoslav Republic of
Islandije, Italije, Latvije, Litve, Luksemburga, Macedonia, France, Germany, Greece, Hungary,
Madžarske, Malte, Nekdanje jugoslovanske Iceland, Ireland, Italy, Latvia, Lithuania,
republike Makedonije, Nemčije, Nizozemske, Luxembourg, Malta, Netherlands, Norway,
Norveške, Poljske, Portugalske, Romunije, Poland, Portugal, Romania, Slovakia, Slovenia,
Slovaške, Slovenije, Španije, Švedske, Švice, Spain, Sweden, Switzerland, Turkey and the
Turčije in Združenega kraljestva. United Kingdom.
Razglasitvena objava Endorsement notice
Besedilo standarda ISO 15189:2012 je CEN The text of ISO 15189:2012 has been approved
odobril brez sprememb kot evropski standard by CEN as EN ISO 15189:2012 without any
SIST EN ISO 15189 : 2013
Predgovor k mednarodnemu standardu Foreword to the International standard
ISO (Mednarodna organizacija za ISO (the International Organization for
Standardization) is a worldwide federation of
standardizacijo) je svetovna zveza nacionalnih
organov za standarde (članov ISO). national standards bodies (ISO member bodies).
Mednarodne standarde po navadi pripravljajo The work of preparing International Standards is
tehnični odbori ISO. Vsak član, ki želi delovati normally carried out through ISO technical
na določenem področju, za katero je bil committees. Each member body interested in a
ustanovljen tehnični odbor, ima pravico biti subject for which a technical committee has been
established has the right to be represented on
zastopan v tem odboru. Pri delu sodelujejo tudi
mednarodne vladne in nevladne organizacije, that committee. International organizations,
povezane z ISO. V vseh zadevah, ki so governmental and non-governmental, in liaison
povezane s standardizacijo na področju with ISO, also take part in the work. ISO
elektrotehnike, ISO tesno sodeluje z collaborates closely with the International
Mednarodno elektrotehniško komisijo (IEC). Electrotechnical Commission (IEC) on all matters
of electrotechnical standardization.
Mednarodni standardi so pripravljeni skladno s International Standards are drafted in
pravili, podanimi v 2. delu Direktiv ISO/IEC. accordance with the rules given in the ISO/IEC
Directives, Part 2.
Glavna naloga tehničnih odborov je priprava The main task of technical committees is to
mednarodnih standardov. Osnutki mednarodnih prepare International Standards. Draft
standardov, ki jih sprejmejo tehnični odbori, se International Standards adopted by t
...
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