EN ISO 15189:2012

Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.
ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO 15189:2012, korrigierte Fassung 2014-08-15)

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 de biologie médicale - Exigences concernant la qualité et la compétence (ISO 15189:2012, Version corrigée 2014-08-15)

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• Status: Withdrawn
• Publication Date: 31-Oct-2012
• Withdrawal Date: 13-Apr-2025
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.100.01 - Laboratory medicine in general
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140/WG 3 - Quality management in the medical laboratory
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 14-Dec-2022
• Completion Date: 14-Apr-2025
• 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
• Mandate: M/417 - Standardisation mandate addessed to CEN, CENELEC, and ETSI for the use of Harmonised Standards in support of the new legal framework and sectoral certification schemes
• Ref Project: SIST EN ISO 15189:2013 - Medical laboratories - Requirements for quality and competence (ISO 15189:2012)

Relations

• Replaces: EN ISO 15189:2007 - Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 15189:2022 - Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
• Effective Date: 26-Sep-2018

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2013
1DGRPHãþD
SIST EN ISO 15189:2007
Medicinski laboratoriji - Zahteve za kakovost in kompetentnost (ISO 15189:2012)
Medical laboratories - Requirements for quality and competence (ISO 15189:2012)
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO
15189:2012)
Laboratoires d'analyses de biologie médicale - Exigences concernant la qualité et la
compétence (ISO 15189:2012)
Ta slovenski standard je istoveten z: EN ISO 15189:2012
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 15189
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2012
ICS 03.120.10; 11.100.01 Supersedes EN ISO 15189:2007
English Version
Medical laboratories - Requirements for quality and competence
(ISO 15189:2012)
Laboratoires de biologie médicale - Exigences concernant Medizinische Laboratorien - Anforderungen an die Qualität
la qualité et la compétence (ISO 15189:2012) und Kompetenz (ISO 15189:2012)
This European Standard was approved by CEN on 31 October 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15189:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 15189:2012) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee CEN/TC 140
“In vitro diagnostic medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the
latest by November 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15189:2007.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15189:2012 has been approved by CEN as a EN ISO 15189:2012 without any modification.

INTERNATIONAL ISO
STANDARD 15189
Third edition
2012-11-01
Medical laboratories — Requirements for
quality and competence
Laboratoires de biologie médicale — Exigences concernant la qualité et
la compétence
Reference number
ISO 15189:2012(E)
©
ISO 2012
ISO 15189:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO 15189:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Management requirements . 5
4.1 Organization and management responsibility . 5
4.2 Quality management system . 8
4.3 Document control . 9
4.4 Service agreements .10
4.5 Examination by referral laboratories . 11
4.6 External services and supplies .12
4.7 Advisory services .12
4.8 Resolution of complaints .12
4.9 Identification and control of nonconformities .12
4.10 Corrective action .13
4.11 Preventive action .13
4.12 Continual improvement .14
4.13 Control of records .14
4.14 Evaluation and audits .15
4.15 Management review .17
5 Technical requirements .18
5.1 Personnel .18
5.2 Accommodation and environmental conditions .20
5.3 Laboratory equipment, reagents, and consumables .22
5.4 Pre-examination processes .25
5.5 Examination processes .28
5.6 Ensuring quality of examination results .31
5.7 Post-examination processes .33
5.8 Reporting of results .33
5.9 Release of results .35
5.10 Laboratory information management .36
Annex A (informative) Correlation with ISO 9001:2008 and ISO/IEC 17025:2005 .38
Annex B (informative) Comparison of ISO 15189:2007 to ISO 15189:2012 .43
Bibliography .47
ISO 15189:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15189 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic
test systems.
This third edition cancels and replaces the second edition (ISO 15189:2007), which has been technically revised.
A correlation between the second and third editions of this International Standard is provided as Annex B. The
third edition continues the alignment established in ISO/IEC 17025:2005.
iv © ISO 2012 – All rights reserved

ISO 15189:2012(E)
Introduction
This International Standard, based upon ISO/IEC 17025 and ISO 9001, specifies requirements for competence
1)
and quality that are particular to medical laboratories . It is acknowledged that a country could have its own
specific regulations or requirements applicable to some or all its professional personnel and their activities and
responsibilities in this domain.
Medical laboratory services are essential to patient care and therefore have to be available to meet the needs
of all patients and the clinical personnel responsible for the care of those patients. Such services include
arrangements for examination requests, patient preparation, patient identification, collection of samples,
transportation, storage, processing and examination of clinical samples, together with subsequent interpretation,
reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work.
Whenever allowed by national, regional or local regulations and requirements, it is desirable that medical
laboratory services include the examination of patients in consultation cases, and that those services actively
participate in the prevention of disease in addition to diagnosis and patient management. Each laboratory
should also provide suitable educational and scientific opportunities for professional staff working with it.
While this International Standard is intended for use throughout the currently recognized disciplines of medical
laboratory services, those 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.”
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 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

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 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

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 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) where potential conflicts in competing interests may exist, they shall be openly and appropriately declared;
d) there are appropriate procedures to ensure that staff treat human samples, tissues or remains according
to relevant legal requirements;
e) confidentiality of information is maintained.
4.1.1.4 Laboratory director
The laboratory shall be directed by a person or persons with the competence and delegated responsibility for
the services provided.
The responsibilities of the laboratory director shall include professional, scientific, consultative or advisory,
organizational, administrative and educational matters relevant to the services offered by the laboratory.
The laboratory director may delegate selected duties and/or responsibilities to qualified personnel; however,
the laboratory director shall maintain the ultimate responsibility for the overall operation and administration of
the laboratory.
The duties and responsibilities of the laboratory director shall be documented.
The laboratory director (or the designates for delegated duties) shall have the necessary competence, authority
and resources in order to fulfil the requirements of this International Standard.
The laboratory director (or designate/s) shall:
a) provide effective leadership of the medical laboratory service, including budget planning and financial
management, in accordance with institutional assignment of such responsibilities;
b) relate and function effectively with applicable accrediting and regulatory agencies, appropriate
administrative officials, the healthcare community, and the patient population served, and providers of
formal agreements, when required;
c) ensure that there are appropriate numbers of staff with the required education, training and competence
to provide medical laboratory services that meet the needs and requirements of the users;
d) ensure the implementation of the quality policy;
e) implement a safe laboratory environment in compliance with good practice and applicable requirements;
f) serve as a contributing member of the medical staff for those facilities served, if applicable and appropriate;
g) ensure the provision of clinical advice with respect to the choice of examinations, use of the service and
interpretation of examination results;
h) select and monitor laboratory suppliers;
i) select referral laboratories and monitor the quality of their service (see also 4.5);
j) provide professional development programmes for laboratory staff and opportunities to participate in
scientific and other activities of professional laboratory organizations;
k) define, implement and monitor standards of performance and quality improvement of the medical laboratory
service or services;
6 © ISO 2012 – All rights reserved

ISO 15189:2012(E)
NOTE This may be done within the context of the various quality improvement committees of the parent
organization, as appropriate, where applicable.
l) monitor all work performed in the laboratory to determine that clinically relevant information is being generated;
m) address any complaint, request or suggestion from staff and/or users of laboratory services (see also 4.8,
4.14.3 and 4.14.4);
n) design and implement a contingency plan to ensure that essential services are available during emergency
situations or other conditions when laboratory services are limited or unavailable;
NOTE Contingency plans should be periodically tested.
o) plan and direct research and development, where appropriate.
4.1.2 Management responsibility
4.1.2.1 Management commitment
Laboratory management shall provide evidence of its commitment to the development and implementation of
the quality management system and continually improve its effectiveness by:
a) communicating to laboratory personnel the importance of meeting the needs and requirements of users
(see 4.1.2.2) as well as regulatory and accreditation requirements;
b) establishing the quality policy (see 4.1.2.3);
c) ensuring that quality objectives and planning are established (see 4.1.2.4);
d) defining responsibilities, authorities and interrelationships of all personnel (see 4.1.2.5);
e) establishing communication processes (see 4.1.2.6);
f) appointing a quality manager, however named (see 4.1.2.7);
g) conducting management reviews (see 4.15);
h) ensuring that all personnel are competent to perform their assigned activities (see 5.1.6);
i) ensuring availability of adequate resources (see 5.1, 5.2 and 5.3) to enable the proper conduct of pre-
examination, examination and post-examination activities (see 5.4, 5,5, and 5.7).
4.1.2.2 Needs of users
Laboratory management shall ensure that laboratory services, including appropriate advisory and interpretative
services, meet the needs of patients and those using the laboratory services. (see also 4.4 and 4.14.3).
4.1.2.3 Quality policy
Laboratory management shall define the intent of its quality management system in a quality policy. Laboratory
management shall ensure that the quality policy:
a) is appropriate to the purpose of the organization;
b) includes a commitment to good professional practice, examinations that are fit for intended use,
compliance with the requirements of this International Standard, and continual improvement of the quality
of laboratory services;
c) provides a framework for establishing and reviewing quality objectives;
d) is communicated and understood within the organization;
e) is reviewed for continuing suitability.
ISO 15189:2012(E)
4.1.2.4 Quality objectives and planning
Laboratory management shall establish quality objectives, including those needed to meet the needs and
requirements of the users, at relevant functions and levels within the organization. The quality objectives shall
be measurable and consistent with the quality policy.
Laboratory management shall ensure that planning of the quality management system is carried out to meet
the requirements (see 4.2) and the quality objectives.
Laboratory management shall ensure that the integrity of the quality management system is maintained when
changes to the quality management system are planned and implemented.
4.1.2.5 Responsibility, authority and interrelationships
Laboratory management shall ensure that responsibilities, authorities and interrelationships are defined,
documented and communicated within the laboratory organization. This shall include the appointment
of person(s) responsible for each laboratory function and appointment of deputies for key managerial and
technical personnel.
NOTE It is recognized that in smaller laboratories individuals can have more than one function and that it could be
impractical to appoint deputies for every function.
4.1.2.6 Communication
Laboratory management shall have an effective means for communicating with staff (see also 4.14.4). Records
shall be kept of items discussed in communications and meetings.
Laboratory management shall ensure that appropriate communication processes are established between
the laboratory and its stakeholders and that communication takes place regarding the effectiveness of the
laboratory’s pre-examination, examination and post-examination processes and quality management system.
4.1.2.7 Quality manager
Laboratory management shall appoint a quality manager who shall have, irrespective of other responsibilities,
delegated responsibility and authority that includes:
a) ensuring that processes needed for the quality management system are established, implemented,
and maintained;
b) reporting to laboratory management, at the level at which decisions are made on laboratory policy, objectives,
and resources, on the performance of the quality management system and any need for improvement;
c) ensuring the promotion of awareness of users’ needs and requirements throughout the laboratory
organization.
4.2 Quality management system
4.2.1 General requirements
The laboratory shall establish, document, implement and maintain a quality management system and continually
improve its effectiveness in accordance with the requirements of this International Standard.
The quality management system shall provide for the integration of all processes required to fulfil its quality
policy and objectives and meet the needs and requirements of the users.
The laboratory shall:
a) determine the processes needed for the quality management system and ensure their application
throughout the laboratory;
b) determine the sequence and interaction of these processes;
8 © ISO 2012 – All rights reserved

ISO 15189:2012(E)
c) determine criteria and methods needed to ensure that both the operation and control of these processes
are effective;
d) ensure the availability of resources and information necessary to support the operation and monitoring of
these processes;
e) monitor and evaluate these processes;
f) implement actions necessary to achieve planned results and continual improvement of these processes.
4.2.2 Documentation requirements
4.2.2.1 General
The quality management system documentation shall include:
a) statements of a quality policy (see 4.1.2.3) and quality objectives (see 4.1.2.4);
b) a quality manual (see 4.2.2.2);
c) procedures and records required by this International Standard;
d) documents, and records (see 4.13), determined by the laboratory to ensure the effective planning, operation
and control of its processes;
e) copies of applicable regulations, standards and other normative documents.
NOTE The documentation can be in any form or type of medium, providing it is readily accessible and protected from
unauthorized changes and undue deterioration.
4.2.2.2 Quality manual
The laboratory shall establish and maintain a quality manual that includes:
a) the quality policy (4.1.2.3) or makes reference to it;
b) a description of the scope of the quality management system;
c) a presentation of the organization and management structure of the laboratory and its place in any parent
organization;
d) a description of the roles and responsibilities of laboratory management (including the laboratory director
and quality manager) for ensuring compliance with this International Standard;
e) a description of the structure and relationships of the documentation used in the quality management system;
f) the documented policies established for the quality management system and reference to the managerial
and technical activities that support them.
All laboratory staff shall have access to and be instructed on the use and application of the quality manual and
the referenced documents.
4.3 Document control
The laboratory shall control documents required by the quality management system and shall ensure that
unintended use of any obsolete document is prevented.
NOTE 1 Documents that should be considered for document control are those that may vary based on changes
in versions or time. Examples include policy statements, instructions for use, flow charts, procedures, specifications,
forms, calibration tables, biological reference intervals and their origins, charts, posters, notices, memoranda, software
documentation, drawings, plans, agreements, and documents of external origin such as regulations, standards and text
books from which examination procedures are taken.
ISO 15189:2012(E)
NOTE 2 Records contain information from a particular point in time stating results achieved or providing evidence of
activities performed and are maintained according to the requirements given in 4.13, Control of records.
The laboratory shall have a documented procedure to ensure that the following conditions are met.
a) All documents, including those maintained in a computerized system, issued as part of the quality
management system are reviewed and approved by authorized personnel before issue.
b) All documents are identified to include:
— a title;
— a unique identifier on each page;
— the date of the current edition and/or edition number;
— page number to total number of pages (e.g. “Page 1 of 5,” “Page 2 of 5,”);
— authority for issue.
NOTE ‘Edition’ is used to mean one of a number of printings issued at separate times that incorporates alterations
and amendments. ‘Edition’ can be regarded as synonymous with ‘revision or version’.
c) Current authorized editions and their distribution are identified by means of a list (e.g. document register,
log or master index).
d) Only current, authorized editions of applicable documents are available at points of use.
e) Where a laboratory’s document control system allows for the amendment of documents by hand, pending
the re-issue of documents, the procedures and authorities for such amendments are defined, amendments
are clearly marked, initialled and dated, and a revised document is issued within a specified time period.
f) Changes to documents are identified.
g) Documents remain legible.
h) Documents are periodically reviewed and updated at a frequency that ensures that they remain fit for purpose.
i) Obsolete controlled documents are dated and marked as obsolete.
j) At least one copy of an obsolete controlled document is retained for a specified time period or in accordance
with applicable specified requirements.
4.4 Service agreements
4.4.1 Establishment of service agreements
The laboratory shall have documented procedures for the establishment and review of agreements for providing
medical laboratory services.
Each request accepted by the laboratory for examination(s) shall be considered an agreement.
Agreements to provide medical laboratory services shall take into account the request, the examination and the
report. The agreement shall specify the information needed on the request to ensure appropriate examination
and result interpretation.
The following conditions shall be met when the laboratory enters into an agreement to provide medical
laboratory services.
a) The requirements of the customers and users, and of the provider of the laboratory services, including the
examination processes to be used, shall be defined, documented and understood (see 5.4.2 and 5.5).
b) The laboratory shall have the capability and resources to meet the requirements.
10 © ISO 2012 – All rights reserved

ISO 15189:2012(E)
c) Laboratory personnel shall have the skills and expertise necessary for the performance of the intended
examinations.
d) Examination procedures selected shall be appropriate and able to meet the customers’ needs (see 5.5.1).
e) Customers and users shall be informed of deviations from the agreement that impact
...

SLOVENSKI SIST EN ISO 15189
STANDARD
marec 2013
Medicinski laboratoriji – Zahteve za kakovost in kompetentnost

(ISO 15189:2012)
Medical laboratories – Requirements for quality and competence

(ISO 15189:2012)
Laboratoires d'analyses de biologie médicale – Exigences concernant la qualité

et la compétence (ISO 15189:2012)

Medizinische Laboratorien – Anforderungen an die Qualität und Kompetenz

(ISO 15189:2012)
Referenčna oznaka
ICS 03.120.10 ; 11.100.01 SIST EN ISO 15189:2013 (sl, en)

Nadaljevanje na straneh II in III ter od 1 do 91

© 2014-11. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 15189 : 2013
NACIONALNI UVOD
Standard SIST EN ISO 15189 (sl, en), Medicinski laboratoriji – Zahteve za kakovost in kompetentnost
(ISO 15189:2012), 2013, ima status slovenskega standarda in je istoveten evropskemu standardu
EN ISO 15189 (en, de, fr), Medical laboratories – Requirements for quality and competence
(ISO 15189:2012), 2012.
Ta dokument nadomešča SIST EN ISO 15189:2007.
NACIONALNI PREDGOVOR
Evropski standard EN ISO 15189:2012 je pripravil tehnični odbor ISO/TC 212 Preskušanje kliničnih
laboratorijev ter diagnostični sistemi in vitro v sodelovanju s tehničnim odborom Evropskega komiteja
za standardizacijo CEN/TC 140 Diagnostični medicinski sistemi in vitro. Slovenski standard SIST EN
ISO 15189:2013 je prevod evropskega standarda EN ISO 15189:2012. V primeru spora glede
besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard.
Slovenski prevod standarda SIST EN ISO 15189:2013 je pripravila delovna skupina strokovnjakov iz
naslednjih nacionalnih tehničnih odborov SIST/TC VAZ Varovanje zdravje, SIST/TC VZK Vodenje in
zagotavljenje kakovosti in SIST/TC UGA Ugotavljanje skladnosti.
Odločitev za izdajo tega standarda je dne 7. februarja 2013 sprejel SIST/TC VAZ Varovanje zdravja.
ZVEZA S STANDARDI
S privzemom tega evropskega standarda veljajo za omenjeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo:
SIST EN ISO/IEC 17000 Ugotavljanje skladnosti – Slovar in splošna načela (enakovreden z
ISO/IEC 17000:2004)
SIST EN ISO/IEC 17025:2005 Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih
laboratorijev (ISO/IEC 17025:2005)
SIST-V ISO/IEC Vodilo 99 Mednarodni slovar za meroslovje – Osnovni in splošni koncepti ter z
njimi povezani izrazi (VIM)
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 15189:2012
PREDHODNA IZDAJA
SIST EN ISO 15189:2007, Medicinski laboratoriji – Posebne zahteve za kakovost in usposobljenost
(ISO 15189:2007)
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v
– Uvod in nacionalni predgovor nista sestavni del standarda.
II
SIST EN ISO 15189 : 2013
– Ta nacionalni dokument je istoveten EN ISO 15189:2012 in je objavljen z dovoljenjem
CEN Management Centre
Avenue Marnix 17
B-1000 Bruxelles
Belgija
This national document is identical with EN ISO 15189:2012 and is published with the permission of
CEN Management Centre
Avenue Marnix 17
B-1000 Bruxelles
Belgium
III
SIST EN ISO 15189 : 2013
(Prazna stran)
IV
EVROPSKI STANDARD EN ISO 15189
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM november 2012

ICS 03.120.10; 11.100.01 Nadomešča EN ISO 15189:2007

Slovenska izdaja
Medicinski laboratoriji – Zahteve za kakovost in kompetentnost
(ISO 15189:2012)
Medical laboratories – Laboratoires d'analyses de biologie Medizinische Laboratorien –
Requirements for quality and médicale – Exigences concernant Anforderungen an die Qualität und
competence (ISO 15189:2012) la qualité et la compétence (ISO Kompetenz
15189:2012) (ISO 15189:2012)
Ta evropski standard je CEN sprejel 31. oktobra 2012.

Člani CEN morajo izpolnjevati notranje predpise CEN/CENELEC, s katerim je predpisano, da mora biti
ta standard brez kakršnih koli sprememb sprejet kot nacionalni standard. Najnovejši seznami teh
nacionalnih standardov z njihovimi bibliografskimi podatki se na zahtevo lahko dobijo pri Upravnem
centru CEN-CENELEC ali pri katerem koli članu CEN.

Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru
CEN-CENELEC, veljajo kot uradne izdaje.

Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Nekdanje jugoslovanske republike Makedonije, Nemčije, Nizozemske, Norveške,
Poljske, Portugalske, Romunije, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in Združenega
kraljestva.
CEN
Evropski komite za standardizacijo
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung

Upravni center: Avenue Marnix 17, B-1000 Brussels

© 2012 CEN. Lastnice avtorskih pravic so vse države članice CEN Ref. oznaka: EN ISO 15189:2012: E

SIST EN ISO 15189 : 2013
VSEBINA StranCONTENTS Page
Predgovor k evropskemu standardu . 3 Foreword to the European standard .3
Predgovor k mednarodnemu standardu. 4 Foreword to the International standard.4
Uvod.5 Introduction.5
1 Področje uporabe . 7 1 Scope .7
2 Zveza s standardi . 7 2 Normative references.7
3 Izrazi in definicije . 7 3 Terms and definitions.7
4 Zahteve za vodenje . 13 4 Management requirements .13
4.1 Organizacija in odgovornost vodstva . 13 4.1 Organization and management
responsibility.13
4.2 Sistem vodenja kakovosti. 18 4.2 Quality management system .18
4.3 Obvladovanje dokumentov. 20 4.3 Document control.20
4.4 Storitvene pogodbe .21 4.4 Service agreements .21
4.5 Preiskava, ki jo opravijo prejemni 4.5 Examination by referral laboratories .23
laboratoriji . 23
4.6 Zunanje storitve in nabava  4.6 External services and supplies .24
materialnih sredstev. 24
4.7 Svetovanje. 24 4.7 Advisory services .24
4.8 Reševanje pritožb. 25 4.8 Resolution of complaints.25
4.9 Identifikacija in obvladovanje  4.9 Identification and control of
neskladnosti.25 nonconformities .25
4.10 Korektivni ukrepi. 26 4.10 Corrective action .26
4.11 Preventivni ukrepi.26 4.11 Preventive action.26
4.12 Nenehno izboljševanje . 27 4.12 Continual improvement .27
4.13 Obvladovanje zapisov . 27 4.13 Control of records.27
4.14 Vrednotenje in presoje . 29 4.14 Evaluation and audits.29
4.15 Vodstveni pregled. 32 4.15 Management review.32
5 Tehnične zahteve . 34 5 Technical requirements.34
5.1 Osebje . 34 5.1 Personnel .34
5.2 Prostori in okoljske razmere. 37 5.2 Accommodation and environmental
conditions .37
5.3 Laboratorijska oprema, reagenti  5.3 Laboratory equipment, reagents, and
in potrošni material . 39    consumables.39
5.4 Predpreiskovalni procesi . 45 5.4 Pre-examination processes .45
5.5 Preiskovalni procesi . 50 5.5 Examination processes.50
5.6 Zagotavljanje kakovosti rezultatov  5.6 Ensuring quality of examination results .55
preiskav. 55
5.7 Popreiskovalni procesi . 58 5.7 Post-examination processes.58
5.8 Poročanje o rezultatih.59 5.8 Reporting of results.59
5.9 Izdajanje rezultatov.61 5.9 Release of results .61
5.10 Vodenje informacij laboratorija. 63 5.10 Laboratory information management.63
Dodatek A (informativni): Primerjava z  Annex A (informative): Correlation with
ISO 9001:2008 in ISO/IEC 17025:2005 . 66 ISO 9001:2008 and ISO/IEC 17025:2005.67
Dodatek B (informativni): Primerjava  Annex B (informative): Comparison of
ISO 15189:2007 z ISO 15189:2012 . 76 ISO 15189:2007 to ISO 15189:2012.77
Literatura.86 Bibliography.86
SIST EN ISO 15189 : 2013
Predgovor k evropskemu standardu Foreword to the European standard

Ta dokument (EN ISO 15189:2012) je pripravil This document (EN ISO 15189:2012) has been
tehnični odbor ISO/TC 212 "Preskušanje prepared by Technical Committee ISO/TC 212
kliničnih laboratorijev ter diagnostični sistemi in "Clinical laboratory testing and in vitro
vitro" v sodelovanju s tehničnim odborom diagnostic test systems" in collaboration with
CEN/TC 140 "Diagnostični medicinski Technical Committee CEN/TC 140 “In vitro
pripomočki in vitro", katerega sekretariat vodi diagnostic medical devices” the secretariat of
DIN. which is held by DIN.
Ta evropski standard mora dobiti status This European Standard shall be given the
nacionalnega standarda bodisi z objavo status of a national standard, either by
istovetnega besedila ali z razglasitvijo najpozneje publication of an identical text or by
maja 2013, nasprotujoče nacionalne standarde pa endorsement, at the latest by May 2013, and
je treba razveljaviti najpozneje novembra 2015. conflicting national standards shall be
withdrawn at the latest by November 2015.

Ta dokument nadomešča EN ISO 15189:2007. This document supersedes EN ISO 15189: 2007.

V skladu z notranjimi predpisi CEN/CENELEC According to the CEN/CENELEC Internal Regu-
morajo ta evropski standard obvezno uvesti lations, the national standards organisations of the
nacionalne organizacije za standardizacijo following countries are bound to implement this
naslednjih držav: Avstrije, Belgije, Bolgarije, European Standard: Austria, Belgium, Bulgaria,
Cipra, Češke republike, Danske, Estonije, Croatia, Cyprus, Czech Republic, Denmark,
Finske, Francije, Grčije, Hrvaške, Irske, Estonia, Finland, Former Yugoslav Republic of
Islandije, Italije, Latvije, Litve, Luksemburga, Macedonia, France, Germany, Greece, Hungary,
Madžarske, Malte, Nekdanje jugoslovanske Iceland, Ireland, Italy, Latvia, Lithuania,
republike Makedonije, Nemčije, Nizozemske, Luxembourg, Malta, Netherlands, Norway,
Norveške, Poljske, Portugalske, Romunije, Poland, Portugal, Romania, Slovakia, Slovenia,
Slovaške, Slovenije, Španije, Švedske, Švice, Spain, Sweden, Switzerland, Turkey and the
Turčije in Združenega kraljestva. United Kingdom.

Razglasitvena objava Endorsement notice

Besedilo standarda ISO 15189:2012 je CEN The text of ISO 15189:2012 has been approved
odobril brez sprememb kot evropski standard by CEN as EN ISO 15189:2012 without any
SIST EN ISO 15189 : 2013
Predgovor k mednarodnemu standardu Foreword to the International standard

ISO (Mednarodna organizacija za ISO (the International Organization for
Standardization) is a worldwide federation of
standardizacijo) je svetovna zveza nacionalnih
organov za standarde (članov ISO). national standards bodies (ISO member bodies).
Mednarodne standarde po navadi pripravljajo The work of preparing International Standards is
tehnični odbori ISO. Vsak član, ki želi delovati normally carried out through ISO technical
na določenem področju, za katero je bil committees. Each member body interested in a
ustanovljen tehnični odbor, ima pravico biti subject for which a technical committee has been
established has the right to be represented on
zastopan v tem odboru. Pri delu sodelujejo tudi
mednarodne vladne in nevladne organizacije, that committee. International organizations,
povezane z ISO. V vseh zadevah, ki so governmental and non-governmental, in liaison
povezane s standardizacijo na področju with ISO, also take part in the work. ISO
elektrotehnike, ISO tesno sodeluje z collaborates closely with the International
Mednarodno elektrotehniško komisijo (IEC). Electrotechnical Commission (IEC) on all matters
of electrotechnical standardization.

Mednarodni standardi so pripravljeni skladno s International Standards are drafted in
pravili, podanimi v 2. delu Direktiv ISO/IEC. accordance with the rules given in the ISO/IEC
Directives, Part 2.
Glavna naloga tehničnih odborov je priprava The main task of technical committees is to
mednarodnih standardov. Osnutki mednarodnih prepare International Standards. Draft
standardov, ki jih sprejmejo tehnični odbori, se International Standards adopted by 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
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".

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.

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
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 za izvedbo aktivnosti ali specified way to carry out an activity or a process
procesa, ki je dokumentiran, izveden in vzdrževan that is documented, implemented and maintained

OPOMBA 1: Zahteva za dokumentiran postopek je lahko NOTE 1 The requirement for a documented
podana v enem samem dokumentu ali v procedure may be addressed in a single
več dokumentih. document or by more than one document.

OPOMBA 2: Prirejeno po ISO 9000:2005, definicija 3.4.5. NOTE 2 Adapted from ISO 9000:2005, definition 3.4.5.
SIST EN ISO 15189 : 2013
3.7 3.7
preiskava examination
niz postopkov, katerih cilj je določiti vrednost ali set of operations having the object of determining
značilnosti posamezne lastnosti the value or characteristics of a property

OPOMBA 1: V nekaterih strokah (npr. v mikrobiologiji) je NOTE 1: In some disciplines (e.g. microbiology) an
preiskava celota večjega števila preskusov, examination is the total activity of a number
opazovanj ali meritev. of tests, observations or measurements.

OPOMBA 2: Laboratorijske preiskave, ki določajo NOTE 2 Laboratory examinations that determine a
vrednost neke lastnosti, se imenujejo value of a property are called quantitative
kvantitativne preiskave; tiste, ki določajo examinations; those that determine the
značilnosti neke lastnosti, pa se imenujejo characteristics of a property are called
kvalitativne preiskave. qualitative examinations.

OPOMBA 3: Laboratorijske preiskave se pogosto NOTE 3 Laboratory examinations are also often
imenujejo tudi testi ali preskusi. called assays or tests.

3.8 3.8
medlaboratorijska primerjava  interlaboratory comparison

organiziranje, izvedba in ovrednotenje meritev organization, performance and evaluation of
ali preskusov, ki jih na istih ali podobnih measurements or tests on the same or similar
preskušancih oziroma vzorcih opravita dva ali items by two or more laboratories in
več laboratorijev skladno z vnaprej določenimi accordance with predetermined conditions
pogoji
[ISO/IEC 17043:2010, definicija 3.4] [ISO/IEC 17043:2010, definition 3.4]

3.9 3.9
vodja laboratorija laboratory director
oseba(-e) z odgovornostjo in pooblastili za person(s) with responsibility for, and authority
laboratorij over, a laboratory

OPOMBA 1: V tem mednarodnem standardu se NOTE 1: For the purposes of this International
ustrezna oseba ali osebe označujejo s Standard, the person or persons referred to
skupnim imenom vodja laboratorija. are designated collectively as "laboratory
director".
OPOMBA 2: Glede kvalifikacij in usposabljanja se lahko NOTE 2: National, regional and local regulations may
uporabljajo nacionalni, regionalni ali lokalni apply with regard to qualifications and
predpisi. training.
3.10 3.10
vodstvo laboratorija laboratory management
oseba(-e), ki usmerja(-jo) in vodi(-jo) aktivnosti person(s) who direct and manage the activities
laboratorija of a laboratory
OPOMBA: Izraz "vodstvo laboratorija" je sopomenka NOTE The term ‘laboratory management’ is
izraza "najvišje vodstvo" v ISO 9000:2005. synonymous with the term ‘top
management’ in ISO 9000:2005.
3.11 3.11
medicinski laboratorij medical laboratory
klinični laboratorij clinical laboratory
laboratorij za izvajanje bioloških, mikrobioloških, laboratory for the biological, microbiological,
imunoloških, kemijskih, imunohematoloških, immunological, chemical, immunohaematological,
hematoloških, biofizikalnih, citoloških, patoloških, haematological, biophysical, cytological, patho-
genetskih ali drugih preiskav materialov, logical, geneticor other examination of materials
pridobljenih iz človeškega telesa, z namenom derived from the human body for the purpose of
pridobiti podatke za postavitev diagnoze, providing information for the diagnosis,
obvladovanje, preprečevanje bolezni in management, prevention and treatment of
SIST EN ISO 15189 : 2013
zdravljenje ljudi ali za ocenjevanje njihovega disease in, or assessment of the health of, human
zdravja in ki lahko zagotavlja tudi svetovalne beings, and which may provide a consultant
storitve, ki zajemajo vse vidike laboratorijskih advisory service covering all aspects of laboratory
preiskav, vključno z interpretacijo rezultatov in investigation including the interpretation of results
svetovanjem o ustreznih nadaljnjih preiskavah and advice on further appropriate investigation

OPOMBA: Te preiskave zajemajo tudi postopke za NOTE These examinations also include
določanje, merjenje ali drugačno opisovanje procedures for determining, measuring or
prisotnosti ali odsotnosti različnih substanc otherwise describing the presence or
absence of various substances or
ali mikroorganizmov.
microorganisms.
3.12  3.12
neskladnost nonconformity
neizpolnjevanje zahteve nonfulfillment of a requirement

[ISO 22870:2006, definicija 3.1] [ISO 22870:2006, definition 3.1]

3.13 3.13
testiranje ob pacientu point-of-care testing
POCT POCT
testiranje v bližini pacienta near patient testing
testiranje, ki se izvaja v bližini pacienta ali ob testing performed near or at the site of a
pacientu, s tem da rezultat privede do možne patient, with the result leading to possible
spremembe pri oskrbi pacienta change in the care of the patient

[ISO 22870:2006, definicija 3.1] [ISO 22870:2006, definition 3.1]

3.14 3.14
popreiskovalni postopki post-examination procedures
poanalitska faza postanalytical phase
procesi, ki sledijo preiskavi, vključno s processes following the examination including
pregledom rezultatov, hrambo in skladiščenjem review of results, retention and storage of
kliničnega materiala, odlaganjem vzorcev (in clinical material, sample (and waste) disposal,
odpadkov) ter oblikovanjem, sproščanjem, and formatting, releasing, reporting and
poročanjem in hrambo rezultatov preiskav retention of examination results

3.15 3.15
predpreiskovalni procesi  pre-examination processes
predanalitska faza preanalytical phase
procesi, ki se po kronološkem vrstnem redu processes that start, in chronological order,
začnejo z naročilom zdravnika ter vključujejo from the clinician’s request and include the
naročilo preiskave, pripravo in identifikacijo examination request, preparation and
pacienta, odvzem primarnega(-ih) vzorca(-ev) identification of the patient, collection of the
ter transport do laboratorija in v njem, končajo primary sample(s), and transportation to and
pa, ko se začne analitska preiskava within the laboratory, and end when the
analytical examination begins
3.16 3.16
primarni vzorec primary sample
vzorec specimen
del telesne tekočine, vzorec izdihanega zraka, discrete portion of a body fluid, breath, hair or
las ali tkivo, odvzeti za preiskavo, preučitev ali tissue taken for examination, study or analysis
analizo ene ali več veličin ali lastnosti, ki of one or more quantities or properties
domnevno veljajo za celoto assumed to apply for the whole

OPOMBA 1: Delovna skupina za svetovno usklajevanje NOTE 1 Global Harmonisation Task Force (GHTF)
(Global Harmonisation Task Force – GHTF) uses the term specimen in its harmonized
uporablja v svojih usklajevalnih dokumentih z guidance documents to mean a sample of
navodili izraz vzorec s pomenom "vzorec biological origin intended for examination by
SIST EN ISO 15189 : 2013
biološkega izvora, namenjen preiskavi v a medical laboratory.
medicinskem laboratoriju".
OPOMBA 2: V nekaterih dokumentih ISO in CEN je NOTE 2 In some ISO and CEN documents, a
vzorec definiran kot “biološki vzorec, ki specimen is defined as “a biological sample
izvira iz človeškega telesa". derived from the human body”.

OPOMBA 3: V nekaterih državah se namesto izraza NOTE 3 In some countries, the term “specimen” is
primarni vzorec (ali njegov podvzorec) used instead of primary sample (or a
uporablja izraz "vzorec", pomeni pa vzorec, subsample of it), which is the sample
ki je pripravljen za pošiljanje v laboratorij ali prepared for sending to, or as received by,
ga laboratorij prejme in je namenjen za the laboratory and which is intended for
preiskavo. examination.
3.17 3.17
proces process
skupek med seboj povezanih ali medsebojno set of interrelated or interacting activities which
vplivajočih aktivnosti, ki pretvarjajo vhode v izhode transform inputs into outputs

OPOMBA 1: Vhodi v proces so na splošno izhodi drugih NOTE 1 Inputs to a process are generally outputs of
procesov. other processes.
OPOMBA 2: Prirejeno po ISO 9000:2005, definicija 3.4.1. NOTE 2 Adapted from ISO 9000:2005, definition 3.4.1.

3.18 3.18
kakovost quality
stopnja, do katere skupek svojstvenih degree to which a set of inherent characteristics
značilnosti izpolnjuje zahteve fulfils requirements

OPOMBA 1: Izraz “kakovost” se lahko uporablja s NOTE 1 The term “quality” can be used with
pridevniki, kot so slaba, dobra ali odlična. adjectives such as poor, good or excellent.

OPOMBA 2: "Svojstven" za razliko od "dodeljen" NOTE 2 “Inherent”, as opposed to “assigned”,
pomeni, da v nečem nekaj obstaja, zlasti means existing in something, especially as
kot trajna značilnost. a permanent characteristic.

[ISO 9000:2005, definicija 3.1.1] [ISO 9000:2005, definition 3.1.1]

3.19 3.19
kazalnik kakovosti quality indicator
merilo, v kolikšni meri skupek svojstvenih measure of the degree to which a set of
značilnosti izpolnjuje zahteve inherent characteristics fulfils requirements

OPOMBA 1: Merilo je na primer lahko izraženo kot
NOTE 1 Measure can be expressed, for example, as
odstotek donosnosti (odstotek znotraj % yield (% within specified requirements), %
določenih zahtev), odstotek napak (odstotek defects (% outside specified requirements),
zunaj določenih zahtev), napake na milijon defects per million occasions (DPMO) or on
priložnosti (DPMO) ali na lestvici Six Sigma. the Six Sigma scale.

OPOMBA 2: S kazalniki kakovosti se lahko meri, kako NOTE 2 Quality indicators can measure how well an
dobro organizacija izpolnjuje potrebe in organization meets the needs and
zahteve uporabnikov ter kakovost vseh requirements of users and the quality of all
delovnih procesov. operational processes.

PRIMER: Če je zahtevano, da morajo biti vsi vzorci EXAMPLE If the requirement is to receive all urine
urina, ki jih laboratorij prejme, neokuženi, je samples in the laboratory uncontaminated,
število prejetih okuženih vzorcev urina kot the number of contaminated urine samples
odstotek vseh prejetih vzorcev urina received as a % of all urine samples
(svojstvena značilnost procesa) merilo received (the inherent characteristic of the
kakovosti procesa. process) is a measure of the quality of the
process.
3.20 3.20
sistem vodenja kakovosti quality management system
sistem vodenja za usmerjanje in obvladovanje management system to direct and control an
organizacije glede kakovosti organization with regard to quality
SIST EN ISO 15189 : 2013
OPOMBA 1: Izraz "sistem vodenja kakovosti" iz te NOTE 1 The term “quality management system”
definicije se nanaša na splošne aktivnosti referred to in this definition relates to
vodenja, na priskrbo in vodenje virov, na general management activities, the
predpreiskovalne in popreiskovalne provision and management of resources,
procese ter na ovrednotenje in nenehno the pre-examination, examination and post-
izboljševanje. examination processes and evaluation and
continual improvement.
OPOMBA 2: Prirejeno po ISO 9000:2005, definicija 3.2.3. NOTE 2 Adapted from ISO 9000:2005, definition 3.2.3

3.21 3.21
politika kakovosti quality policy
splošni nameni in usmeritev laboratorija v zvezi overall intentions and direction of a laboratory
s kakovostjo, ki jih formalno izrazi vodstvo related to quality as formally expressed by
laboratorija laboratory management

OPOMBA 1: Politika kakovosti je na splošno usklajena s NOTE 1 Generally the quality policy is consistent
celovito politiko organizacije in tvori okvir za with the overall policy of an organization
zastavljanje ciljev kakovosti. and provides a framework for setting quality
objectives.
OPOMBA 2: Prirejeno po ISO 9000:2005, definicija 3.2.4. NOTE 2 Adapted from ISO 9000:2005, definition 3.2.4.

3.22 3.22
cilj kakovosti quality objective
nekaj, za kar se prizadeva ali na kar se meri v something sought, or aimed for, related to
zvezi s kakovostjo quality
OPOMBA 1: Cilji kakovosti so na splošno zasnovani na NOTE 1 Quality objectives are generally based on
podlagi politike kakovosti laboratorija. the laboratory’s quality policy.

OPOMBA 2: Cilji kakovosti so na splošno opredeljeni za NOTE 2 Quality objectives are generally specified
pomembne funkcije in ravni v organizaciji. for relevant functions and levels in the
organization.
OPOMBA 3: Prirejeno po ISO 9000:2005, definicija 3.2.5. NOTE 3 Adapted from ISO 9000:2005, definition 3.2.5.

3.23 3.23
prejemni laboratorij referral laboratory
zunanji laboratorij, kateremu se vzorec predloži external laboratory to which a sample is submitted
v preiskavo for examination
OPOMBA: Prejemni laboratorij je tisti, ki ga vodstvo NOTE A referral laboratory is one to which
laboratorija izbere, da mu predloži v
laboratory management chooses to submit
preiskavo vzorec ali podvzorec ali kadar a sample or sub-sample for examination or
sam ne more izvesti rutinskih preiskav. S when routine examinations cannot be
tem se razlikuje od laboratorija, ki lahko carried out. This differs from a laboratory
vključuje tudi javno zdravstvo, forenziko, that may include public health, forensics,
register raka ali centralni (matični) objekt, tumour registry, or a central (parent) facility
kateremu je po strukturi ali predpisu treba to which submission of samples is required
predložiti vzorce. by structure or regulation.

3.24 3.24
vzorec sample
eden ali več delov, odvzetih iz primarnega one or more parts taken from a primary sample
vzorca
PRIMER: Količina seruma, odvzeta iz večje količine EXAMPLE A volume of serum taken from a larger
seruma. volume of serum.
3.25 3.25
čas izvedbe turnaround time
čas, ki preteče med dvema določenima elapsed time between two specified points
točkama v predpreiskovalnih, preiskovalnih in through pre-examination, examination and post-
popreiskovalnih procesih examination processes
SIST EN ISO 15189 : 2013
3.26 3.26
validacija validation
potrditev na podlagi stvarnih dokazov, da so confirmation, through the provision of ob
...