ISO/TS 23824:2024
(Main)Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology
Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology
This document provides guidance to anatomic pathology (AP) laboratories on implementing a management system to meet requirements for quality and competence of ISO 15189. NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
Laboratoires médicaux — Recommandations pour l'application de l'ISO 15189 en anatomopathologie
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Technical
Specification
ISO/TS 23824
First edition
Medical laboratories — Guidance
2024-05
on application of ISO 15189 in
anatomic pathology
Laboratoires médicaux — Recommandations pour l'application
de l'ISO 15189 en anatomopathologie
Reference number
ISO/TS 23824:2024(en) © ISO 2024
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ISO/TS 23824:2024(en)
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© ISO 2024
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be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
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Published in Switzerland
© ISO 2024 – All rights reserved
ii
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ISO/TS 23824:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Anatomic pathology (AP) laboratory .3
4.2 Examples of process actions and risks for general requirements of ISO 15189 .4
5 Structural and governance requirements . 5
5.1 Structure of a management system .5
5.2 Examples of process actions and risks for structural and governance requirements of
ISO 15189.6
6 Resource requirements . 8
6.1 Managing personnel in anatomic pathology (AP) .8
6.2 Examples of process actions and risks for resource requirements of ISO 15189:2022 .9
7 Process requirements .15
7.1 Managing processes in anatomic pathology (AP) . 15
7.2 Examples of process actions and risks for the process requirements of ISO 15189:2022.16
8 Management system requirements .25
8.1 Managing risk in anatomic pathology (AP) . 25
8.2 Managing nonconforming work in anatomic pathology (AP).
...
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Technical
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ISO/DTS 23824
ISO/TC 212
Medical laboratories — Guidance
Secretariat: ANSI
on application of ISO 15189 in
Voting begins on:
anatomic pathology
2024-02-28
Voting terminates on:
2024-04-24
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Reference number
ISO/DTS 23824:2024(en) © ISO 2024
---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/DTS 23824:2024(en)
Technical
Specification
ISO/DTS 23824
ISO/TC 212
Medical laboratories — Guidance
Secretariat: ANSI
on application of ISO 15189 in
Voting begins on:
anatomic pathology
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DTS 23824:2024(en) © ISO 2024
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO/DTS 23824:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Anatomic pathology (AP) laboratory .3
4.2 Examples of process actions and risks for general requirements of ISO 15189 .4
5 Structural and governance requirements . 5
5.1 Structure of a management system .5
5.2 Examples of process actions and risks for structural and governance requirements of
ISO 15189.6
6 Resource requirements . 8
6.1 Managing person
...
ISO/DTS 23824: 2024(E)
Secretariat: ANSI
ISO TC 212/WG 1
Date: 2023-12-082024-02
Medical laboratories -— Guidance on application of ISO 15189 in anatomic pathology
DTS stage
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This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
change without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
© ISO 2023 – All rights reserved
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© ISO 2023
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ISO/DTS 23824:2024(E)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part
of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or
mechanical, including photocopying, or posting on the internet or an intranet, without prior written
permission. Permission can be requested from either ISO at the address below or ISO’s member body
in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
4 © ISO 2023 – All rights reserved
iv © ISO 2024 – All rights reserved
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ISO/DTS 23824:2024(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documentsdocument 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 drawnISO draws attention to the possibility that some of the elementsimplementation of this
document could bemay involve the subjectuse of (a) patent(s). ISO takes no position concerning the
evidence, validity or applicability of any claimed patent rights. in respect thereof. As of the date of
publication of this document, ISO had not received notice of (a) patent(s) which may be required to
implement this document. However, implementers are cautioned that this may not represent the latest
information, which may be obtained from the patent database available at www.iso.org/patents. 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.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
© ISO 2023 – All rights reserved 5
© ISO 2024 – All rights reserved v
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ISO/DTS 23824:2024(E)
Introduction
Anatomic pathology (AP) is the branch of medicine that examines tissue samples and cells by microscopy
and other methods. AP seeks to answer clinical questions (e.g.,. Is it neoplastic? Is it malignant? Where
does it arise? How can it be treated?) by rendering a diagnosis that allows the patient’s caregiver to treat
the patient’s condition, predict the condition’s response to treatment and make a judgement about the
condition’s prognosis.
Three components comprise AP services: histopathology (examiningcomprises three activities:
examination of tissue obtained from the body
...
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