ISO/TS 23824:2024

Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology

ISO/TS 23824:2024

Name:ISO/TS 23824:2024   Standard name:Medical laboratories — Guidance on application of ISO 15189 in anatomic pathology
Standard number:ISO/TS 23824:2024   language:English language
Release Date:23-May-2024   technical committee:ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
Drafting committee:ISO/TC 212/WG 1 - Quality and competence in the medical laboratory   ICS number:03.120.10 - Quality management and quality assurance
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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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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