ISO/TS 5441:2024

Competence requirements for biorisk management advisors

ISO/TS 5441:2024

Name:ISO/TS 5441:2024   Standard name:Competence requirements for biorisk management advisors
Standard number:ISO/TS 5441:2024   language:English language
Release Date:14-May-2024   technical committee:ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
Drafting committee:ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems   ICS number:07.100.01 - Microbiology in general
Technical
Specification
ISO/TS 5441
First edition
Competence requirements for
2024-05
biorisk management advisors
Exigences de compétences pour les conseillers en management
des biorisques
Reference number
ISO/TS 5441:2024(en) © ISO 2024

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ISO/TS 5441:2024(en)
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© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland

© ISO 2024 – All rights reserved
ii

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ISO/TS 5441:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context for biorisk management advice . 4
5 Functions of biorisk management advisor(s) . 4
6 Biorisk management advisor knowledge, skills, and experience . 5
7 Competence . 5
7.1 General prerequisites .5
7.2 Range and subject matter of competencies .5
7.2.1 Scientific, technical and management background .5
7.2.2 Planning of biorisk management .6
7.2.3 Support of personnel .7
7.2.4 Controls and containment . .10
7.2.5 Operation and safe practices .11
7.2.6 Performance evaluation and improvement . 13
7.2.7 International and national regulatory framework, standards, guidelines, and
conventions . 13
7.3 Competencies relevant for specific work areas . 13
7.4 Competence documentation including continuing professional development .
...

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