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)
This International Standard specifies requirements for quality and competence in medical laboratories. This International Standard 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.
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SLOVENSKI STANDARD
SIST EN ISO 15189:2013
01-marec-2013
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SIST EN ISO 15189:2007
Medicinski laboratoriji - Zahteve za kakovost in kompetentnost (ISO 15189:2012)
Medical laboratories - Requirements for quality and competence (ISO 15189:2012)
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO
15189:2012)
Laboratoires d'analyses de biologie médicale - Exigences concernant la qualité et la
compétence (ISO 15189:2012)
Ta slovenski standard je istoveten z: EN ISO 15189:2012
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
SIST EN ISO 15189:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 15189:2013
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SIST EN ISO 15189:2013
EUROPEAN STANDARD
EN ISO 15189
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2012
ICS 03.120.10; 11.100.01 Supersedes EN ISO 15189:2007
English Version
Medical laboratories - Requirements for quality and competence
(ISO 15189:2012)
Laboratoires de biologie médicale - Exigences concernant Medizinische Laboratorien - Anforderungen an die Qualität
la qualité et la compétence (ISO 15189:2012) und Kompetenz (ISO 15189:2012)
This European Standard was approved by CEN on 31 October 2012.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15189:2012: E
worldwide for CEN national Members.
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SIST EN ISO 15189:2013
EN ISO 15189:2012 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 15189:2013
EN ISO 15189:2012 (E)
Foreword
This document (EN ISO 15189:2012) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee CEN/TC 140
“In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the
latest by November 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15189:2007.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15189:2012 has been approved by CEN as a EN ISO 15189:2012 without any modification.
3
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SIST EN ISO 15189:2013
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SIST EN ISO 15189:2013
INTERNATIONAL ISO
STANDARD 15189
Third edition
2012-11-01
Medical laboratories — Requirements for
quality and competence
Laboratoires de biologie médicale — Exigences concernant la qualité et
la compétence
Reference number
ISO 15189:2012(E)
©
ISO 2012
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SIST EN ISO 15189:2013
ISO 15189:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
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
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SIST EN ISO 15189:2013
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
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SIST EN ISO 15189:2013
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
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SIST EN ISO 15189:2013
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 working in other services and disciplines such as clinical physiology, medical imaging
and medical physics 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 in accordance
with ISO/IEC 17011 and which takes into account the particular requirements of medical laboratories.
This International Standard is not intended to be used for the purposes of certification, however a medical
laboratory’s fulfilment of the requirements of this International Standard means the laboratory meets both the
technical competence requirements and the management system requirements that are necessary for it to
consistently deliver technically valid results. The management system requirements in Clause 4 are written in
a language relevant to a medical laboratory’s operations and meet the principles of ISO 9001:2008, Quality
management systems — Requirements, and are aligned with its pertinent requirements (Joint IAF-ILAC-ISO
Communiqué issued in 2009).
The correlation between the clauses and subclauses of this third edition of ISO 15189 and those of ISO 9001:2008
and of ISO/IEC 17025:2005 is detailed in Annex A of this International Standard.
Environmental issues associated with medical laboratory activity are generally addressed throughout this
International Standard, with specific references in 5.2.2, 5.2.6, 5.3, 5.4, 5.5.1.4 and 5.7.
1) In other languages, these laboratories can be designated by the equivalent of the English term “clinical laboratories.”
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SIST EN ISO 15189:2013
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SIST EN ISO 15189:2013
INTERNATIONAL STANDARD ISO 15189:2012(E)
Medical laboratories — Requirements for quality and competence
1 Scope
This International Standard specifies requirements for quality and competence in medical laboratories.
This International Standard 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.
NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this
International Standard.
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/IEC 17000, Conformity assessment —Vocabulary and general principles
ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories
ISO/IEC Guide 2, Standardization and related activities — General vocabulary
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC 17000, ISO/IEC Guide 2 and
ISO/IEC Guide 99 and the following apply.
3.1
accreditation
procedure by which an authoritative body gives formal recognition that an organization is competent to carry
out specific tasks
3.2
alert interval
critical interval
interval of examination results for an alert (critical) test that indicates an immediate risk to the patient of injury or death
NOTE 1 The interval may be open ended, where only a threshold is defined.
NOTE 2 The laboratory determines the appropriate list of alert tests for its patients and users.
3.3
automated selection and reporting of results
process by which patient examination results are sent to the laboratory information system and compared with
laboratory-defined acceptance criteria, and in which results that fall within the defined criteria are automatically
included in patient report formats without any additional intervention
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SIST EN ISO 15189:2013
ISO 15189:2012(E)
3.4
biological reference interval
reference interval
specified interval of the distribution of values taken from a biological reference population
EXAMPLE The central 95 % biological reference interval for sodium ion concentration values in serum from a
population of presumed healthy male and female adults is 135 mmol/l to 145 mmol/l.
NOTE 1 A reference interval is commonly defined as the central 95 % interval. Another size or an asymmetrical location
of the reference interval could be more appropriate in particular cases.
NOTE 2 A reference interval can depend upon the type of primary samples and the examination procedure used.
NOTE 3 In some cases, only one biological reference limit is important, for example, an upper limit, x, so that the
corresponding biological reference interval would be less than or equal to x.
NOTE 4 Terms such as ‘normal range’, ‘normal values’, and ‘clinical range’ are ambiguous and therefore discouraged.
3.5
competence
demonstrated ability to apply knowledge and skills
NOTE The concept of competence is defined in a generic sense in this International Standard. The word usage can
be more specific in other ISO documents.
[ISO 9000:2005, definition 3.1.6]
3.6
documented procedure
specified way to carry out an activity or a process that is documented, implemented and maintained
NOTE 1 The requirement for a documented procedure may be addressed in a single document or by more than
one document.
NOTE 2 Adapted from ISO 9000:2005, definition 3.4.5.
3.7
examination
set of operations having the object of determining the value or characteristics of a property
NOTE 1 In some disciplines (e.g. microbiology) an examination is the total activity of a number of tests, observations or
measurements.
NOTE 2 Laboratory examinations that determine a value of a property are called quantitative examinations; those that
determine the characteristics of a property are called qualitative examinations.
NOTE 3 Laboratory examinations are also often called assays or tests.
3.8
interlaboratory comparison
organization, performance and evaluation of measurements or tests on the same or similar items by two or
more laboratories in accordance with predetermined conditions
[ISO/IEC 17043:2010, definition 3.4]
3.9
laboratory director
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.
2 © ISO 2012 – All rights reserved
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SIST EN ISO 15189:2013
ISO 15189:2012(E)
3.10
laboratory management
person(s) who direct and manage the activities of a laboratory
NOTE The term ‘laboratory management’ is synonymous with the term ‘top management’ in ISO 9000:2005.
3.11
medical laboratory
clinical laboratory
laboratory for the biological, microbiological, immunological, chemical, immunohaematological, haematological,
biophysical, cytological, pathological, genetic or other examination of materials derived from the human body
for the purpose of providing information for the diagnosis, management, 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 microorganisms.
3.12
nonconformity
nonfulfillment of a requirement
[ISO 9000:2005, definition 3.6.2].
NOTE Other terms frequently used include: accident, adverse event, error, event, incident, and occurrence.
3.13
point-of-care testing
POCT
near-patient testing
testing performed near or at the site of a patient, with the result leading to possible change in the care of the patient
[ISO 22870:2006, definition 3.1]
3.14
post-examination processes
postanalytical phase
processes following the examination including review of results, retention and storage of clinical material,
sample (and waste) disposal, and formatting, releasing, reporting and retention of examination results
3.15
pre-examination processes
preanalytical phase
processes that start, in chronological order, from the clinician’s request and include the examination request,
preparation and identification of the patient, collection of the primary sample(s), and transportation to and
within the laboratory, and end when the analytical examination begins
3.16
primary sample
specimen
discrete portion of a body fluid, breath, hair or tissue taken for examination, study or analysis of one or more
quantities or properties assumed to apply for the whole
NOTE 1 Global Harmonisation Task Force (GHTF) uses the term specimen in its harmonized guidance documents to
mean a sample of biological origin intended for examination by a medical laboratory.
NOTE 2 In some ISO and CEN documents, a specimen is defined as “a biological sample derived from the human body”.
NOTE 3 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.
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SIST EN ISO 15189:2013
ISO 15189:2012(E)
3.17
process
set of interrelated or interacting activities which transform inputs into outputs
NOTE 1 Inputs to a process are generally outputs of other processes.
NOTE 2 Adapted from ISO 9000:2005, definition 3.4.1.
3.18
quality
degree to which a set of inherent characteristics fulfils requirements
NOTE 1 The term “quality” can be used with adjectives such as poor, good or excellent.
NOTE 2 “Inherent”, as opposed to “assigned”, means existing in something, especially as a permanent characteristic.
[ISO 9000:2005, definition 3.1.1]
3.19
quality indicator
measure of the degree to which a set of inherent characteristics fulfils requirements
NOTE 1 Measure can be expressed, for example, as % yield (% within specified requirements), % defects (% outside
specified requirements), defects per million occasions (DPMO) or on the Six Sigma scale.
NOTE 2 Quality indicators can measure how well an organization meets the needs and requirements of users and the
quality of all operational processes.
EXAMPLE If the requirement is to receive all urine samples in the laboratory uncontaminated, the number of
contaminated urine samples received as a % of all urine samples received (the inherent characteristic of the process) is a
measure of the quality of the process.
3.20
quality management system
management system to direct and control an organization with regard to quality
NOTE 1 The term “quality management system” referred to in this definition relates to general management activities,
the provision and management of resources, the pre-examination, examination and post-examination processes and
evaluation and continual improvement.
NOTE 2 Adapted from ISO 9000:2005, definition 3.2.3.
3.21
quality policy
overall intentions and direction of a laboratory related to quality as formally expressed by laboratory management
NOTE 1 Generally the quality policy is consistent with the overall policy of an organization and provides a framework
for setting quality objectives.
NOTE 2 Adapted from ISO 9000:2005, definition 3.2.4
3.22
quality objective
something sought, or aimed for, related to quality
NOTE 1 Quality objectives are generally based on the laboratory’s quality policy.
NOTE 2 Quality objectives are generally specified for relevant functions and levels in the organization.
NOTE 3 Adapted from ISO 9000:2005, definition 3.2.5.
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SIST EN ISO 15189:2013
ISO 15189:2012(E)
3.23
referral laboratory
external laboratory to which a sample is submitted for examination
NOTE A referral laboratory is one to which laboratory management chooses to submit a sample or sub-sample for
examination or when routine examinations cannot be carried out. This differs from a laboratory that may include public health,
forensics, tumour registry, or a central (parent) facility to which submission of samples is required by structure or regulation.
3.24
sample
one or more parts taken from a primary sample
EXAMPLE A volume of serum taken from a larger volume of serum.
3.25
turnaround time
elapsed time between two specified points through pre-examination, examination and post-examination processes
3.26
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or
application have been fulfilled
NOTE 1 The term “validated” is used to designate the corresponding status.
NOTE 2 Adapted from ISO 9000:2005, definition 3.8.5.
3.27
verification
confirmation, through provision of objective evidence, that specified requirements have been fulfilled
NOTE 1 The term “verified” is used to designate the corresponding status.
NOTE 2 Confirmation can comprise activities such as
— performing alternative calculations,
— comparing a new design specification with a similar proven design specification,
— undertaking tests and demonstrations, and
— reviewing documents prior to issue.
[ISO 9000:2005, definition 3.8.4]
4 Management requirements
4.1 Organization and management responsibility
4.1.1 Organization
4.1.1.1 General
The medical laboratory (hereinafter referred to as ‘the laboratory’) shall meet the requirements of this
International Standard when carrying out work at its permanent facilities, or in associated or mobile facilities.
4.1.1.2 Legal entity
The laboratory or the organization of which the laboratory is a part shall be an entity that can be held legally
responsible for its activities.
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SIST EN ISO 15189:2013
ISO 15189:2012(E)
4.1.1.3 Ethical conduct
Laboratory management shall have arrangements in place to ensure the following:
a) there is no involvement in any activities that would diminish confidence in the laboratory’s competence,
impartiality, judgement or operational integrity;
b) management and personnel are free from any undue commercial, financial, or other pressures and
influences that may adversely affect the quality of their work;
c) whe
...
SLOVENSKI SIST EN ISO 15189
STANDARD
marec 2013
Medicinski laboratoriji – Zahteve za kakovost in kompetentnost
(ISO 15189:2012)
Medical laboratories – Requirements for quality and competence
(ISO 15189:2012)
Laboratoires d'analyses de biologie médicale – Exigences concernant la qualité
et la compétence (ISO 15189:2012)
Medizinische Laboratorien – Anforderungen an die Qualität und Kompetenz
(ISO 15189:2012)
Referenčna oznaka
ICS 03.120.10 ; 11.100.01 SIST EN ISO 15189:2013 (sl, en)
Nadaljevanje na straneh II in III ter od 1 do 91
© 2014-11. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 15189 : 2013
NACIONALNI UVOD
Standard SIST EN ISO 15189 (sl, en), Medicinski laboratoriji – Zahteve za kakovost in kompetentnost
(ISO 15189:2012), 2013, ima status slovenskega standarda in je istoveten evropskemu standardu
EN ISO 15189 (en, de, fr), Medical laboratories – Requirements for quality and competence
(ISO 15189:2012), 2012.
Ta dokument nadomešča SIST EN ISO 15189:2007.
NACIONALNI PREDGOVOR
Evropski standard EN ISO 15189:2012 je pripravil tehnični odbor ISO/TC 212 Preskušanje kliničnih
laboratorijev ter diagnostični sistemi in vitro v sodelovanju s tehničnim odborom Evropskega komiteja
za standardizacijo CEN/TC 140 Diagnostični medicinski sistemi in vitro. Slovenski standard SIST EN
ISO 15189:2013 je prevod evropskega standarda EN ISO 15189:2012. V primeru spora glede
besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard.
Slovenski prevod standarda SIST EN ISO 15189:2013 je pripravila delovna skupina strokovnjakov iz
naslednjih nacionalnih tehničnih odborov SIST/TC VAZ Varovanje zdravje, SIST/TC VZK Vodenje in
zagotavljenje kakovosti in SIST/TC UGA Ugotavljanje skladnosti.
Odločitev za izdajo tega standarda je dne 7. februarja 2013 sprejel SIST/TC VAZ Varovanje zdravja.
ZVEZA S STANDARDI
S privzemom tega evropskega standarda veljajo za omenjeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo:
SIST EN ISO/IEC 17000 Ugotavljanje skladnosti – Slovar in splošna načela (enakovreden z
ISO/IEC 17000:2004)
SIST EN ISO/IEC 17025:2005 Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih
laboratorijev (ISO/IEC 17025:2005)
SIST-V ISO/IEC Vodilo 99 Mednarodni slovar za meroslovje – Osnovni in splošni koncepti ter z
njimi povezani izrazi (VIM)
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 15189:2012
PREDHODNA IZDAJA
SIST EN ISO 15189:2007, Medicinski laboratoriji – Posebne zahteve za kakovost in usposobljenost
(ISO 15189:2007)
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v
SIST EN ISO 15189:2013 to pomeni “slovenski standard”.
– Uvod in nacionalni predgovor nista sestavni del standarda.
II
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SIST EN ISO 15189 : 2013
– Ta nacionalni dokument je istoveten EN ISO 15189:2012 in je objavljen z dovoljenjem
CEN Management Centre
Avenue Marnix 17
B-1000 Bruxelles
Belgija
This national document is identical with EN ISO 15189:2012 and is published with the permission of
CEN Management Centre
Avenue Marnix 17
B-1000 Bruxelles
Belgium
III
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SIST EN ISO 15189 : 2013
(Prazna stran)
IV
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EVROPSKI STANDARD EN ISO 15189
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM november 2012
ICS 03.120.10; 11.100.01 Nadomešča EN ISO 15189:2007
Slovenska izdaja
Medicinski laboratoriji – Zahteve za kakovost in kompetentnost
(ISO 15189:2012)
Medical laboratories – Laboratoires d'analyses de biologie Medizinische Laboratorien –
Requirements for quality and médicale – Exigences concernant Anforderungen an die Qualität und
competence (ISO 15189:2012) la qualité et la compétence (ISO Kompetenz
15189:2012) (ISO 15189:2012)
Ta evropski standard je CEN sprejel 31. oktobra 2012.
Člani CEN morajo izpolnjevati notranje predpise CEN/CENELEC, s katerim je predpisano, da mora biti
ta standard brez kakršnih koli sprememb sprejet kot nacionalni standard. Najnovejši seznami teh
nacionalnih standardov z njihovimi bibliografskimi podatki se na zahtevo lahko dobijo pri Upravnem
centru CEN-CENELEC ali pri katerem koli članu CEN.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru
CEN-CENELEC, veljajo kot uradne izdaje.
Člani CEN so nacionalni organi za standarde Avstrije, 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
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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
2
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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
EN ISO 15189:2012. modifications.
3
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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 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 Attention is drawn to the possibility that some of
nekaj elementov tega dokumenta predmet the elements of this document may be the
patentnih pravic. ISO ne prevzema subject of patent rights. ISO shall not be held
odgovornosti za identifikacijo katerih koli ali responsible for identifying any or all such patent
vseh takih patentnih 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 tretja izdaja razveljavlja in nadomešča This third edition cancels and replaces the
drugo izdajo (ISO 15189:2007), ki je strokovno second edition (ISO 15189:2007) which has
revidirana. been technically revised
V dodatku B je podana primerjava med drugo A correlation between the second and third
in tretjo izdajo tega mednarodnega standarda. editions of this International Standard is
V tretji izdaji se nadaljuje usklajevanje, provided as Annex B. The third edition
vzpostavljeno v ISO/IEC 17025:2005 continues the alignment established in ISO/IEC
17025:2005
4
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SIST EN ISO 15189 : 2013
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 kompetentnost 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 preiskav, priprave pacienta, examination requests, patient preparation,
identifikacije pacienta, odvzema vzorcev, patient identification, collection of samples,
transporta, shranjevanja, obdelave in preiskave transportation, storage, processing and
kliničnih vzorcev, skupaj s poznejšo examination of clinical samples, together with
interpretacijo, poročanjem in svetovanjem, ob subsequent interpretation, reporting and advice,
upoštevanju varnosti in etike pri delu v in addition to the considerations of safety and
medicinskih laboratorijih. ethics in medical laboratory work.
Kadar nacionalni, regionalni ali lokalni predpisi Whenever allowed by national, regional or local
to dopuščajo, je zaželeno, da v primerih regulations, it is desirable that medical laboratory
konzultacije storitve medicinskih laboratorijev services include the examination of patients in
zajemajo tudi pregled pacientov ter da te consultation cases, and that those services
storitve poleg diagnoze in oskrbe pacientov actively participate in the prevention of disease in
aktivno sodelujejo pri preprečevanju bolezni. addition to diagnosis and patient management.
Vsak laboratorij naj strokovnemu osebju, ki zanj Each laboratory should also provide suitable
dela, zagotavlja tudi ustrezne možnosti educational and scientific opportunities for
izobraževanja in znanstvenega dela. professional staff working with it.
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 such as
laboratorije, ki izvajajo storitve v drugih strokah, clinical physiology, medical imaging and medical
kot so na primer klinična fiziologija, medicinsko physics could also find it useful and appropriate.
slikanje in medicinska fizika. Poleg tega bodo In addition, bodies engaged in the recognition of
lahko ta mednarodni standard kot podlago za the competence of medical laboratories will be
svoje dejavnosti uporabljali tudi organi, ki se able to use this International Standard as the
ukvarjajo s priznavanjem kompetentnosti basis for their activities. If a laboratory seeks
medicinskih laboratorijev. Če želi laboratorij accreditation, it should select an accrediting
pridobiti akreditacijo, naj izbere akreditacijski body which operates in accordance with ISO/IEC
organ, ki deluje po ustreznih mednarodnih 17011 and which takes into account the
standardih in ki upošteva posebne zahteve particular requirements of medical laboratories.
medicinskih laboratorijev.
Čeprav ta mednarodni standard ni namenjen This International Standard is not intended to be
uporabi za namene certificiranja, pa used for the purposes of certification, however a
izpolnjevanje zahtev tega mednarodnega medical laboratory’s fulfilment of the
1) 1)
V drugih jezikih so ti laboratoriji lahko poimenovani z In other languages, these laboratories can be
drugim izrazom, ki je enakovreden angleškemu izrazu designated by the equivalent of the English term
"clinical laboratories". "clinical laboratories".
5
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SIST EN ISO 15189 : 2013
standarda pomeni, da medicinski laboratorij requirements of this International Standard
izpolnjuje tako zahteve za strokovno means the laboratory meets both the technical
kompetentnost kot tudi zahteve za sistem competence requirements and the
vodenja, ki so potrebne, da laboratorij dosledno management system requirements that are
dosega strokovno veljavne rezultate. Zahteve necessary for it to consistently deliver
za sistem vodenja v 4. točki so zapisane v technically valid results. The management
jeziku, ki ustreza delovanju medicinskega system requirements in Clause 4 are written in
laboratorija, in izpolnjujejo načela ISO a language relevant to a medical laboratory’s
9001:2008, Sistemi vodenja kakovosti – operations and meet the principles of
Zahteve, ter so usklajene z ustreznimi ISO 9001:2008, Quality management systems
zahtevami tega standarda (Skupno sporočilo – Requirements, and are aligned with its
IAF-ILAC-ISO, izdano leta 2009). pertinent requirements (Joint IAE-ILAC-ISO
Communiqué issued in 2009).
Primerjava med točkami in podtočkami te tretje The correlation between the clauses and
izdaje ISO 15189 ter točkami in podtočkami ISO subclauses of this third edition of ISO 15189
9001:2008 in ISO/IEC 17025:2005 je podrobneje and those of ISO 9001:2008 and of ISO/IEC
opisana v dodatku A k temu mednarodnemu 17025:2005 is detailed in Annex A of this
standardu. International Standard.
Okoljska vprašanja, povezana z dejavnostjo Environmental issues associated with medical
medicinskega laboratorija, so na splošno laboratory activity are generally addressed
obravnavana v tem celotnem mednarodnem throughout this International Standard, with
standardu, posebej v točkah 5.2.2, 5.2.6, 5.3, specific references in 5.2.2, 5.2.6, 5.3, 5.4,
5.4, 5.5.1.4 in 5.7. 5.5.1.4 and 5.7.
6
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SIST EN ISO 15189 : 2013
Medicinski laboratoriji – Zahteve za Medical laboratories – Requirements
kakovost in kompetentnost for quality and competence
1 Področje uporabe 1 Scope
Ta mednarodni standard opredeljuje zahteve za This International Standard specifies
kakovost in kompetentnost medicinskih requirements for quality and competence in
laboratorijev. medical laboratories.
Medicinski laboratoriji lahko ta mednarodni This International Standard can be used by
standard uporabljajo pri razvijanju svojih sistemov medical laboratories in developing their quality
vodenja kakovosti in ocenjevanju lastne management systems and assessing their own
kompetentnosti. Uporabljajo ga lahko tudi competence. It can also be used for confirming
odjemalci laboratorija, regulativni organi in or recognising the competence of medical
akreditacijski organi za potrjevanje ali priznavanje laboratories by laboratory customers, regulating
kompetentnosti medicinskih laboratorijev. authorities and accreditation bodies.
2 Zveza s standardi 2 Normative references
Za uporabo tega standarda so nujno potrebni The following referenced documents are
spodaj navedeni referenčni dokumenti. Pri indispensable for the application of this
datiranih sklicevanjih se uporablja le navedena document. For dated references, only the
izdaja. Pri nedatiranih sklicevanjih se uporablja edition cited applies. For undated references,
zadnja izdaja publikacije (vključno z dopolnili). the latest edition of the referenced document
(including any amendments) applies.
ISO/IEC 17000, Ugotavljanje skladnosti – ISO/IEC 17000, Conformity assessment –
Slovar in splošna načela Vocabulary and general principles
ISO/IEC 17025:2005, Splošne zahteve za ISO/IEC 17025:2005: General requirements for
kompetentnost preskuševalnih in kalibracijskih the competence of testing and calibration
laboratorijev laboratories
ISO/IEC Vodilo 2, Standardizacija in z njo ISO/IEC Guide 2, Standardization and related
povezane dejavnosti – Splošni slovar activities – General vocabulary
ISO/IEC Vodilo 99, Mednarodni slovar meroslovja ISO/IEC Guide 99, International vocabulary of
– Osnovni in splošni pojmi ter z njimi povezani metrology – Basic and general concepts and
izrazi (VIM) associated terms (VIM)
3 Izrazi in definicije 3 Terms and definitions
V tem dokumentu se uporabljajo izrazi in For the purposes of this document, the terms
definicije iz ISO/IEC 17000, ISO/IEC Vodila 2 in and definitions given in ISO/IEC 17000,
ISO/IEC Vodila 99 ter naslednji izrazi in ISO/IEC Guide 2 and ISO/IEC Guide 99 and
definicije: the following apply.
3.1 3.1
akreditacija accreditation
postopek, s katerim pooblaščeni organ procedure by which an authoritative body gives
formalno priznava, da je neka organizacija formal recognition that an organization is
kompetentna za izvajanje specifičnih nalog competent to carry out specific tasks
3.2 3.2
opozorilni interval alert interval
kritični interval critical interval
interval rezultatov preiskave za opozorilni interval of examination results for an alert
(kritični) preskus, ki označuje takojšnje tveganje (critical) test that indicates an immediate risk to
za pacientovo poškodbo ali smrt the patient of injury or death
7
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SIST EN ISO 15189 : 2013
OPOMBA 1: Interval je lahko odprt, pri čemer je določen NOTE 1 The interval may be open ended, where
samo prag. only a threshold is defined.
OPOMBA 2: Laboratorij za svoje paciente in uporabnike NOTE 2 The laboratory determines the appropriate
določi ustrezen seznam opozorilnih preskusov. list of alert tests for its patients and users.
3.3 3.3
avtomatizirana izbira rezultatov in poročanje automated selection and reporting of results
o njih
proces, s katerim se rezultati preiskav pacienta process by which patient examination results
pošljejo v informacijski sistem laboratorija in are sent to the laboratory information system
primerjajo s kriteriji sprejemljivosti, ki jih določi and compared with laboratory-defined
laboratorij, ter v katerem se rezultati, ki so znotraj acceptance criteria, and in which results that fall
določenih kriterijev, avtomatsko in brez vsakršnih within the defined criteria are automatically
dodatnih posegov vključijo v obrazce pacientovih included in patient report formats without any
izvidov additional intervention
3.4 3.4
biološki referenčni interval biological reference interval
referenčni interval reference interval
specificiran interval porazdelitve vrednosti, vzet specified interval of the distribution of values
od biološke referenčne populacije taken from a biological reference population
PRIMER: Osrednji 95-odstotni biološki referenčni EXAMPLE The central 95 % biological reference
interval za koncentracijske vrednosti interval for sodium ion concentration values
natrijevih ionov v serumu populacije in serum from a population of presumed
domnevno zdravih odraslih moških in žensk healthy male and female adults is 135
je od 135 mmol/l do 145 mmol/l. mmol/l to 145 mmol/l.
OPOMBA 1: Referenčni interval je navadno določen kot NOTE 1 A reference interval is commonly defined as
osrednji 95-odstotni interval. V posameznih the central 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. particular cases.
OPOMBA 2: Referenčni interval je lahko odvisen od NOTE 2 A reference interval can depend upon the
vrste primarnih vzorcev in od uporabljenega type of primary samples and the
postopka preiskave. examination procedure used.
OPOMBA 3: V nekaterih primerih je pomembna samo NOTE 3 In some cases, only one biological
ena biološka referenčna meja, na primer reference limit is important, for example, an
zgornja meja x, tako da bi bil ustrezni upper limit, x, so that the corresponding
biološki referenčni interval manj kot x ali biological reference interval would be less
enak x. than or equal to x.
OPOMBA 4: Izrazi, kot so "normalno območje", NOTE 4 Terms such as ‘normal range’, ‘normal
"normalne vrednosti" in "klinično območje", values’, and ‘clinical range’ are ambiguous
so dvoumni in se zato odsvetujejo. and therefore discouraged.
3.5 3.5
kompetentnost competence
izkazana zmožnost za uporabo znanja in veščin demonstrated ability to apply knowledge and skills
[ISO 9000:2005, definicija 3.1.6] [ISO 9000:2005, definition 3.1.6]
3.6 3.6
dokumentiran postopek documented procedure
specificiran način
...
SLOVENSKI STANDARD
oSIST prEN ISO 15189:2011
01-marec-2011
Medicinski laboratoriji - Posebne zahteve za kakovost in usposobljenost (ISO/DIS
15189:2011)
Medical laboratories - Requirements for quality and competence (ISO/DIS 15189:2011)
Medizinische Laboratorien - Besondere Anforderungen an die Qualität und Kompetenz
(ISO/DIS 15189:2011)
Laboratoires d'analyses de biologie médicale - Exigences concernant la qualité et la
compétence (ISO/DIS 15189:2011)
Ta slovenski standard je istoveten z: prEN ISO 15189
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
oSIST prEN ISO 15189:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 15189:2011
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oSIST prEN ISO 15189:2011
EUROPEAN STANDARD
DRAFT
prEN ISO 15189
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2011
ICS 03.120.10; 11.100.01 Will supersede EN ISO 15189:2007
English Version
Medical laboratories - Requirements for quality and competence
(ISO/DIS 15189:2011)
Laboratoires d'analyses de biologie médicale - Exigences Medizinische Laboratorien - Besondere Anforderungen an
concernant la qualité et la compétence (ISO/DIS die Qualität und Kompetenz (ISO/DIS 15189:2011)
15189:2011)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 140.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
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© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 15189:2011: E
worldwide for CEN national Members.
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oSIST prEN ISO 15189:2011
prEN ISO 15189:2011 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 15189:2011
prEN ISO 15189:2011 (E)
Foreword
This document (prEN ISO 15189:2011) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee CEN/TC 140
“In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 15189:2007.
Endorsement notice
The text of ISO/DIS 15189:2011 has been approved by CEN as a prEN ISO 15189:2011 without any
modification.
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oSIST prEN ISO 15189:2011
DRAFT INTERNATIONAL STANDARD ISO/DIS 15189
ISO/TC 212 Secretariat: ANSI
Voting begins on Voting terminates on
2011-01-06 2011-06-06
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Medical laboratories — Particular requirements for quality and
competence
Laboratoires d'analyses de biologie médicale — Exigences particulières concernant la qualité et la
compétence
[Revision of second edition (ISO 15189:2007)]
ICS 03.120.10; 11.100.01
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME
STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
© International Organization for Standardization, 2011
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oSIST prEN ISO 15189:2011
ISO/DIS 15189
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ISO/DIS 15189
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Management requirements . 9
4.1 Organisation and management responsibility . 9
4.2 Quality management system . 12
4.3 Document control . 14
4.4 Service agreements . 15
4.5 Examination by referral laboratories . 16
4.6 External services and supplies . 17
4.7 Advisory services . 17
4.8 Resolution of complaints . 18
4.9 Identification and control of nonconformities . 18
4.10 Corrective action . 18
4.11 Preventive action . 19
4.12 Continual improvement . 19
4.13 Control of records . 20
4.14 Evaluation and internal audits . 21
4.15 Management review . 23
5 Technical requirements . 24
5.1 Personnel . 24
5.2 Accommodation and environmental conditions . 26
5.3 Laboratory equipment, reagents, and consumables . 28
5.4 Pre-examination processes. 31
5.5 Examination processes . 34
5.6 Ensuring quality of examination results . 37
5.7 Post examination processes . 39
5.8 Reporting of results . 40
5.9 Laboratory information management . 43
Annex A (informative) Correlation with ISO 9001:2008 and ISO/IEC 17025:2005 . 45
Annex B (informative) Comparison of ISO 15189:2007 to ISO 15189: 20XX . 49
Annex C (informative) Ethics in laboratory medicine . 53
Bibliography . 56
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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, Subcommittee SC , .
This second/third/. edition cancels and replaces the first/second/. edition (), [clause(s) / subclause(s) /
table(s) / figure(s) / annex(es)] of which [has / have] been technically revised.
This third edition cancels and replaces the second edition (ISO 15189:2007). A correlation between the
second and third editions of this Standard is provided as Annex C.
The third edition continues the alignment established with the drafting of the second edition with the second
edition of ISO/IEC 17025.
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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 examination request, 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, 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
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 such as clinical physiology, medical
imaging and medical physics 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 ISO/IEC 17011 and which takes into account the particular requirements of medical laboratories.
This International Standard is not intended to be used for the purposes of certification, however:
A medical laboratory’s fulfilment of the requirements of ISO 15189:2007 means the laboratory meets both the
technical competence requirements and the management system requirements that are necessary for it to
consistently deliver technically valid results. The management system requirements in ISO 15189 (Section 4)
are written in a language relevant to a medical laboratories operations and meet the principles of ISO
9001:2008 Quality management systems- Requirements and are aligned with its pertinent requirements
(Joint IAF-ILAC-ISO Communiqué issued in 2009)
The correlation between the clauses and subclauses of this third edition of ISO 15189 and those of
ISO 9001:2008 and of ISO/IEC 17025:2005 is detailed in Annex A of this International Standard.
Environmental issues associated with medical laboratory activity are generally addressed throughout this
Standard, with specific references in Sections 5.2.6, 5.3, 5.4 and 5.7.
1) In other languages, these laboratories can be designated by the equivalent of the English term “clinical laboratories.”
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DRAFT INTERNATIONAL STANDARD ISO/DIS 15189
Medical laboratories — Particular requirements for quality and
competence
1 Scope
1.1 This International Standard specifies the requirements for quality and competence in medical
laboratories.
1.2 This International Standard is for use by medical laboratories in developing their quality management
systems and assessing their own competence. Laboratory customers, regulating authorities, and accreditation
bodies may also use it for confirming or recognizing the competence of medical laboratories.
This International Standard is not intended to be used as the basis for certification of laboratories.
1.3 International, national, or regional regulations or requirements may apply to specific topics covered in
this International Standard and shall be followed when applicable.
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/IEC80000 (all parts), Quantities and units
ISO 9001:2008, Quality management systems — Requirements
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 terms and definitions given in ISO 9000, ISO/IEC Guide 2, ISO 17000,
ISO/IEC Guide 99:2007 and the following apply.
3.1
accreditation
procedure by which an authoritative body gives formal recognition that an organisation or person is competent
to carry out specific tasks
3.2
automated selection and reporting of results
process by which patient examination results are sent to the laboratory information system and compared with
laboratory-defined acceptance criteria, and in which results that fall within the defined criteria are automatically
included in patient report formats without any additional intervention
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3.3
biological reference interval
reference interval
specified interval of the distribution of values taken from a biological reference population
EXAMPLE The central 95% biological reference interval for sodium ion concentration values in serum from a
population of healthy male and female adults is 135 mmol/l to 145 mmol/l.
NOTE 1 A reference interval is commonly defined as the central 95 % interval. Another size or an asymmetrical
location of the reference interval could be more appropriate in particular cases.
NOTE 2 A reference interval can depend upon the type of primary samples and the examination procedure used.
NOTE 3 In some cases, only one biological reference limit is important, for example, an upper limit, “x”, so that the
corresponding biological reference interval would be less than or equal to “x”.
NOTE 4 Terms such as “normal range”, “normal values”, and “clinical range” are ambiguous and therefore
discouraged.
3.4
detection limit
limit of detection
measured quantity value, obtained by a given measurement procedure, for which the probability of falsely
claiming the absence of a component in a material is β, given a probability α of falsely claiming its presence
NOTE 1 IUPAC recommends default values for α and β equal to 0.05.
NOTE 2 The abbreviation LOD is sometimes used and is discouraged.
NOTE 3 The term ‘analytical sensitivity’ ” is sometimes used to mean detection limit, but such usage is now discouraged
[ISO/IEC Guide 99:2007, definition 4.18]
3.5
competence
demonstrated ability to apply knowledge and skills
NOTE The concept of competence is defined in a generic sense in this International Standard. The word usage can
be more specific in other ISO documents.
[ISO 9000:2005, definition 3.1.6]
3.6
examination
set of operations having the object of determining the value or characteristics of a property
NOTE 1 In some disciplines (e.g., microbiology) an examination is the total activity of a number of tests, observations
or measurements.
NOTE 2 Laboratory examinations that determine the value of a property are called quantitative examinations; those
that determine the characteristics of a property are called qualitative examinations.
NOTE 3 In clinical chemistry, laboratory examinations are called assays or tests.
3.7
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.
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NOTE 2 National, regional and local regulations may apply with regard to qualifications and training
3.8
laboratory management
person(s) who direct and manage the activities of a laboratory
NOTE The term ‘laboratory management’ is synonymous with the term ‘top management’ in ISO 9000:2005.
3.9
measurand
quantity intended to be measured
NOTE 1 The specification of a measurand in laboratory medicine requires knowledge of the kind of quantity (e.g., mass
concentration), a description of the matrix carrying the quantity (e.g., blood plasma), and the chemical entities involved
(e.g., the analyte).
EXAMPLES In “mass of protein in 24-hour urine”, “protein” is the analyte and “mass” is the property. In “concentration
of glucose in plasma”, “glucose” is the analyte and “concentration” is the property. In both cases, the full phrase
designates the measurand
NOTE 2 The measurand can be a biological activity.
NOTE 3 In chemistry, “analyte”, or the name of a substance or compound, are terms sometimes used for “measurand”.
This usage is erroneous because these terms do not refer to quantities.
[ISO/IEC Guide 99:2007, definition 2.3]
3.10
measurement
process of experimentally obtaining one or more quantity values that can reasonably be attributed to a
quantity
NOTE 1 Measurement implies comparison of quantities or counting of entities.
NOTE 2 Measurement presupposes description of the quantity commensurate with the intended use of the
measurement result, of a measurement procedure, and of a calibrated measuring system operating according to the
specified measurement.
NOTE 3 The operations can be performed automatically.
[ISO/IEC Guide 99:2007, definition 2.1]
3.11
measurement accuracy
accuracy of measurement
accuracy
closeness of the agreement between a measured quantity value, and a true quantity value of the measurand
NOTE 1 The concept ‘measurement accuracy’ is not a quantity and is not given a numerical quantity value. A
measurement is said to be more accurate when it offers a smaller measurement error.
NOTE 2 The term “measurement accuracy” should not be used for measurement trueness and the term measurement
precision should not be used for ‘measurement accuracy’, which, however, is related to both these concepts.
NOTE 3 ‘Measurement accuracy’ is sometimes understood as closeness of agreement between measured quantity
values that are being attributed to the measurand
[ISO/IEC Guide 99:2007, definition 2.13]
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3.12
measurement precision
precision
closeness of agreement between indications or measured quantity values obtained by replicate
measurements on the same or similar objects under specified conditions
NOTE 1 Measurement precision is usually expressed numerically by measures of imprecision, such as standard
deviation, variance, or coefficient of variation under the specified conditions of measurement.
NOTE 2 The specified conditions can be, for example, repeatability conditions of measurement, intermediate precision
conditions of measurement, or reproducibility conditions of measurement (see ISO 5725-5 [78]).
NOTE 3 Measurement precision is used to define measurement repeatability, intermediate measurement precision and
measurement reproducibility.
NOTE 4 Replicate measurements means measurements that are obtained in a manner not influenced by a previous
measurement on the same or similar sample.
[ISO/IEC Guide 99:2007, definition 2.15]
3.13
measurement trueness
trueness of measurement
trueness
closeness of agreement between the average of an infinite number of replicate measured quantity values and
a reference quantity value
NOTE 1 Measurement trueness is not a quantity and cannot be expressed numerically, but measures for closeness of
agreement are given in ISO 5725-3.
NOTE 2 Measurement trueness is inversely related to systematic measurement error (measurement bias or bias is an
estimate of systematic measurement error), but is not related to random error measurement.
NOTE 3 The term “measurement trueness” should not be used for “measurement accuracy” and vice versa.
[ISO/IEC Guide 99:2007, definition 2.14]
3.14
measurement uncertainty
uncertainty of measurement
non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand,
based on the information used
NOTE 1 Measurement uncertainty includes components arising from systematic effects, such as components
associated with corrections and the assigned quantity values of measurement standards, as well as the definitional
uncertainty. Sometimes estimated systematic effects are not corrected for but instead associated measurement
uncertainty components are incorporated.
NOTE 2 The parameter cannot be negative. The parameter might be, for example, a standard deviation called
standard measurement uncertainty (or a specified multiple of it), or the half-width of an interval, having a stated coverage
probability.
NOTE 3 The standard measurement uncertainty that is obtained from the measurement results of the input quantities
in a measurement model is called combined standard measurement uncertainty. The product of a combined standard
meas
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