Biotechnology -- Biobanking -- Implementation guide for ISO 20387

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.

Biotechnologie -- Biobanking -- Guide de mise en oeuvre de l'ISO 20387

Le présent document fournit des recommandations ŕ l'attention des biobanques quant ŕ la façon de mettre en œuvre les exigences techniques, de gestion et de management de la qualité de l'ISO 20387. Il développe des aspects de l'ISO 20387 et produit des exemples ŕ des fins d'illustration. L'objet du présent document est d'assister les biobanques autour de la compétence du personnel et de la qualité appropriée des collections de matériels biologiques et de données. Le présent document s'applique aussi bien aux biobanques émergentes qu'aux biobanques existantes. Le présent document est applicable ŕ toutes les organisations qui pratiquent le «biobanking» pour la recherche et le développement, y compris le «biobanking» de matériels biologiques issus d'organismes pluricellulaires (par exemple humains, animaux, champignons et végétaux) et de micro-organismes. Le présent document ne s'applique pas aux matériels biologiques destinés ŕ la production de denrées alimentaires/d'aliments pour animaux, aux laboratoires effectuant des analyses pour la production de denrées alimentaires/d'aliments pour animaux et/ou ŕ une utilisation thérapeutique.

General Information

Status
Published
Publication Date
28-May-2020
Current Stage
6060 - International Standard published
Start Date
29-May-2020
Ref Project

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TECHNICAL ISO/TR
REPORT 22758
First edition
2020-05
Biotechnology — Biobanking —
Implementation guide for ISO 20387
Biotechnologie — Biobanking — Guide de mise en oeuvre de l'ISO
20387
Reference number
ISO/TR 22758:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TR 22758:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TR 22758:2020(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Background information for the development of ISO 20387 ................................................................................. 1

4.1 General ........................................................................................................................................................................................................... 1

4.2 Intended audience for ISO 20387 and this document .......................................................................................... 2

4.3 Implementation of ISO 20387 ................................................................................................................................................... 2

5 Fitness for the intended purpose (FIP) (ISO 20387:2018, 3.24) in biobanking .................................3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Fitness for the intended purpose and biological material and/or associated data

(BMaD) life cycle .................................................................................................................................................................................... 3

5.3 Factors affecting fitness for the intended purpose .................................................................................................. 4

5.4 Determination of the pre-arranged requirements for FIP ................................................................................ 5

5.5 Decision whether the biological material and associated data is truly fit for an

intended purpose .................................................................................................................................................................................. 5

6 Process landscape ............................................................................................................................................................................................... 5

7 Conformity with ISO 20387 ....................................................................................................................................................................... 7

7.1 Scopes of Conformity ......................................................................................................................................................................... 7

7.1.1 General...................................................................................................................................................................................... 7

7.1.2 Determination of the scope of conformity ................................................................................................. 7

7.2 Conformity Assessment (CA) Practices (General aspects and applicability for biobanks) .. 8

8 Guidance on the interpretation of selected ISO 20387:2018 text parts .....................................................8

8.1 General Requirements (ISO 20387:2018, Clause 4) ............................................................................................... 8

8.1.1 General...................................................................................................................................................................................... 8

8.1.2 Impartiality (ISO 20387:2018, 4.2) ................................................................................................................. 9

8.1.3 Confidentiality (ISO 20387:2018, 4.3) .......................................................................................................... 9

8.2 Structural requirements (20387:2018, Clause 5) .................................................................................................... 9

8.2.1 General...................................................................................................................................................................................... 9

8.2.2 ISO 20387:2018, 5.1 ..................................................................................................................................................... 9

8.2.3 ISO 20387:2018, 5.3 ..................................................................................................................................................... 9

8.2.4 ISO 20387:2018, 5.5 ..................................................................................................................................................... 9

8.2.5 ISO 20387:2018, 5.7 ..................................................................................................................................................10

8.2.6 ISO 20387:2018, 5.8, a) ...........................................................................................................................................10

8.2.7 ISO 20387:2018, 5.9 ..................................................................................................................................................10

8.3 Resource requirements (ISO 20387:2018, Clause 6) .........................................................................................11

8.3.1 General...................................................................................................................................................................................11

8.3.2 ISO 20387:2018, 6.1.2 ..............................................................................................................................................11

8.3.3 ISO 20387:2018, 6.2.1.2 .........................................................................................................................................12

8.3.4 ISO 20387:2018, 6.2.1.4 .........................................................................................................................................12

8.3.5 ISO 20387:2018, 6.2.2.1 .........................................................................................................................................12

8.3.6 ISO 20387:2018, 6.2.2.3 .........................................................................................................................................12

8.3.7 ISO 20387:2018, 6.2.3 ..............................................................................................................................................12

8.3.8 ISO 20387:2018, 6.2.3.3 .........................................................................................................................................12

8.3.9 ISO 20387:2018, 6.3 ..................................................................................................................................................12

8.3.10 ISO 20387:2018, 6.3.2 ..............................................................................................................................................13

8.3.11 ISO 20387:2018, 6.3.3 ..............................................................................................................................................14

8.3.12 ISO 20387:2018, 6.3.5 ..............................................................................................................................................14

8.3.13 ISO 20387:2018, 6.3.7 ..............................................................................................................................................14

8.3.14 ISO 20387:2018, 6.4.1.1 .........................................................................................................................................14

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ISO/TR 22758:2020(E)

8.3.15 ISO 20387:2018, 6.4.1.5 .........................................................................................................................................14

8.3.16 ISO 20387:2018, 6.4.1.6 .........................................................................................................................................15

8.3.17 ISO 20387:2018, 6.5.1 ..............................................................................................................................................15

8.3.18 ISO 20387:2018, 6.5.3 ..............................................................................................................................................15

8.3.19 ISO 20387:2018, 6.5.6 ..............................................................................................................................................15

8.3.20 ISO 20387:2018, 6.5.10 ...........................................................................................................................................15

8.3.21 ISO 20387:2018, 6.5.11 ...........................................................................................................................................15

8.3.22 ISO 20387:2018, 6.5.12 ...........................................................................................................................................15

8.4 Process requirements (ISO 20387:2018, Clause 7) .............................................................................................16

8.4.1 General...................................................................................................................................................................................16

8.4.2 ISO 20387:2018, 7.1.1 ..............................................................................................................................................16

8.4.3 ISO 20387:2018, 7.2.1.1 .........................................................................................................................................16

8.4.4 ISO 20387:2018, 7.2.3.4 .........................................................................................................................................16

8.4.5 ISO 20387:2018, 7.3.1.1 .........................................................................................................................................16

8.4.6 ISO 20387:2018, 7.3.2.4 .........................................................................................................................................17

8.4.7 ISO 20387:2018, 7.3.2.5 .........................................................................................................................................17

8.4.8 ISO 20387:2018, 7.3.3.2 .........................................................................................................................................18

8.4.9 ISO 20387:2018, 7.4.2 ..............................................................................................................................................18

8.4.10 ISO 20387:2018, 7.4.5 ..............................................................................................................................................18

8.4.11 ISO 20387:2018, 7.6.2 ..............................................................................................................................................18

8.4.12 ISO 20387:2018, 7.7.1 ..............................................................................................................................................18

8.4.13 ISO 20387:2018, 7.7.3 ..............................................................................................................................................19

8.4.14 ISO 20387:2018, 7.7.5 ..............................................................................................................................................19

8.4.15 ISO 20387:2018, 7.7.7 ..............................................................................................................................................19

8.4.16 ISO 20387:2018, 7.8.1.2 .........................................................................................................................................19

8.4.17 ISO 20387:2018, 7.9.1.1 .........................................................................................................................................20

8.4.18 ISO 20387:2018, 7.10.5 ...........................................................................................................................................20

8.4.19 ISO 20387:2018, 7.12.2.1 ......................................................................................................................................20

8.4.20 ISO 20387:2018, 7.13.2 ...........................................................................................................................................20

8.5 Quality management system requirements (ISO 20387:2018, Clause 8) .........................................20

8.5.1 General...................................................................................................................................................................................20

8.5.2 ISO 20387:2018, 8.1.1, 8.1.2 and 8.1.3 .................. .....................................................................................20

8.5.3 ISO 20387:2018, 8.3.1 ..............................................................................................................................................21

8.5.4 ISO 20387:2018, 8.4.1, 8.4.2 and 8.4.3 .................. .....................................................................................21

8.5.5 ISO 20387:2018, 8.5.1, 8.5.2 and 8.5.3 .................. .....................................................................................22

8.5.6 ISO 20387:2018, 8.6.1 ..............................................................................................................................................22

8.5.7 ISO 20387:2018, 8.8.1 and 8.8.2 .....................................................................................................................22

Bibliography .............................................................................................................................................................................................................................23

iv © ISO 2020 – All rights reserved
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ISO/TR 22758:2020(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 documents 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 drawn to the possibility that some of the elements of this document may be the subject of

patent rights. 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 276, Biotechnology.

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 2020 – All rights reserved v
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ISO/TR 22758:2020(E)
Introduction

This document is intended to be a supplement to, rather than a substitute for, ISO 20387; as such, it is

not a stand-alone document. It can be helpful for the reader to first review ISO 20387, and refer to this

technical report in parallel or thereafter.
The following is noted in regards to the contents of this document:

— A technical report, by definition, contains no requirements. For this reason, the language is

intentionally non-prescriptive to avoid the introduction of new requirements.

— This document does not address those clauses and subclauses of ISO 20387 which are considered to

be self-explanatory (e.g. ISO 20387:2018, Clauses 1, 2, and 3, and Annexes A, B, and C, etc.).

— Clauses 4, 5, 6 and 7 of this document address some general concepts that underlie the requirements

of ISO 20387.

— Clause 8 of this document addresses a selection of the specific requirements in ISO 20387, as

noted above.

— Examples are provided throughout the text of this document, and are used to illustrate a non-

exhaustive list of possibilities.
— Acronyms are used to simplify the text:

1) BMaD: ISO 20387 defines biological material (ISO 20387:2018, 3.7) and associated data

(ISO 20387:2018, 3.3). For the purpose of this document the terms are combined as "biological

materials and/or associated data" (BMaD). There are places where references are made to

either biological material or associated data. The term is spelled out in these cases.

2) FIP: Fit for purpose or fitness for intended purpose (ISO 20387:2018, 3.24) is also defined by

ISO 20387. For the purpose of this document this term is denoted by FIP.

The term biobank has been previously defined in a number of ways and no single definition has yet

been universally accepted by the scientific community.

ISO 20387 defines a biobank (ISO 20387:2018, 3.5) as a legal entity or part of a legal entity that performs

biobanking, and the term biobanking (ISO 20387:2018, 3.6) as the process of acquisitioning and storing,

together with some or all of the activities related to collection, preparation, preservation, testing, analysing

and distributing defined biological material as well as related information and data. For the purposes of

this document, the term biobank includes the personnel performing biobanking activities on behalf of

the biobank, as well as the entity itself.
Biobanks can vary widely in:

— domains that are managed, e.g., human, animal, fungus, microbial, and/or plant, etc. or a multiple

of these;

— types of biological material and data in the biobank, e.g. nucleic acids, tissue, etc.;

— activities being performed;
— types of organizations that are involved; and
— structure, governance, oversight, and operation.

At the time of acquisition, biobanks can perform acquisition, processing and storage of BMaD for not-

yet-identified future use(s). In these cases, the biobank can acquire the BMaD according to standard

operating procedures (SOPs) appropriate for the projected end-use(s). Alternatively, biobanks can

acquire BMaD in response to a request from a user. The user can specify criteria for the BMaD and/or

SOPs developed or applied for that specific use.
vi © ISO 2020 – All rights reserved
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ISO/TR 22758:2020(E)

Biobanks can acquire BMaD for investigators studying new methods of collecting, storing, or processing

biological materials and the effects of these new methods on various analytes. In these cases, the

biobank can tailor the procedures to specifically meet the investigator’s needs rather than following

widely-accepted SOPs for handling of the BMaD.

Biobanks vary in the types of activities they perform. They can either perform the full range of

activities included in the definition of biobanking in ISO 20387, i.e. collecting/acquisitioning, preparing,

preserving, testing, storage, analysing and distributing BMaD or a subset of these activities for example

collecting/acquisitioning and distributing.

Biobanks can involve different types of organizations. They can be independent legal entities or reside

within governmental entities, academic institutions, hospitals, non-profit or commercial organizations.

Biobanks can include multiple sites of operation and can sometimes involve parties at multiple

institutions or organizations. In addition, they can involve sites of operations within different regions

or sometimes even different countries.

It is up to the biobank to identify the scope of biobank activities for which it wants to implement

ISO 20387.
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TECHNICAL REPORT ISO/TR 22758:2020(E)
Biotechnology — Biobanking — Implementation guide for
ISO 20387
1 Scope

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.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 20387:2018, Biotechnology — Biobanking — General requirements for biobanking
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 20387 apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Background information for the development of ISO 20387
4.1 General

ISO 20387 was developed to benefit biobanks of all sizes, types, resources and levels of maturity and/or

complexity as covered by the scope.

The motivation for the development of ISO 20387 was to enable robustness and reliability of research

undertaken with these BMaD, supporting quality and reproducibility in research and development. This

in turn can contribute to increased and broader utilization of biological materials and associated data.

It is intended that conformity to ISO 20387 can help demonstrate a commitment to professionalism

within biobanking, promoting trust for key stakeholders, such as the public, donors, patients, users,

or funders. Benefits such as increased efficiency of biobank operations and interoperability among

biobanks, and improved marketability can result from a commitment to ISO 20387. These benefits can

also facilitate sustainability at a time of increasing complexity of research requirements.

© ISO 2020 – All rights reserved 1
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ISO/TR 22758:2020(E)
4.2 Intended audience for ISO 20387 and this document

Because ISO 20387 covers a wide variety of biobanks, the intended audience is broad. This document

serves as a tool to assist with implementation of ISO 20387 for the spectrum of biobanks and their

activities, such as:

a) multicellular organism (e.g., human, animal, plant) and microorganism biobanks (for

implementation and self-assessment);

b) biobanks with a wide range of processes such as collecting/procuring and/or acquiring and

receiving, tagging, accessioning/logging, cataloguing/classifying, examining, preparing,

preserving, storing, managing data, destroying, packaging as well as safeguarding, distributing

and transporting (ISO 20387:2018, 4.1.1);

c) biobanks with a focus on some of the above processes such as acquisition and storage;

d) biobanks at different stages of implementation, such as newly established and existing biobanks;

e) biobanks located in countries of diverse economical scales, such as high, middle or low-income

countries;

f) biobanks, assessors and others interested in biobanking conformity assessment schemes, such as

first party (self-declaration), second party (contract/agreement), and third party (certification/

accreditation) approaches;

g) biobanks that wish to incorporate innovative approaches such as biological material-related data

repositories (virtual biobanking).

Biological material from multicellular organisms and microorganisms share many common

requirements in the implementation of ISO 20387, but each of these fields has its own needs. Domain

specificity can influence biobanking and subsequently the quality management due to the different

nature of biological material, special regulations, ethical guidelines, procedural needs or scientific and

user-based requirements. More specific biobanking-related standards are currently under development

in ISO/TC 276 Biotechnology.
4.3 Implementation of ISO 20387

Implementing ISO 20387 and the guidance as set out in this document can provide confidence in the

quality of the samples and subsequent data analysis. However, implementing the standard will require

resources. A gap analysis of a biobank’s current practice against these standard requirements can be

beneficial, and can lead to a plan for implementation of requirements. This can be done in a phased

approach and can take some time, particularly for smaller organizations where resources can be

constrained.

Each biobank can identify and implement corresponding requirements according to its defined and

documented individual activities (ISO 20387:2018, 5.7). ISO 20387, as a conformity assessment enabling

standard, can be described as having three types of requirements – general, QMS, and competence:

a) General requirements are found in all standards by definition. By demonstrating that a product

or service meets specific requirements in a standard, a potential user has a basis for assessing a

product’s fitness for an intended purpose.

b) A Quality Management System (QMS) addresses quality policies and objectives in its processes,

thus enabling the demonstration of efficient use of resources, improved risk management, and

increased robustness of practices, plans, and records, all of which serves to further increase user

confidence.

c) Technical competence adds the assessment of personnel to the evaluation, and provides means of

demonstrating that an entity has the ability to apply knowledge and skill to successfully achieve

...

TECHNICAL ISO/TR
REPORT 22758
First edition
Biotechnology — Biobanking —
Implementation guide for ISO 20387
PROOF/ÉPREUVE
Reference number
ISO/TR 22758:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TR 22758:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TR 22758:2020(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Background information for the development of ISO 20387 ................................................................................. 1

4.1 General ........................................................................................................................................................................................................... 1

4.2 Intended audience for ISO 20387 and this document .......................................................................................... 2

4.3 Implementation of ISO 20387 ................................................................................................................................................... 2

5 Fitness for the intended purpose (FIP) (ISO 20387:2018, 3.24) in biobanking .................................3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Fitness for the intended purpose and biological material and/or associated data

(BMaD) life cycle .................................................................................................................................................................................... 3

5.3 Factors affecting fitness for the intended purpose .................................................................................................. 4

5.4 Determination of the pre-arranged requirements for FIP ................................................................................ 5

5.5 Decision whether the biological material and associated data is truly fit for an

intended purpose .................................................................................................................................................................................. 5

6 Process landscape ............................................................................................................................................................................................... 5

7 Conformity with ISO 20387 ....................................................................................................................................................................... 7

7.1 Scopes of Conformity ......................................................................................................................................................................... 7

7.1.1 General...................................................................................................................................................................................... 7

7.1.2 Determination of the scope of conformity ................................................................................................. 7

7.2 Conformity Assessment (CA) Practices (General aspects and applicability for biobanks) .. 8

8 Guidance on the interpretation of selected ISO 20387:2018 text parts .....................................................8

8.1 General Requirements (ISO 20387:2018, Clause 4) ............................................................................................... 8

8.1.1 General...................................................................................................................................................................................... 8

8.1.2 Impartiality (ISO 20387:2018, 4.2) ................................................................................................................. 9

8.1.3 Confidentiality (ISO 20387:2018, 4.3) .......................................................................................................... 9

8.2 Structural requirements (20387:2018, Clause 5) .................................................................................................... 9

8.2.1 General...................................................................................................................................................................................... 9

8.2.2 ISO 20387:2018, 5.1 ..................................................................................................................................................... 9

8.2.3 ISO 20387:2018, 5.3 ..................................................................................................................................................... 9

8.2.4 ISO 20387:2018, 5.5 ..................................................................................................................................................... 9

8.2.5 ISO 20387:2018, 5.7 ..................................................................................................................................................10

8.2.6 ISO 20387:2018, 5.8, a) ...........................................................................................................................................10

8.2.7 ISO 20387:2018, 5.9 ..................................................................................................................................................10

8.3 Resource requirements (ISO 20387:2018, Clause 6) .........................................................................................11

8.3.1 General...................................................................................................................................................................................11

8.3.2 ISO 20387:2018, 6.1.2 ..............................................................................................................................................11

8.3.3 ISO 20387:2018, 6.2.1.2 .........................................................................................................................................12

8.3.4 ISO 20387:2018, 6.2.1.4 .........................................................................................................................................12

8.3.5 ISO 20387:2018, 6.2.2.1 .........................................................................................................................................12

8.3.6 ISO 20387:2018, 6.2.2.3 .........................................................................................................................................12

8.3.7 ISO 20387:2018, 6.2.3 ..............................................................................................................................................12

8.3.8 ISO 20387:2018, 6.2.3.3 .........................................................................................................................................12

8.3.9 ISO 20387:2018, 6.3 ..................................................................................................................................................12

8.3.10 ISO 20387:2018, 6.3.2 ..............................................................................................................................................13

8.3.11 ISO 20387:2018, 6.3.3 ..............................................................................................................................................14

8.3.12 ISO 20387:2018, 6.3.5 ..............................................................................................................................................14

8.3.13 ISO 20387:2018, 6.3.7 ..............................................................................................................................................14

8.3.14 ISO 20387:2018, 6.4.1.1 .........................................................................................................................................14

© ISO 2020 – All rights reserved PROOF/ÉPREUVE iii
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ISO/TR 22758:2020(E)

8.3.15 ISO 20387:2018, 6.4.1.5 .........................................................................................................................................14

8.3.16 ISO 20387:2018, 6.4.1.6 .........................................................................................................................................15

8.3.17 ISO 20387:2018, 6.5.1 ..............................................................................................................................................15

8.3.18 ISO 20387:2018, 6.5.3 ..............................................................................................................................................15

8.3.19 ISO 20387:2018, 6.5.6 ..............................................................................................................................................15

8.3.20 ISO 20387:2018, 6.5.10 ...........................................................................................................................................15

8.3.21 ISO 20387:2018, 6.5.11 ...........................................................................................................................................15

8.3.22 ISO 20387:2018, 6.5.12 ...........................................................................................................................................15

8.4 Process requirements (ISO 20387:2018, Clause 7) .............................................................................................16

8.4.1 General...................................................................................................................................................................................16

8.4.2 ISO 20387:2018, 7.1.1 ..............................................................................................................................................16

8.4.3 ISO 20387:2018, 7.2.1.1 .........................................................................................................................................16

8.4.4 ISO 20387:2018, 7.2.3.4 .........................................................................................................................................16

8.4.5 ISO 20387:2018, 7.3.1.1 .........................................................................................................................................16

8.4.6 ISO 20387:2018, 7.3.2.4 .........................................................................................................................................17

8.4.7 ISO 20387:2018, 7.3.2.5 .........................................................................................................................................17

8.4.8 ISO 20387:2018, 7.3.3.2 .........................................................................................................................................18

8.4.9 ISO 20387:2018, 7.4.2 ..............................................................................................................................................18

8.4.10 ISO 20387:2018, 7.4.5 ..............................................................................................................................................18

8.4.11 ISO 20387:2018, 7.6.2 ..............................................................................................................................................18

8.4.12 ISO 20387:2018, 7.7.1 ..............................................................................................................................................18

8.4.13 ISO 20387:2018, 7.7.3 ..............................................................................................................................................19

8.4.14 ISO 20387:2018, 7.7.5 ..............................................................................................................................................19

8.4.15 ISO 20387:2018, 7.7.7 ..............................................................................................................................................19

8.4.16 ISO 20387:2018, 7.8.1.2 .........................................................................................................................................19

8.4.17 ISO 20387:2018, 7.9.1.1 .........................................................................................................................................20

8.4.18 ISO 20387:2018, 7.10.5 ...........................................................................................................................................20

8.4.19 ISO 20387:2018, 7.12.2.1 ......................................................................................................................................20

8.4.20 ISO 20387:2018, 7.13.2 ...........................................................................................................................................20

8.5 Quality management system requirements (ISO 20387:2018, Clause 8) .........................................20

8.5.1 General...................................................................................................................................................................................20

8.5.2 ISO 20387:2018, 8.1.1, 8.1.2 and 8.1.3 .................. .....................................................................................20

8.5.3 ISO 20387:2018, 8.3.1 ..............................................................................................................................................21

8.5.4 ISO 20387:2018, 8.4.1, 8.4.2 and 8.4.3 .................. .....................................................................................21

8.5.5 ISO 20387:2018, 8.5.1, 8.5.2 and 8.5.3 .................. .....................................................................................22

8.5.6 ISO 20387:2018, 8.6.1 ..............................................................................................................................................22

8.5.7 ISO 20387:2018, 8.8.1 and 8.8.2 .....................................................................................................................22

Bibliography .............................................................................................................................................................................................................................23

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ISO/TR 22758:2020(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 documents 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 drawn to the possibility that some of the elements of this document may be the subject of

patent rights. 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 276, Biotechnology.

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.
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ISO/TR 22758:2020(E)
Introduction

This document is intended to be a supplement to, rather than a substitute for, ISO 20387; as such, it is

not a stand-alone document. It can be helpful for the reader to first review ISO 20387, and refer to this

technical report in parallel or thereafter.
The following is noted in regards to the contents of this document:

— A technical report, by definition, contains no requirements. For this reason, the language is

intentionally non-prescriptive to avoid the introduction of new requirements.

— This document does not address those clauses and subclauses of ISO 20387 which are considered to

be self-explanatory (e.g., ISO 20387:2018, Clauses 1, 2, and 3, and Annexes A, B, and C etc.).

— Clauses 4, 5, 6 and 7 of this document address some general concepts that underlie the requirements

of ISO 20387.

— Clause 8 of this document addresses a selection of the specific requirements in ISO 20387, as

noted above.

— Examples are provided throughout the text of this document, and are used to illustrate a non-

exhaustive list of possibilities.
— Acronyms are used to simplify the text:

1) BMaD: ISO 20387 defines biological material (3.7) and associated data (3.3). For the purpose

of this document the terms are combined as "biological materials and/or associated data"

(BMaD). There are places where references are made to either biological material or associated

data. The term is spelled out in these cases.

2) FIP: Fit for purpose or fitness for intended purpose (3.24) is also defined by ISO 20387. For the

purpose of this document this term is denoted by FIP.

The term biobank has been previously defined in a number of ways and no single definition has yet

been universally accepted by the scientific community.

ISO 20387 defines a biobank (ISO 20387:2018, 3.5) as a legal entity or part of a legal entity that performs

biobanking, and the term biobanking (ISO 20387:2018, 3.6) as the process of acquisitioning and storing,

together with some or all of the activities related to collection, preparation, preservation, testing, analysing

and distributing defined biological material as well as related information and data. For the purposes of

this document, the term biobank includes the personnel performing biobanking activities on behalf of

the biobank, as well as the entity itself.
Biobanks can vary widely in:

— domains that are managed, e.g., human, animal, fungus, microbial, and/or plant, etc. or a multiple

of these;

— types of biological material and data in the biobank, e.g. nucleic acids, tissue, etc.;

— activities being performed;
— types of organizations that are involved; and
— structure, governance, oversight, and operation.

At the time of acquisition, biobanks can perform acquisition, processing and storage of BMaD for not-

yet-identified future use(s). In these cases, the biobank can acquire the BMaD according to standard

operating procedures (SOPs) appropriate for the projected end-use(s). Alternatively, biobanks can

acquire BMaD in response to a request from a user. The user can specify criteria for the BMaD and/or

SOPs developed or applied for that specific use.
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ISO/TR 22758:2020(E)

Biobanks can acquire BMaD for investigators studying new methods of collecting, storing, or processing

biological materials and the effects of these new methods on various analytes. In these cases, the

biobank can tailor the procedures to specifically meet the investigator’s needs rather than following

widely-accepted SOPs for handling of the BMaD.

Biobanks vary in the types of activities they perform. can either perform the full range of activities

included in the definition of biobanking, that is, collecting/acquisitioning, preparing, preserving,

testing, storage, analysing and distributing BMaD, in ISO 20387 or a subset of these activities for

example collecting/acquisitioning and distributing.

Biobanks can involve different types of organizations. They can be independent legal entities or reside

within governmental entities, academic institutions, hospitals, non-profit or commercial organizations.

Biobanks can include multiple sites of operation and can sometimes involve parties at multiple

institutions or organizations. In addition, they can involve sites of operations within different regions

or sometimes even different countries.

It is up to the biobank to identify the scope of biobank activities for which it wants to implement

ISO 20387.
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TECHNICAL REPORT ISO/TR 22758:2020(E)
Biotechnology — Biobanking — Implementation guide for
ISO 20387
1 Scope

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.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 20387:2018, Biotechnology — Biobanking — General requirements for biobanking
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 20387 apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Background information for the development of ISO 20387
4.1 General

ISO 20387 was developed to benefit biobanks of all sizes, types, resources and levels of maturity and/or

complexity as covered by the scope.

The motivation for the development of ISO 20387 was to enable robustness and reliability of research

undertaken with these BMaD, supporting quality and reproducibility in research and development. This

in turn can contribute to increased and broader utilization of biological materials and associated data.

It is intended that conformity to ISO 20387 can help demonstrate a commitment to professionalism

within biobanking, promoting trust for key stakeholders, such as the public, donors, patients, users,

or funders. Benefits such as increased efficiency of biobank operations and interoperability among

biobanks, and improved marketability can result from a commitment to ISO 20387. These benefits can

also facilitate sustainability at a time of increasing complexity of research requirements.

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ISO/TR 22758:2020(E)
4.2 Intended audience for ISO 20387 and this document

Because ISO 20387 covers a wide variety of biobanks, the intended audience is broad. This document

serves as a tool to assist with implementation of ISO 20387 for the spectrum of biobanks and their

activities, such as:

a) multicellular organism (e.g., human, animal, plant) and microorganism biobanks (for

implementation and self-assessment);

b) biobanks with a wide range of processes such as collecting/procuring and/or acquiring and

receiving, tagging, accessioning/logging, cataloguing/classifying, examining, preparing,

preserving, storing, managing data, destroying, packaging as well as safeguarding, distributing

and transporting (ISO 20387:2018, 4.1.1);

c) biobanks with a focus on some of the above processes such as acquisition and storage;

d) biobanks at different stages of implementation, such as newly established and existing biobanks;

e) biobanks located in countries of diverse economical scales, such as high, middle or low-income

countries;

f) biobanks, assessors and others interested in biobanking conformity assessment schemes, such as

first party (self-declaration), second party (contract/agreement), and third party (certification/

accreditation) approaches;

g) biobanks that wish to incorporate innovative approaches such as biological material-related data

repositories (virtual biobanking).

Biological material from multicellular organisms and microorganisms share many common

requirements in the implementation of ISO 20387, but each of these fields has its own needs. Domain

specificity can influence biobanking and subsequently the quality management due to the different

nature of biological material, special regulations, ethical guidelines, procedural needs or scientific and

user-based requirements. More specific biobanking-related standards are currently under development

in ISO/TC 276 Biotechnology.
4.3 Implementation of ISO 20387

Implementing ISO 20387 and the guidance as set out in this document can provide confidence in the

quality of the samples and subsequent data analysis. However, implementing the standard will require

resources. A gap analysis of a biobank’s current practice against these standard requirements can be

beneficial, and can lead to a plan for implementation of requirements. This can be done in a phased

approach and can take some time, particularly for smaller organizations where resources can be

constrained.

Each biobank can identify and implement corresponding requirements according to its defined and

documented individual activities (ISO 20387:2018, 5.7). ISO 20387, as a conformity assessment enabling

standard, can be described as having three types of requirements – general, QMS, and competence:

a) General requirements are found in all standards by definition. By demonstrating that a product

or service meets specific requirements in a standard, a potential user has a basis for assessing a

product’s fitness for an intended purpose.

b) A Quality Management System (QMS) addresses quality policies and objectives in its processes,

thus enabling the demonstration of efficient use of resources, improved risk management, and

increased robustness of practices, plans, and records, all of which serves to further increase user

confidence.

c) Technical competence adds the assessment of personnel to the evaluation, and provides means of

demonstrating that an entity has the ability to apply knowledge and skill to successfully achieve an

intend
...

RAPPORT ISO/TR
TECHNIQUE 22758
Première édition
2020-05
Biotechnologie — Biobanking — Guide
de mise en oeuvre de l'ISO 20387
Biotechnology — Biobanking — Implementation guide for ISO 20387
Numéro de référence
ISO/TR 22758:2020(F)
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TR 22758:2020(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2020

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publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
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Publié en Suisse
ii © ISO 2020 – Tous droits réservés
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ISO/TR 22758:2020(F)
Sommaire Page

Avant-propos ................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Domaine d'application ................................................................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 1

3 Termes et définitions ....................................................................................................................................................................................... 1

4 Informations relatives au contexte de développement de l'ISO 20387 .......................................................1

4.1 Généralités .................................................................................................................................................................................................. 1

4.2 Public visé par l'ISO 20387 et le présent document ............................................................................................... 2

4.3 Mise en œuvre de l'ISO 20387 ................................................................................................................................................... 2

5 Adéquation à l'usage prévu (AUP) (FIP) (ISO 20387:2018, 3.24) dans le domaine du

«biobanking» ............................................................................................................................................................................................................ 3

5.1 Généralités .................................................................................................................................................................................................. 3

5.2 Adéquation à l'usage prévu et cycle de vie du matériel biologique et/ou des

données associées (MaBiDa) ...................................................................................................................................................... 4

5.3 Facteurs ayant une incidence sur l'adéquation à l'usage prévu ................................................................... 5

5.4 Détermination des exigences préétablies pour l'AUP ............................................................................................ 5

5.5 Décision relative à l'adéquation réelle du matériel biologique et des données

associées à l'usage prévu................................................................................................................................................................ 6

6 Paysage de processus ....................................................................................................................................................................................... 6

7 Conformité à l'ISO 20387 ............................................................................................................................................................................. 8

7.1 Périmètres de la conformité ........................................................................................................................................................ 8

7.1.1 Généralités ............................................................................................................................................................................ 8

7.1.2 Détermination du périmètre de la conformité ....................................................................................... 9

7.2 Pratiques d'évaluation de la conformité (EC) (aspects généraux et applicabilité aux

biobanques) ............................................................................................................................................................................................... 9

8 Recommandations sur l'interprétation de certaines parties du texte de

l'ISO 20387:2018 ...............................................................................................................................................................................................10

8.1 Exigences générales (ISO 20387:2018, Article 4) .................................................................................................10

8.1.1 Généralités .........................................................................................................................................................................10

8.1.2 Impartialité (ISO 20387:2018, 4.2) ..............................................................................................................10

8.1.3 Confidentialité (ISO 20387:2018, 4.3) .......................................................................................................10

8.2 Exigences structurelles (20387:2018, Article 5) ....................................................................................................10

8.2.1 Généralités .........................................................................................................................................................................10

8.2.2 ISO 20387:2018, 5.1 ..................................................................................................................................................10

8.2.3 ISO 20387:2018, 5.3 ..................................................................................................................................................11

8.2.4 ISO 20387:2018, 5.5 ..................................................................................................................................................11

8.2.5 ISO 20387:2018, 5.7 ..................................................................................................................................................11

8.2.6 ISO 20387:2018, 5.8, a) ...........................................................................................................................................11

8.2.7 ISO 20387:2018, 5.9 ..................................................................................................................................................11

8.3 Exigences relatives aux ressources (ISO 20387:2018, Article 6) .............................................................12

8.3.1 Généralités .........................................................................................................................................................................12

8.3.2 ISO 20387:2018, 6.1.2 ..............................................................................................................................................13

8.3.3 ISO 20387:2018, 6.2.1.2 .........................................................................................................................................13

8.3.4 ISO 20387:2018, 6.2.1.4 .........................................................................................................................................13

8.3.5 ISO 20387:2018, 6.2.2.1 .........................................................................................................................................13

8.3.6 ISO 20387:2018, 6.2.2.3 .........................................................................................................................................14

8.3.7 ISO 20387:2018, 6.2.3 ..............................................................................................................................................14

8.3.8 ISO 20387:2018, 6.2.3.3 .........................................................................................................................................14

8.3.9 ISO 20387:2018, 6.3 ..................................................................................................................................................14

8.3.10 ISO 20387:2018, 6.3.2 ..............................................................................................................................................15

8.3.11 ISO 20387:2018, 6.3.3 ..............................................................................................................................................16

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ISO/TR 22758:2020(F)

8.3.12 ISO 20387:2018, 6.3.5 ..............................................................................................................................................16

8.3.13 ISO 20387:2018, 6.3.7 ..............................................................................................................................................16

8.3.14 ISO 20387:2018, 6.4.1.1 .........................................................................................................................................17

8.3.15 ISO 20387:2018, 6.4.1.5 .........................................................................................................................................17

8.3.16 ISO 20387:2018, 6.4.1.6 .........................................................................................................................................17

8.3.17 ISO 20387:2018, 6.5.1 ..............................................................................................................................................17

8.3.18 ISO 20387:2018, 6.5.3 ..............................................................................................................................................17

8.3.19 ISO 20387:2018, 6.5.6 ..............................................................................................................................................17

8.3.20 ISO 20387:2018, 6.5.10 ...........................................................................................................................................17

8.3.21 ISO 20387:2018, 6.5.11 ...........................................................................................................................................18

8.3.22 ISO 20387:2018, 6.5.12 ...........................................................................................................................................18

8.4 Exigences relatives aux processus (ISO 20387:2018, Article 7) ...............................................................18

8.4.1 Généralités .........................................................................................................................................................................18

8.4.2 ISO 20387:2018, 7.1.1 ..............................................................................................................................................18

8.4.3 ISO 20387:2018, 7.2.1.1 .........................................................................................................................................18

8.4.4 ISO 20387:2018, 7.2.3.4 .........................................................................................................................................19

8.4.5 ISO 20387:2018, 7.3.1.1 .........................................................................................................................................19

8.4.6 ISO 20387:2018, 7.3.2.4 .........................................................................................................................................20

8.4.7 ISO 20387:2018, 7.3.2.5 .........................................................................................................................................20

8.4.8 ISO 20387:2018, 7.3.3.2 .........................................................................................................................................20

8.4.9 ISO 20387:2018, 7.4.2 ..............................................................................................................................................20

8.4.10 ISO 20387:2018, 7.4.5 ..............................................................................................................................................21

8.4.11 ISO 20387:2018, 7.6.2 ..............................................................................................................................................21

8.4.12 ISO 20387:2018, 7.7.1 ..............................................................................................................................................21

8.4.13 ISO 20387:2018, 7.7.3 ..............................................................................................................................................21

8.4.14 ISO 20387:2018, 7.7.5 ..............................................................................................................................................21

8.4.15 ISO 20387:2018, 7.7.7 ..............................................................................................................................................22

8.4.16 ISO 20387:2018, 7.8.1.2 .........................................................................................................................................22

8.4.17 ISO 20387:2018, 7.9.1.1 .........................................................................................................................................22

8.4.18 ISO 20387:2018, 7.10.5 ...........................................................................................................................................23

8.4.19 ISO 20387:2018, 7.12.2.1 ......................................................................................................................................23

8.4.20 ISO 20387:2018, 7.13.2 ...........................................................................................................................................23

8.5 Exigences relatives au système de management de la qualité (ISO 20387:2018,

Article 8) ....................................................................................................................................................................................................23

8.5.1 Généralités .........................................................................................................................................................................23

8.5.2 ISO 20387:2018, 8.1.1, 8.1.2 et 8.1.3 ...........................................................................................................23

8.5.3 ISO 20387:2018, 8.3.1 ..............................................................................................................................................24

8.5.4 ISO 20387:2018, 8.4.1, 8.4.2 et 8.4.3 ...........................................................................................................24

8.5.5 ISO 20387:2018, 8.5.1, 8.5.2 et 8.5.3 ...........................................................................................................25

8.5.6 ISO 20387:2018, 8.6.1 ..............................................................................................................................................25

8.5.7 ISO 20387:2018, 8.8.1 et 8.8.2 ..........................................................................................................................25

Bibliographie ...........................................................................................................................................................................................................................26

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ISO/TR 22758:2020(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.

L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www

.iso .org/ directives).

L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de

brevets reçues par l’ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité à l'intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion

de l'ISO aux principes de l'Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir le lien suivant: www .iso .org/ iso/ fr/ avant -propos .html.

Le présent document a été élaboré par le comité technique ISO/TC 276, Biotechnologie.

Il convient que l’utilisateur adresse tout retour d'information ou toute question concernant le présent

document à l'organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l'adresse www .iso .org/ fr/ members .html.
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ISO/TR 22758:2020(F)
Introduction

Le présent document est destiné à compléter l'ISO 20387 plutôt qu'à s'y substituer; à cet effet, il ne

constitue pas en soi un document autonome. Il peut être utile pour le lecteur de consulter l'ISO 20387 au

préalable et de se référer au présent Rapport technique en parallèle ou ultérieurement.

Les remarques suivantes se rapportent au contenu du présent document:

— Un rapport technique, par définition, ne contient aucune exigence. Le langage employé n'a donc

volontairement aucun caractère directif afin d'éviter l'introduction de nouvelles exigences.

— Le présent document ne traite pas des articles et paragraphes de l'ISO 20387 jugés suffisamment

explicites (par exemple, l'ISO 20387:2018, Articles 1, 2 et 3, et Annexes A, B et C etc.).

— Les Articles 4, 5, 6 et 7 du présent document abordent certains concepts généraux qui sous-tendent

les exigences de l'ISO 20387.

— L'Article 8 du présent document couvre une sélection d'exigences spécifiques de l'ISO 20387, comme

indiqué ci-dessus.

— Des exemples sont donnés dans l'ensemble du corps du présent document afin d'illustrer une liste

non exhaustive de possibilités.
— Des acronymes sont utilisés afin de simplifier le texte:

1) MaBiDa: l'ISO 20387 définit les termes matériel biologique (3.7) et données associées (3.3).

Pour les besoins du présent document, les termes sont combinés sous la forme jointe «matériel

biologique et/ou données associées» (MaBiDa). Certains articles ou paragraphes font référence

soit au matériel biologique soit aux données associées. Dans ces cas de figure, le terme est

donné en toutes lettres.

2) AUP: les termes «adapté à l'usage prévu ou finalité» ou «adéquation à l'usage prévu» (3.24) sont

également définis dans l'ISO 20387. Pour les besoins du présent document, ces termes sont

désignés par l'abréviation AUP.

Le terme biobanque a été précédemment défini de multiples manières et aucune définition spécifique

n'a encore été universellement acceptée par la communauté scientifique.

L'ISO 20387 définit une biobanque (ISO 20387:2018, 3.5) comme une entité juridique ou partie d'entité

juridique pratiquant le «biobanking», et le terme biobanking (ou mise en banque de matériel biologique)

(ISO 20387:2018, 3.6) comme le processus d'acquisition et de stockage, ainsi que tout ou partie des

activités liées au prélèvement, à la préparation, à la préservation, aux tests, à l'analyse et à la distribution

de matériels biologiques définis, y compris les informations et les données associées. Pour les besoins

du présent document, le terme biobanque englobe à la fois le personnel qui mène des activités de

«biobanking» pour le compte de la biobanque et l'entité elle-même.
Les biobanques peuvent présenter d'importantes différences sur divers plans:

— les domaines gérés, par exemple humain, animal, fongique, microbien et/ou végétal, etc., ou une

combinaison de ces domaines;

— les types de matériel biologique et de données se trouvant dans la biobanque, par exemple acides

nucléiques, tissus, etc.;
— les activités réalisées;
— les types d'organismes impliqués; et
— la structure, la gouvernance, la supervision et l'exploitation.

Au moment de l'acquisition, les biobanques peuvent entreprendre des activités d'acquisition, de

traitement et de stockage de MaBiDa dans le cadre d'une ou plusieurs utilisations qui n'a pas encore

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ISO/TR 22758:2020(F)

été identifiées. Dans ces cas, la biobanque peut acquérir les MaBiDa conformément à des procédures

normalisées qui conviennent au vu de la ou des utilisations finales prévues. Les biobanques peuvent

également acquérir des MaBiDa en réponse à une demande d'un utilisateur. L'utilisateur peut spécifier

des critères pour les MaBiDa et/ou les procédures normalisées qui ont été développés ou appliqués

pour cette utilisation spécifique.

Les biobanques peuvent acquérir des MaBiDa pour des chercheurs qui étudient de nouvelles méthodes

de prélèvement, de stockage ou de traitement de matériel biologique, ainsi que les effets de ces nouvelles

méthodes sur les divers analytes. Dans ces cas, la biobanque peut adapter les procédures pour les

aligner spécifiquement sur les besoins du chercheur, plutôt que de suivre les procédures normalisées

largement acceptées pour le traitement des MaBiDa.

Les biobanques entreprennent des types d'activité très variables. Elles peuvent assurer soit l'ensemble

des activités couvertes par la définition du «biobanking», à savoir le prélèvement/l'acquisition, la

préparation, la préservation, les tests, le stockage, l'analyse et la distribution de MaBiDa, donnée dans

l'ISO 20387, soit un sous-ensemble de ces activités, par exemple le prélèvement/l'acquisition et la

distribution.

Les biobanques peuvent impliquer différents types d'organismes. Elles peuvent former des entités

juridiques indépendantes ou être attachées à des entités gouvernementales, des institutions

académiques, des hôpitaux, des organismes à but non lucratif ou des organisations commerciales.

Les biobanques peuvent comprendre plusieurs sites d'exploitation et peuvent parfois impliquer des

parties intervenant dans plusieurs institutions ou organismes. Elles peuvent également détenir des

sites d'exploitation dans différentes régions, voire parfois dans différents pays.

Il appartient à la biobanque d'identifier le périmètre des activités biobancaires pour lesquelles elle

souhaite mettre en œuvre l'ISO 20387.
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RAPPORT TECHNIQUE ISO/TR 22758:2020(F)
Biotechnologie — Biobanking — Guide de mise en oeuvre
de l'ISO 20387
1 Domaine d'application

Le présent document fournit des recommandations à l'attention des biobanques quant à la façon de

mettre en œuvre les exigences techniques, de gestion et de management de la qualité de l'ISO 20387. Il

développe des aspects de l'ISO 20387 et produit des exemples à des fins d'illustration. L'objet du présent

document est d'assister les biobanques autour de la compétence du personnel et de la qualité appropriée

des collections de matériels biologiques et de données. Le présent document s'applique aussi bien aux

biobanques émergentes qu'aux biobanques existantes.

Le présent document est applicable à toutes les organisations qui pratiquent le «biobanking» pour la

recherche et le développement, y compris le «biobanking» de matériels biologiques issus d'organismes

pluricellulaires (par exemple humains, animaux, champignons et végétaux) et de micro-organismes.

Le présent document ne s'applique pas aux matériels biologiques destinés à la production de denrées

alimentaires/d'aliments pour animaux, aux laboratoires effectuant des analyses pour la production de

denrées alimentaires/d'aliments pour animaux et/ou à une utilisation thérapeutique.

2 Références normatives

Les documents suivants cités dans le texte constituent, pour tout ou partie de leur contenu, des

exigences du présent document. Pour les références datées, seule l'édition citée s'applique. Pour les

références non datées, la dernière édition du document de référence s'applique (y compris les éventuels

amendements).

ISO 20387:2018, Biotechnologie — «Biobanking» — Exigences générales relatives au «biobanking»

3 Termes et définitions

Pour les besoins du présent document, les termes et définitions donnés dans l'ISO 20387 s'appliquent.

L'ISO et l'IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:

— ISO Online browsing platform: disponible à l'adresse https:// www .iso .org/ obp

— IEC Electropedia: disponible à l'adresse http:// www .electropedia .org/
4 Informations relatives au contexte de développement de l'ISO 20387
4.1 Généralités

L'ISO 20387 a été élaborée afin que les biobanques en bénéficient, quels que soient leur taille, leur type,

leurs ressources et leurs niveaux de maturité et/ou de complexité dans la mesure où elles entrent dans

son domaine d'application.

L'élaboration de l'ISO 20387 a été motivée par la volonté de garantir la robustesse et la fiabilité des

recherches entreprises autour de ces MaBiDa, en soutenant la qualité et la reproductibilité de la

recherche et du développement. Cette approche peut, à son tour, contribuer à renforcer et élargir

l'utilisation de matériel biologique et des données associées. Une conformité à l'ISO 20387 peut aider

à démontrer un engagement de professionnalisme dans le domaine du «biobanking», en instillant un

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ISO/TR 22758:2020(F)

sentiment de confiance chez les principales parties prenantes, telles que le public, les donateurs, les

patients, les utilisateurs ou les organismes de financement. Un engagement à se conformer à l'ISO 20387

peut apporter divers avantages, notamment une plus grande efficacité des opérations d'une biobanque,

une meilleure interopérabilité entre les biobanques et davantage de possibilités de commercialisation.

Ces avantages peuvent également soutenir le développement durable à une époque marquée par des

exigences de plus en plus complexes en matière de recherche.
4.2 Public visé par l'ISO 20387 et le présent document

L'ISO 20387 couvre une grande diversité de biobanques et, à ce titre, elle s'adresse à un vaste public.

Le présent document tient lieu d'outil conçu pour faciliter la mise en œuvre de l'ISO 20387 pour les

biobanques et leurs activités dans toute leur diversité, à savoir:

a) les biobanques d'organismes multicellulaires (par exemple, humains, animaux et végétaux) et de

micro-organismes (pour la mise en œuvre et pour l'auto-évaluation);

b) les biobanques qui appliquent divers processus, tels que le prélèvement/l'achat et/ou l'acquisition et

la réception, le marquage, l'inscription/l'enregistrement,
...

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