Draft International Standard ISO DIS 15189 Medical Laboratories

DRAFT INTERNATIONAL STANDARD
ISO/DIS 15189
ISO/TC 212 Secretariat: ANSI

Voting begins on: Voting terminates on:
2021-10-19 2022-01-11
Medical laboratories — Requirements for quality and

competence
Laboratoires de biologie médicale — Exigences concernant la qualité et la compétence
ICS: 11.100.01; 03.120.10
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Contents Page
Foreword......................................................................................................................................................................................................................................... vi
Introduction............................................................................................................................................................................................................................... vii
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references....................................................................................................................................................................................... 1
3 Terms and definitions...................................................................................................................................................................................... 1
4 General requirements...................................................................................................................................................................................... 7
4.1 Impartiality................................................................................................................................................................................................. 7
4.2 Confidentiality.......................................................................................................................................................................................... 7
4.3 Requirements regarding patients............................................................................................................................................ 8
5 Structural and governance requirements................................................................................................................................... 8
5.1 Legal entity.................................................................................................................................................................................................. 8
5.2 Laboratory director............................................................................................................................................................................. 8
5.2.1 Laboratory director competence........................................................................................................................ 8
5.2.2 Laboratory director responsibilities............................................................................................................... 8
5.2.3 Delegation of duties....................................................................................................................................................... 9
5.3 Laboratory activities........................................................................................................................................................................... 9
5.3.1 Scope of laboratory activities................................................................................................................................. 9
5.3.2 Conformance with requirements....................................................................................................................... 9
5.3.3 Advisory activities........................................................................................................................................................... 9
5.4 Structure and authority.................................................................................................................................................................... 9
5.4.1 General...................................................................................................................................................................................... 9
5.4.2 Quality management.................................................................................................................................................. 10
5.5 Objectives and policies................................................................................................................................................................... 10
5.6 Risk management............................................................................................................................................................................... 10
6 Resource requirements...............................................................................................................................................................................11
6.1 General......................................................................................................................................................................................................... 11
6.2 Personnel................................................................................................................................................................................................... 11
6.2.1 General................................................................................................................................................................................... 11
6.2.2 Qualification, duties and responsibilities................................................................................................. 11
6.2.3 Training and competence assessment........................................................................................................ 11
6.2.4 Continuing education and professional development................................................................... 12
6.2.5 Authorization.................................................................................................................................................................... 12
6.3 Facilities and environmental conditions........................................................................................................................ 12
6.3.1 General................................................................................................................................................................................... 12
6.3.2 Facility controls.............................................................................................................................................................. 12
6.3.3 Storage facilities............................................................................................................................................................. 13
6.3.4 Personnel facilities....................................................................................................................................................... 13
6.3.5 Specimen collection facilities.............................................................................................................................. 13
6.4 Equipment................................................................................................................................................................................................. 13
6.4.1 General................................................................................................................................................................................... 13
6.4.2 Equipment requirements....................................................................................................................................... 13
6.4.3 Equipment acceptance testing........................................................................................................................... 14
6.4.4 Equipment instructions for use........................................................................................................................ 14
6.4.5 Equipment maintenance and repair............................................................................................................. 14
6.4.6 Equipment adverse incident reporting...................................................................................................... 14
6.4.7 Equipment records...................................................................................................................................................... 15
6.5 Equipment calibration and metrological traceability......................................................................................... 15
6.5.1 Metrological traceability of equipment and method...................................................................... 15
6.5.2 Metrological traceability of measurement results............................................................................ 16
6.6 Reagents and consumables........................................................................................................................................................ 16
6.6.1 Reagents and consumables - General.......................................................................................................... 16
6.6.2 Licensed
Reagents and consumables
to: White, Graham Professor - Receipt and storage............................................................................ 16
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6.6.3 Reagents and consumables - Acceptance testing.............................................................................. 17

6.6.4 Reagents and consumables - Inventory management................................................................... 17
6.6.5 Reagents and consumables - Instructions for use............................................................................ 17
6.6.6 Reagents and consumables - Adverse incident reporting.......................................................... 17
6.6.7 Reagents and consumables - Records......................................................................................................... 17
6.7 Service agreements........................................................................................................................................................................... 17
6.8 Externally provided products and services.................................................................................................................. 18
6.8.1 General................................................................................................................................................................................... 18
6.8.2 Referral laboratories and consultants....................................................................................................... 18
6.8.3 Review and approval of externally provided products and services................................ 18
7 Process requirements...................................................................................................................................................................................19
7.1 Pre-examination processes........................................................................................................................................................ 19
7.1.1 Laboratory information for patients and users.................................................................................. 19
7.1.2 Requests for providing laboratory examinations.............................................................................. 19
7.1.3 Primary sample collection and handling.................................................................................................. 20
7.1.4 Sample transportation.............................................................................................................................................. 21
7.1.5 Sample receipt................................................................................................................................................................. 22
7.1.6 Pre-examination handling, preparation, and storage.................................................................... 22
7.2 Examination processes.................................................................................................................................................................. 23
7.2.1 General................................................................................................................................................................................... 23
7.2.2 Verification of examination methods........................................................................................................... 23
7.2.3 Validation of examination methods............................................................................................................... 23
7.2.4 Measurement uncertainty of measured quantity values............................................................ 24
7.2.5 Biological reference intervals and clinical decision limits......................................................... 24
7.2.6 Documentation of examination procedures........................................................................................... 25
7.2.7 Ensuring the validity of examination results........................................................................................ 25
7.3 Post-examination processes...................................................................................................................................................... 28
7.3.1 Result reporting.............................................................................................................................................................. 28
7.3.2 Post-examination handling of samples...................................................................................................... 30
7.4 Nonconforming work...................................................................................................................................................................... 30
7.5 Control of data and information management.......................................................................................................... 31
7.5.1 General................................................................................................................................................................................... 31
7.5.2 Authorities and responsibilities for information management............................................ 31
7.5.3 Information systems management................................................................................................................ 31
7.5.4 Contingency plans........................................................................................................................................................ 32
7.5.5 Off site management................................................................................................................................................... 32
7.7 Continuity and emergency preparedness planning.............................................................................................. 32
8 Management system requirements................................................................................................................................................33
8.1 General requirements and options...................................................................................................................................... 33
8.2 Management system documentation................................................................................................................................ 34
8.2.1 General................................................................................................................................................................................... 34
8.2.2 Competence, impartiality, and consistency............................................................................................ 34
8.2.3 Evidence of commitment........................................................................................................................................ 34
8.2.4 Documentation................................................................................................................................................................ 34
8.2.5 Personnel access............................................................................................................................................................ 34
8.3 Control of management system documents................................................................................................................ 34
8.3.1 Control of Documents................................................................................................................................................ 34
8.3.2 Management of documents.................................................................................................................................. 34
8.4 Control of records............................................................................................................................................................................... 35
8.4.1 Creation of records....................................................................................................................................................... 35
8.4.2 Amendment of records............................................................................................................................................. 35
8.4.3 Retention of records................................................................................................................................................... 35
8.5 Actions to address risks and opportunities................................................................................................................. 35
8.5.1 Identification of risks and opportunities.................................................................................................. 35
8.5.2 Acting on risks................................................................................................................................................................. 36
8.6 Improvement.......................................................................................................................................................................................... 36
8.6.1 Continual
Licensed improvement
to: White, Graham ...........................................................................................................................................
Professor 36
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ISO/DIS 15189:2021(E)

8.6.2 Laboratory patients, user, and personnel feedback........................................................................ 36

8.7 Corrective Action................................................................................................................................................................................. 37
8.7.1 Actions when nonconformity occurs........................................................................................................... 37
8.7.2 Corrective action effectiveness.......................................................................................................................... 37
8.7.3 Records of nonconformities................................................................................................................................. 37
8.8 Evaluations............................................................................................................................................................................................... 37
8.8.1 General................................................................................................................................................................................... 37
8.8.2 Quality indicators.......................................................................................................................................................... 37
8.8.3 Internal audits.................................................................................................................................................................. 38
8.9 Management reviews...................................................................................................................................................................... 38
8.9.1 General................................................................................................................................................................................... 38
8.9.2 Review input...................................................................................................................................................................... 38
8.9.3 Review output.................................................................................................................................................................. 39
Annex A (informative) ......................................................................................................................................................................................................40
Annex B (informative) Comparison of ISO 15189:2012 to ISO 15189:2022.............................................................50
Bibliography.............................................................................................................................................................................................................................. 56

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ISO/DIS 15189:2021(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 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
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 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.
This fourth edition cancels and replaces the third edition ISO 15189:2012, which has been technically
revised.
The fourth edition provides alignment with ISO/IEC 17025:2017
Correlations between this document, ISO 9001:2015 and ISO/IEC 17025:2017 are in Annex A. The
comparison of ISO 15189:2012 to ISO 15189:2022 is in Annex B.
Any feedback or questions on this document should be directed through the user’s national standards
body. A complete listing of these bodies can be found at www.iso.org/members.html.

vi © ISO 2021 – All rights reserved
ISO/DIS 15189:2021(E)

Introduction
This document is based upon ISO/IEC 17025:2017 General requirements for the competence of testing and
calibration laboratories. It has been developed with the objective of promoting the welfare of patients
through confidence in the quality and competence of medical laboratories.
Because the primary consideration is the welfare of patients and the satisfaction of users, this document
contains requirements for the medical laboratory to plan and implement actions to address risks and
opportunities. This is the basis for increasing the effectiveness of the management system, achieving
improved results, and preventing negative effects which could result in harm to patients, laboratory
personnel, the public and the environment.
The requirements for risk management are aligned with the principles of ISO 22367:2020 Medical
laboratories – Application of risk management to medical laboratories.
The requirements for laboratory safety are aligned with the principles of ISO 15190:2020 Medical
laboratories – Requirements for Safety.
The requirements for sample collection and transport are aligned with ISO/TS 20658:2017 Medical
laboratories - Requirements for collection and transport of samples.
This document contains the requirements for point-of-care testing (POCT) and supersedes
ISO 22870:2016 Point-of-care testing (POCT) – Requirements for quality and competence, which is to be
withdrawn.
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,
patient preparation, patient identification, collection of samples, transportation, processing of clinical
samples, selection of examinations that are fit for intended use, examination of samples, sample
storage, together with subsequent interpretation, reporting and advice to users. This may also include
the provision of results to the patient, arrangements for urgent testing and the notification of critical
results. It is recommended that the medical laboratory provide advice on patient cases where indicated.
While this document is intended for use throughout the currently recognized medical laboratory
disciplines, it can effectively be applied to other healthcare services, such as diagnostic imaging,
respiratory therapy, physiological sciences, blood banks and transfusion services.
The use of this document will facilitate cooperation between medical laboratories and other healthcare
services, assist in the exchange of information, and in the harmonization of methods and procedures.
The consistency of results between countries is facilitated when medical laboratories conform to
this document. Also, laboratories conforming to this document will contribute to reduction of waste,
minimize repeat testing, and sometimes reduce carbon emissions.
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.
The management system requirements in Clause 8 are written in a language relevant to a medical
laboratory’s operations and meet the principles of ISO 9001:2015 Quality management systems –
Requirements.
In this document, the following verbal forms are used:
• ‘shall’ indicates a requirement;
• ‘should’ indicates a recommendation;
• ‘may’ indicates aLicensed
permission;
to: White, Graham Professor
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ISO/DIS 15189:2021(E)

• ‘can’ indicates a possibility or capability.

viii © ISO 2021 – All rights reserved
DRAFT INTERNATIONAL STANDARD ISO/DIS 15189:2021(E)
Medical laboratories — Requirements for quality and

competence
1 Scope
This document specifies requirements for quality and competence in medical laboratories.
This document can be used by medical laboratories in developing their management systems and
assessing their competence. It can also be used for confirming or recognizing the competence of medical
laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document includes requirements for Point of Care Testing (POCT).
NOTE International, national, or regional regulations or requirements may 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
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.
ISO/IEC 17000:2020, Conformity assessment — Vocabulary and general principles
ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories
ISO/IEC Guide 99:2007, International vocabulary of metrology — Basic and general concepts and
associated terms (VIM)
NOTE ISO/IEC Guide 99 is also known as the Joint Commission for Guides in Metrology (JCGM) 200.
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 terminological 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 applies to quantitative measurements only.
[SOURCE: ISO/IEC Guide 99:2007 2.18, Note has been added]

3.2
critical limit
critical decision limit
examination (3.6) result that indicates an immediate risk to the patient of injury or death
© ISO 2021 – All rights reserved 1
ISO/DIS 15189:2021(E)

3.3
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 (3.20) and the examination
method (3.7) used.
Note 3 to entry: 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 to entry: Terms such as ‘normal range’, ‘normal values’, and ‘clinical range’ are ambiguous and therefore
discouraged.
[SOURCE: ISO 18113-1]

3.4
commutability of a reference material
commutability
property of a reference material, demonstrated by the closeness of agreement between the relation
among the measurement results for a stated quantity in this material, obtained according to two given
measurement procedures (3.15) and the relation obtained among the measurement results for other
specified materials
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]

3.5
complaint
expression of dissatisfaction by any person or organization to a laboratory (3.18), 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”.]
3.6
examination
set of operations having the objective of determining the value or characteristics of a property
Note 1 to entry: An examination may be the total of a number of activities, observations or measurements.
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.

2 © ISO 2021 – All rights reserved
ISO/DIS 15189:2021(E)

3.7
examination method
detailed description of the different steps for processing a sample/specimen including the pre-
examination, examination and post-examination. An examination method can include a measurement
procedure (3.15)
3.8
impartiality
objectivity with regard to the outcome of tasks performed by the medical laboratory
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 17000-1:2020 2.2.3 modified — “outcome of a conformity assessment activity” has
been changed to “tasks performed by the medical laboratory”]
3.9
interlaboratory comparison
organization, performance and evaluation of measurements or examinations 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]
3.10
external quality assessment
EQA
evaluation of participant performance against pre-established criteria by means of interlaboratory
comparison (3.9)
Note 1 to entry: This is also known as proficiency testing (PT).
Note 2 to entry: External quality assessment (EQA) is an interlaboratory comparison organized by a provider
that distributes EQA materials as blinded samples with no prior knowledge of the results by the participants.
According to ISO/IEC 17043:2010 the EQA provider reports the findings to the participants in a way that
facilitates the verification of trueness, to establish the corrective actions needed and to assess the success of
prior corrective actions.
[SOURCE: ISO/IEC 17043:2010 3.7, modified — Term and definition are used here without the original
notes.]
3.11
internal quality control (IQC)
quality control (QC)
internal procedure which monitors the testing process to decide if the system is working correctly and
gives confidence that the results are reliable enough to be released
[SOURCE: ISO/TS 22583:2019 3.9]
3.12
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
receptacles, software, and related instruments or apparatus or other articles
[SOURCE: ISO 18113-1:2009 3.27]

ISO/DIS 15189:2021(E)

3.13
laboratory management
person(s) with responsibility for, and authority over a laboratory (3.18)
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.
3.14
management system
set of interrelated or interacting elements of an organization to establish objectives and policies, with
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 are omitted and a new Note 1 to
entry has been added]
3.15
measurement procedure
detailed description of a measurement according to one or more measurement principles and to a
given measurement method, based on a measurement model and including any calculation to obtain a
measurement result
Note 1 to entry: A measurement procedure is usually documented in sufficient detail to enable an operator to
perform a measurement.
Note 2 to entry: A measurement procedure can include a statement concerning a target measurement uncertainty
(3.17).
Note 3 to entry: A measurement procedure is sometimes called a standard operating procedure, abbreviated
SOP.
[SOURCE: ISO/IEC Guide 99:2007 2.6]

3.17
measurement uncertainty
MU
non-negative parameter characterizing the dispersion of the quantity values being attributed to a
measurement 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
for, but instead, the associated MU components are incorporated.
Note 2 to entry: The parameter may be, for example, a standard deviation (SD) called standard MU (or a specified
multiple of it), or the half-width 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
evaluation of MU from the statistical distribution of the quantity values from series of measurements and can
be 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.
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 results in a modification of the
associated uncertainty.

ISO/DIS 15189:2021(E)

Note 5 to entry: All measurements have bias 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 with Notes 5 and 6 replaced by Notes 5 to 8 from
ISO/TS 20914:2019]
3.18
medical laboratory
clinical laboratory
laboratory
an entity for the examination (3.6) of materials for the purpose of providing information for the
diagnosis, management, prevention and treatment of disease, or assessment of health; the laboratory
can also provide advice covering all aspects of examinations (3.6) including the interpretation of results
and advice on further examinations
3.19
point-of-care testing
POCT
examination (3.6) performed near or at the site of a patient
[SOURCE: ISO22583:2019 3.11]
3.20
primary sample
specimen
discrete portion of material intended for examination (3.6), study or analysis of one or more quantities
or properties and assumed to apply for 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 (3.18).
Note 2 to entry: In some ISO and CEN documents, a specimen is defined as “a biological sample derived from the
human body”.
[SOURCE: ISO 15189:2012 3.16]

3.21
quality indicator
measure of the degree to which a set of inherent 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.
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.
[SOURCE: ISO 15189:2012 3.19]

ISO/DIS 15189:2021(E)

3.22
referral laboratory
external laboratory to which a sample is submitted for examination (3.6)
Note 1 to entry: A referral laboratory is one to which laboratory management chooses to submit a sample or sub-
sample for examination (3.6), 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.
[SOURCE: ISO 15189:2012 3.23]

3.23
sample
one or more parts taken from a primary sample
[SOURCE: ISO 15189:2012 3.24 Example excluded]
3.24
trueness of measurement
measurement trueness
trueness
closeness of agreement between the average of an infinite number of replicates 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.
Note 2 to entry: Measurement trueness is inversely related to systematic measurement error but is not related to
random measurement error.
Note 3 to entry: ‘Measurement accuracy” should not be used for ‘measurement trueness’.
Note 4 to entry: For qualitative examinations (3.9), trueness of measurement (closeness of agreement) can be
expressed in terms of concordance (i.e., percent agreement with a reference examination).
Note 5 to entry: Trueness is a property of the measurement procedure (3.15 ) that reflects the bias (3.3) of the
measurements from the expected or target value. It is described qualitatively as good or bad. A measurement
procedure (3.15 ) has good trueness if the bias (3.1) of the measurements is low.
[SOURCE: ISO/IEC Guide 99:2007 2.14, modified — Note 3 to entry has been added.]
3.25
validation
confirmation, through the provision of objective evidence that the particular requirements for a specific
intended use or application have been fulfilled
Note 1 to entry: Objective evidence can be obtained through observation, measurement, examination (3.6), 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
characteristics: measurement trueness (3.24), 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 9000:2015 3.8.13 Note 3 has been added]

3.26
verification
provision of objective evidence, that a given item fulfils specified requirements
EXAMPLE 1 Confirmation that performance properties of a measuring system are achieved.
ISO/DIS 15189:2021(E)

EXAMPLE 2 Confirmation that a target measurement uncertainty can be met.
Note 1 to entry: Verification is the process by which the laboratory (3.18) confirms that the established
performance claims of an in-vitro diagnostic device (IVD) (3.12) (e.g., trueness, precision, reportable range) can
be replicated in the laboratory before human sample examination is performed.
Note 2 to entry: The objective evidence needed for a verification can be the results of an inspection, or other
forms of determination, such as performing alternative calculations or reviewing documents.
Note 3 to entry: Verification may be sufficient to implement a new IVD under circumstances where the
examination (3.6) is performed and used in the manner as directed in the package insert.
Note 4 to entry: The word “verified” is used to designate the corresponding status.
[SOURCE: ISO/IEC Guide 99:2007 2.44 with the addition of notes from ISO17511]
4 General requirements
4.1 Impartiality
4.1.1 Laboratory activities shall be undertaken impartially. The laboratory shall be structured and
managed to safeguard impartiality.
4.1.2 The laboratory management shall be committed to impartiality.
4.1.3 The laboratory shall be responsible for the impartiality of its laboratory activities and shall not
allow commercial, financial or other pressures to compromise impartiality.
4.1.4 The laboratory shall monitor its activities and its relationships to identify threats to its impar-
tiality. This monitoring shall include relationships of its personnel.
NOTE A relationship that threatens the impartiality of the laboratory can be based on ownership,
governance, management, personnel, shared resources, finances, contracts, marketing (including brand-
ing), and payment of a sales commission or other inducement for the referral of new users, etc. Such
relationships do not necessarily present the laboratory with a threat to impartiality.
4.1.5 If a threat to impartiality is identified, the effect shall be eliminated or minimized so that the
impartiality is not compromised. The laboratory shall be able to demonstrate how it mitigates such
threat.
4.2 Confidentiality
4.2.1 Management of information

The laboratory shall be responsible, through legally enforceable agreements, for the management of all
patient information obtained or created during the performance of laboratory activities. Management
of patient information shall include privacy and confidentiality. The laboratory shall inform the user
and/or the patient in advance, of the information it intends to place in the public domain. Except for
information that the user and/or the patient makes publicly available, or when agreed between the
laboratory and the patient (e.g., for the purpose of responding to complaints), all other information is
considered proprietary information and shall be regarded as confidential.
4.2.2 Release of information
When the laboratory is required by law or authorized by contractual arrangements to release confidential
information, the patient concerned shall be notified of the information released, unless prohibited by law.
Information about the patient from a source other than the patient (e.g., complainant, regulator) shall
be kept confidential by the laboratory. The identity of the source shall be kept confidential by the labo-
ratory and shall not be shared with the patient, unless agreed by the source.

ISO/DIS 15189:2021(E)

4.2.3 Personnel responsibility
Personnel, including any committee members, contractors, personnel of external bodies, or individu-
als with access to laboratory information acting on the laboratory’s behalf, shall keep confidential all
information obtained or created during the performance of laboratory activities.
4.3 Requirements regarding patients

Laboratory management shall ensure that patients’ well-being, safety and rights are the primary
considerations. The laboratory shall establish and implement the following processes:
a) opportunities for patients and users to provide helpful information to aid the laboratory in the
selection of the examination methods, and the interpretation of the examination results;
b) provision of patients and users with publicly available information about the examination process,
including costs when applicable, and when to expect results;
c) periodic review of the examinations offered by the laboratory to ensure they are clinically
appropriate and necessary;
d) where appropriate, disclosure to patients, users and any other relevant persons, of incidents that
resulted or could have resulted in patient harm, and records of actions taken to mitigate those
harms;
e) treatment of human samples, or remains, with due care and respect;
f) obtaining informed consent when required;
g) ensuring the ongoing availability and integrity of retained patient samples and records in the event
of the closure, amalgamation, or merger of the laboratory;
h) making relevant information available to a patient and any other health service provider at the
request of the patient or the request of a healthcare provider acting on their behalf; and
i) upholding the rights of patients to equitable care that is free from discrimination.
NOTE Statutory or regulatory requirements can apply to some of these requirements.
5 Structural and governance requirements
5.1 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.
5.2 Laboratory director
5.2.1 Laboratory director competence
The laboratory shall be directed by a person or persons however named, with the specified qualifications,
competence and delegated authority, responsibility, and resources to fulfil the requirements of this
document.
5.2.2 Laboratory director responsibilities
The laboratory director is responsible for the implementation of the management system, including the
application of risk management to all aspects of the laboratory operations so that risks to patient care
and opportunities to improve are systematically identified and addressed.
ISO/DIS 15189:2021(E)

The duties and responsibilities of the laboratory director shall be documented.
5.2.3 Delegation of duties
The laboratory director may delegate selected duties and/or responsibilities to qualified personnel
and such delegation shall be documented. However, the laboratory director shall maintain the ultimate
responsibility for the overall operation and administration of the laboratory.
5.3 Laboratory activities
5.3.1 Scope of laboratory activities
The laboratory shall define and document the range of laboratory activities, including sites other than
the main location, for which it conforms with this document (e.g., Point-of-care-testing). The laboratory
shall only claim conformity with this document for this range of laboratory activities, which excludes
externally provided laboratory activities on an ongoing basis.
5.3.2 Conformance with requirements
Laboratory activities shall be carried out in such a way as to meet the requirements of this document,
the laboratory's own management system and the laboratory's users. This shall include laboratory
activities performed in all its permanent facilities, at sites away from its permanent facilities, in
associated temporary or mobile facilities or any activities performed at a user's location.
5.3.3 Advisory activities
Laboratory management shall ensure that appropriate laboratory advice and interpretation are
available and meet the needs of patients and users.
The laboratory shall establish arrangements for communicating with users on the following:
a) advising on choice and use of examinations, including required type of sample, clinical indications
and limitations of examination methods, and the frequency of requesting the examination;
b) providing professional judgments on the interpretation of the results of examinations;
c) promoting the effective utilization of laboratory examinations;
d) advising on scientific and logistic matters such as instances of failure of sample(s) to meet
acceptance criteria.
5.4 Structure and authority
5.4.1 General
The laboratory shall:

a) define its organization and management structure, its place in any parent organization, and the
relationships between management, technical operations and support services;
b) specify the responsibility, authority, lines of communication and interrelationship of all personnel
who manage, perform or verify work affecting the results of laboratory activities;
c) define its procedures to the extent necessary to ensure the consistent application of its laboratory
activities and the validity of the results.

ISO/DIS 15189:2021(E)

5.4.2 Quality management
The laboratory shall have personnel who, irrespective of other responsibilities, have the authority and
resources needed to carry out their duties, including:
a) implementation, maintenance and improvement of the management system;
b) identification of deviations from the management system or from the procedures for performing
laboratory activities;
c) initiation of actions to prevent or minimize such deviations;
d) reporting to laboratory management on the performance of the management system and any need
for improvement;
e) ensuring the effectiveness of laboratory activities.
NOTE These responsibilities can be assigned to one or more persons.
5.5 Objectives and policies
5.5.1 Laboratory management shall establish and maintain objectives and policies for:
— meeting the needs and requirements of patients and users;

— committing to good professional practice;
— providing examinations that fulfil their intended use;
— conforming with this document.
5.5.2 Objectives shall be measurable, and consistent with policies. The laboratory shall ensure that the
objectives and policies are implemented at all levels of the laboratory organization.
5.5.3 Laboratory management shall ensure that planning of the management system described in
Clause 8 is carried out to meet requirements and the laboratory's objectives.
NOTE The management system documents described in Clause 8 can, but are not required to, be contained
in a collection previously referred to as a "quality manual."
5.5.4 Laboratory management shall ensure that the integrity of the management system is maintained
when changes to the management system are planned and implemented.
5.5.5 The laboratory shall establish quality indicators to monitor and evaluate performance throughout
key aspects of pre-examination, examination, and post-examination processes.
EXAMPLES of quality indicators are number of unacceptable samples relative to the number received, number
of errors at registration and/or sample receipt, number of corrected reports, rate of achievement of turnaround
times.
5.6 Risk management
5.6.1 Laboratory management shall establish, implement, and maintain processes for identifying risks
of harm to patients and opportunities for improved patient care associated with its examinations and
activities, and develop actions to address both risks and opportunities. (See 8.5)
5.6.2 The laboratory director shall ensure that these processes are evaluated for effectiveness and
modified, when identified as being ineffective
ISO/DIS 15189:2021(E)

NOTE 1 ISO 22367:2020 provides details for managing risk in medical laboratories.
NOTE 2 ISO 35001:2019 provides details for laboratory biorisk management.
6 Resource requirements
6.1 General
The laboratory shall have available the personnel, facilities, equipment, reagents, consumables, systems
and support services necessary to manage and perform its activities.
6.2 Personnel
6.2.1 General
The laboratory shall have access to a sufficient number of competent persons to perform its activities.
All personnel of the laboratory, either internal or external, that could influence the laboratory activities
shall act impartially, ethically, be competent and work in accordance with the laboratory’s management
system.
The laboratory shall have a process for managing competence of its personnel.
The laboratory shall have documented information demonstrating competence of its personnel.
EXAMPLES of competence assessment methods that can be used in any combination:
— direct observation of an activity
— monitoring the recording and reporting of examination results
— review of work records
— assessment of problem-solving skills
— examination of specially provided samples, such as previously examined samples, interlaboratory comparison
materials, or split samples.
6.2.2 Qualification, duties and responsibilities
The laboratory shall document the competence requirements for each function influencing the
results of laboratory activities, including requirements for education, qualification, training, technical
knowledge, skills and experience.
The laboratory shall communicate to laboratory personnel the importance of meeting the needs and
requirements of users as well as the requirements of this document.
The laboratory shall have a programme to introduce personnel to the organization, the department or
area in which the person will work, the terms and conditions of employment, staff facilities, health and
safety requirements and occupational health services
6.2.3 Training and competence assessment
The laboratory shall ensure that personnel have the competence to perform laboratory activities for
which they are responsible and to evaluate the significance of deviations.
The laboratory shall have procedures and retain records for:
a) determining the competence requirements and professional qualifications,
b) selection of personnel,
ISO/DIS 15189:2021(E)

c) training and re-training of personnel,

d) authorization of personnel,
e) monitoring competence of personnel.
f) reports of accidents and exposure to occupational hazards, and
g) immunization of personnel - as applicable.
6.2.4 Continuing education and professional development
A continuing education programme shall be available to personnel who participate in managerial and
technical processes. All personnel shall participate in continuing education and regular professional
development, or other professional liaison activities.
The effectiveness and pertinence of the programmes and activities shall be periodically reviewed.
6.2.5 Authorization
The laboratory shall authorize personnel to perform specific laboratory activities, including but not
limited to, the following:
a) development, modification, verification and validation of methods;
b) analysis of results, including interpretations and advice;
c) report, review, and release of results;
d) use of laboratory information systems, in particular: accessing patient data and information,
entering patient data and examination results, changing patient data or examination results;
6.3 Facilities and environmental conditions
6.3.1 General
The requirements for facilities and environmental conditions necessary for the performance of the
laboratory activities shall be defined, monitored, and recorded.
The facilities and environmental conditions shall be suitable for the laboratory activities and shall not
adversely affect the validity of results, or the safety of patients, visitors, users, and personnel. This shall
include pre-examination related facilities and sites other than the main laboratory premises where
examinations are performed, for example POCT under the laboratory's management.
NOTE 1 Environmental conditions that can adversely affect the validity of results include but are not limited
to adventitious amplified nucleic acid, microbial contamination, dust, electromagnetic disturbances, radiation,
lighting conditions (illumination), humidity, electrical supply, temperature, sound and vibration.
NOTE 2 ISO 15190:2020 provides details for facility and environmental conditions.
6.3.2 Facility controls
Processes to control facilities shall be implemented, recorded, monitored and periodically reviewed,
and shall include:
a) control of access, taking into consideration safety, confidentiality, quality, and safeguarding medical
information and patient samples;
b) prevention of contamination, interference, or adverse influences on laboratory activities that could
arise from energy sources, lighting, ventilation, noise, water and waste disposal;
ISO/DIS 15189:2021(E)

c) prevention of cross-contamination, where examination procedures pose a risk, or where work

could be affected or influenced by lack of separation;
d) provision of safety facilities and devices, where applicable and regularly verifying their functioning;
EXAMPLES The operation of emergency release, intercom and alarm systems for cold rooms and walk-
in freezers, accessibility of emergency showers, eyewash and resuscitation equipment.
e) maintenance of laboratory facilities in a functional and reliable condition.
6.3.3 Storage facilities
a) Storage space, with conditions that ensure the continuing integrity of, samples, equipment,
reagents, consumables, documents and records, shall be provided.
b) Patient samples and materials used in examination processes shall be stored in a manner that
prevents cross contamination and deterioration.
c) Storage and disposal facilities for hazardous materials shall be appropriate to the classification of
the materials in the context of any statutory or regulatory requirements.
6.3.4 Personnel facilities
There shall be adequate access to toilet facilities and a supply of drinking water, as well as facilities for
storage of personal protective equipment and clothing.
Space for personnel activities such as meetings, quiet study and a rest area may be provided.
6.3.5 Specimen collection facilities
Specimen collection facilities shall:

a) enable collection to be undertaken in a manner that does not invalidate results or adversely affect
the quality of examinations;
b) consider privacy, comfort and needs (e.g. disabled access, toilet facility) and accommodation of
accompanying persons (e.g. guardian or interpreter) during collection;
c) provide separate patient reception and collection areas;
d) maintain first aid materials for both patients and personnel.
NOTE ISO/TS 20658:2017 provides details for sample collection facilities.
6.4 Equipment
6.4.1 General
The laboratory shall have processes for the selection, procurement, installation, acceptance criteria and
testing, handling, transport, storage, use, maintenance, and decommissioning of equipment, in order to
ensure proper functioning and to prevent contamination or deterioration.
NOTE Laboratory equipment includes hardware and software of instruments, measuring systems, and
laboratory information systems, or any equipment that influences the results of laboratory activities, including
specimen transportation systems.
6.4.2 Equipment requirements
a) The laboratory shall have access to equipment required for the correct performance of laboratory
activities and that can influence the results.
ISO/DIS 15189:2021(E)

b) Where the equipment is used outside the laboratory's permanent control, or equipment
manufacturer's functional specification, laboratory management shall ensure that the requirements
of this document are met.
c) Each item of equipment that can influence laboratory activities shall be uniquely labelled, marked
or otherwise identified and a register maintained.
d) The laboratory shall maintain and replace equipment as needed to ensure the quality of examination
results.
6.4.3 Equipment acceptance testing
The laboratory shall verify that the equipment conforms to specified requirements before being placed
or returned into service.
Equipment used for measurement shall be capable of achieving the measurement accuracy and/or
measurement uncertainty to provide a valid result. (see section 7.2.2 and 7.2.3 for details)
NOTE 1 This requirement applies to equipment used in the laboratory, equipment on loan, or equipment used
in associated or mobile facilities, by others authorized by the laboratory.
NOTE 2 The verification of equipment acceptance testing can be, where relevant, based on the calibration
certificate of the returned equipment.
6.4.4 Equipment instructions for use
Equipment shall be always operated by trained, authorized, and competent personnel.

Instructions for the use of equipment, including those provided by the manufacturer, shall be readily
available.
The equipment shall be used as recommended unless validated by the laboratory. (see 7.2.2)
6.4.5 Equipment maintenance and repair
a) The laboratory shall have a preventive maintenance programme (performed by the manufacturer
and/or the laboratory) based on manufacturer’s instructions. Deviations from the manufacturer's
schedules or instructions shall be recorded.
b) Equipment shall be maintained in a safe working condition and working order. This shall include
electrical safety, any emergency stop devices and the safe handling and disposal of hazardous
materials by authorized persons.
c) Equipment that is defective or outside specified requirements, shall be taken out of service. It shall
be clearly labelled or marked as being out of service, until it has been verified to perform correctly.
The laboratory shall examine the effect of the defect or deviation from specified requirements and
shall initiate actions when nonconformity occurs. (see 7.4)
d) When applicable, the laboratory shall decontaminate equipment before service, repair or
decommissioning, provide suitable space for repairs and provide appropriate personal protective
equipment.
6.4.6 Equipment adverse incident reporting
Adverse incidents and accidents that can be attributed directly to specific equipment shall be
investigated and reported to the manufacturer and appropriate authorities, as required.
The laboratory shall have a process for responding to any manufacturer's recall notice and the action(s)
performed.

ISO/DIS 15189:2021(E)

6.4.7 Equipment records
Records shall be maintained for each item of equipment that influences the results of laboratory
activities.
These records shall include the following, where relevant:
a) manufacturer and supplier details, and sufficient information to uniquely identify each item of
equipment, including software and firmware, where relevant;
b) dates of receipt, acceptance testing and entering into service;
c) evidence that equipment conforms with specified requirements;
f) the current location;
g) condition when received (e.g.. new, used or reconditioned);
h) manufacturer's instructions;
i) the schedule for preventive maintenance;
j) any maintenance activities performed by the laboratory or approved external service provider;
k) damage to, malfunction, modification, or repair of the equipment;
l) equipment performance records such as reports or certificates of calibrations and/or verifications,
including dates, times and results;
m) status of the equipment such as active or in-service, out-of-service, quarantined, retired or obsolete.
These records shall be maintained and shall be readily available for the lifespan of the equipment or
longer, as specified in the laboratory's Control of Records procedure. (see 8.4)
6.5 Equipment calibration and metrological traceability
6.5.1 Metrological traceability of equipment and method
The laboratory shall have procedures for the calibration of equipment that directly or indirectly affects
examination results. The procedures shall specify:
a) conditions of use and manufacturer's instructions for calibration and re-calibration;
b) recording of the metrological traceability;
c) verification of the required measurement accuracy and the functioning of the measuring system at
defined intervals;
d) recording the calibration status and date of re-calibration;
e) ensuring that, where correction factors are employed, these are updated when re- calibration
occurs;
f) handling of situations when calibration may have been out of control, to minimize risk to service
operation and to patients;
g) safeguards to prevent adjustments to calibration that might invalidate examination results.

ISO/DIS 15189:2021(E)

6.5.2 Metrological traceability of measurement results
a) The laboratory shall establish and maintain metrological traceability of its measurement results
by means of a documented unbroken chain of calibrations, each contributing to the measurement
uncertainty, linking them to an appropriate reference.
NOTE Information of traceability to a higher order reference material or reference procedure can
be provided by an examination system manufacturer. Such documentation is acceptable as long as the
manufacturer's examination system and calibration procedures are used without modification.
b) The laboratory shall ensure that measurement results are traceable to the highest possible order of
traceability and as close as possible to the International System of Units (SI) through:
— calibration provided by a competent laboratory; or
NOTE 1 Laboratories fulfilling the requirements of ISO/IEC 17025 are considered competent for
performing calibrations.
— certified values of certified reference materials provided by a competent producer with stated
metrological traceability to the SI; or
NOTE 2 Reference material producers fulfilling the requirements of ISO 17034 are considered to be
competent.
— direct realization of the SI units ensured by comparison, directly or indirectly, with national or
international standards.
NOTE 3 Details of practical realization of the definitions of some important units are given in the SI
Brochure.
c) Where this is not possible or relevant, other means for providing confidence in the results shall be
applied, including but not limited to the following:
— results of reference measurement procedures, specified methods or consensus standards, that
are clearly described and accepted as providing measurement results fit for their intended use
and ensured by suitable comparison;
— examination of calibration by another procedure
NOTE ISO 17511:2020 provides further information on how to deal with the compromises in the metrological
traceability of measurands.
6.6 Reagents and consumables
6.6.1 Reagents and consumables - General
The laboratory shall have processes for the selection, procurement, reception, storage, acceptance
testing and inventory management of reagents and consumables.
NOTE Reagents include substances which are commercially supplied or prepared in-house, reference
materials, (calibrators and quality control materials); consumables include culture media, pipette tips, glass
slides, POCT supplies, etc.
6.6.2 Reagents and consumables - Receipt and storage
The laboratory shall store reagents and consumables according to manufacturers' specifications and
monitor the environmental conditions where relevant.
When the laboratory is not the receiving facility, it shall verify that the receiving facility has adequate
storage and handling capabilities to maintain supplies in a manner that prevents damage and
deterioration.
ISO/DIS 15189:2021(E)

6.6.3 Reagents and consumables - Acceptance testing
Each reagent or new formulation of examination kits with changes in reagents or procedure, or a new
lot or shipment, shall be verified for performance before placing into use, or before release of results, as
appropriate.
Consumables that can affect the quality of examinations shall be verified for performance before
placing into use.
NOTE 1 Comparative IQC performance of new reagent lots and that of previous lots can be used as evidence
for acceptance. (see 7.2.7.3) Patient samples are preferred when comparing different reagent lots to avoid issues
with commutability of IQC materials.
NOTE 2 The verification of reagents can be, where relevant, based on the certificate of analysis of the reagent.
6.6.4 Reagents and consumables - Inventory management
The laboratory shall establish an inventory management system for reagents and consumables.
The system for inventory management shall segregate reagents and consumables that have been
accepted for use from those that have been neither inspected nor accepted for use
6.6.5 Reagents and consumables - Instructions for use
Instructions for the use of reagents and consumables, including those provided by the manufacturers,
shall be readily available. Reagents and consumables shall be used according to the manufacturer's
specifications. If they are intended to be used for other purposes, see 7.2.3.
6.6.6 Reagents and consumables - Adverse incident reporting
Adverse incidents and accidents that can be attributed directly to specific reagents or consumables
shall be investigated and reported to the manufacturer and appropriate authorities, as required.
6.6.7 Reagents and consumables - Records
Records shall be maintained for each reagent and consumable that contributes to the performance of
examinations. These records shall include but not be limited to the following:
a) identity of the reagent or consumable;
b) manufacturer's information, including instructions, name and batch code or lot number;
c) date of receipt and condition when received, the expiry date, date of first use and, where applicable,
the date the reagent or consumable was taken out of service;
d) records that confirm the reagent's or consumable's initial and ongoing acceptance for use.
Where the laboratory uses reagents prepared or completed in-house, the records shall include, in
addition to the relevant information above, reference to the person or persons undertaking the
preparation, as well as the dates of preparation and expiry.
6.7 Service agreements

a) The laboratory shall have a process to establish and periodically review agreements for providing
laboratory activities.
The process shall ensure:
— the requirements are adequately defined;
— the laboratory has the
Licensed to:capability andProfessor
White, Graham resources to meet the requirements;
ISO/DIS 15189:2021(E)

— when applicable, the laboratory advises the user of the specific activities to be performed by
referral laboratories and consultants.
Users shall be informed of any changes to an agreement that can affect examination results.
Records of reviews, including any significant changes, shall be retained.
NOTE A request from a user to perform an examination is considered an agreement. (see 7.1.2.1 a)
b) Service agreements between the laboratory and other parts of the organization using laboratory
supported POCT, shall ensure that respective responsibilities and authorities are defined and
communicated.
NOTE Established multidisciplinary POCT committees can be used to manage such service agreements.
6.8 Externally provided products and services
6.8.1 General
The laboratory shall ensure that externally provided products and services that affect laboratory
activities are suitable when such services are:
a) intended for incorporation into the laboratory's own activities;
b) provided, in part or in full, directly to the user by the laboratory, as received from the external
provider;
c) used to support the operation of the laboratory.
It may be necessary to collaborate with other organizational departments or functions to fulfil this
requirement.
NOTE Services include, for example, specimen collection services, pipette and other calibration services,
facility and equipment maintenance services, external quality assessment (EQA) services.
6.8.2 Referral laboratories and consultants
The laboratory shall communicate its requirements, to referral laboratories and consultants who
provide opinions and interpretations, for:
— the procedures, examinations, reports and consulting activities to be provided;
— management of critical results;
— any required personnel qualifications and demonstration of competence;
— any activities that the laboratory intends to perform at the referral laboratories’ premises.
Unless otherwise specified in the agreement, the referring laboratory (and not the referral laboratory)
shall be responsible for ensuring that examination results of the referral laboratory are provided to the
person making the request.
A register of all referral laboratories and consultants shall be maintained.
6.8.3 Review and approval of externally provided products and services
The laboratory shall have processes and retain records for:

a) defining, reviewing, and approving the laboratory's requirements for externally provided products
and services;

ISO/DIS 15189:2021(E)

b) defining the criteria for evaluation, selection, monitoring of performance and re-evaluation of the
external providers;
c) referral of samples;
d) ensuring that externally provided services conform to the laboratory's established requirements,
or when applicable to the relevant requirements of this document, before they are used or directly
provided to the user;
e) taking any actions arising from evaluations of the performance of the external providers.
7 Process requirements
The laboratory shall identify potential risks to patient care in the pre-examination, examination
and post-examination processes. These risks shall be assessed, mitigated to the extent possible and
communicated to users as appropriate.
The identified risks and effectiveness of the mitigation processes shall be monitored and evaluated
according to the potential harm to the patient.
The laboratory shall also identify opportunities to improve patient care and develop a framework to
manage these opportunities. (see 8.5)
7.1 Pre-examination processes

The laboratory shall have procedures for all pre-examination processes and make them accessible
to relevant personnel. The pre-examination processes may influence the outcome of the intended
examination.
NOTE ISO/TS 20658 :2017 provides detailed information for sample collection and transport.
7.1.1 Laboratory information for patients and users
The laboratory shall have appropriate information available for its users and patients. The information
shall be sufficiently detailed to provide users with a comprehensive understanding of the laboratory's
scope of activities and requirements.
The information shall include as appropriate:
a) the location(s) of the laboratory, operating hours and contact information;
b) the requirements for requesting and the collection of samples;
c) the scope and availability of clinical advice offered;
d) requirements for patient consent,;
e) factors known to significantly impact the performance of the examination or the interpretation of
the results; and
f) the laboratory complaint procedure.
7.1.2 Requests for providing laboratory examinations
7.1.2.1 General
a) Each request accepted by the laboratory for examination(s) shall be considered an agreement.

ISO/DIS 15189:2021(E)

b) The examination request shall provide sufficient information to ensure:

— unequivocal traceability of the patient to the request and sample;
— identity and contact information of requester;
— examinations requested;
— informed clinical and technical advice and interpretation can be provided
c) The examination request information may be provided in a format or medium as deemed
appropriate by the laboratory and acceptable to the user.
d) Where necessary for patient care, the laboratory shall communicate with users or their
representatives, to clarify the user's request.
7.1.2.2 Oral requests
The laboratory shall have a procedure for managing oral requests for examinations that includes the
provision of documented confirmation of the examination request to the laboratory, within a given
time.
7.1.3 Primary sample collection and handling
7.1.3.1 General
The laboratory shall have procedures for the collection and handling of primary samples. Information
shall be available to those responsible for sample collection.
Any deviation from the established collection procedures shall be clearly recorded. The potential risk
and impact on the patient outcome of acceptance or rejection of the sample shall be assessed, recorded
and shall be communicated to the appropriate personnel.
The laboratory shall periodically review requirements for sample volume, collection device and
preservatives for all sample types, as applicable, to ensure that neither insufficient nor excessive
amounts of sample are collected, and samples are properly collected to preserve the measurand.
7.1.3.2 Instructions for pre-collection activities
The laboratory's instructions for pre-collection activities shall include sufficient detail to ensure that
the integrity of the sample is not compromised.
This shall include:
a) preparation of the patient (e.g. instructions to caregivers, phlebotomists, sample collectors and
patients);
b) type and amount of the primary sample to be collected with descriptions of the primary sample
containers and any necessary additives;
c) special timing of collection, where relevant;
d) provision of clinical information relevant to, or affecting sample collection, examination
performance or result interpretation (e.g. history of administration of drugs);
e) sample labelling system for unequivocal identification of the patient, source and site of specimen,
and labelling, when several samples from the same patient are to be collected, including multiple
pieces of tissue or slides.

ISO/DIS 15189:2021(E)

7.1.3.3 Instructions for collection activities
The laboratory shall provide instructions for safe, accurate and clinically appropriate sample collection
and pre-examination storage.
The laboratory’s instructions for collection activities shall include the following:
a) determination of the identity of the patient from whom a primary sample is collected;
b) verification that the patient meets pre-examination requirements [e.g. fasting status, medication
status (time of last dose, cessation), sample collection at predetermined time or time intervals,
etc.];
c) instructions for collection of primary samples, with descriptions of the primary sample containers
and any necessary additives;
d) instructions for labelling of primary samples in a manner that provides an unequivocal link with
the patients from whom they are collected.
e) recording of the identity of the person collecting the primary sample and the collection date, and,
when needed, recording of the collection time;
f) requirements for separating or dividing the primary sample when necessary;
g) instructions for proper storage conditions before collected samples are delivered to the laboratory;
h) safe disposal of materials used in the collection.
All procedures carried out on a patient require the informed consent of the patient. For most routine
laboratory procedures, consent can be inferred when the patient willingly submits to the sample
collecting procedure, for example, venepuncture.
Special procedures, including more invasive procedures, or those with an increased risk of complications
to the procedure, may need a more detailed explanation and, in some cases, written consent.
NOTE In emergency situations, consent might not be possible; under these circumstances it is acceptable to
carry out necessary procedures, provided they are in the patient’s best interest.
7.1.4 Sample transportation
To ensure the timely and safe and transportation of samples, the laboratory shall provide instructions
for:
— packaging of samples for transportation;
— ensuring the time between collection and receipt in the laboratory is appropriate for the requested
examinations;
— maintaining the temperature interval specified for sample collection and handling;
— use of designated preservatives to ensure integrity of samples.
When sample integrity is compromised and the safety of the carrier or the general public is placed at
risk, the sender shall be notified immediately and informed of the measures required to mitigate the
risk and to avoid recurrence.

ISO/DIS 15189:2021(E)

7.1.5 Sample receipt
7.1.5.1 Sample receipt procedure
The laboratory shall have a procedure for sample receipt that includes:
a) the unequivocal traceability of samples by request and labelling, to a uniquely identified patient
and when applicable the anatomical site;
b) criteria for acceptance and rejection of samples;
c) recording the date and time of receipt of the sample and when relevant, the identity of the person
receiving the sample;
d) evaluation of received samples, by authorized personnel, to ensure compliance with acceptance
criteria relevant for the requested examination(s);
e) instructions for samples specifically marked as urgent, which include details of special labelling,
transport, any rapid processing method, turnaround times and special reporting criteria to be
followed.
f) ensuring that all portions of the primary sample shall be unequivocally traceable to the original
primary sample.
7.1.5.2 Sample receipt exceptions
The laboratory shall have a process that does not disadvantage the patient in receiving care, when a
sample has been compromised due to:
— problems with patient or sample identification,
— sample instability due to, for example, delay in transport,
— incorrect storage or handling temperature,
— inappropriate container(s), and
— insufficient sample volume.
When a compromised clinically critical or irreplaceable sample is accepted, after consideration of the
risk to patient safety, the final report shall indicate the nature of the problem and where applicable,
advising caution when interpreting results that could be affected.
7.1.6 Pre-examination handling, preparation, and storage
7.1.6.1 Sample protection
The laboratory shall have procedures and appropriate facilities for securing patient samples, ensuring
sample integrity and preventing loss or damage during pre-examination activities, transportation,
handling, preparation and storage.
7.1.6.2 Criteria for additional examination requests
Laboratory procedures shall include time limits for requesting additional examinations, or further
examinations on the same primary sample.
7.1.6.3 Sample stability
Considering the stability of the measurand in a primary sample, the time between sample collection
and performing the examination shall be specified and monitored where relevant.
ISO/DIS 15189:2021(E)

7.2 Examination processes
7.2.1 General
a) The laboratory shall select and use examination methods which have been validated for their
intended use to assure the clinical accuracy of the examination for patient testing.
NOTE Preferred methods are those specified in the instructions for use of in vitro diagnostic medical
devices or those that have been published in established/authoritative textbooks, peer-reviewed texts,
or journals, or in international and national consensus standards or guidelines, or national or regional
regulations.
b) The performance specifications for each examination method shall relate to the intended use of
that examination and its impact on patient care.
c) Personnel shall follow established examination procedures and the identity of persons performing
significant activities in examinations processes shall be recorded.
d) All methods, procedures and supporting documentation, such as instructions, standards, manuals
and reference data relevant to the laboratory activities, shall be kept up to date and shall be readily
available to personnel (see 8.3).
e) Authorized personnel shall periodically evaluate the examination methods provided by the
laboratory to ensure they are clinically appropriate for the requests received.
7.2.2 Verification of examination methods
a) The laboratory shall have a procedure to verify that it can properly perform examination methods
before introducing into use, by ensuring that it can achieve the required performance as specified
by the manufacturer or method.
b) The performance specifications for the examination method confirmed during the verification
process shall be those relevant to the intended use of the examination results.
c) The laboratory shall ensure the extent of the verification of examination methods is sufficient to
ensure the consistent validity of results pertinent to clinical decision making.
d) Personnel with the appropriate authority and competence shall review the verification results and
record that the results meet the specified requirements.
e) If a method is revised by the issuing body, the laboratory shall repeat verification to the extent
necessary.
f) The following records of verification shall be retained:
— performance specifications to be achieved,
— results obtained,
— a statement of whether the performance specifications were achieved, and
7.2.3 Validation of examination methods
a) The laboratory shall validate examination methods derived from the following sources:
— laboratory designed or developed methods;
— methods used outside their intended scope (i.e. outside of the manufacturer's instructions for
use, or original validated measurement range);
— validated methods subsequently modified.
ISO/DIS 15189:2021(E)

b) The validation shall be as extensive as is necessary and confirm, through the provision of objective
evidence in the form of performance characteristics, that the specific requirements for the intended
use of the examination have been fulfilled. The laboratory shall ensure the extent of validation of
examination method is sufficient to ensure the consistent validity of results pertinent to clinical
decision making.
c) Personnel with the appropriate authority and competence shall review the validation results and
record the review.
d) When changes are proposed to a validated examination method, the clinical impact shall be
reviewed, and an assessment made as to whether to implement the modified method
e) The laboratory shall retain the following records of validation:
— the validation procedure used;
— specification of the requirements in the form of performance specifications;
— determination of the performance characteristics of the method;
— results obtained; and
— a statement on the validity of the method, detailing its fitness for the intended use.
7.2.4 Measurement uncertainty of measured quantity values
a) The measurement uncertainty (MU) of measured quantity values shall be evaluated and maintained
for its intended use, where relevant.
NOTE ISO/TS 20914:2019 provides detail on these activities together with examples.
b) MU estimations shall be regularly reviewed.

c) For measurements where estimation of MU is not possible or applicable, the rationale for exclusion
from MU estimation shall be documented.
d) MU information shall be made available to laboratory users on request.
e) When users have inquiries on MU, the laboratory's response should take into account other sources
of uncertainty, such as, but not limited to biological variation.
f) If the qualitative result of an examination relies on a test which produces quantitative output data
and is defined as positive or negative, based on a threshold, MU in the output quantity should be
estimated using representative positive and negative samples.
g) For examinations with nominal data, MU in intermediate measurement steps or quality control
results which produce quantitative data should also be considered for key (high risk) parts of the
process.
h) MU should be taken into consideration when performing verification, when relevant.
7.2.5 Biological reference intervals and clinical decision limits
Biological reference intervals and clinical decision limits for interpretation of examination results shall
be defined, their basis documented and communicated to users.
a) The laboratory shall define biological reference intervals and clinical decision limits, to reflect the
patient population served by the laboratory, while considering the risk to patients.
b) Reference interval and clinical decision limits shall be periodically reviewed, and any changes
communicated to users.
ISO/DIS 15189:2021(E)

c) When changes are made to an examination method or pre-examination procedure, the laboratory
shall review the impact on associated biological reference intervals and clinical decision limits and
communicate to the users when applicable.
7.2.6 Documentation of examination procedures
a) The laboratory shall document its examination procedures to the extent necessary to ensure the
consistent application of its activities and the validity of its results.
b) Procedures shall be written in a language understood by laboratory personnel and be available in
appropriate locations.
c) Any abbreviated document content shall correspond to the procedure.
NOTE Working instructions, flow process diagrams or similar systems that summarize key information
are acceptable for use as a quick reference at the workbench, provided that a full procedure is available for
reference and that the summarized information is updated as needed, concurrently with the full procedure
update.
d) Information from product instructions for use, that contain sufficient information, can be
incorporated into examination procedures by reference.
e) When the laboratory intends to make a validated change to an examination procedure which could
affect interpretation of results, the implications of this shall be explained to users.
f) All documents associated with the performance of examinations, shall be subject to document
control. (see 8.3)
7.2.7 Ensuring the validity of examination results
7.2.7.1 General
The laboratory shall have a procedure for monitoring the validity of results. The resulting data shall be
recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be
applied to review the results.
7.2.7.2 Internal quality control (IQC)
a) The laboratory shall have an IQC procedure for monitoring the ongoing validity of examination
results, according to defined criteria, that verifies the attainment of the intended quality and
ensures consistent validity pertinent to clinical decision making.
— The intended clinical application of the examination should be considered, as the performance
specifications for the same measurand may differ in different clinical settings.
— The procedure should also allow for the detection of lot-to-lot reagent and/or calibrator
variation of the examination method. To enable this, the use of third-party IQC material should
be considered, either as an alternative to, or in addition to, control material supplied by the
reagent or instrument manufacturer.
NOTE Monitoring of interpretations and opinions can be achieved through regular peer review of
examination results.
b) The laboratory shall select IQC material that is fit for its intended purpose. Considerations when
selecting IQC material shall include:
— its stability;
— that the matrix is as close as possible to that of patient samples;

ISO/DIS 15189:2021(E)

— that the IQC material reacts to the examination method in a manner as close as possible to
patient samples;
— that the IQC material provides a clinically relevant challenge to the examination method, has
concentrations levels at or near clinical decision points and covers the relevant range of the
examination method;
c) If appropriate IQC material is not available, the laboratory shall consider the use of other methods
for internal quality control.
Examples of such other methods may include:
— trend analysis of patient samples, (e.g. with moving average of patient samples, or percentage of
samples with results below or above certain values or associated with a diagnosis);
— comparison of results for patient samples on a specified schedule to results for patient samples
examined by an alternative procedure validated to have its calibration metrologically traceable to
the same or higher order references as specified in ISO 17511:2020;
— retesting of retained patient samples.
a) IQC shall be performed at a frequency that is based on the stability and robustness of the
examination method and the risk of harm to the patient from an erroneous result.
b) The resulting data shall be recorded in such a way that trends and shifts are detectable and, where
applicable, statistical techniques shall be applied to review the results.
c) IQC data shall be reviewed, at regular intervals and in a timeframe, which allows a meaningful
indication of current performance.
d) IQC data shall be evaluated against pre-defined acceptance criteria. Where IQC fails the pre-
determined criteria, corrective action shall be undertaken to rectify the failure.
e) The laboratory shall have a procedure to prevent the release of patient results in the event of IQC
failure.
— When IQC criteria are not fulfilled and indicate results are likely to contain clinically significant
errors, the results shall be rejected and relevant patient samples re-examined after the error
has been corrected (see 7.4).
— The laboratory shall also evaluate the results from patient samples that were examined after
the last successful IQC event.
7.2.7.3 External quality assessment (EQA)
a) The laboratory shall monitor the performance of its examination methods, by participation
in external quality assessment (EQA), appropriate to the examination and interpretation of
examination results, including POCT examination methods.
b) The laboratory shall establish a procedure for EQA enrolment, participation and performance for
examination methods used, where such programs are available.
c) EQA shall be performed by personnel who routinely perform pre-examination, examination, and
post examination processes.
NOTE 1 EQA is retrospective and cannot be used as a substitute IQC.
NOTE 2 EQA programme(s) that fulfil ISO/IEC 17043 requirements are preferred.
d) The EQA programme(s) selected by the laboratory shall, to the extent possible:
— Have the effect of checking pre-examination, examination, and post examination processes.
ISO/DIS 15189:2021(E)

— provide clinically relevant challenges that mimic patient samples,

e) When selecting EQA programme(s) the laboratory shall consider the type of target value offered.
These may include target values:
— independently set by a reference method,
— set by overall consensus data or/and
— set by method peer group consensus data.
NOTE 1 When method independent target values are not available, consensus values can be used to
determine whether deviations are laboratory- or method-specific.
NOTE 2 Where commutability of EQA materials could hamper comparison between some methods, it can
still be useful for comparisons to be made with other methods rather than relying only on within-method
comparisons.
f) When an external quality assessment (EQA) programme is either not available, or not considered
suitable, the laboratory shall use alternative methodologies to monitor examination method
performance. The laboratory shall justify the rationale for the chosen alternative and provide
evidence of its effectiveness.
Acceptable alternatives include:
— participation in sample exchanges with other laboratories;
— Inter-laboratory comparison of the results of the examination of identical IQC materials;
NOTE This evaluates individual laboratory IQC results against pooled results from participants
using the same IQC material.
— analysis of a different lot number of the manufacturer's end-user calibrator or the manufacturer's
trueness control material;
— analysis of surrogate microbiological organisms;
— analysis of reference materials considered to be commutable with patient samples;
— clinical correlation studies.
g) EQA data shall be reviewed at regular intervals with defined acceptance criteria, in a timeframe
which allows for a meaningful indication of current performance
h) Where EQA results fall outside pre-defined acceptance criteria, appropriate action shall be taken
(see 8.7), including an assessment of whether the non-conformance is clinically significant as it
relates to patient samples.
i) Where it is determined that the impact is clinically significant a review of patient results that
may have been affected and the need for amendment shall be considered and users advised as
appropriate.
7.2.7.4 Comparability of examination results
a) When different methods and/or equipment are used for an examination, and/or the examination is
performed at a different site, a procedure for establishing the comparability of results for patient
samples throughout the clinically significant intervals shall be defined.
NOTE The use of patient samples when comparing different examination methods avoids the difficulties
linked to the limited commutability of IQC materials. When patient samples are either not available or
impractical, see all options described for internal and external quality control.
b) The laboratory shall record

Licensed the results
to: White, ofProfessor
Graham comparability performed.
ISO/DIS 15189:2021(E)

c) The laboratory shall periodically review the comparability of results.

d) Where differences are identified, the impact of those differences on reference intervals and clinical
decision limits shall be evaluated and acted upon.
e) The laboratory shall advise users of any clinically significant differences in comparability of results.
7.3 Post-examination processes
7.3.1 Result reporting
7.3.1.1 General
Examination results shall be reported accurately, clearly, unambiguously and in accordance with any
specific instructions in the examination procedure. The report shall include all available information
necessary for the interpretation of the results.
The laboratory shall have a procedure to notify users when examination results are delayed, based on
the impact of the delay on the patient
All information associated with issued reports shall be retained in accordance with management
system requirements.
7.3.1.2 Common requirements for reports
Each report shall include the following information, unless the laboratory has documented reasons for
omitting any items:
a) clear, unambiguous identification of the examinations performed;
b) identification of the laboratory issuing the report;
c) identification of all examinations or parts of examinations that have been performed by a referral
laboratory
d) unique patient identification;
e) name or other unique identifier of the user and contact details;
f) date of primary sample collection and, when necessary for patient care, the time of primary sample
collection;
g) type of primary sample and any specific information necessary to describe the sample (e.g. source,
site of specimen, macroscopic description);
h) measurement procedure, where relevant, including, where possible and necessary, harmonized
(electronic) identification of the measurand and measurement principle;
NOTE 1 Logical Observation Identifiers Names and Codes (LOINC) and Nomenclature for Properties and Units
(NPU, NGC) and SNOMED CT are examples of electronic identification.
i) examination results with, where appropriate, the units of measurement, reported in SI units, units
traceable to SI units, or other applicable units;
j) biological reference intervals, clinical decision limits, likelihood ratios or diagrams/nomograms
supporting clinical decision limits as necessary;
NOTE Lists or tables of biological reference intervals can be distributed to users of the laboratory at
sites where reports are received.
k) identification of examinations undertaken as part of a research or development programme and for

which no specific claimsLicensed
on measurement performance
to: White, Graham Professorare available;
ISO/DIS 15189:2021(E)

l) date of the report, and time of release (if time is not contained in the report, readily available when
needed);
m) identification of any results that need to be considered as preliminary;
n) indications of any critical results;
In addition and when applicable, comments on:
— sample quality and suitability that might compromise the clinical value of examination results;
— the possibility of different results when examinations are performed by different procedures or in
different locations;
— possible risk of misinterpretation when different units of measurement are in use regionally or
nationally;
— result trends or significant changes over time.
7.3.1.3 Release of results including critical results
a) Responsibilities and procedures for how examination results are released, including by whom and
to whom, shall be defined.
b) When examination results fall within established "alert" or "critical" intervals:
— the user or other authorized person is notified as soon as relevant, based on clinical information
available;
— actions taken are documented, including date, time, responsible person, person notified,
results conveyed, verification of accuracy of communication, and any difficulties encountered
in notification;
— the laboratory shall have an escalation procedure for laboratory personnel when a responsible
person cannot be contacted.
c) When results are transmitted as a preliminary report, the final report shall always be forwarded
to the user.
d) Records shall be kept of all results which are provided orally. Such results shall always be followed
by a final report.
e) There shall be clear identification of any results generated by POCT.
f) The identification of the person(s) reviewing the results and authorizing release of the results shall
be readily available, if not contained in the report.
g) Special counselling may be needed for examination results with serious implications for the patient
(e.g. for genetic or certain infectious diseases). Laboratory management should ensure that these
results are not communicated to the patient without the opportunity for adequate counselling.
h) Results of laboratory examinations that have been anonymized may be used for such purposes as
epidemiology, demography, or other statistical analyses, provided that all risks to patient privacy
and confidentiality is mitigated and in accordance with any legal/regulatory requirements.
7.3.1.4 Amendments to reports
Procedures for the issue of amended or revised results shall specify:

a) the reason for the change is recorded and included in the report, when relevant;

ISO/DIS 15189:2021(E)

b) revised results shall be delivered only in the form of an additional document or data transfer, and
clearly identified as having been revised. The date and patient's identity in the original report shall
be indicated;
c) the date and time of the revision and the name of the person responsible for it is identified;
d) the user is made aware of the revision;
e) when it is necessary to issue a completely new report, this shall be uniquely identified and shall
contain a reference and traceability to the original report that it replaces;
f) when the reporting system cannot capture revisions, a record of such shall be kept.
7.3.1.5 Automated selection, review and reporting of results
When the laboratory implements a system for automated selection, review and reporting of results, it
shall establish a procedure to ensure that:
a) the criteria for automated selection, review and reporting are defined, approved, readily available
and understood by personnel responsible for authorizing the release of results;
b) the criteria are validated and approved before use, regularly reviewed and verified after changes
to the reporting system that might affect their proper functioning and place patient care at risk;
c) results selected by automated reporting system for manual review are identifiable and as
appropriate include the date and time of selection as well as the time of manual review and identity
of the reviewer;
d) when necessary, rapid suspension of automated selection and reporting is applied.
7.3.2 Post-examination handling of samples
The laboratory shall define the length of time samples are to be retained following examination and the
conditions under which samples are to be stored.
The laboratory shall ensure that after the examination, the
a) patient and source identification of the sample is maintained;
b) suitability of the sample for additional examination is known;
c) sample is stored in a manner that optimally preserves suitability for additional examination;
d) sample can be located and retrieved, and
e) sample is discarded appropriately.
7.4 Nonconforming work

The laboratory shall have a process that shall be implemented when any aspect of its laboratory
activities or examination results do not conform to its own procedures, quality specifications, or the
user requirements (e.g., equipment or environmental conditions are out of specified limits, results of
monitoring fail to meet specified criteria). The procedure shall ensure that:
a) the responsibilities and authorities for the management of nonconforming work are defined;
b) immediate and long-term actions are defined and based upon the risk analysis process established
by the laboratory;
c) examinations are halted, and reports withheld when there is a risk of harm to patients;

ISO/DIS 15189:2021(E)

d) an evaluation is made of the clinical significance of the nonconforming work, including an impact
analysis on examination results which may have been released prior to identification of the
nonconformance;
e) a decision is made on the acceptability of the nonconforming work;
f) when necessary, examination results are revised, and the user is notified;
g) the responsibility for authorizing the resumption of work is defined.
The laboratory shall implement corrective action commensurate with the risk of recurrence of the
nonconforming work.
The laboratory shall retain records of nonconforming work and actions as specified in 7.4 a) to g).
7.5 Control of data and information management
7.5.1 General
The laboratory shall have access to the data and information needed to provide a service which meets
the needs and requirements of the user.
NOTE 1 In this document, "laboratory information systems" includes the management of data and information
contained in both computer and non-computerized systems. Some of the requirements can be more applicable to
computer systems than to non-computerized systems.
NOTE 2 Commercial generic software used within its designed application range may be considered
sufficiently validated (e.g., word processing and spreadsheet software and quality management software
programs).
NOTE 3 Risks associated with computerized laboratory information systems are discussed in ISO 22367:2020,
Clause A.13 Control of laboratory information systems.
NOTE 4 The information security controls, strategies and best practices to ensure the preservation of
confidentiality, integrity and availability of information, are listed in ISO/IEC 27001:2013, Annex A Reference
control objectives and controls.
7.5.2 Authorities and responsibilities for information management
The laboratory shall ensure that the authorities and responsibilities for the management of the
information systems are defined, including the maintenance and modification to the information
systems that can affect patient care. The laboratory is ultimately responsible for the information
systems.
7.5.3 Information systems management
The system(s) used for the collection, processing, recording, reporting, storage or retrieval of
examination data and information shall be:
a) validated by the supplier and verified for functioning by the laboratory before introduction, with
any changes to the system authorized, documented and validated before implementation;
NOTE Validation and verification include, where applicable, the proper functioning of interfaces
between the laboratory information system and other systems such as with laboratory instrumentation,
hospital patient administration systems and systems in primary care.
b) documented, and the documentation readily available to authorized users , including that for day to
day functioning of the system;
c) implemented taking cybersecurity into account, to protect the system from unauthorized access
and safeguarded data against tampering or loss;
ISO/DIS 15189:2021(E)

d) operated in an environment that complies with supplier specifications or, in the case of non-
computerized systems, provides conditions which safeguard the accuracy of manual recording and
transcription;
e) maintained in a manner that ensures the integrity of the data and information and includes the
recording of system failures and the appropriate immediate and corrective actions.
7.5.4 Contingency plans
The laboratory shall have contingency plans to maintain operations in the event of failure or downtime
in information systems that affects the laboratory's ability to provide service. This includes automated
selection and release of results.
7.5.5 Off site management
When the information system(s) are managed and maintained off-site or subcontracted to an alternative
provider, laboratory management shall be responsible for ensuring that the provider or operator of the
system complies with all applicable requirements of this document.
7.6 Complaints
7.6.1 Process
The laboratory shall have a documented procedure for handling complaints that shall include at least
the following:
a) a description of the process for receiving, substantiating and investigating the complaint, and de-
ciding what actions shall be taken in response;
b) tracking and recording the complaint, including the actions undertaken to resolve it;
c) ensuring appropriate action is taken.
A description of the process for handling complaints shall be publicly available.
7.6.2 Receipt of complaint
a) Upon receipt of a complaint, the laboratory shall confirm whether the complaint relates to laboratory
activities that the laboratory is responsible for and, if so, shall resolve the complaint.
b) The laboratory receiving the complaint shall be responsible for gathering all necessary information
to determine whether the complaint is substantiated.
c) Whenever possible the laboratory shall acknowledge receipt of the complaint, and provide the
complainant with the outcome and, if applicable, progress reports.
7.6.3 Resolution of complaint
Investigation and resolution of complaints shall not result in any discriminatory actions.
The resolution of complaints shall be made by, or reviewed and approved by, persons not involved in
the subject of the complaint in question. Where resources do not permit this, any alternative approach
shall not compromise impartiality.
7.7 Continuity and emergency preparedness planning

The laboratory shall ensure that risks associated with emergency situations or other conditions when
laboratory activities are limited, or unavailable, have been identified, and a coordinated strategy that
involves plans, procedures, and technical measures to enable the recovery of systems and continued
operations after a disruption. Emergency preparedness plans shall be periodically assessed.
The laboratory shall:
a) establish a planned response to emergency situations, taking into account the needs and capabilities
of all relevant parties;
ISO/DIS 15189:2021(E)

b) provide relevant information and training as appropriate to relevant parties;

c) periodically test and exercise the planned response capability, where practicable;
d) respond to actual emergency situations;
e) take action to prevent or mitigate the consequences of emergency situations, appropriate to the
magnitude of the emergency and the potential impact;
f) evaluate the performance of the planned response and revise it as necessary, including after the
occurrence of emergency situations and after testing and exercising.
8 Management system requirements
8.1 General requirements and options
8.1.1 General
The laboratory shall establish, document, implement and maintain a management system to support
and demonstrate the consistent fulfilment of the requirements of this document.
As a minimum, the management system of the laboratory shall include at least the following:
— Policies (see 8.2)
— Responsibilities (see 5)
— management reviews (see 8.9)

— evaluations and internal audits (see 8.8)
— corrective action (see 8.7)
— actions to address risks and opportunities (see 8.5);
— documented information (see 8.2, 8.3 and 8.4))
— continual improvement (see 8.6).
8.1.2 Fulfilment of management system requirements

The laboratory may meet 8.1.1 by establishing, implementing, and maintaining a quality management
system (e.g., in accordance with the requirements of ISO 9001) (see Annex A.1). This quality management
system shall support and demonstrate the consistent fulfilment of the requirements of Clauses 4 to 7
and the requirements specified in 8.2 to 8.9.
8.1.3 Management system awareness
The organization shall ensure that persons doing work under the organization’s control are aware of:
a) relevant objectives and policies;
b) their contribution to the effectiveness of the management system, including the benefits of
improved performance;
c) the implications of not conforming with the management system requirements.

ISO/DIS 15189:2021(E)

8.2 Management system documentation
8.2.1 General
Laboratory management shall establish, document, and maintain objectives and policies for the
fulfilment of the purposes of this document and shall ensure that the objectives and policies are
acknowledged and implemented at all levels of the laboratory organization.
8.2.2 Competence, impartiality, and consistency
The objectives and policies shall address the competence, impartiality, and consistent operation of the
laboratory.
8.2.3 Evidence of commitment
Laboratory management shall provide evidence of commitment to the development and implementation
of the management system and to continually improving its effectiveness.
8.2.4 Documentation
All documentation, processes, systems, and records, related to the fulfilment of the requirements of
this document shall be included in, referenced from, or linked to the management system.
8.2.5 Personnel access
All personnel involved in laboratory activities shall have access to the parts of the management system
documentation and related information that are applicable to their responsibilities.
8.3 Control of management system documents
8.3.1 Control of Documents
The laboratory shall control the documents (internal and external) that relate to the fulfilment of this
document.
NOTE In this context, "document" can be policy statements, procedures and related job aids, flow charts,
instructions for use, specifications, manufacturer's instructions, calibration tables, biological reference intervals
and their origins, charts, posters, notices, memoranda, software documentation, drawings, plans, agreements,
and documents of external origin such as laws, regulations, standards and textbooks from which examination
methods are taken, documents describing personnel qualifications (such as job descriptions), etc. These can be in
any form or type of medium, such as hard copy or digital.
8.3.2 Management of documents
The laboratory shall ensure that:

a) documents are uniquely identified;
b) documents are approved for adequacy before issue by authorized personnel who have the expertise
and competence to determine adequacy;
c) documents are periodically reviewed and updated as necessary;
d) relevant versions of applicable documents are available at points of use and, where necessary, their
distribution is controlled;
e) changes and the current revision status of documents are identified;
f) documents are protected from unauthorized changes and any deletion or removal;
ISO/DIS 15189:2021(E)

g) documents are protected from unauthorized access;

h) the unintended use of obsolete documents is prevented, and suitable identification is applied to
them if they are retained for any purpose;
i) at least one paper or electronic copy of each obsolete controlled document is retained for a specified
time period or in accordance with applicable specified requirements.
8.4 Control of records
8.4.1 Creation of records
The laboratory shall establish and retain legible records to demonstrate fulfilment of the requirements
of this document.
Records shall be created at the time each activity that affects the quality of the examination is
performed.
NOTE Records can be in any form or type of medium.
8.4.2 Amendment of records
The laboratory shall ensure that amendments to records can be traced to previous versions or to
original observations. Both the original and amended data and files shall be kept, including the date and
where relevant, the time, of alteration, an indication of the altered aspects and the personnel making
the alterations.
8.4.3 Retention of records
a) The laboratory shall implement the measures needed for the identification, storage, protection
from unauthorized access and changes, back-up, archive, retrieval, retention time, and disposal of
its records.
b) The retention times for records shall be defined.
NOTE 1 Regulatory, accreditation, national, regional, local, and organizational requirements can apply.
NOTE 2 In addition to requirements, retention times can be chosen based on identified risks.
c) Reported examination results shall be retrievable for as long as necessary or as required.

d) Legal liability concerns regarding certain types of procedures (e.g. histology examinations, genetic
examinations, pediatric examinations) may require the retention of certain records for much
longer times than for other records.
e) All records shall be accessible throughout the entire retention period, legible in whichever medium
the laboratory keeps records, and available for laboratory management review (see 8.9).
8.5 Actions to address risks and opportunities
8.5.1 Identification of risks and opportunities
The laboratory shall identify risks and opportunities associated with the laboratory activities to:
a) prevent or reduce, undesired impacts and potential failures in the laboratory activities;
b) achieve improvement, by acting on opportunities;
c) assure that the management system achieves its intended results;
ISO/DIS 15189:2021(E)

d) help achieve the purpose and objectives of the laboratory.
8.5.2 Acting on risks
The laboratory shall act on identified risks. Actions taken to address risks shall be proportional to the
potential impact on laboratory examination results, as well as patient and personnel safety.
The laboratory shall record decisions made and actions taken on risks and opportunities.
The laboratory shall integrate and implement actions on identified risks into its management system
and evaluate their effectiveness.
NOTE 1 Options to address risks can include identifying and avoiding threats, eliminating a risk source,
reducing the likelihood or consequences of a risk, transferring a risk, taking a risk in order to pursue an
opportunity, or retaining risk by informed decision.
NOTE 2 Although this document requires that the laboratory identifies and addresses risks, there is
no requirement for any particular risk management method. Laboratories can use ISO 22367:2020 and
ISO 35001:2019 for guidance.
NOTE 3 Opportunities can lead to expanding the scope of the laboratory activities, applying new technology,
or creating other possibilities to fulfil patient and user needs.
8.6 Improvement
8.6.1 Continual improvement
a) The laboratory shall continually improve the effectiveness of the management system, including
the pre-examination, examination and post-examination processes as stated in the objectives and
policies.
b) The laboratory shall identify and select opportunities for improvement and develop, document,
and implement any necessary actions. Improvement activities shall be directed at areas of highest
priority based on risk assessments and the opportunities identified. (see 8.5)
NOTE Opportunities for improvement can be identified through risk assessment; use of the policies;
review of the operational procedures, overall objectives, external evaluation reports, internal audit findings,
complaints, corrective actions, management reviews, suggestions from personnel, suggestions or feedback
from patients and users, analysis of data and proficiency testing results.
c) The laboratory shall evaluate the effectiveness of the actions taken.

d) Laboratory management shall ensure that the laboratory participates in continual improvement
activities that encompass relevant areas and outcomes of patient care.
e) Laboratory management shall communicate to personnel its improvement plans and related goals.
8.6.2 Laboratory patients, user, and personnel feedback
The laboratory shall seek feedback from its patients, users, and personnel. The feedback shall be
analyzed and used to improve the management system, laboratory activities and laboratory services
to users.
Records of feedback shall be maintained including the action taken. Communication shall be provided
to personnel on actions taken arising from their feedback.

ISO/DIS 15189:2021(E)

8.7 Corrective Action
8.7.1 Actions when nonconformity occurs
When a nonconformity occurs, the laboratory shall:

a) react to the nonconformity and, as applicable:
— take immediate action to control and correct the nonconformity;
— address the consequences, with a particular focus on patient safety including escalation to the
appropriate person, per laboratory policy;
b) evaluate the need for corrective action to eliminate the cause(s) of the nonconformity, in order to
reduce the likelihood of recurrence or occurrence elsewhere, by:
— reviewing and analyzing the nonconformity;
— determining whether similar nonconformities exist, or could potentially occur;
— assessing the potential risk(s) and effect(s) if the nonconformity recurs
c) implement any action needed;
d) review and evaluate the effectiveness of any corrective action taken;
e) update risks and opportunities, as needed;
f) make changes to the management system, if necessary.
8.7.2 Corrective action effectiveness
Corrective actions shall be appropriate to the effects of the nonconformities encountered and shall
mitigate the identified cause(s).
8.7.3 Records of nonconformities
The laboratory shall retain records as evidence of the:

a) nature of the nonconformities, cause(s) and any subsequent actions taken; and
b) evaluation of the effectiveness of any corrective action.
8.8 Evaluations
8.8.1 General
The laboratory shall conduct evaluations at planned intervals to demonstrate that the management,
support, and pre-examination, examination, and post-examination processes meet the needs and
requirements of patients and users; and to ensure conformity to the requirements of this document;
8.8.2 Quality indicators
The process of monitoring quality indicators (see 5.5.5) shall be planned, which includes establishing
the objectives, methodology, interpretation, limits, action plan and duration of monitoring. The
indicators shall be periodically reviewed, to ensure their continued appropriateness.

ISO/DIS 15189:2021(E)

8.8.3 Internal audits
8.8.3.1 The laboratory shall conduct internal audits at planned intervals to provide information on
whether the management system conforms to:
— the laboratory’s own requirements for its management system, including the laboratory activities;
— the requirements of this document; and
— is effectively implemented and maintained.
NOTE When performed, POCT is considered to be part of the laboratory activities.
8.8.3.2 The laboratory shall plan, establish, implement and maintain an internal audit programme that
includes:
a) priority given to risk to patients from laboratory activities;

b) a schedule which takes into consideration identified risks; the outcomes of both external evaluations
and previous internal audits; the occurrence of nonconformities, incidents, and complaints; and
changes affecting the laboratory activities;
c) defined audit objectives, criteria and scope for each audit;
d) selection of auditors who are trained and qualified/authorized to assess the performance of the
laboratory's management system, and, whenever resources permit, are independent of the activity
to be audited;
e) conducting of audits to ensure objectivity and impartiality of the audit process;
f) ensuring that the results of the audits are reported to relevant personnel;
g) implementation of appropriate correction and corrective actions without undue delay; and a review
of the effectiveness of corrective actions;
h) retention of records as evidence of the implementation of the audit programme and audit results.
NOTE ISO 19011:2018 provides guidance for auditing management systems.
8.9 Management reviews
8.9.1 General
Laboratory management shall review its management system at planned intervals to ensure it meets
stated objectives and policies, identifies opportunities and sets priorities for continuing improvement.
8.9.2 Review input
The inputs to management review shall be recorded and shall include evaluations of at least the
following:
a) status of actions from previous management reviews, internal and external changes to the
management system, changes in the volume and type of laboratory activities and adequacy of
resources;
b) fulfilment of objectives and suitability of policies and procedures;
c) outcomes of recent evaluations, internal audits, analysis of non-conformities, corrective actions
and assessments by external bodies;
d) user and personnel feedback andto:complaints;
Licensed White, Graham Professor
ISO/DIS 15189:2021(E)

e) quality assurance of result validity, effectiveness of any implemented improvements and actions
taken to address risks and opportunities, and performance of external providers;
f) results of participation in interlaboratory comparison programmes (EQA/PT);
g) evaluation of POCT activities, and
h) other relevant factors, such as monitoring activities and training.
8.9.3 Review output
The outputs from the management review shall record all decisions and actions related to at least:
a) the effectiveness of the management system and its processes;
b) improvement of the laboratory activities related to the fulfilment of the requirements of this
document;
c) provision of required resources;
d) improvement of services to users;
e) any need for change.
Laboratory management shall ensure that actions arising from management review are completed
within a defined timeframe.
Findings and actions arising from management reviews shall be communicated to laboratory personnel.
The laboratory director shall ensure that appropriate administrative officials are informed of actions
required, as well as resources necessary to complete the identified actions.

ISO/DIS 15189:2021(E)

Annex A
(informative)
The ISO 9001 quality system series is the parent document for a quality management system
standard. Table A.1 illustrates the conceptual relationship between this International Standard and
ISO 9001:2015.
The format of this edition more closely resembles that of ISO/IEC 17025:2017, used by ISO TC 212 as the
model for the structure of this international Standard with specific adjustment for medical laboratories.
Table A.2 shows the correlation between these two documents.
Table A.1 — Correlation between ISO 9001:2015 and this International Standard
ISO 9001:2015 ISO 15189:2022
1 Scope 1 Scope
2.0 Normative references 2 Normative references
3 Terms and definitions 3 Terms and definitions
4 Context of the organization 4 General requirements
4.1 Understanding the organization and its context 4.1 Impartiality
4.2 Understanding the needs and expectations of inter- 4.2 Confidentiality
ested parties
4.3 Determining the scope of the quality management
system
4.4 Quality management system and its processes
8 Management system requirements
8.1 General requirements and options
8.1.1 General
5 Leadership 5 Structural requirements
5.1 Leadership and commitment 5.1 Legal Entity
5.1.1 General 5.2 Laboratory director
5.1.2 Customer focus 5.2.1 Laboratory director competence
5.2 Policy 5.2.2 Laboratory director responsibilities
5.2.1 Establishing the quality policy 5.2.3 Delegation of duties
5.2.2 Communicating the quality policy 5.3 Laboratory activities
5.3 Organizational roles, responsibilities and authori- 5.3.1 Scope of laboratory activities
ties
5.4.1 General

ISO/DIS 15189:2021(E)

Table A.1 (continued)

ISO 9001:2015 ISO 15189:2022
6 Planning 8.5 Actions to address risks and opportunities
6.1 Actions to address risks and opportunities 8.5.1 Identification of risks and opportunities
6.2 Quality objectives and planning to achieve them 8.5.2 Acting on risks
6.3 Planning of changes 5.5 Objectives and policies
5.6 Risk management
7 Support 6 Resource requirements
7.1 Resources 6.1 General
7.1.1 General 6.2 Personnel
7.1.2 People 6.2.1 General
7.1.3 Infrastructure 6.2.2 Qualification, duties and responsibilities
7.1.4 Environment for the operation of processes 6.2.4 Continuing education and professional develop-
ment
7.1.5 Monitoring and measuring resources
6.2.5 Authorization
7.1.6 Organizational knowledge
6.3 Facilities and environmental conditions
6.3.1 General
7.2 Competence 6.2.3 Training and competence assessment
7.3 Awareness 8.1.3 Management system awareness
7.4 Communication 7.5 Control of data and information management
7.5.1 General
7.5.2 Authorities and responsibilities for information
management

ISO/DIS 15189:2021(E)


ISO 9001:2015 ISO 15189:2022
7.5 Documented information 8.2 Management system documentation
7.5.1 General 8.2.1 General
7.5.2 Creating and updating 8.2.2 Competence, Impartiality and consistency
7.5.3 Control of documented information 8.2.3 Evidence of commitment
8.2.4 Documentation
8.3 Control of management system documents
8.3.1 Control of documents
8.4 Control of records
8 Operation 6.4 Equipment
8.1 Operational planning and control 6.4.1 General
6.4.3 Equipment acceptance
6.5 Equipment calibration and metrological traceabil-
ity
6.5.1 Metrological traceability of equipment and meth-
od

ISO/DIS 15189:2021(E)


ISO 9001:2015 ISO 15189:2022
8.2 Requirements for products and services 6.6 Reagents and Consumables
8.2.1 Customer communication 6.6.1 Reagents and consumables – General
8.2.2 Determining the requirements for products and 6.6.2 Reagents and consumables – Receipt and storage
services
6.6.3 Reagents and consumables – Acceptance testing
8.2.3 Review of the requirements for products and
6.6.4 Reagents and consumables – Inventory manage-
services
ment
8.2.4 Changes to requirements for products and ser-
6.6.5 Reagents and consumables – Instructions for use
vices
6.6.6 Reagents and consumables – Adverse incident
reporting
6.6.7 Reagents and consumables – Records
7.5 Control of data and information management
7.5.1 General
management
8.3 Design and development of products and services 7 Process requirements
8.3.1 General 7.1 Pre-examination processes
8.3.2 Design and development planning 7.1.1 Laboratory information for patients and users
8.3.3 Design and development inputs 7.1.2 Requests for providing laboratory examinations
8.3.4 Design and development controls 7.1.2.1 General
8.3.5 Design and development outputs 7.1.2.2 Oral requests
8.3.6 Design and development changes 7.1.3 Primary sample collection and handling
7.1.3.1 General
7.1.6 Pre-examination handling, preparation and
storage
8.4 Control of externally provided processes, products 6.7 Service agreements
and services
8.4.1 General
6.8.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
6.8.3 Review and approval of externally provided
products and services
ISO/DIS 15189:2021(E)


ISO 9001:2015 ISO 15189:2022
8.5 Production and service provision 7.2 Examination processes
8.5.1 Control of production and service provision 7.2.1 General
8.5.2 Identification and traceability 7.2.2 Verification of examination methods
8.5.3 Property belonging to customers or external 7.2.3 Validation of examination methods
providers
7.2.5 Biological reference intervals and clinical deci-
8.5.4 Preservation sion limits
8.5.5 Post-delivery activities 7.2.6 Documentation of examination procedures
8.5.6 Control of changes 7.3.2 Post-examination handling of samples
8.6 Release of products and services 7.3 Post-examination processes
7.3.1.1 General
7.3.1.2 Common requirements for reports
7.3.1.5 Automated selection, review and reporting of
results
8.7 Control of nonconforming outputs 7.4 Nonconforming work
9 Performance evaluation 7.2.4 Measurement uncertainty of measured quantity
values
9.1 Monitoring, measurement, analysis and evaluation
7.2.7 Ensuring the validity of examination results
9.1.1 General
7.2.7.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit 8.8 Evaluations
8.8.1 General
9.3 Management review 8.9 Management reviews
9.3.2 Management review inputs 8.9.2 Review input
9.3.3 Management review outputs 8.9.3 Review output
10 Improvement 8.6 Improvement
10.1 General 8.6.2 Laboratory patients, user and personnel feed-
back

ISO/DIS 15189:2021(E)


ISO 9001:2015 ISO 15189:2022
10.2 Nonconformity and corrective action 7.6 Complaints
7.6.1 Process
8.7 Corrective Action
10.3 Continual improvement 8.6.1 Continual improvement
Table A.2 — Correlation between ISO/IEC 17025:2017 and this International Standard
ISO/IEC 17025:2017 ISO 15189:2022
1. Scope 1 Scope
2. Normative references 2 Normative references
3. Terms and definitions 3 Terms and definitions
4. General requirements 4 General requirements
4.1 Impartiality 4.1 Impartiality
4.2 Confidentiality 4.2 Confidentiality
5. Structural requirements 5 Structural requirements
5.1 Legal Entity
5.2 Laboratory director
5.2.1 Laboratory director competence
5.4.1 General
5.5 Objectives and policies
5.6 Risk management
6. Resource requirements 6 Resource requirements
6.1 General 6.1 General

ISO/DIS 15189:2021(E)


ISO/IEC 17025:2017 ISO 15189:2022
6.2 Personnel 6.2 Personnel
6.2.1 General
6.2.2 Qualifications duties and responsibilities
6.2.3 Training and competence assessment
6.2.4 Continuing education and professional develop-
ment
6.2.5 Authorization
6.3 Facilities and environmental conditions 6.3 Facilities and environmental conditions
6.3.1 General
6.4 Equipment 6.4 Equipment
6.4.1 General
6.4.3 Equipment acceptance
6.5 Metrological traceability 6.5 Equipment calibration and metrological traceabil-
ity
od
6.6 Externally provided products and services 6.6 Reagents and Consumables
6.6.1 Reagents and consumables – General
6.6.2 Reagents and consumables – Receipt and storage
ment
reporting
6.7 Service agreements
6.8.1 General
ISO/DIS 15189:2021(E)


ISO/IEC 17025:2017 ISO 15189:2022
7. Process requirements 7 Process requirements
7.1 Review of requests, tenders and contracts 7.1 Pre-examination processes
7.1.1 Laboratory information for patients and users
7.1.2 Requests for providing laboratory examinations
7.1.2.1 General
7.1.2.2 Oral requests
7.1.3 Primary sample collection and handling
7.1.3.1 General
storage
7.2 Selection, verification and validation of methods 7.2 Examination processes
7.2.1 Selection and verification of methods 7.2.1 General
7.2.2 Verification of examination methods
7.2.2 Validation of methods 7.2.3 Validation of examination methods
7.2.5 Biological reference intervals and clinical deci-
sion limits
7.3 Sampling See 7.1
7.4 Handling of test or calibration items 7.3.2 Post-examination handling of samples
7.5 Technical records 7.2.6 Documentation of examination procedures
See also 7.11
7.6 Evaluation of measurement uncertainty 7.2.4 Measurement uncertainty of measured quantity
values
7.7 Ensuring the validity of results 7.2.7 Ensuring the validity of examination results
7.2.7.1 General
7.8 Reporting of results 7.3 Post-examination processes
7.8.1 General 7.3.1.1 General

ISO/DIS 15189:2021(E)


ISO/IEC 17025:2017 ISO 15189:2022
7.8.2 Common requirements for reports (test, calibra- 7.3.1.2 Common requirements for reports
tion or sampling)
7.8.3 Specific requirements for test reports
7.8.4 Specific requirements for calibration certificates
7.3.1.5 Automated selection, review, and reporting of
7.8.5 Reporting sampling – specific requirements results
7.8.6 Reporting statements of conformity
7.8.7 Reporting opinions and interpretations
7.8.8 Amendments to reports
7.9 Complaints 7.6 Complaints
7.6.1 Process
7.10 Nonconforming work 7.4 Nonconforming work
7.11 Control of data and information management 7.5 Control of data and information management
7.5.1 General
management
8. Management system requirements 8 Management system requirements
8.1 Options 8.1 General requirements and options
8.1.2 Option A 8.1.2 Fulfilment of management system requirements
8.1.3 Option B 8.1.3 Management system awareness
8.2 Management system documentation (Option A) 8.2 Management system documentation
8.2.1 General
8.2.2 Competence, impartiality, and consistency
8.2.3 Evidence of commitment
8.2.4 Documentation
8.3 Control of management system documents 8.3 Control of management system documents
(Options A)
8.4 Control of records (Options A) 8.4 Control of records
8.5 Actions to address risks and opportunities 8.5 Actions to address risks and opportunities
(Option A)
Licensed to: White, Graham 8.5.2 Acting on risks

Professor
ISO/DIS 15189:2021(E)


ISO/IEC 17025:2017 ISO 15189:2022
8.6 Improvement (Option A) 8.6 Improvement
8.6.2 Laboratory patients, user and personnel feed-
back
8.7 Corrective actions (Option A) 8.7 Corrective Action
8.8 Internal audits (Option A) 8.8 Evaluations
8.8.1 General
8.9 Management reviews (Option A) 8.9 Management reviews
8.9.1 General
8.9.2 Review input
8.9.3 Review output

ISO/DIS 15189:2021(E)

Annex B
(informative)
Comparison of ISO 15189:2012 to ISO 15189:2022
Table B.1 — Correlation of ISO 15189:2012 to ISO 15189:2022

ISO 15189:2012 ISO 15189:2022
Foreword Foreword
Introduction Introduction
1 Scope 1 Scope
2 Normative references 2 Normative references
3 Terms and definitions 3 Terms and definitions
4 Management requirements 4 General requirements
4.1 Organization and management responsibility 4.1 Impartiality
4.1.1 Organization 4.2 Confidentiality
4.1.1.1 General 4.2.1 Management of information
4.1.1.3 Ethical conduct 4.2.2 Release of information
[includes confidentiality in (e)] 4.2.3 Personnel responsibility
4.1.1.2 Legal entity 5 Structural requirements
4.1.1.4 Laboratory director 5.1 Legal Entity
4.1.2 Management responsibility 5.2 Laboratory director
4.1.2.1 Management commitment 5.2.1 Laboratory director competence
5.4.1 General
4.1.2.2 Needs of users 4.3 Requirements regarding patients
4.1.2.3 Quality policy 5.5 Objectives and policies
4.1.2.4 Quality objectives and planning 5.5 Objectives and policies
4.1.2.5 Responsibility, authority, and interrelation- 5.4 Structure and authority
ships
4.1.2.6 Communication 5.4.1 General b)
4.1.2.7 Quality manager 5.4.2 Quality management
4.2 Quality management system 8 Management system requirements
4.2.1 General requirements 8.1 General requirements and options
8.1.1 General
8.1.2 Fulfilment of management requirements
8.1.3 Management system awareness
ISO/DIS 15189:2021(E)

Table B.1 (continued)

ISO 15189:2012 ISO 15189:2022
4.2.2 Documentation requirements 8.2 Management system documentation
4.2.2.1General 8.2.1 General
4.2.2.2 Quality manual See 5.5.3 NOTE
4.3 Document control 8.3 Control of management system documents
4.4 Service agreements 6.7 Service agreements
4.4.1 Establishment of service agreements
4.4.2 Review of service agreements
4.5 Examination by referral laboratories 6.8.2 Referral laboratories and consultants
4.5.1 Selecting and evaluating referral laboratories
and consultants
4.5.2 Provision of examination results
4.6 External services and supplies 6.8 Externally provided products and services
4.7 Advisory services 5.3.3 Advisory activities
4.8 Resolution of complaints 7.6 Complaints
7.6.1 Process
4.9 Identification and control of nonconformities 7.4 Nonconforming work
4.10 Corrective action 8.7 Corrective action
8.7.2 Actions appropriate to effects
8.7.4 Reviews of records of nonconformities
4.11 Preventive action 8.5 Actions to address risks and opportunities
4.12 Continual improvement 8.6 Improvement
8.6.2 Laboratory patients, user and personnel feed-
back
4.13 Control of records 8.4 Control of records
4.14 Evaluation and audits 8.8 Evaluations

ISO/DIS 15189:2021(E)


ISO 15189:2012 ISO 15189:2022
4.14.2 Periodic review of requests, and suitability of 7.1.3 Primary sample collection and handling
procedures, and sample requirements
7.1.3.1 General
7.2 Examination processes
7.2.1 General e)
4.14.3 Assessment of user feedback 8.6.2 Laboratory user and personnel feedback
4.14.4 Staff suggestions
4.14.5 Internal audit 8.8.3 Internal audits
4.14.6 Risk management 5.6 Risk management
8.5 Actions to address risks and opportunities
8.5.1 Identifications of risks and actions taken
4.14.7 Quality indicators 8.8.2 Quality indicators
See also 5.5.5
4.14.8 Reviews by external organizations
4.15 Management review 8.9 Management review
4.15.2 Review input 8.9.2 Review input
4.15.3 Review activities
4.15.4 Review output 8.9.3 Review output
5 Technical requirements 6 Resource requirements
5.1 Personnel 6.2 Personnel
5.1.2 Personnel qualifications 6.2.2 Qualification, duties and responsibilities
5.1.3 Job descriptions 6.2.4 Continuing education and professional develop-
ment
5.1.4 Personnel introduction to the organizational
environment 6.2.5 Authorization
5.1.5 Training
5.1.6 Competence assessment
5.1.7 Review of staff performance
5.1.8 Continuing education and professional develop-
ment
5.1.9 Personnel records
5.2 Accommodation and environmental conditions 6.3 Facilities and environmental conditions
5.2.2 Laboratory and office facilities 6.3.2 Facility controls
5.2.3 Storage facilities 6.3.3 Storage facilities
5.2.4 Staff facilities 6.3.4 Personnel facilities
5.2.5 Patient sample collection facilities 6.3.5 Specimen collection facilities
5.2.6 Facility maintenance and environmental condi-
tions

ISO/DIS 15189:2021(E)


ISO 15189:2012 ISO 15189:2022
5.3 Laboratory equipment, reagents, and consumables
5.3.1 Equipment 6.4 Equipment
5.3.1.1 General 6.4.1 General
5.3.1.2 Equipment acceptance testing 6.4.2 Equipment requirements
5.3.1.3 Equipment instructions for use 6.4.3 Equipment acceptance
5.3.1.4 Equipment calibration and metrological trace- 6.4.4 Equipment instructions for use
ability
5.3.1.5 Equipment maintenance and repair
5.3.1.6 Equipment adverse incident reporting
5.3.1.7 Equipment records
6.5 Equipment calibration and metrological traceabil-
ity
od
5.3.2 Reagents and consumables 6.6 Reagents and consumables
5.3.2.1 General 6.6.1 Reagents and consumables – General
5.3.2.2 Reagents and consumables – reception and 6.6.2 Reagents and consumables – Receipt and storage
storage
5.3.2.3 Reagents and consumables – acceptance testing
5.3.2.4 Reagents and consumables – inventory man- ment
agement
5.3.2.5 Reagents and consumables – instructions for
use
reporting
5.3.2.6 Reagents and consumables – adverse incident
reporting
5.3.2.7 Reagents and consumables – records

ISO/DIS 15189:2021(E)


ISO 15189:2012 ISO 15189:2022
5.4 Pre-examination processes 7.1 Pre-examination processes
5.4.1 General 7.1 Pre-examination processes
5.4.2 Information for patients and users 7.1.1 Laboratory information for patients and users
5.4.3 Request form information 7.1.2 Requests for providing laboratory examinations
5.4.4 Primary sample collection and handling 7.1.2.1 General
5.4.4.1 General 7.1.2.2 Oral requests
5.4.4.2 Instructions for pre-collection activities 7.1.3 Primary sample collection and handling
5.4.4.3 Instructions for collection activities 7.1.3.1 General
5.4.5 Sample transportation 7.1.3.2 Instructions for pre-collection activities
5.4.6 Sample reception 7.1.3.3 Instructions for collection activities
5.4.7 Pre-examination handling, preparation, and 7.1.4 Sample transportation
storage
storage
5.5 Examination processes 7.2 Examination processes
5.5.1 Selection, verification, and validation of examina- 7.2.1 General
tion procedures
5.5.1.2 Verification of examination procedures 7.2.2 Verification of examination procedures
5.5.1.3 Validation of examination procedures 7.2.3 Validation of examination methods
5.5.1.4 Measurement uncertainty of measured quanti- 7.2.4 Measurement uncertainty of measured quantity
ty values values
5.5.2 Biological reference intervals or clinical decision 7.2.5 Biological reference intervals and clinical deci-
values sion limits
5.5.3 Documentation of examination procedures 7.2.6 Documentation of examination procedures
5.6 Ensuring quality of examination results 5.6.1 7.2.7 Ensuring the validity of examination results
General
7.2.7.1 General
5.6.2 Quality control 7.2.7.2 Internal quality control (IQC)
5.6.2.1 General
5.6.2.2 Quality control materials
5.6.2.3 Quality control data
5.6.3 Interlaboratory comparisons 7.2.7.3 External quality assessment (EQA)
5.6.3.1 Participation
5.6.3.2 Alternative approaches
5.6.3.3 Analysis of interlaboratory comparison sam-
ples
5.6.3.4 Evaluation of laboratory performance
5.6.4 Comparability of examination results 7.2.7.4 Comparability of examination results
ISO/DIS 15189:2021(E)


ISO 15189:2012 ISO 15189:2022
5.7 Post-examination processes 7.3 Post-examination processes
5.7.1 Review of results 7.3.1.3 Release of results including critical results
a)
5.7.2 Storage, retention, and disposal of clinical sam- 7.3.2 Post-examination handling of samples
ples
5.8 Reporting of results 7.3.1 Result reporting
5.8.1 General 7.3.1.1 General
5.8.2 Report attributes 7.3.1.2 Common requirements for reports
5.8.3 Report content 7.3.1.3 Release of results including critical results
5.9 Release of results 7.3.1.3 Release of results including critical results
5.9.1 Automated selection and reporting of results 7.3.1.5 Automated selection, review and reporting of
results
5.9.2 Revised reports 7.3.1.4 Amendments to reports
5.10 Laboratory information management 7.5 Control of data and information management
5.10.2 Authorities and responsibilities 7.5.2 Authorities and responsibilities for information
management
5.10.3 Information system management
Annex A Table 1 Correlation between ISO 9001:2008 Annex A Table A.1 Correlation between ISO 9001:2015
and this International standard and this International Standard
Table A2 Correlation between and ISO/IEC 17025:2005 Table A.2 Correlation between ISO/IEC 17025:2017
and this International Standard and this International Standard
Annex B Table B.1Comparison of ISO 15189:2007 with Annex B Table B.1
ISO 15189:2012
Comparison of ISO 15189:2012 with ISO 15189:2022

ISO/DIS 15189:2021(E)

Bibliography
[1] ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
[2] ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and
associated terms (VIM)
[3] ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
[4] ISO 22367, Medical laboratories — Application of risk management to medical laboratories
[5] ISO 15190, Medical laboratories — Requirements for safety
[6] ISO 20658, Medical laboratories – Requirements for collection and transport of samples
[7] ISO 22870, Point-of-care testing (POCT) — Requirements for quality and competence
[8] ISO TS/20914, Medical laboratories – Practical guide for the estimation of measurement uncertainty
[9] ISO 35001, Biorisk management for laboratories and other related organisations
ISO TS/22583, Guidance for supervisors and operators of point-of-care testing equipment
[11] ISO 17511, In vitro diagnostic medical devices — Requirements for establishing metrological
traceability of values assigned to calibrators, trueness control materials and human samples
[12] ISO 9001, Quality management systems — Requirements
[13] ISO 15194, In vitro diagnostic medical devices — Measurement of quantities in samples of
biological origin — Requirements for certified reference materials and the content of supporting
documentation
[14] ISO/IEC 17011, Conformity assessment — Requirements for accreditation bodies accrediting
conformity assessment bodies
[15] ISO 17034, General requirements for the competence of reference material producers
[16] ISO/IEC 17043, Conformity assessment — General requirements for proficiency testing
[17] ISO 19011, Guidelines for auditing management systems
[18] ISO 18113-1, In Vitro diagnostic medical devices – Information supplied by the manufacturer
(Labelling). Terms, definitions, and general requirements
[19] ISO/IEC 27001, Information technology — Security techniques — Information security management
systems — Requirements
[20] Joint Commission for Guides in Metrology (JCGM) International vocabulary of metrology – Basic
and general concepts and associated terms (VIM) 3rd edition
[21] Joint B.I.P.M. OIML, ILAC and ISO declaration on metrological traceability, 2011 (http://w ww
.bipm.org/utils/common/pdf/BIPM-OIML-ILAC-ISO_joint_declaration_ 2011.pdf)
[22] International Laboratory Accreditation Cooperation (ILAC). https://ilac.org/
[23] Brochure S.I. The International System of Units (SI), BIPM (http://w ww.bipm.org/en/
publications/si-brochure/)
[24] Logical Observation Identifiers Names and Codes (LOINC and Nomenclature for Properties and
Units (NPU, NGC) and SNOMED CT (https://loinc.org)
[25] CASCO QS-CAS-PROC/33, Common
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Graham ISO/CASCO Standards 2020

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DRAFT INTERNATIONAL STANDARD

ISO/TC 212 Secretariat: ANSI

Medical laboratories — Requirements for quality and

ICS: 11.100.01; 03.120.10

THIS DOCUMENT IS A DRAFT CIRCULATED

COPYRIGHT PROTECTED DOCUMENT

6.6.3 Reagents and consumables - Acceptance testing.............................................................................. 17

8.6.2 Laboratory patients, user, and personnel feedback........................................................................ 36

Licensed to: White, Graham Professor

Licensed to: White, Graham Professor

• ‘can’ indicates a possibility or capability.

Licensed to: White, Graham Professor

Medical laboratories — Requirements for quality and

3 Terms and definitions

[SOURCE: ISO/IEC Guide 99:2007 2.18, Note has been added]

[SOURCE: ISO 18113-1]

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

[SOURCE: ISO 17511:2020 3.10]

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

Licensed to: White, Graham Professor

Licensed to: White, Graham Professor

[SOURCE: ISO/IEC Guide 99:2007 2.6]

Licensed to: White, Graham Professor

[SOURCE: ISO 15189:2012 3.16]

[SOURCE: ISO 15189:2012 3.19]

Licensed to: White, Graham Professor

[SOURCE: ISO 15189:2012 3.23]

[SOURCE: ISO 9000:2015 3.8.13 Note 3 has been added]

EXAMPLE 2 Confirmation that a target measurement uncertainty can be met.

4.2.1 Management of information

Licensed to: White, Graham Professor

4.2.3 Personnel responsibility

4.3 Requirements regarding patients

5 Structural and governance requirements

5.1 Legal entity

5.2 Laboratory director

5.2.1 Laboratory director competence

5.2.2 Laboratory director responsibilities

The duties and responsibilities of the laboratory director shall be documented.

5.2.3 Delegation of duties

5.3 Laboratory activities

5.3.1 Scope of laboratory activities

5.3.2 Conformance with requirements

5.3.3 Advisory activities

5.4 Structure and authority

The laboratory shall:

Licensed to: White, Graham Professor

5.4.2 Quality management

5.5 ​Objectives and policies

— meeting the needs and requirements of patients and users;

5.6 Risk management

NOTE 2 ISO 35001:2019 provides details for laboratory biorisk management.

— direct observation of an activity

— monitoring the recording and reporting of examination results

— review of work records

— assessment of problem-solving skills

6.2.2 Qualification, duties and responsibilities

6.2.3 Training and competence assessment

c) training and re-training of personnel,

6.2.4 Continuing education and professional development

5.5 Objectives and policies

7.2.2 Verification of examination methods