SIST EN ISO 20387:2020
(Main)Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.
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.
Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.
This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.
Biotechnologie - Biobanking - Allgemeine Anforderungen an Biobanking (ISO 20387:2018)
Biotechnologie - «Biobanking» - Exigences générales relatives au «biobanking» (ISO 20387:2018)
Le présent document spécifie les exigences générales pour la compétence, l'impartialité et l'exploitation cohérente des biobanques, y compris les exigences en matière de contrôle qualité, pour assurer la qualité appropriée des collections de matériels biologiques et des données associées.
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.
Les utilisateurs des biobanques, les autorités réglementaires, les organisations et les systèmes utilisant l'évaluation par les pairs, les organismes d'accréditation et d'autres entités peuvent également utiliser ce document pour confirmer ou reconnaître la compétence des biobanques.
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.
NOTE 1 Des réglementations ou exigences internationales, nationales ou régionales peuvent également s'appliquer à des sujets spécifiques traités dans le présent document.
NOTE 2 Pour les entités ayant à traiter des matériels humains acquis et utilisés à des fins diagnostiques et thérapeutiques, l'ISO 15189 et les autres normes cliniques doivent s'appliquer en priorité.
Biotehnologija - Biobančništvo - Splošne zahteve za biobančništvo (ISO 20387:2018)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 20387:2020
01-november-2020
Biotehnologija - Biobančništvo - Splošne zahteve za biobančništvo (ISO
20387:2018)
Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
Biotechnologie - Biobanking - Allgemeine Anforderungen an Biobanking (ISO
20387:2018)
Biotechnologie - «Biobanking» - Exigences générales relatives au «biobanking» (ISO
20387:2018)
Ta slovenski standard je istoveten z: EN ISO 20387:2020
ICS:
07.080 Biologija. Botanika. Zoologija Biology. Botany. Zoology
SIST EN ISO 20387:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 20387:2020
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SIST EN ISO 20387:2020
EUROPEAN STANDARD
EN ISO 20387
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2020
ICS 07.080
English version
Biotechnology - Biobanking - General requirements for
biobanking (ISO 20387:2018)
Biotechnologie - "Biobanking" - Exigences générales Biotechnologie - Biobanking - Allgemeine
relatives au "biobanking" (ISO 20387:2018) Anforderungen an Biobanking (ISO 20387:2018)
This European Standard was approved by CEN on 31 August 2020.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2020 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 20387:2020 E
reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST EN ISO 20387:2020
EN ISO 20387:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 20387:2020
EN ISO 20387:2020 (E)
European foreword
The text of ISO 20387:2018 has been prepared by Technical Committee ISO/TC 276 "Biotechnology” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 20387:2020
by Technical Committee CEN/CLC/JTC 1 “Criteria for conformity assessment bodies” the secretariat of
which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2021, and conflicting national standards shall
be withdrawn at the latest by March 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 20387:2018 has been approved by CEN as EN ISO 20387:2020 without any modification.
3
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SIST EN ISO 20387:2020
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SIST EN ISO 20387:2020
INTERNATIONAL ISO
STANDARD 20387
First edition
2018-08
Biotechnology — Biobanking —
General requirements for biobanking
Biotechnologie — «Biobanking» — Exigences générales relatives au
«biobanking»
Reference number
ISO 20387:2018(E)
©
ISO 2018
---------------------- Page: 7 ----------------------
SIST EN ISO 20387:2020
ISO 20387:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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 2018 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 20387:2020
ISO 20387:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 8
4.1 General . 8
4.2 Impartiality . 9
4.3 Confidentiality . 9
5 Structural requirements . 9
6 Resource requirements .10
6.1 General .10
6.2 Personnel .11
6.2.1 General.11
6.2.2 Competence and competence assessment .11
6.2.3 Training .11
6.3 Facilities/dedicated areas and environmental conditions .12
6.4 Externally provided processes, products and services .12
6.5 Equipment .13
7 Process requirements .14
7.1 General .14
7.2 Collection of biological material and associated data .15
7.2.1 Documented information requirements .15
7.2.2 Pre-acquisition information .15
7.2.3 Collection procedure .15
7.3 Reception and distribution of biological material and associated data.15
7.3.1 Access principles .15
7.3.2 Reception .15
7.3.3 Distribution .16
7.4 Transport of biological material and associated data .16
7.5 Traceability of biological material and associated data .17
7.6 Preparation and preservation of biological material .18
7.7 Storage of biological material .18
7.8 Quality control of biological material and associated data .19
7.8.1 General.19
7.8.2 Quality control of processes .19
7.8.3 Quality control of data .20
7.9 Validation and verification of methods .20
7.9.1 General.20
7.9.2 Validation .20
7.9.3 Verification .20
7.10 Management of information and data .21
7.11 Nonconforming output .21
7.11.1 General.21
7.11.2 Control of nonconforming output .22
7.12 Report requirements .22
7.12.1 General.22
7.12.2 Content of the report .22
7.13 Complaints .23
8 Quality management system requirements .24
8.1 Options .24
© ISO 2018 – All rights reserved iii
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SIST EN ISO 20387:2020
ISO 20387:2018(E)
8.1.1 General.24
8.1.2 Option A .24
8.1.3 Option B .24
8.2 Documented information for the quality management system (Option A) .24
8.3 Control of quality management system documents (Option A) .25
8.4 Control of records (Option A).25
8.5 Actions to address risks and opportunities (Option A) .25
8.6 Improvement (Option A) .26
8.7 Corrective action for nonconforming output (Option A) .26
8.8 Internal audits (Option A) .27
8.9 Quality management reviews (Option A) .27
Annex A (normative) Documentation requirements .29
Annex B (informative) Implementation guidance for Annex A .31
Annex C (informative) Quality management system options .34
Bibliography .35
iv © ISO 2018 – All rights reserved
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SIST EN ISO 20387:2020
ISO 20387:2018(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 2018 – All rights reserved v
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SIST EN ISO 20387:2020
ISO 20387:2018(E)
Introduction
This document has been developed with the objective of promoting confidence in biobanking. It
contains requirements to enable biobanks to demonstrate competent biobank operation and the ability
to provide biological material and associated data of appropriate quality for research and development.
This is intended to be achieved by the planning and implementation of policies, processes and
procedures covering the life cycle of biological materials and their associated data. The use of this
document facilitates cooperation, fosters exchange, and assists in the harmonization of practices among
biobanks, researchers and other parties.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Further details can be found in the ISO/IEC Directives, Part 2.
vi © ISO 2018 – All rights reserved
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SIST EN ISO 20387:2020
INTERNATIONAL STANDARD ISO 20387:2018(E)
Biotechnology — Biobanking — General requirements for
biobanking
1 Scope
This document specifies general requirements for the competence, impartiality and consistent
operation of biobanks including quality control requirements to ensure biological material and data
collections of appropriate quality.
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.
Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation
bodies, and others can also use this document in confirming or recognizing the competence of biobanks.
This document does not apply to biological material intended for food/feed production, laboratories
undertaking analysis for food/feed production, and/or therapeutic use.
NOTE 1 International, national or regional regulations or requirements can also apply to specific topics
covered in this document.
NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes
ISO 15189 and other clinical standards are intended to apply first and foremost.
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 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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/
3.1
accessioning
logging
documenting the addition of a new biological material and/or associated data to a biobank
3.2
acquisition
act of obtaining possession and/or custody of biological material and/or associated data
© ISO 2018 – All rights reserved 1
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SIST EN ISO 20387:2020
ISO 20387:2018(E)
3.3
associated data
any information affiliated with biological material including but not limited to research, phenotypic,
clinical, epidemiologic, and procedural data
3.4
authentication
process by which biological material is characterized to a defined level of specification using appropriate
technology/documentation to establish a conclusive basis for accepting the material as genuine
3.5
biobank
legal entity or part of a legal entity that performs biobanking (3.6)
3.6
biobanking
process of acquisitioning (3.2) 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
3.7
biological material
any substance derived or part obtained from an organic entity such as a human, animal, plant,
microorganism(s) or multicellular organism(s) that is(are) neither animal nor plant (e.g. brown
seaweed, fungi)
3.8
biosafety
containment principles, technologies and practices that are implemented to prevent unintentional
exposure to pathogens and toxins, or their accidental release
[SOURCE: Laboratory Biosafety Manual, third edition, WHO, 2004]
3.9
biosecurity
institutional and personal security measures and procedures designed to prevent the loss, theft,
misuse, diversion or intentional/unintentional release of pathogens, genetically modified organisms,
toxin-producing organisms, or parts thereof, as well as such toxins that are held, transferred and/or
supplied by the biobank
3.10
catalogue
systematically arranged list or record often including descriptive information
3.11
cataloguing
act of creating and maintaining a systematically arranged list or record often including descriptive
information
3.12
chain of custody
responsibility for or control of materials and associated data as they move through each step of a process
3.13
competence
ability to apply knowledge, experience, and skills to achieve intended results
[SOURCE: ISO 17100:2015, 2.4.9]
2 © ISO 2018 – All rights reserved
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SIST EN ISO 20387:2020
ISO 20387:2018(E)
3.14
complaint
expression of dissatisfaction other than appeal by any person or organization to a biobank (3.5), relating
to the activities, products or results of that biobank where a response is expected
Note 1 to entry: The wording “activities, products or results” includes biological material and/or associated data.
Note 2 to entry: “Appeal” is defined in ISO/IEC 17000:2004, 6.4.
[SOURCE: ISO/IEC 17000:2004, 6.5 modified — “conformity assessment body or accreditation body”
has been replaced by “biobank”, the words “products or results” have been added, Note 1 to entry and
Note 2 to entry have been added]
3.15
conformity
fulfillment of a requirement
Note 1 to entry: In English the word “conformance” is synonymous but deprecated. In French the word
“compliance” is synonymous but deprecated.
Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original
definition has been modified by adding Note 1 to entry.
[SOURCE: ISO 9000:2015, 3.6.11]
3.16
critical
having a potential impact on the fitness for the intended purpose of biological material and/or
associated data
3.17
dedicated area
space containing the biological material kept by the biobank (3.5) or where the biobank activities
take place
3.18
destruction
process of eliminating biological material and/or deleting associated data, beyond any possible
reconstruction
3.19
disposal
act of removing a biological material and/or associated data usually for scrapping, destruction or
returning to provider/donor
3.20
distribution
process of providing selected biological material and/or associated data to recipient(s)/user(s)
3.21
documented information
information required to be controlled and maintained by an organization and the medium on which it
is contained
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 2 to entry: Documented information can refer to:
— the management system, including related processes;
— information created in order for the organization to operate (documentation);
© ISO 2018 – All rights reserved 3
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SIST EN ISO 20387:2020
ISO 20387:2018(E)
— evidence of results achieved.
Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.
[SOURCE: ISO 9000:2015, 3.8.6]
3.22
donor
organic entity such as a human, animal, plant etc. from which the biological material and/or associated
data is collected for biobanking (3.6)
Note 1 to entry: A human donor can also be a provider (3.41).
3.23
examination
set of operations having the objective of determining the value or characteristics of a property
[SOURCE: ISO 15189:2012, 3.7, modified — Notes to entry have been deleted]
3.24
fit for purpose
fitness for the intended purpose
in line with prearranged requirements for an intended use
Note 1 to entry: The definition of such requirements can take place within the biobank itself and/or in
collaboration with users and should consider analytical and other relevant criteria.
3.25
governance
leadership that sets policy and management of operations and can advise/decide on scientific,
administrative, technical, financial and other issues
3.26
impartiality
presence of objectivity
Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely
influence the activities of the biobank.
Note 2 to entr
...
SLOVENSKI STANDARD
oSIST prEN ISO 20387:2020
01-junij-2020
Biotehnologija - Biobančništvo - Splošne zahteve za biobančništvo (ISO
20387:2018)
Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
Biotechnologie - «Biobanking» - Exigences générales relatives au «biobanking» (ISO
20387:2018)
Ta slovenski standard je istoveten z: prEN ISO 20387
ICS:
07.080 Biologija. Botanika. Zoologija Biology. Botany. Zoology
oSIST prEN ISO 20387:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 20387:2020
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oSIST prEN ISO 20387:2020
INTERNATIONAL ISO
STANDARD 20387
First edition
2018-08
Biotechnology — Biobanking —
General requirements for biobanking
Biotechnologie — «Biobanking» — Exigences générales relatives au
«biobanking»
Reference number
ISO 20387:2018(E)
©
ISO 2018
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oSIST prEN ISO 20387:2020
ISO 20387:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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 2018 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 20387:2020
ISO 20387:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 8
4.1 General . 8
4.2 Impartiality . 9
4.3 Confidentiality . 9
5 Structural requirements . 9
6 Resource requirements .10
6.1 General .10
6.2 Personnel .11
6.2.1 General.11
6.2.2 Competence and competence assessment .11
6.2.3 Training .11
6.3 Facilities/dedicated areas and environmental conditions .12
6.4 Externally provided processes, products and services .12
6.5 Equipment .13
7 Process requirements .14
7.1 General .14
7.2 Collection of biological material and associated data .15
7.2.1 Documented information requirements .15
7.2.2 Pre-acquisition information .15
7.2.3 Collection procedure .15
7.3 Reception and distribution of biological material and associated data.15
7.3.1 Access principles .15
7.3.2 Reception .15
7.3.3 Distribution .16
7.4 Transport of biological material and associated data .16
7.5 Traceability of biological material and associated data .17
7.6 Preparation and preservation of biological material .18
7.7 Storage of biological material .18
7.8 Quality control of biological material and associated data .19
7.8.1 General.19
7.8.2 Quality control of processes .19
7.8.3 Quality control of data .20
7.9 Validation and verification of methods .20
7.9.1 General.20
7.9.2 Validation .20
7.9.3 Verification .20
7.10 Management of information and data .21
7.11 Nonconforming output .21
7.11.1 General.21
7.11.2 Control of nonconforming output .22
7.12 Report requirements .22
7.12.1 General.22
7.12.2 Content of the report .22
7.13 Complaints .23
8 Quality management system requirements .24
8.1 Options .24
© ISO 2018 – All rights reserved iii
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oSIST prEN ISO 20387:2020
ISO 20387:2018(E)
8.1.1 General.24
8.1.2 Option A .24
8.1.3 Option B .24
8.2 Documented information for the quality management system (Option A) .24
8.3 Control of quality management system documents (Option A) .25
8.4 Control of records (Option A).25
8.5 Actions to address risks and opportunities (Option A) .25
8.6 Improvement (Option A) .26
8.7 Corrective action for nonconforming output (Option A) .26
8.8 Internal audits (Option A) .27
8.9 Quality management reviews (Option A) .27
Annex A (normative) Documentation requirements .29
Annex B (informative) Implementation guidance for Annex A .31
Annex C (informative) Quality management system options .34
Bibliography .35
iv © ISO 2018 – All rights reserved
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oSIST prEN ISO 20387:2020
ISO 20387:2018(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 2018 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 20387:2020
ISO 20387:2018(E)
Introduction
This document has been developed with the objective of promoting confidence in biobanking. It
contains requirements to enable biobanks to demonstrate competent biobank operation and the ability
to provide biological material and associated data of appropriate quality for research and development.
This is intended to be achieved by the planning and implementation of policies, processes and
procedures covering the life cycle of biological materials and their associated data. The use of this
document facilitates cooperation, fosters exchange, and assists in the harmonization of practices among
biobanks, researchers and other parties.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Further details can be found in the ISO/IEC Directives, Part 2.
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INTERNATIONAL STANDARD ISO 20387:2018(E)
Biotechnology — Biobanking — General requirements for
biobanking
1 Scope
This document specifies general requirements for the competence, impartiality and consistent
operation of biobanks including quality control requirements to ensure biological material and data
collections of appropriate quality.
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.
Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation
bodies, and others can also use this document in confirming or recognizing the competence of biobanks.
This document does not apply to biological material intended for food/feed production, laboratories
undertaking analysis for food/feed production, and/or therapeutic use.
NOTE 1 International, national or regional regulations or requirements can also apply to specific topics
covered in this document.
NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes
ISO 15189 and other clinical standards are intended to apply first and foremost.
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 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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/
3.1
accessioning
logging
documenting the addition of a new biological material and/or associated data to a biobank
3.2
acquisition
act of obtaining possession and/or custody of biological material and/or associated data
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3.3
associated data
any information affiliated with biological material including but not limited to research, phenotypic,
clinical, epidemiologic, and procedural data
3.4
authentication
process by which biological material is characterized to a defined level of specification using appropriate
technology/documentation to establish a conclusive basis for accepting the material as genuine
3.5
biobank
legal entity or part of a legal entity that performs biobanking (3.6)
3.6
biobanking
process of acquisitioning (3.2) 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
3.7
biological material
any substance derived or part obtained from an organic entity such as a human, animal, plant,
microorganism(s) or multicellular organism(s) that is(are) neither animal nor plant (e.g. brown
seaweed, fungi)
3.8
biosafety
containment principles, technologies and practices that are implemented to prevent unintentional
exposure to pathogens and toxins, or their accidental release
[SOURCE: Laboratory Biosafety Manual, third edition, WHO, 2004]
3.9
biosecurity
institutional and personal security measures and procedures designed to prevent the loss, theft,
misuse, diversion or intentional/unintentional release of pathogens, genetically modified organisms,
toxin-producing organisms, or parts thereof, as well as such toxins that are held, transferred and/or
supplied by the biobank
3.10
catalogue
systematically arranged list or record often including descriptive information
3.11
cataloguing
act of creating and maintaining a systematically arranged list or record often including descriptive
information
3.12
chain of custody
responsibility for or control of materials and associated data as they move through each step of a process
3.13
competence
ability to apply knowledge, experience, and skills to achieve intended results
[SOURCE: ISO 17100:2015, 2.4.9]
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3.14
complaint
expression of dissatisfaction other than appeal by any person or organization to a biobank (3.5), relating
to the activities, products or results of that biobank where a response is expected
Note 1 to entry: The wording “activities, products or results” includes biological material and/or associated data.
Note 2 to entry: “Appeal” is defined in ISO/IEC 17000:2004, 6.4.
[SOURCE: ISO/IEC 17000:2004, 6.5 modified — “conformity assessment body or accreditation body”
has been replaced by “biobank”, the words “products or results” have been added, Note 1 to entry and
Note 2 to entry have been added]
3.15
conformity
fulfillment of a requirement
Note 1 to entry: In English the word “conformance” is synonymous but deprecated. In French the word
“compliance” is synonymous but deprecated.
Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original
definition has been modified by adding Note 1 to entry.
[SOURCE: ISO 9000:2015, 3.6.11]
3.16
critical
having a potential impact on the fitness for the intended purpose of biological material and/or
associated data
3.17
dedicated area
space containing the biological material kept by the biobank (3.5) or where the biobank activities
take place
3.18
destruction
process of eliminating biological material and/or deleting associated data, beyond any possible
reconstruction
3.19
disposal
act of removing a biological material and/or associated data usually for scrapping, destruction or
returning to provider/donor
3.20
distribution
process of providing selected biological material and/or associated data to recipient(s)/user(s)
3.21
documented information
information required to be controlled and maintained by an organization and the medium on which it
is contained
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 2 to entry: Documented information can refer to:
— the management system, including related processes;
— information created in order for the organization to operate (documentation);
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— evidence of results achieved.
Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system
standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.
[SOURCE: ISO 9000:2015, 3.8.6]
3.22
donor
organic entity such as a human, animal, plant etc. from which the biological material and/or associated
data is collected for biobanking (3.6)
Note 1 to entry: A human donor can also be a provider (3.41).
3.23
examination
set of operations having the objective of determining the value or characteristics of a property
[SOURCE: ISO 15189:2012, 3.7, modified — Notes to entry have been deleted]
3.24
fit for purpose
fitness for the intended purpose
in line with prearranged requirements for an intended use
Note 1 to entry: The definition of such requirements can take place within the biobank itself and/or in
collaboration with users and should consider analytical and other relevant criteria.
3.25
governance
leadership that sets policy and management of operations and can advise/decide on scientific,
administrative, technical, financial and other issues
3.26
impartiality
presence of objectivity
Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely
influence the activities of the biobank.
Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “independence”,
“freedom from conflicts of interests”, “freedom from bias”, “lack of prejudice”, “neutrality”, “fairness”, “open-
mindedness”, “even-handedness”, “detachment”, “balance”.
[SOURCE: ISO/IEC 17021-1:2015, 3.2, modified — In Note 1 to entry “certification body” has been
replaced by “biobank”]
3.27
interlaboratory comparison
organization, performance and evaluation of measurements or tests on the same or similar items by
two or more laboratories in accordance with predetermined conditions
[SOURCE: ISO/IEC 17043:2010, 3.4]
3.28
interoperability
capability to communicate, execute programs, or transfer data among various functional units in a
manner that requires the user to have little or no knowledge of the unique characteristics of those units
[SOURCE: ISO/IEC 20944-1:2013, 3.6.1.24]
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3.29
life cycle
consecutive and interlinked processes applied to biological material and associated data from collection,
if applicable, acquisition or reception to distribution, disposal or destruction
Note 1 to entry: This term refers to the biobanking life cycle only.
3.30
metrological traceability
property of a measurement result whereby the result can be related to a reference through a
documented unbroken chain of calibrations, each contributing to the measurement uncertainty
[SOURCE: ISO/IEC 17043:2010, 3.15]
3.31
microorganism
entity of microscopic size
Note 1 to entry: Microorganisms include viruses, all prokaryotes (archaea and bacteria), several eukaryotic
organisms (fungi including yeasts, algae, protists).
3.32
nonconforming
deviating from a particular requirement
3.33
personnel
person(s) employed by or working for the biobank (3.5)
3.34
preservation
act to prevent or retard biological or physical deterioration of biological material
3.35
procedure
specified way to carry out an activity or a process
3.36
processing
performing any activity on biological material and associated data during all stages of the life cycle (3.29)
3.37
preparation
activities, taking place in a laboratory after acquisitioning, to make biological material ready for further
use in the life cycle (3.29), storage (3.47) or distribution (3.20)
Note 1 to entry: These activities can include, e.g. centrifuging, homogenizing, purifying, fixing, stabilizing,
replicating, filtering, sorting, culturing, vacuum drying, freeze drying, freezing and thawing, tissue sectioning,
fractionating, dispensing/aliquoting, cryopreserving.
3.38
processing method
procedure, applied to biological material and/or associated data during processing (3.36), with potential
to impact the intrinsic properties of the biological material and/or associated data produced as output
3.39
process
set of interrelated or interacting activities that use inputs to deliver an intended result
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3.40
proficiency testing
evaluation of participant performance against pre-established criteria by means of interlaboratory
comparisons
Note 1 to entry: For the purposes of this document, the term “proficiency testing” is taken in its widest sense and
includes, but is not limited to:
a) quantitative scheme — where the objective is to quantify one or more measurands of the proficiency test item;
b) qualitative scheme — where the objective is to identify or describe one or more characteristics of the
proficiency test item;
c) sequential scheme — where one or more proficiency test items are distributed sequentially for testing or
measurement and returned to the proficiency testing provider at intervals;
d) simultaneous scheme — where proficiency test items are distributed for concurrent testing or measurement
within a defined time period;
e) single occasion exercise — where proficiency test items are provided on a single occasion;
f) continuous scheme — where proficiency test items are provided at reg
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