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eLibrary > PD ISO/TR 22758:2020 Biotechnology. Biobanking. Implementation guide for ISO 20387 >

PD ISO/TR 22758:2020 Biotechnology. Biobanking. Implementation guide for ISO 20387, 2020

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PD ISO/TR 22758:2020 Biotechnology. Biobanking. Implementation guide for ISO 20387, 2020

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Background information for the development of ISO 20387
4.1 General
4.2 Intended audience for ISO 20387 and this document
4.3 Implementation of ISO 20387
5 Fitness for the intended purpose (FIP) (ISO 20387:2018, 3.24) in biobanking
5.1 General
5.2 Fitness for the intended purpose and biological material and/or associated data (BMaD) life cycle
5.3 Factors affecting fitness for the intended purpose
5.4 Determination of the pre-arranged requirements for FIP
5.5 Decision whether the biological material and associated data is truly fit for an intended purpose
6 Process landscape
7 Conformity with ISO 20387
7.1 Scopes of Conformity
7.1.1 General
7.1.2 Determination of the scope of conformity
7.2 Conformity Assessment (CA) Practices (General aspects and applicability for biobanks)
8 Guidance on the interpretation of selected ISO 20387:2018 text parts
8.1 General Requirements (ISO 20387:2018, Clause 4)
8.1.1 General
8.1.2 Impartiality (ISO 20387:2018, 4.2)
8.1.3 Confidentiality (ISO 20387:2018, 4.3)
8.2 Structural requirements (20387:2018, Clause 5)
8.2.1 General
8.2.2 ISO 20387:2018, 5.1
8.2.3 ISO 20387:2018, 5.3
8.2.4 ISO 20387:2018, 5.5
8.2.5 ISO 20387:2018, 5.7
8.2.6 ISO 20387:2018, 5.8, a)
8.2.7 ISO 20387:2018, 5.9
8.3 Resource requirements (ISO 20387:2018, Clause 6)
8.3.1 General
8.3.2 ISO 20387:2018, 6.1.2
8.3.3 ISO 20387:2018, 6.2.1.2
8.3.4 ISO 20387:2018, 6.2.1.4
8.3.5 ISO 20387:2018, 6.2.2.1
8.3.6 ISO 20387:2018, 6.2.2.3
8.3.7 ISO 20387:2018, 6.2.3
8.3.8 ISO 20387:2018, 6.2.3.3
8.3.9 ISO 20387:2018, 6.3
8.3.10 ISO 20387:2018, 6.3.2
8.3.11 ISO 20387:2018, 6.3.3
8.3.12 ISO 20387:2018, 6.3.5
8.3.13 ISO 20387:2018, 6.3.7
8.3.14 ISO 20387:2018, 6.4.1.1
8.3.15 ISO 20387:2018, 6.4.1.5
8.3.16 ISO 20387:2018, 6.4.1.6
8.3.17 ISO 20387:2018, 6.5.1
8.3.18 ISO 20387:2018, 6.5.3
8.3.19 ISO 20387:2018, 6.5.6
8.3.20 ISO 20387:2018, 6.5.10
8.3.21 ISO 20387:2018, 6.5.11
8.3.22 ISO 20387:2018, 6.5.12
8.4 Process requirements (ISO 20387:2018, Clause 7)
8.4.1 General
8.4.2 ISO 20387:2018, 7.1.1
8.4.3 ISO 20387:2018, 7.2.1.1
8.4.4 ISO 20387:2018, 7.2.3.4
8.4.5 ISO 20387:2018, 7.3.1.1
8.4.6 ISO 20387:2018, 7.3.2.4
8.4.7 ISO 20387:2018, 7.3.2.5
8.4.8 ISO 20387:2018, 7.3.3.2
8.4.9 ISO 20387:2018, 7.4.2
8.4.10 ISO 20387:2018, 7.4.5
8.4.11 ISO 20387:2018, 7.6.2
8.4.12 ISO 20387:2018, 7.7.1
8.4.13 ISO 20387:2018, 7.7.3
8.4.14 ISO 20387:2018, 7.7.5
8.4.15 ISO 20387:2018, 7.7.7
8.4.16 ISO 20387:2018, 7.8.1.2
8.4.17 ISO 20387:2018, 7.9.1.1
8.4.18 ISO 20387:2018, 7.10.5
8.4.19 ISO 20387:2018, 7.12.2.1
8.4.20 ISO 20387:2018, 7.13.2
8.5 Quality management system requirements (ISO 20387:2018, Clause 8)
8.5.1 General
8.5.2 ISO 20387:2018, 8.1.1, 8.1.2 and 8.1.3
8.5.3 ISO 20387:2018, 8.3.1
8.5.4 ISO 20387:2018, 8.4.1, 8.4.2 and 8.4.3
8.5.5 ISO 20387:2018, 8.5.1, 8.5.2 and 8.5.3
8.5.6 ISO 20387:2018, 8.6.1
8.5.7 ISO 20387:2018, 8.8.1 and 8.8.2
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PD ISO/TR 22758:2020 Biotechnology. Biobanking. Implementation guide for ISO 20387, 2020

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