INTERNATIONAL ISO

STANDARD 15189

Fourth edition
2022-12

Medical laboratories — Requirements

for quality and competence
Laboratoires de biologie médicale — Exigences concernant la qualité
et la compétence

iTeh STANDARD PREVIEW

(standards.iteh.ai)
ISO 15189:2022
https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
15189-2022

Reference number
ISO 15189:2022(E)

© ISO 2022
ISO 15189:2022(E)

iTeh STANDARD PREVIEW

(standards.iteh.ai)
ISO 15189:2022
https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
15189-2022

COPYRIGHT PROTECTED DOCUMENT

© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: [email protected]
Website: www.iso.org
Published in Switzerland

ii  © ISO 2022 – All rights reserved


 ISO 15189:2022(E)

Contents Page

Foreword........................................................................................................................................................................................................................................ vi
Introduction..............................................................................................................................................................................................................................vii
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references...................................................................................................................................................................................... 1
3 Terms and definitions..................................................................................................................................................................................... 1
4 General requirements..................................................................................................................................................................................... 8
4.1 Impartiality................................................................................................................................................................................................ 8
4.2 Confidentiality......................................................................................................................................................................................... 8
4.2.1 Management of information...................................................................................................................................... 8
4.2.2 Release of information................................................................................................................................................... 9
4.2.3 Personnel responsibility.............................................................................................................................................. 9
4.3 Requirements regarding patients.......................................................................................................................................... 9
5 Structural and governance requirements................................................................................................................................. 9
5.1 Legal entity................................................................................................................................................................................................. 9
5.2 Laboratory director......................................................................................................................................................................... 10
5.2.1 Laboratory director competence....................................................................................................................... 10
5.2.2 Laboratory director responsibilities.............................................................................................................. 10
5.2.3 Delegation of duties....................................................................................................................................................... 10
5.3
iTeh STANDARD PREVIEW
Laboratory activities....................................................................................................................................................................... 10
5.3.1 General...................................................................................................................................................................................... 10
5.3.2 Conformance with requirements...................................................................................................................... 10
(standards.iteh.ai)
5.3.3 Advisory activities.......................................................................................................................................................... 10
5.4 Structure and authority............................................................................................................................................................... 11
5.4.1 General...................................................................................................................................................................................... 11
5.4.2 Quality management ISO.....................................................................................................................................................
15189:2022 11
https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
5.5 Objectives and policies.................................................................................................................................................................. 11
5.6 15189-2022
Risk management............................................................................................................................................................................... 12
6 Resource requirements..............................................................................................................................................................................12
6.1 General......................................................................................................................................................................................................... 12
6.2 Personnel................................................................................................................................................................................................... 12
6.2.1 General...................................................................................................................................................................................... 12
6.2.2 Competence requirements...................................................................................................................................... 12
6.2.3 Authorization...................................................................................................................................................................... 13
6.2.4 Continuing education and professional development..................................................................... 13
6.2.5 Personnel records........................................................................................................................................................... 13
6.3 Facilities and environmental conditions....................................................................................................................... 13
6.3.1 General...................................................................................................................................................................................... 13
6.3.2 Facility controls................................................................................................................................................................. 14
6.3.3 Storage facilities............................................................................................................................................................... 14
6.3.4 Personnel facilities......................................................................................................................................................... 14
6.3.5 Sample collection facilities...................................................................................................................................... 14
6.4 Equipment................................................................................................................................................................................................. 15
6.4.1 General...................................................................................................................................................................................... 15
6.4.2 Equipment requirements.......................................................................................................................................... 15
6.4.3 Equipment acceptance procedure.................................................................................................................... 15
6.4.4 Equipment instructions for use.......................................................................................................................... 15
6.4.5 Equipment maintenance and repair............................................................................................................... 15
6.4.6 Equipment adverse incident reporting......................................................................................................... 16
6.4.7 Equipment records......................................................................................................................................................... 16
6.5 Equipment calibration and metrological traceability....................................................................................... 17
6.5.1 General...................................................................................................................................................................................... 17
6.5.2 Equipment calibration................................................................................................................................................. 17

© ISO 2022 – All rights reserved  iii

ISO 15189:2022(E)

6.5.3 Metrological traceability of measurement results............................................................................ 17

6.6 Reagents and consumables....................................................................................................................................................... 18
6.6.1 General...................................................................................................................................................................................... 18
6.6.2 Reagents and consumables — Receipt and storage.......................................................................... 18
6.6.3 Reagents and consumables — Acceptance testing............................................................................ 18
6.6.4 Reagents and consumables — Inventory management................................................................. 18
6.6.5 Reagents and consumables — Instructions for use.......................................................................... 19
6.6.6 Reagents and consumables — Adverse incident reporting....................................................... 19
6.6.7 Reagents and consumables — Records....................................................................................................... 19
6.7 Service agreements.......................................................................................................................................................................... 19
6.7.1 Agreements with laboratory users.................................................................................................................. 19
6.7.2 Agreements with POCT operators.................................................................................................................... 19
6.8 Externally provided products and services............................................................................................................... 20
6.8.1 General...................................................................................................................................................................................... 20
6.8.2 Referral laboratories and consultants.......................................................................................................... 20
6.8.3 Review and approval of externally provided products and services................................ 20
7 Process requirements.................................................................................................................................................................................. 21
7.1 General......................................................................................................................................................................................................... 21
7.2 Pre-examination processes....................................................................................................................................................... 21
7.2.1 General...................................................................................................................................................................................... 21
7.2.2 Laboratory information for patients and users.................................................................................... 21
7.2.3 Requests for providing laboratory examinations............................................................................... 21
7.2.4 Primary sample collection and handling.................................................................................................... 22
iTeh STANDARD PREVIEW
7.2.5 Sample transportation................................................................................................................................................ 23
7.2.6 Sample receipt.................................................................................................................................................................... 24
7.2.7 Pre-examination handling, preparation, and storage.................................................................... 24
7.3 (standards.iteh.ai)
Examination processes................................................................................................................................................................. 25
7.3.1 General...................................................................................................................................................................................... 25
7.3.2 Verification of examination methods............................................................................................................. 25
7.3.3 Validation of examinationISO methods 15189:2022 ................................................................................................................ 25
https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
7.3.4 Evaluation of measurement uncertainty (MU)..................................................................................... 26
7.3.5 Biological reference intervals 15189-2022
and clinical decision limits......................................................... 26
7.3.6 Documentation of examination procedures............................................................................................ 27
7.3.7 Ensuring the validity of examination results......................................................................................... 27
7.4 Post-examination processes..................................................................................................................................................... 30
7.4.1 Reporting of results....................................................................................................................................................... 30
7.4.2 Post-examination handling of samples........................................................................................................ 32
7.5 Nonconforming work...................................................................................................................................................................... 33
7.6 Control of data and information management......................................................................................................... 33
7.6.1 General...................................................................................................................................................................................... 33
7.6.2 Authorities and responsibilities for information management............................................. 33
7.6.3 Information systems management.................................................................................................................. 34
7.6.4 Downtime plans................................................................................................................................................................ 34
7.6.5 Off site management..................................................................................................................................................... 34
7.7 Complaints............................................................................................................................................................................................... 34
7.7.1 Process...................................................................................................................................................................................... 34
7.7.2 Receipt of complaint...................................................................................................................................................... 35
7.7.3 Resolution of complaint.............................................................................................................................................. 35
7.8 Continuity and emergency preparedness planning............................................................................................ 35
8 Management system requirements............................................................................................................................................... 35
8.1 General requirements.................................................................................................................................................................... 35
8.1.1 General...................................................................................................................................................................................... 35
8.1.2 Fulfilment of management system requirements.............................................................................. 36
8.1.3 Management system awareness......................................................................................................................... 36
8.2 Management system documentation............................................................................................................................... 36
8.2.1 General...................................................................................................................................................................................... 36
8.2.2 Competence and quality............................................................................................................................................ 36

iv  © ISO 2022 – All rights reserved


 ISO 15189:2022(E)

8.2.3 Evidence of commitment........................................................................................................................................... 36

8.2.4 Documentation.................................................................................................................................................................. 36
8.2.5 Personnel access............................................................................................................................................................... 36
8.3 Control of management system documents............................................................................................................... 37
8.3.1 General...................................................................................................................................................................................... 37
8.3.2 Control of documents................................................................................................................................................... 37
8.4 Control of records.............................................................................................................................................................................. 37
8.4.1 Creation of records......................................................................................................................................................... 37
8.4.2 Amendment of records............................................................................................................................................... 37
8.4.3 Retention of records...................................................................................................................................................... 38
8.5 Actions to address risks and opportunities for improvement................................................................... 38
8.5.1 Identification of risks and opportunities for improvement....................................................... 38
8.5.2 Acting on risks and opportunities for improvement....................................................................... 38
8.6 Improvement.......................................................................................................................................................................................... 39
8.6.1 Continual improvement............................................................................................................................................. 39
8.6.2 Laboratory patients, user, and personnel feedback.......................................................................... 39
8.7 Nonconformities and corrective actions....................................................................................................................... 39
8.7.1 Actions when nonconformity occurs............................................................................................................. 39
8.7.2 Corrective action effectiveness........................................................................................................................... 40
8.7.3 Records of nonconformities and corrective actions......................................................................... 40
8.8 Evaluations.............................................................................................................................................................................................. 40
8.8.1 General...................................................................................................................................................................................... 40
8.8.2 Quality indicators............................................................................................................................................................ 40
8.8.3 Internal audits.................................................................................................................................................................... 40
8.9 iTeh STANDARD PREVIEW
Management reviews...................................................................................................................................................................... 41
8.9.1 General...................................................................................................................................................................................... 41
(standards.iteh.ai)
8.9.2 Review input........................................................................................................................................................................ 41
8.9.3 Review output..................................................................................................................................................................... 41
Annex A (normative) Additional requirements for Point-of-Care Testing (POCT)..........................................43
ISO 15189:2022
Annex B (informative) Comparison between ISO 9001:2015 and ISO 15189:2022 (this
https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
document)................................................................................................................................................................................................................
15189-2022 44
Annex C (informative) Comparison between ISO 15189:2012 and ISO 15189:2022 (this
document).................................................................................................................................................................................................................54
Bibliography.............................................................................................................................................................................................................................. 61

© ISO 2022 – All rights reserved  v

ISO 15189:2022(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
iTeh STANDARD PREVIEW
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
(standards.iteh.ai)
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in
vitro diagnostic test systems, in collaboration with the European Committee for Standardization (CEN)
ISO 15189:2022
Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement
https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
on technical cooperation between ISO and CEN (Vienna Agreement).
15189-2022
This fourth edition cancels and replaces the third edition (ISO 15189:2012), which has been technically
revised. It also replaces ISO 22870:2016.
The main changes are as follows:
— Alignment with ISO/IEC 17025:2017 resulted in the management requirements now appearing at
the end of the document;
— Requirements for point-of-care testing (POCT), previously in ISO 22870, have been incorporated;
— Increased emphasis on risk management.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

vi  © ISO 2022 – All rights reserved


 ISO 15189:2022(E)

Introduction
The objective of this document is to promote the welfare of patients and satisfaction of laboratory users
through confidence in the quality and competence of medical laboratories.
This document contains requirements for the medical laboratory to plan and implement actions
to address risks and opportunities for improvement. Benefits of this approach include: increasing
the effectiveness of the management system, decreasing probability of invalid results, and reducing
potential harm to patients, laboratory personnel, the public and the environment.
The requirements for risk management are aligned with the principles of ISO 22367.
The requirements for laboratory safety are aligned with the principles of ISO 15190.
The requirements for sample collection and transport are aligned with ISO 20658.1)
This document contains the requirements for point-of-care testing (POCT) and supersedes ISO 22870,
which will be withdrawn upon publication of this document.
The format of this document is based on ISO/IEC 17025:2017.
The medical laboratory is essential to patient care; activities are provided within an ethical and
governance framework, that recognizes the obligations of healthcare providers to the patient. These
activities are undertaken in a timely manner to meet the needs of all patients and the personnel
responsible for the care of those patients. Activities include arrangements for examination requests,
iTeh STANDARD PREVIEW
patient preparation, patient identification, collection of samples, transportation, processing of patient
samples, selection of examinations that are fit for intended use, examination of samples, sample storage,
(standards.iteh.ai)
as well as subsequent interpretation, result reporting and advice to laboratory users. This may also
include the provision of results to the patient, arrangements for urgent testing and the notification of
critical results.
ISO 15189:2022
While this document is intended for use throughout the currently recognized medical laboratory
https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
disciplines, it can effectively be applied to other healthcare services, such as diagnostic imaging,
15189-2022
respiratory therapy, physiological sciences, blood banks and transfusion services.
The use of this document facilitates cooperation between medical laboratories and other healthcare
services, assists in the exchange of information, and in the harmonization of methods and procedures.
The comparability of patient examination results between medical laboratories, regardless of city or
country, is facilitated when medical laboratories conform to this document.
When a laboratory seeks accreditation, it should select an accreditation body which operates in
accordance with ISO/IEC 17011, and which takes into account the particular requirements of medical
laboratories.
Comparisons between this document, ISO 9001:2015 and ISO/IEC 17025:2017 are in Annex  B. The
comparison of ISO 15189:2012 to ISO 15189:2022 (this document) is in Annex C.

1) First edition under preparation (previous edition was a Technical Specification). Stage at the time of publication:
ISO/DIS 20658:2022.

© ISO 2022 – All rights reserved  vii

 iTeh STANDARD PREVIEW
(standards.iteh.ai)
ISO 15189:2022
https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
15189-2022
INTERNATIONAL STANDARD ISO 15189:2022(E)

Medical laboratories — Requirements for quality and

competence

1 Scope
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and
assessing their competence. It is also applicable for confirming or recognizing the competence of
medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics
covered in this document.

2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
iTeh STANDARD PREVIEW
constitutes requirements 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.

associated terms (VIM)

(standards.iteh.ai)
ISO/IEC  Guide  99:2007, International vocabulary of metrology — Basic and general concepts and

NOTE ISO/IEC Guide 99 is also known ISO

as the15189:2022
Joint Committee for Guides in Metrology (JCGM) 200.
https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
ISO/IEC 17000:2020, Conformity assessment — Vocabulary and general principles
15189-2022
ISO/IEC 17025:2017, 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/IEC Guide 99 and
ISO/IEC 17000 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://​w ww​.iso​.org/​obp
— IEC Electropedia: available at https://​w ww​.electropedia​.org/​
3.1
bias
measurement bias
estimate of a systematic measurement error
Note 1 to entry: This definition only applies to quantitative measurements

[SOURCE: ISO/IEC Guide 99:2007, 2.18, modified — Note 1 to entry has been added.]

© ISO 2022 – All rights reserved  1

ISO 15189:2022(E)

3.2
biological reference interval
reference interval
specified interval of the distribution of values taken from a biological reference population
Note  1  to entry:  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  to entry:  A reference interval can depend upon the type of primary sample (3.25) and the examination
procedure (3.9) used.

Note 3 to entry: In some cases, only one biological reference limit is important, usually an upper limit, “x”, so that
the corresponding biological reference interval would be less than or equal to “x”.

Note 4 to entry: Terms such as ‘normal range’, ‘normal values’, and ‘clinical range’ are ambiguous and therefore
discouraged.

[SOURCE: ISO 18113-1:2022, 3.1.9, modified — The EXAMPLE has been removed.]
3.3
clinical decision limit
examination (3.8) result that indicates a higher risk of adverse clinical outcomes, or is diagnostic for the
presence of a specifc disease
Note 1 to entry: Clinical decision limits for therapeutic drugs are called "therapeutic range".

iTeh STANDARD PREVIEW

Note 2 to entry: It is used to determine risk of disease, to diagnose or to treat.

3.4
(standards.iteh.ai)
commutability of a reference material
commutability
property of a reference material, demonstrated by the closeness of agreement between the relation
ISO 15189:2022
among the measurement results for a stated quantity in this material, obtained according to two given
https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
measurement procedures and the relation obtained among the measurement results for other specified
materials 15189-2022
Note 1 to entry: The reference material in question is usually a calibrator and the other specified materials are
usually routine samples.

Note 2 to entry: It is typical that there are more than two measurement procedures available and comparison
among all applicable measurement procedures is desirable.

Note  3  to entry:  Closeness of agreement of measurement results is defined in terms of fitness for purpose as
appropriate for the intended use of the reference material.

Note  4  to entry:  A commutability statement is restricted to the measurement procedures as specified in a

particular comparison.

[SOURCE: ISO 17511:2020 3.10, modified — Note 2 to entry has been replaced by a new Note 2 to entry.]
3.5
competence
demonstrated ability to apply knowledge and skills to achieve intended results
[SOURCE: ISO/IEC 17021-1:2015, 3.7, modified — "demonstrated" added to the beginning of the
definition.]

2  © ISO 2022 – All rights reserved


 ISO 15189:2022(E)

3.6
complaint
expression of dissatisfaction by any person or organization to a laboratory (3.20), relating to the
activities or results of that laboratory, where a response is expected
[SOURCE: ISO/IEC 17000:2020, 8.7, modified — The words “other than appeal” have been deleted, and
the words “a conformity assessment body or accreditation body, relating to the activities of that body”
have been replaced by “a laboratory, relating to the activities or results of that laboratory”.]
3.7
consultant
person who provides expert advice professionally
3.8
examination
set of operations having the objective of determining the numerical value, text value or characteristics
of a property
Note  1  to entry:  An examination may be the total of a number of activities, observations or measurements
required to determine a value or characteristic.

Note 2 to entry: Laboratory examinations that determine a numerical value of a property are called "quantitative
examinations"; those that determine the characteristics of a property are called "qualitative examinations".

Note 3 to entry: Laboratory examinations are also called "assays" or "tests".

3.9 iTeh STANDARD PREVIEW

examination procedure
(standards.iteh.ai)
specifically described set of operations used in the performance of an examination (3.8) according to a
given method
Note 1 to entry: In the IVD medical deviceISO
industry and in many laboratories that use IVD medical devices, an
15189:2022
examination procedure for an analyte in a biological sample is commonly referred to as an analytical method,
https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
analytical procedure or test procedure.
15189-2022
[SOURCE: ISO 15198:2004, 3.7, modified — “set of operations described specifically” changed to
“specifically described set of operations”.]
3.10
external quality assessment
EQA
evaluation of participant performance against pre-established criteria by means of interlaboratory
comparisons
Note 1 to entry: Also known as proficiency testing (PT)

[SOURCE: ISO/IEC 17043:2010, 3.7 modified — The term “external quality assessment”, which was
given in Note 2 to entry, is used as the main term. Notes to entry 1 and 2 have been omitted and a new
Note 1 to entry added.]
3.11
impartiality
objectivity with regard to the outcome of tasks performed by the medical laboratory (3.20)
Note 1 to entry: Objectivity can be understood as freedom from bias or freedom from conflicts of interest.

Note  2  to entry:  Other terms that are useful in conveying the element of impartiality include “independence”,
“lack of prejudice”, “neutrality”, “fairness”, “open-mindedness”, “even-handedness”, “detachment”, “balance”.

[SOURCE: ISO/IEC 17000:2020 5.3 modified — “outcome of a conformity assessment activity” has been
changed to “tasks performed by the medical laboratory”. Note 2 to entry has been added.]

© ISO 2022 – All rights reserved  3


ISO 15189:2022(E)

3.12
interlaboratory comparison
organization, performance and evaluation of measurements or examinations (3.8) on the same or similar
materials by two or more independent laboratories in accordance with pre-determined conditions
[SOURCE: ISO/IEC 17043:2010 3.4, modified — "tests" has been replaced by "examinations". "items" has
been replaced by "materials". "laboratories" has been replaced by "independent laboratories".]
3.13
internal quality control
IQC
quality control
QC
internal procedure which monitors the testing process to verify the system is working correctly and
gives confidence that the results are reliable enough to be released
[SOURCE: ISO/TS 22583:2019 3.9, modified — “decide” has been replaced by “verify”. Note 1 to entry
has been removed. ]
3.14
in vitro diagnostic medical device
IVD medical device
device, whether used alone or in combination, intended by the manufacturer for the in vitro examination
of specimens derived from the human body solely or principally to provide information for diagnostic,
monitoring or compatibility purposes and including reagents, calibrators, control materials, specimen
iTeh STANDARD PREVIEW
receptacles, software, and related instruments or apparatus or other articles

definition. "and including reagents,(standards.iteh.ai)

[SOURCE: ISO 18113-1:2022, 3.1.33, modified — "medical" has been removed from the beginning of the
calibrators, control materials, specimen receptacles, software, and
related instruments or apparatus or other articles" has been added to the end of the definition. Notes 1
and 2 to entry have been removed.] ISO 15189:2022
3.15 https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
laboratory management 15189-2022
person(s) with responsibility for, and authority over a laboratory (3.20)
Note 1 to entry: Laboratory management has the power to delegate authority and provide resources within the
laboratory.

Note  2  to entry:  The laboratory management includes the laboratory director(s) and delegates together with
individuals specifically assigned to ensure the quality of the activities of the laboratory.

3.16
laboratory user
individual or entity requesting services of the medical laboratory (3.20)
Note 1 to entry: Users can include patients, clinicians, and, other laboratories or institutions that send samples
for examination.

3.17
management system
set of interrelated or interacting elements of an organization to establish policies and objectives, and
processes to achieve those objectives
Note 1 to entry: This was formerly referred to and is synonymous with “quality management system”.

Note  2  to entry:  The management system elements establish the organization’s structure, roles and
responsibilities, planning, operation, policies, practices, rules, beliefs, objectives, and processes to achieve those
objectives.

[SOURCE: ISO 9000:2015, 3.5.3 modified — Notes to entry 1, 3 and 4 have been removed and a new
Note 1 to entry has been added.]

4  © ISO 2022 – All rights reserved


 ISO 15189:2022(E)

3.18
measurement accuracy
accuracy of measurement
accuracy
closeness of agreement between a measured quantity value and a true quantity value of a measurand
Note  1  to entry:  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 to entry: 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 to entry: ‘Measurement accuracy’ is sometimes understood as closeness of agreement between measured

quantity values that are being attributed to the measurand.

[SOURCE: ISO/IEC Guide 99:2007, 2.13]

3.19
measurement uncertainty
MU
non-negative parameter characterizing the dispersion of the quantity values being attributed to a
measurand, based on the information used
Note  1  to entry:  MU includes components arising from systematic effects, as in the case of corrections to the
assigned quantity values of measurement standards. Sometimes estimated systematic effects are not corrected
iTeh STANDARD PREVIEW
for, but instead, the associated MU components are incorporated.

multiple of it), or the half-width(standards.iteh.ai)

Note 2 to entry: The parameter may be, for example, a standard deviation (SD) called standard MU (or a specified
of an interval, having a stated coverage probability.

Note  3  to entry:  MU comprises, in general, of many components. Some of these may be evaluated by Type  A
ISO 15189:2022
evaluation of MU from the statistical distribution of the quantity values from series of measurements and can
behttps://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
characterized by SD. The other components, which may be evaluated by Type B evaluation of MU, can also be
characterized by SD or evaluated from probability density functions based on experience or other information.
15189-2022
Note 4 to entry: In general, for a given set of information, it is understood that the MU is associated with a stated
quantity value attributed to the measurand. A modification of this value may result in a modification of the
associated uncertainty.

Note  5  to entry:  All measurements have bias (3.1) and imprecision. For example, replicate measurements of a
sample performed under repeatability conditions generally produce different values for the same measurand.
Because the different values could all be reasonably attributed to the same amount of measurand, there is
uncertainty as to which value should be reported as the value of the measurand.

Note 6 to entry: Based on available data about the analytical performance of a given measurement procedure,
an estimation of MU provides an interval of values that is believed to include the actual value of the measurand,
with a stated level of confidence.

Note  7  to entry:  Available data about the analytical performance of a given measurement procedure typically
comprise uncertainty of calibrator assigned values and long-term imprecision of IQC materials.

Note 8 to entry: In medical laboratories, most measurements are performed in singleton, and are taken to be an
acceptable estimate of the value of the measurand, while the MU interval indicates other results that are also
possible.

[SOURCE: ISO/IEC Guide 99:2007 2.26, modified — Notes to entry 5 to 8 have been added from
ISO/TS 20914:2019 3.26.]

© ISO 2022 – All rights reserved  5


ISO 15189:2022(E)

3.20
medical laboratory
laboratory
entity for the examination (3.8) of materials derived from the human body for the purpose of providing
information for the diagnosis, monitoring, management, prevention and treatment of disease, or
assessment of health
Note 1 to entry: The laboratory can also provide advice covering all aspects of examinations including appropriate
selection, the interpretation of results and advice on further examinations.

Note  2  to entry:  Laboratory activities include pre-examination (3.24), examination (3.8) and post-examination
processes (3.23).

Note 3 to entry: Materials for examination (3.8) include but are not limited to, microbiological, immunological,
biochemical, immunohaematological, haematological, biophysical, cytological, tissue and cells, and genetic
material.

3.21
patient
person who is the source of material for an examination (3.8)
3.22
point-of-care testing
POCT
examination (3.8) performed near or at the site of a patient (3.21)
iTeh STANDARD PREVIEW
[SOURCE: ISO/TS 22583:2019, 3.11]
3.23
post-examination processes (standards.iteh.ai)
processes following the examination (3.8) including review of results, formatting, releasing, reporting
and retention of examination results, retentionISO storage of clinical material, sample (3.28) and waste
and 15189:2022
disposalhttps://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
3.24 15189-2022
pre-examination processes
processes that start, in chronological order, from the user’s request and include the examination (3.8)
request, preparation and identification of the patient (3.21), collection of the primary sample(s) (3.25),
transportation to and within the laboratory (3.20), ending when the examination (3.8) begins
3.25
primary sample
specimen
discrete portion of a body fluid or tissue or other sample associated with the human body taken for
examination (3.8), study or analysis of one or more quantities or characteristics to determine the
character of the whole
Note  1  to  entry:  The International Medical Device Regulators Forum (IMDRF) uses the term specimen in its
harmonized guidance documents to mean a sample of biological origin intended for examination by a medical
laboratory (3.20).

[SOURCE: ISO 18113-1:2022, 3.1.65, modified — Note 1 to entry has been modified. Note 2 to entry has
been deleted.]
3.26
quality indicator
measure of the degree to which a large number of characteristics of an object fulfils requirements
Note 1 to entry: 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.

6  © ISO 2022 – All rights reserved


 ISO 15189:2022(E)

Note 2 to entry: Quality indicators can measure how well an organization meets the needs and requirements of
users and the quality of all operational processes.

3.27
referral laboratory
external laboratory (3.20) to which a sample or data is submitted for examination (3.8)
Note 1 to entry: A referral laboratory is one to which laboratory management chooses to submit a sample or sub-
sample for examination, data for analysis or interpretation, or when routine examinations cannot be carried out.

Note 2 to entry: This differs from a laboratory to which submission of samples is required by regulation, or a so
called reference laboratory, e.g. public health, forensic, tumour registry, or a central (parent) facility to which
submission of samples is required by structure.

3.28
sample
one or more parts taken from a primary sample (3.25)
3.29
trueness
measurement trueness
closeness of agreement between the average of an infinite number of replicate measured quantity
values and a reference quantity value
Note 1 to entry: Measurement trueness is not a quantity and thus cannot be expressed numerically, but measures
for closeness of agreement are given in ISO 5725-1.
iTeh STANDARD PREVIEW
Note 2 to entry: Measurement trueness is inversely related to systematic measurement error, but is not related to
random measurement error.
(standards.iteh.ai)
Note 3 to entry: ‘Measurement accuracy” should not be used for ‘measurement trueness’.

ISO 15189:2022
Note  4  to entry:  For qualitative examinations, trueness of measurement (closeness of agreement) can be
expressed in terms of concordance (i.e. percent agreement with a reference examination).
https://standards.iteh.ai/catalog/standards/sist/bfa0676a-b5b4-4bd7-9a24-831505fcfb20/iso-
15189-2022
Note  5  to entry:  Trueness is a property of the examination procedure (3.9) that reflects the bias (3.1) of the
measurements from the expected or target value. It is described qualitatively as good or bad. An examination
procedure (3.9) has good trueness if the bias (3.1) of the measurements is acceptable.

[SOURCE: ISO/IEC Guide 99:2007, 2.14, modified — Notes to entry 4 and 5 have been added.]
3.30
turnaround time
elapsed time between two specified points through pre-examination (3.24), examination (3.8), and post-
examination processes (3.23)
3.31
validation
confirmation of plausibility for a specific intended use or application through the provision of objective
evidence that specified requirements have been fulfilled
Note 1 to entry: Objective evidence can be obtained through observation, measurement, examination or by other
means.

Note 2 to entry: The word “validated” is used to designate the corresponding status.

Note  3  to entry:  Specified requirements of an examination method may include the following performance
specifications: measurement trueness, measurement precision including measurement repeatability, and
measurement intermediate precision, analytical specificity, including interfering substances, detection limit and
quantitation limit, measuring interval, clinical relevance, diagnostic specificity and diagnostic sensitivity.

[SOURCE: ISO/IEC 17000:2020, 6.5, modified — Notes 1 to 3 to entry have been added.]

© ISO 2022 – All rights reserved  7