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BSI PD ISO/TR 22758:2020

BSI PD ISO/TR 22758:2020

$167.15

Biotechnology. Biobanking. Implementation guide for ISO 20387

Published By Publication Date Number of Pages
BSI 2020 34
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This document provides guidance to biobanks on how to implement the quality management, management, and technical requirements of ISO 20387. It expands on aspects of ISO 20387 and provides examples for illustration purposes. The aim of this document is to assist biobanks to address competency of personnel and appropriate quality of biological material and data collections. This document is equally applicable to newly established and existing biobanks.

This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g., human, animal, fungus and plant) and microorganisms for research and development.

This document does not apply to biological material intended for feed/food production, laboratories undertaking analysis for food/feed production and/or therapeutic use.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
4 Background information for the development of ISO 20387
4.1 General
12 4.2 Intended audience for ISO 20387 and this document
4.3 Implementation of ISO 20387
13 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
14 5.3 Factors affecting fitness for the intended purpose
15 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
17 7 Conformity with ISO 20387
7.1 Scopes of Conformity
7.1.1 General
7.1.2 Determination of the scope of conformity
18 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
19 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
20 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
21 8.3 Resource requirements (ISO 20387:2018, Clause 6)
8.3.1 General
8.3.2 ISO 20387:2018, 6.1.2
22 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
23 8.3.10 ISO 20387:2018, 6.3.2
24 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
25 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
26 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
27 8.4.6 ISO 20387:2018, 7.3.2.4
8.4.7 ISO 20387:2018, 7.3.2.5
28 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
29 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
30 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
31 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
32 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
33 Bibliography
BSI PD ISO/TR 22758:2020
$167.15