SIST EN ISO 15189:2013

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.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 19-Apr-2011
• Publication Date: 20-Feb-2013
• Withdrawal Date: 13-Feb-2023
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.100.01 - Laboratory medicine in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 14-Feb-2023
• Due Date: 09-Mar-2023
• Completion Date: 14-Feb-2023
• Directive: 765/2008 - REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
• Ref Project: EN ISO 15189:2012 - Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)

Relations

• Replaced By: SIST EN ISO 15189:2023 - Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
• Effective Date: 01-Mar-2023
• Replaces: SIST EN ISO 15189:2007 - Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007)
• Effective Date: 01-Mar-2013
• Replaces: SIST EN ISO 15189:2007 - Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15189:2013
01-marec-2013
1DGRPHãþD
SIST EN ISO 15189:2007
Medicinski laboratoriji - Zahteve za kakovost in kompetentnost (ISO 15189:2012)
Medical laboratories - Requirements for quality and competence (ISO 15189:2012)
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO
15189:2012)

Laboratoires d'analyses de biologie médicale - Exigences concernant la qualité et la

compétence (ISO 15189:2012)
Ta slovenski standard je istoveten z: EN ISO 15189:2012
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
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

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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.

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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 [e-mail]
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

© ISO 2012 – All rights reserved iii
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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

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.”

© ISO 2012 – All rights reserved v
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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
© ISO 2012 – All rights reserved 1
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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.

© ISO 2012 – All rights reserved 3
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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.
4 © ISO 2012 – All rights reserved
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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.
© ISO 2012 – All rights reserved 5
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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.
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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)
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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

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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.
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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
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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".
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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.
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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
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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
Management Centre: Avenue Marnix 17, B-1000 Brussels

© 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

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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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ii © ISO 2011 – All rights reserved
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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

© ISO 2010 – All rights reserved iii
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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

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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oSIST prEN ISO 15189:2011
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
...