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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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.
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
ISO 15189:2007(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2007
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 2007 – All rights reserved
ISO 15189:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Management requirement . 4
4.1 Organization and management . 4
4.2 Quality management system . 5
4.3 Document control . 6
4.4 Review of contracts. 7
4.5 Examination by referral laboratories . 8
4.6 External services and supplies . 8
4.7 Advisory services . 9
4.8 Resolution of complaints. 9
4.9 Identification and control of nonconformities .9
4.10 Corrective action. 10
4.11 Preventive action . 10
4.12 Continual improvement. 10
4.13 Quality and technical records . 11
4.14 Internal audits . 11
4.15 Management review. 12
5 Technical requirements . 13
5.1 Personnel. 13
5.2 Accommodation and environmental conditions . 15
5.3 Laboratory equipment. 16
5.4 Pre-examination procedures . 18
5.5 Examination procedures. 20
5.6 Assuring quality of examination procedures . 22
5.7 Post-examination procedures . 23
5.8 Reporting of results. 23
Annex A (Informative) Correlation with ISO 9001:2000 and ISO/IEC 17025:2005. 26
Annex B (informative) Recommendations for protection of laboratory information systems (LIS). 30
Annex C (informative) Ethics in laboratory medicine. 34
Bibliography . 37
ISO 15189:2007(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 second edition cancels and replaces the first edition (ISO 15189:2003) which has been technically
revised in order to align it more closely with the second edition of ISO/IEC 17025.
iv © ISO 2007 – All rights reserved
ISO 15189:2007(E)
Introduction
This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for
1)
competence 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 requisition, patient preparation, patient identification, collection of samples, transportation,
storage, processing and examination of clinical samples, together with subsequent validation, interpretation,
reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work.
Whenever allowed by national regulations, 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 ought also to provide suitable
educational and scientific opportunities for professional staff working with it.
While this International Standard is intended for use throughout the currently recognised disciplines of medical
laboratory services, those working in other services and disciplines could also find it useful and appropriate. In
addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this
International Standard as the basis for their activities. If a laboratory seeks accreditation, it should select an
accrediting body which operates to appropriate international standards and which takes into account the
particular requirements of medical laboratories.
Demonstrated conformity to this International Standard does not imply conformity of the qualit
...
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.
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
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
SIST EN ISO 15189 : 2007
IV
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, Francije, Grčije, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske. Malte, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Romunije, Slovaške,
Slovenije, Španije, Švedske, Švice in Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de normalisation
Europäisches Komitee für Normung
Upravni center: Rue de Stassart, 36 B-1050 Brussels
© 2007 CEN. Lastnice avtorskih pravic so vse države članice CEN Ref. oznaka: EN ISO 15189:2007: E
SIST EN ISO 15189 : 2007
VSEBINA Stran Contents Page
Predgovor.4 Foreword.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 Zahteva za vodenje . 11 4 Management requirement .11
4.1 Organizacija in vodenje.11 4.1 Organization and management.11
4.2 Sistem vodenja kakovosti.12 4.2 Quality management system.12
4.3 Obvladovanje dokumentov. 14 4.3 Document control .14
4.4 Pregled pogodb.16 4.4 Review of contracts.16
4.5 Preiskava, ki jo opravijo prejemni 4.5 Examination by referral
laboratoriji. 17 laboratories .17
4.6 Zunanje storitve in nabava 4.6 External services and supplies.18
materialnih sredstev. 18
4.7 Svetovanje. 19 4.7 Advisory services .19
4.8 Reševanje pritožb. 19 4.8 Resolution of complaints .19
4.9 Prepoznavanje in obvladovanje 4.9 Identification and control of
neskladnosti . 19 nonconformities.19
4.10 Korektivni ukrepi. 20 4.10 Corrective action .20
4.11 Preventivni ukrepi.21 4.11 Preventive action.21
4.12 Nenehno izboljševanje . 21 4.12 Continual improvement .21
4.13 Zapisi o kakovosti in tehnični zapisi . 22 4.13 Quality and technical records.22
4.14 Notranje presoje.23 4.14 Internal audits.23
4.15 Vodstveni pregled. 24 4.15 Management review.24
5 Tehnične zahteve . 25 5 Technical requirements.25
5.1 Osebje . 25 5.1 Personnel .25
5.2 Prostori in pogoji okolja.28 5.2 Accommodation and environmental
conditions.28
5.3 Laboratorijska oprema.30 5.3 Laboratory equipment .30
5.4 Predpreiskovalni postopki. 33 5.4 Pre-examination procedures.33
5.5 Preiskovalni postopki. 37 5.5 Examination procedures .37
5.6 Zagotavljanje kakovosti preiskovalnih 5.6 Assuring quality of examination
postopkov. 39 procedures.39
5.7 Popreiskovalni postopki. 41 5.7 Post-examination procedures .41
5.8 Poročanje o rezultatih. 41 5.8 Reporting of results .41
Dodatek A (informativni): Primerjava z Annex A (informative): Correlation with
ISO 9001:2000 in ISO/IEC 17025:2005. 46 ISO 9001:2000 and ISO/IEC 17025:2005.47
Dodatek B (informativni): Priporočila za Annex B (informative): Recommendations for
varovanje laboratorijskih informacijskih protection of laboratory information systems
sistemov (LIS) . 54 (LIS).55
Dodatek C (informativni): Etika v Annex C (informative): Ethics in laboratory
laboratorijski medicini. 59 medicine.59
Literatura.64 Bibliography.64
SIST EN ISO 15189 : 2007
Foreword
Predgovor
Ta dokument (EN ISO 15189:2007) je pripravil This document (EN ISO 15189:2007) has
tehnični odbor ISO/TC 212 Preskušanje been prepared by Technical Committee
kliničnih laboratorijev ter diagnostični sistemi in ISO/TC 212 "Clinical laboratory testing and in
vitro v sodelovanju s tehničnim odborom vitro diagnostic test systems" in collaboration
CEN/TC 140 Diagnostični medicinski with Technical Committee CEN/TC 140 "In
pripomočki in vitro, katerega sekretariat vodi vitro diagnostic medical devices", the
DIN. secretariat of 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
oktobra 2007, nasprotujoče nacionalne standarde endorsement, at the latest by October 2007,
pa je treba razveljaviti najpozneje oktobra 2007. and conflicting national standards shall be
withdrawn at the latest by October 2007.
Ta dokument nadomešča EN ISO 15189:2003. This document supersedes EN ISO 15189:
2003.
V skladu z notranjimi predpisi CEN/CENELEC According to the CEN/CENELEC Internal
morajo ta evropski standard obvezno uvesti Regulations, the national standards
nacionalne organizacije za standardizacijo organizations of the following countries are
naslednjih držav: Avstrije, Belgije, Bolgarije, bound to implement this European Standard:
Cipra, Češke republike, Danske, Estonije, Austria, Belgium, Bulgaria, Cyprus, Czech
Finske, Francije, Grčije, Irske, Islandije, Italije, Republic, Denmark, Estonia, Finland, France,
Latvije, Litve, Luksemburga, Madžarske, Malte, Germany, Greece, Hungary, Iceland, Ireland,
Nemčije, Nizozemske, Norveške, Poljske, Italy, Latvia, Lithuania, Luxembourg, Malta,
Portugalske, Romunije, Slovaške, Slovenije, Netherlands, Norway, Poland, Portugal,
Španije, Švedske, Švice in Združenega Romania, Slovakia, Slovenia, Spain,
kraljestva. Sweden, Switzerland and United Kingdom.
Razglasitvena objava Endorsement notice
Besedilo standarda ISO 15189:2007 je CEN The text of ISO 15189:2007 has been
odobril kot evropski standard EN ISO approved by CEN as EN ISO 15189:2007
15189:2007 brez sprememb. without any modifications.
SIST EN ISO 15189 : 2007
Predgovor Foreword
ISO (Mednarodna organizacija za standardizacijo) ISO (the International Organization for
je svetovna zveza nacionalnih organov za Standardization) is a worldwide federation of
standarde (članov ISO). Mednarodne standarde national standards bodies (ISO member bodies).
ponavadi pripravljajo tehnični odbori ISO. Vsak The work of preparing International Standards is
član, ki želi delovati na določenem področju, za normally carried out through ISO technical
katero je bil ustanovljen tehnični odbor, ima committees. Each member body interested in a
pravico biti zastopan v tem odboru. Pri delu subject for which a technical committee has
sodelujejo tudi mednarodne vladne in nevladne been established has the right to be represented
organizacije, povezane z ISO. V vseh zadevah, on that committee. International organizations,
ki so povezane s standardizacijo na področju governmental and non-governmental, in liaison
elektrotehnike, ISO tesno sodeluje z with ISO, also take part in the work. ISO
Mednarodno elektrotehniško komisijo (IEC). collaborates closely with the International
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 the technical
pošljejo vsem članom v glasovanje. Za objavo committees are circulated to the member bodies
mednarodnega standarda je treba pridobiti for voting. Publication as an International
soglasje najmanj 75 odstotkov članov, ki se Standard requires approval by at least 75 % of
udeležijo glasovanja. the member bodies casting a vote.
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some o
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.