SIST 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)
This International Standard specifies requirements for quality and competence particular to medical laboratories. This International Standard 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 particulieres 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.
---------------------- Page: 1 ----------------------
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.
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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
---------------------- Page: 4 ----------------------
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.
COPYRIGHT PROTECTED DOCUMENT
© 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
---------------------- Page: 5 ----------------------
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 2007 – All rights reserved iii
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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 quality management
system within which the laboratory operates to all the requirements of ISO 9001. This International Standard is
not intended to be used for the purposes of certification.
The correlation between the clauses and subclauses of this second edition of ISO 15189 and those of
ISO 9001:2000 and of ISO/IEC 17025:2005 is detailed in Annex A of this International Standard.
1) In other languages, these laboratories can be designated by the equivalent of the English term “clinical laboratories.”
© ISO 2007 – All rights reserved v
---------------------- Page: 8 ----------------------
INTERNATIONAL STANDARD ISO 15189:2007(E)
Medical laboratories — Particular requirements for quality and
competence
1 Scope
1.1 This International Standard specifies requirements for quality and competence particular to medical
laboratories.
1.2 This International Standard 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 31 (all parts), Quantities and units
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary
ISO 9001:2000, Quality management systems — Requirements
ISO/IEC Guide 43-1, Proficiency testing by interlaboratory comparisons — Part 1: Development and operation
of proficiency testing schemes
ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accreditation
procedure by which an authoritative body gives formal recognition that a body or person is competent to carry
out specific tasks
3.2
accuracy of measurement
closeness of the agreement between the result of a measurement and a true value of the measurand
[VIM:1993, definition 3.5]
© ISO 2007 – All rights reserved 1
---------------------- Page: 9 ----------------------
ISO 15189:2007(E)
3.3
biological reference interval
reference interval
central 95 % interval of the distribution of reference values
NOTE 1 This supersedes such incorrectly used terms as “normal range”.
NOTE 2 It is an arbitrary but common convention to define the reference interval as the central 95 % interval. Another
size or an asymmetrical location of the reference interval could be more appropriate in particular cases. See [13] in the
Bibliography.
3.4
examination
set of operations having the object of determining the value or characteristics of a property
NOTE In some disciplines (e.g. microbiology) an examination is the total activity of a number of tests, observations or
measurements.
3.5
laboratory capability
physical, environmental and information resources, personnel, skills and expertise available for the
examinations in question
NOTE A review of laboratory capability could include results of earlier participation in interlaboratory comparisons or
external quality assessment schemes or the running of trial examination programmes, or all these, in order to demonstrate
uncertainties of measurement, limits of detection, etc.
3.6
laboratory director
competent person(s) with responsibility for, and authority over, a laboratory
NOTE 1 For the purposes of this International Standard, the person or persons referred to are designated collectively
as "laboratory director".
NOTE 2 National, regional and local regulations may apply with regard to qualifications and training.
3.7
laboratory management
person(s) who manage the activities of a laboratory headed by a laboratory director
3.8
measurement
set of operations having the object of determining a value of a quantity
[VIM:1993, definition 2.1]
3.9
medical laboratory
clinical laboratory
laboratory for the biological, microbiological, immunological, chemical, immunohaematological, haematological,
biophysical, cytological, pathological or other examination of materials derived from the human body for the
purpose of providing information for the diagnosis, prevention and treatment of disease in, or assessment of
the health of, human beings, and which may provide a consultant advisory service covering all aspects of
laboratory investigation including the interpretation of results and advice on further appropriate investigation
NOTE These examinations also include procedures for determining, measuring or otherwise describing the presence
or absence of various substances or micro-organisms. Facilities which only collect or prepare specimens, or act as a
mailing or distribution centre, are not considered to be medical or clinical laboratories, although they may be part of a
larger laboratory network or system.
2 © ISO 2007 – All rights reserved
---------------------- Page: 10 ----------------------
ISO 15189:2007(E)
3.10
post-examination procedures
postanalytical phase
processes following the examination including systematic review, formatting and interpretation, authorization
for release, reporting and transmission of the results, and storage of samples of the examinations
3.11
pre-examination procedures
preanalytical phase
steps starting, in chronological order, from the clinician’s request and including the examination requisition,
preparation of the patient, collection of the primary sample, and transportation to and within the laboratory,
and ending when the analytical examination procedure begins
3.12
primary sample
specimen
set of one or more parts initially taken from a system
NOTE In some countries, the term “specimen” is used instead of primary sample (or a subsample of it), which is the
sample prepared for sending to, or as received by, the laboratory and which is intended for examination.
3.13
quantity
attribute of a phenomenon, body or substance that may be distinguished qualitatively and determined
quantitatively
[VIM:1993, definition 1.1]
3.14
quality management system
management system to direct and control an organization with regard to quality
[ISO 9000:2005, definition 3.2.3]
NOTE For the purposes of this International standard, the "quality" referred to in this definition relates to matters of
both management and technical competence.
3.15
referral laboratory
external laboratory to which a sample is submitted for a supplementary or confirmatory examination procedure
and report
3.16
sample
one or more parts taken from a system and intended to provide information on the system, often to serve as a
basis for decision on the system or its production
EXAMPLE A volume of serum taken from a larger volume of serum.
3.17
traceability
property of the result of a measurement or the value of a standard whereby it can be related to stated
references, usually national or international standards, through an unbroken chain of comparisons all having
stated uncertainties
[VIM:1993, definition 6.10]
© ISO 2007 – All rights reserved 3
---------------------- Page: 11 ----------------------
ISO 15189:2007(E)
3.18
trueness of measurement
closeness of agreement between the average value obtained from a large series of results of measurements
and a true value
NOTE Adapted from ISO 3534-1:1993, definition 3.12
3.19
uncertainty of measurement
parameter, associated with the result of a measurement, that characterizes the dispersion of the values that
could reasonably be attributed to the measurand
[VIM:1993, definition 3.9]
4 Management requirement
4.1 Organization and management
4.1.1 The medical laboratory or the organization of which the laboratory is a part shall be legally identifiable.
4.1.2 Medical laboratory services, including appropriate interpretation and advisory services, shall be
designed to meet the needs of patients and all clinical personnel responsible for patient care.
4.1.3 The medical laboratory (hereafter referred to as “the laboratory”) shall meet the relevant requirements
of this International Standard when carrying out work in its permanent facilities, or at sites other than the
permanent facilities for which it is responsible.
4.1.4 The responsibilities of personnel in the laboratory with an involvement or influence on the examination
of primary samples shall be defined in order to identify conflicts of interest. Financial or political considerations
(e.g. inducements) should not influence testing.
4.1.5 Laboratory management shall have responsibility for the design, implementation, maintenance and
improvement of the quality management system. This shall include the following:
a) management support of all laboratory personnel by providing them with the appropriate authority and
resources to carry out their duties;
b) arrangements to ensure that management and personnel are free from any undue internal and external
commercial, financial or other pressures and influences that may adversely affect the quality of their work;
c) policies and procedures for ensuring the protection of confidential information (see Annex C);
d) policies and procedures for avoiding involvement in any activities that would diminish confidence in its
competence, impartiality, judgement or operational integrity;
e) the organizational and management structure of the laboratory and its relationship to any other
organization with which it may be associated;
f) specified responsibilities, authority and interrelationships of all personnel;
g) adequate training of all staff and supervision appropriate to their experience and level of responsibility by
competent persons conversant with the purpose, procedures and assessment of results of the relevant
examination procedures;
h) technical management which has overall responsibility for the technical operations and the provision of
resources needed to ensure the required quality of laboratory procedures;
4 © ISO 2007 – All rights reserved
---------------------- Page: 12 ----------------------
ISO 15189:2007(E)
i) appointment of a quality manager (however named) with delegated responsibility and authority to oversee
compliance with the requirements of the quality management system, who shall report directly to the level
of laboratory management at which decisions are made on laboratory policy and resources;
j) appointment of deputies for all key functions, while recognizing that in smaller laboratories individuals can
have more than one function and that it could be impractical to appoint deputies for every function.
4.1.6 Laboratory management shall ensure that appropriate communication processes are established
within the laboratory and that communication takes place regarding the effectiveness of the quality
management system.
4.2 Quality management system
4.2.1 Policies, processes, programmes, procedures and instructions shall be documented and
communicated to all relevant personnel. The management shall ensure that the documents are understood
and implemented.
4.2.2 The quality management system shall include, but not be limited to, internal quality control and
participation in organized interlaboratory comparisons such as external quality assessment schemes.
4.2.3 Policies and objectives of the quality management system shall be defined in a quality policy
statement under the authority of the laboratory director and documented in a quality manual. This policy shall
be readily available to appropriate personnel, shall be concise and shall include the following:
a) the scope of service the laboratory intends to provide;
b) the laboratory management’s statement of the laboratory’s standard of service;
c) the objectives of the quality management system;
d) a requirement that all personnel concerned with examination activities familiarize themselves with the
quality documentation and implement the policies and procedures at all times;
e) the laboratory’s commitment to good professional practice, the quality of its examinations, and
compliance with the quality management system;
f) the laboratory management’s commitment to compliance with this International Standard.
4.2.4 A quality manual shall describe the quality management system and the structure of the
documentation used in the quality management system. The quality manual shall include or make reference to
the supporting procedures including technical procedures. It shall outline the structure of the documentation in
the quality management system. The roles and responsibilities of technical management and the quality
manager, including their responsibility for ensuring compliance with this International Standard, shall be
defined in the quality manual.
All personnel shall be instructed on the use and application of the quality manual and all referenced
documents, and of the requirements for their implementation. The quality manual shall be kept up to date
under the authority and responsibility of an individual appointed to be responsible for quality by the laboratory
management [see 4.1.5 i)].
The table of contents of a quality manual for a medical laboratory might be as follows.
a) Introduction.
b) Description of the medical laboratory, its legal identity, resources and main duties.
c) Quality policy.
d) Staff education and training.
© ISO 2007 – All rights reserved 5
---------------------- Page: 13 ----------------------
ISO 15189:2007(E)
e) Quality assurance.
f) Document control.
g) Records, maintenance and archiving.
h) Accommodation and environment.
i) Instruments, reagents and/or relevant consumables management.
j) Validation of examination procedures.
k) Safety.
l) Environmental aspects [e.g., transportation, consumables and waste disposal, in addition to, and different
from, h) and i)].
m) Research and development (If appropriate).
n) List of examination procedures.
o) Request protocols, primary sample, collection and handling of laboratory samples.
p) Validation of results.
q) Quality control (including interlaboratory comparisons).
r) Laboratory information system (see Annex B).
s) Reporting of results.
t) Remedial actions and handling of complaints.
u) Communications and other interactions with patients, health professionals, referral laboratories and
suppliers.
v) Internal audits.
w) Ethics (see Annex C).
4.2.5 Laboratory management shall establish and implement a programme that regularly monitors and
demonstrates proper calibration and function of instruments, reagents and analytical systems. It shall also
have a documented and recorded programme of preventive maintenance and calibration (see 5.3.2), which, at
a minimum, follows manufa
...
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.
---------------------- Page: 1 ----------------------
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
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
SIST EN ISO 15189 : 2007
IV
---------------------- Page: 4 ----------------------
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
---------------------- Page: 5 ----------------------
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
2
---------------------- Page: 6 ----------------------
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.
3
---------------------- Page: 7 ----------------------
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 of
elementov tega dokumenta predmet patentnih the elements of this document may be the
pravic. ISO ne prevzema odgovornosti za subject of patent rights. ISO shall not be held
identifikacijo katerihkoli ali vseh takih patentnih responsible for identifying any or all such patent
pravic. rights.
ISO 15189 je pripravil tehnični odbor ISO/TC ISO 15189 was prepared by Technical
212 Preskušanje kliničnih laboratorijev ter Committee ISO/TC 212, Clinical laboratory
diagnostični sistemi in vitro. testing and in vitro diagnostic test systems.
Ta druga izdaja razveljavlja in nadomešča prvo This second edition cancels and replaces the
izdajo (ISO 15189:2003), ki je bila strokovno first edition (ISO 15189:2003) which has been
revidirana z namenom natančnejše uskladitve z technically revised in order to align it more
drugo izdajo ISO/IEC 17025. closely with the second edition of ISO/IEC
17025.
4
---------------------- Page: 8 ----------------------
SIST EN ISO 15189 : 2007
Uvod Introduction
Ta mednarodni standard, ki temelji na This International Standard, based upon ISO/IEC
standardih ISO/IEC 17025 in ISO 9001, podaja 17025 and ISO 9001, provides requirements for
zahteve za usposobljenost in kakovost, competence and quality that are particular to
1) 1)
namenjene posebej za medicinske laboratorije . medical laboratories. It is acknowledged that a
Dopušča se, da ima država lastne specifične country could have its own specific regulations or
predpise ali zahteve, ki veljajo za določeno ali requirements applicable to some or all its
vse njeno strokovno osebje ter njihove professional personnel and their activities and
aktivnosti in odgovornosti na tem področju. responsibilities in this domain.
Storitve medicinskih laboratorijev so bistvenega Medical laboratory services are essential to
pomena za oskrbo pacientov in morajo biti zato patient care and therefore have to be available to
na voljo za izpolnjevanje potreb vseh pacientov meet the needs of all patients and the clinical
in kliničnega osebja, odgovornega za oskrbo personnel responsible for the care of those
teh pacientov. Take storitve vključujejo načine patients. Such services include arrangements for
urejanja naročil, priprave pacienta, identifikacije requisition, patient preparation, patient identifi-
pacienta, odvzema vzorcev, transporta, cation, collection of samples, transportation,
shranjevanja, obdelave in preiskave kliničnih storage, processing and examination of clinical
vzorcev, skupaj s poznejšimi validacijo, samples, together with subsequent validation,
interpretacijo, poročanjem in svetovanjem, ob interpretation, reporting and advice, in addition to
upoštevanju varnosti in etike pri delu v the considerations of safety and ethics in
medicinskih laboratorijih. medical laboratory work.
Kadar nacionalni predpisi to dopuščajo, je Whenever allowed by national regulations, it is
zaželeno, da v primerih konzultacije storitve desirable that medical laboratory services include
medicinskih laboratorijev zajemajo tudi pregled the examination of patients in consultation cases,
pacientov ter da te storitve poleg diagnoze in and that those services actively participate in the
oskrbe pacientov aktivno sodelujejo pri prevention of disease in addition to diagnosis and
preprečevanju bolezni. Vsak laboratorij bi moral patient management. Each laboratory ought also
strokovnemu osebju, ki zanj dela, zagotavljati to provide suitable educational and scientific
tudi ustrezne možnosti izobraževanja in opportunities for professional staff working with it.
znanstvenega dela.
Medtem ko je ta mednarodni standard While this International Standard is intended for
namenjen uporabi v vseh trenutno priznanih use throughout the currently recognised
strokah medicinskih laboratorijskih storitev, pa disciplines of medical laboratory services, those
je lahko uporaben in ustrezen tudi za working in other services and disciplines could
laboratorije, ki izvajajo storitve v drugih strokah. also find it useful and appropriate. In addition,
Poleg tega bodo lahko ta mednarodni standard bodies engaged in the recognition of the
kot podlago za svoje dejavnosti uporabljali tudi competence of medical laboratories will be able
organi, ki se ukvarjajo s priznavanjem to use this International Standard as the basis for
usposobljenosti medicinskih laboratorijev. Če their activities. If a laboratory seeks accredi-
želi laboratorij pridobiti akreditacijo, naj izbere tation, it should select an accrediting body which
akreditacijski organ, ki deluje po ustreznih operates to appropriate international standards
mednarodnih standardih in ki upošteva and which takes into account the particular
posebne zahteve medicinskih laboratorijev. requirements of medical laboratories.
Izkazana skladnost s tem mednarodnim Demonstrated conformity to this International
standardom pa ne pomeni skladnosti sistema Standard does not imply conformity of the quality
vodenja kakovosti, v okviru katerega laboratorij management system within which the laboratory
deluje, z vsemi zahtevami ISO 9001. Ta operates to all the requirements of ISO 9001. This
mednarodni standard ni namenjen uporabi za International Standard is not intended to be used
namene certificiranja. for the purposes of certification.
1) 1)
V drugih jezikih so ti laboratoriji lahko poimenovani z In other languages, these laboratories can be designated
drugim izrazom, ki je enakovreden angleškemu izrazu by the equivalent of the English term "clinical
"clinical laboratories". laboratories".
5
---------------------- Page: 9 ----------------------
SIST EN ISO 15189 : 2007
Primerjava med točkami in podtočkami te druge The correlation between the clauses and
izdaje ISO 15189 ter točkami in podtočkami ISO subclauses of this second edition of ISO 15189
9001:2000 in ISO/IEC 17025:2005 je podrobneje and those of ISO 9001:2000 and of ISO/IEC
opisana v dodatku A k temu mednarodnemu
17025:2005 is detailed in Annex A of this
standardu. International Standard.
6
---------------------- Page: 10 ----------------------
SIST EN ISO 15189 : 2007
Medicinski laboratoriji – Medical laboratories –
Posebne zahteve za kakovost in Particular requirements for quality
usposobljenost and competence
1 Področje uporabe 1 Scope
1.1 Ta mednarodni standard opredeljuje 1.1 This International Standard specifies
zahteve za kakovost in usposobljenost requirements for quality and competence
posameznih medicinskih laboratorijev. particular to medical laboratories.
1.2 Medicinski laboratoriji naj ta mednarodni 1.2 This International Standard is for use by
standard uporabljajo pri razvijanju svojih medical laboratories in developing their quality
sistemov vodenja kakovosti in ocenjevanju management systems and assessing their own
lastne usposobljenosti, akreditacijski organi pa competence, and for use by accreditation
za potrjevanje ali priznavanje usposobljenosti bodies in confirming or recognising the
medicinskih laboratorijev. competence of medical laboratories.
2 Zveza s standardi 2 Normative references
Za uporabo tega standarda so nujno potrebni The following referenced documents are
spodaj navedeni dokumenti. Pri datiranih indispensable for the application of this
dokumentih velja samo navedena izdaja. Pri document. For dated references, only the
nedatiranih dokumentih velja najnovejša izdaja edition cited applies. For undated references,
dokumenta (vključno z morebitnimi spremembami). the latest edition of the referenced document
(including any amendments) applies.
ISO 31 (vsi deli), Veličine in enote ISO 31 (all parts), Quantities and units
ISO 9000:2005, Sistemi vodenja kakovosti – ISO 9000:2005, Quality management systems –
Osnove in slovar Fundamentals and vocabulary
ISO 9001:2000, Sistemi vodenja kakovosti – ISO 9001:2000, Quality management systems –
Zahteve Requirements
Vodilo ISO/IEC 43-1, Preskušanje strokovne ISO/IEC Guide 43-1: Proficiency testing by
usposobljenosti z medlaboratorijskimi primerjavami interlaboratory comparisons – Part 1:
– 1. del: Razvoj in delovanje shem strokovne Development and operation of proficiency testing
usposobljenosti schemes
ISO/IEC 17025:2005, Splošne zahteve za ISO/IEC 17025:2005: General requirements for
usposobljenost preskuševalnih in kalibracijskih the competence of testing and calibration
laboratorijev laboratories
3 Izrazi in definicije 3 Terms and definitions
V tem dokumentu se uporabljajo naslednji izrazi For the purposes of this document, the
in definicije: following terms and definitions apply.
3.1 3.1
akreditacija accreditation
postopek, s katerim pooblaščeni organ procedure by which an authoritative body gives
formalno priznava, da je neki organ ali oseba formal recognition that a body or person is
usposobljena za izvajanje specifičnih nalog competent to carry out specific tasks
3.2 3.2
merilna točnost accuracy of measurement
ujemanje merilnega rezultata s pravo vrednostjo closeness of the agreement between the result
merjene veličine [VIM:1993, definicija 3.5] of a measurement and a true value of the
measurand [VIM:1993, definition 3.5]
7
---------------------- Page: 11 ----------------------
SIST EN ISO 15189 : 2007
3.3 3.3
biološki referenčni interval biological reference interval
referenčni interval reference interval
osrednji 95-odstotni interval porazdelitve central 95 % interval of the distribution of
referenčnih vrednosti reference values
OPOMBA 1: To nadomešča take nepravilno uporabljene NOTE 1: This supersedes such incorrectly used
izraze, kot je npr. "normalno območje". terms as “normal range”.
OPOMBA 2: Označevanje referenčnega intervala kot NOTE 2: It is an arbitrary but common convention to
osrednji 95-odstotni interval je poljubno, a define the reference interval as the central
splošno dogovorjeno. V posameznih 95 % interval. Another size or an
primerih bi bila mogoče ustreznejša asymmetrical location of the reference
drugačna velikost ali nesimetrična lokacija interval could be more appropriate in
referenčnega intervala. Glej [13] v literaturi. particular cases. See [13] in the
Bibliography.
3.4 3.4
preiskava examination
niz postopkov, katerih cilj je določiti vrednost ali set of operations having the object of determining
značilnosti posamezne lastnosti the value or characteristics of a property
OPOMBA: V nekaterih strokah (npr. v mikrobiologiji) je NOTE: In some disciplines (e.g. microbiology) an
preiskava celota večjega števila preskusov, examination is the total activity of a number
opazovanj ali meritev. of tests, observations or measurements.
3.5 3.5
zmogljivost laboratorija laboratory capability
fizični, okoljski in informacijski viri, osebje, physical, environmental and information
veščine in strokovnost, ki so na voljo za resources, personnel, skills and expertise
zadevne preiskave available for the examinations in question
OPOMBA Pregled zmogljivosti laboratorija lahko NOTE: A review of laboratory capability could
vključuje rezultate predhodnega sodelovanja include results of earlier participation in
v medlaboratorijskih primerjavah ali shemah interlaboratory comparisons or external
za zunanjo oceno kakovosti ali vodenje quality assessment schemes or the running
programov poskusnih preiskav, ali pa vse te of trial examination programmes, or all
aktivnosti, da bi se dognale merilne these, in order to demonstrate uncertainties
negotovosti, meje detekcije itd. of measurement, limits of detection, etc.
3.6 3.6
vodja laboratorija laboratory director
usposobljena(-e) oseba(-e) z odgovornostjo in competent person(s) with responsibility for, and
pooblastili za laboratorij authority over, a laboratory
OPOMBA 1: V tem mednarodnem standardu se NOTE 1: For the purposes of this International
ustrezna oseba ali osebe označujejo s Standard, the person or persons referred to
skupnim imenom "vodja laboratorija". are designated collectively as "laboratory
director".
OPOMBA 2: Glede kvalifikacij in usposobljenosti se NOTE 2: National, regional and local regulations may
lahko uporabljajo nacionalni, regionalni ali apply with regard to qualifications and
lokalni predpisi. training.
3.7 3.7
vodstvo laboratorija laboratory management
oseba(-e), ki vodi(-jo) dejavnosti laboratorija, na person(s) who manage the activities of a
čelu z vodjo laboratorija laboratory headed by a laboratory director
3.8 3.8
meritev, merjenje measurement
niz operacij, da se ugotovi vrednost veličine set of operations having the object of
determining a value of a quantity
[VIM:1993, definicija 2.1] [VIM:1993, definition 2.1]
8
---------------------- Page: 12 ----------------------
SIST EN ISO 15189 : 2007
3.9 3.9
medicinski laboratorij medical laboratory
klinični laboratorij clinical laboratory
laboratorij za izvajanje bioloških, mikrobioloških, laboratory for the biological, microbiological,
imunoloških, kemijskih, imunohematoloških, immunological, chemical, immunohaematological,
hematoloških, biofizikalnih, citoloških, patoloških haematological, biophysical, cytological, patho-
ali drugih preiskav materialov, pridobljenih iz logical or other examination of materials derived
človeškega telesa, z namenom pridobiti podatke from the human body for the purpose of providing
za postavitev diagnoze, preprečevanje bolezni in information for the diagnosis, prevention and
zdravljenje človeških bitij ali za ocenjevanje treatment of disease in, or assessment of the
njihovega zdravja in ki lahko zagotavlja tudi health of, human beings, and which may provide
svetovalne storitve, ki zajemajo vse vidike a consultant advisory service covering all aspects
laboratorijskih preiskav, vključno z interpretacijo of laboratory investigation including the
rezultatov in svetovanjem glede ustreznih interpretation of results and advice on further
nadaljnjih preiskav appropriate investigation
OPOMBA: Te preiskave zajemajo tudi postopke za NOTE: These examinations also include
določanje, merjenje ali drugačno opisovanje procedures for determining, measuring or
prisotnosti ali odsotnosti različnih substanc otherwise describing the presence or
ali mikroorganizmov. Prostori in oprema, ki absence of various substances or micro-
so namenjeni samo odvzemu in pripravi organisms. Facilities which only collect or
vzorcev ali kot zbirni ali distribucijski centri, prepare specimens, or act as a mailing or
se ne štejejo za medicinske ali klinične distribution centre, are not considered to be
laboratorije, čeprav so lahko sestavni del medical or clinical laboratories, although
večje mreže ali sistema laboratorijev. they may be part of a larger laboratory
network or system.
3.10 3.10
popreiskovalni postopki post-examination procedures
poan
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.