Biotechnologie – Biobanking – Exigences générales
relatives au “biobanking”
(ISO 20387:2018)

Biotechnologie – Biobanking – Allgemeine Anforderungen an Biobanking
(ISO 20387:2018)

Obsah

Contents

Strana

Page

Předmluva................................................................................................................................................................................................. 9

Úvod......................................................................................................................................................................................................... 10

1............ Předmět normy....................................................................................................................................................................... 11

2............ Citované dokumenty............................................................................................................................................................. 11

3............ Termíny a definice................................................................................................................................................................. 11

4............ Obecné požadavky................................................................................................................................................................ 20

4.1......... Obecně..................................................................................................................................................................................... 20

4.2......... Nestrannost............................................................................................................................................................................. 21

4.3......... Důvěrnost................................................................................................................................................................................ 21

5............ Požadavky na strukturu......................................................................................................................................................... 21

6............ Požadavky na zdroje............................................................................................................................................................. 23

6.1......... Obecně..................................................................................................................................................................................... 23

6.2......... Pracovníci................................................................................................................................................................................ 23

6.2.1...... Obecně..................................................................................................................................................................................... 23

6.2.2...... Kompetence a hodnocení kompetencí.............................................................................................................................. 23

6.2.3...... Výcvik....................................................................................................................................................................................... 24

6.3......... Zařízení/vyhrazené prostory a podmínky
prostředí................................................................................................................................................................................... 24

6.4......... Externě poskytované procesy, produkty
a služby.................................................................................................................................................................................... 25

6.5......... Vybavení.................................................................................................................................................................................. 26

7............ Požadavky na proces............................................................................................................................................................ 28

7.1......... Obecně..................................................................................................................................................................................... 28

7.2......... Sběr biologického materiálu a souvisejících
dat............................................................................................................................................................................................. 28

7.2.1...... Požadavky na dokumentované informace....................................................................................................................... 28

7.2.2...... Informace před získáním...................................................................................................................................................... 29

7.2.3...... Postup sběru........................................................................................................................................................................... 29

7.3......... Příjem a distribuce biologického materiálu a souvisejících dat.................................................................................... 29

7.3.1...... Zásady přístupu...................................................................................................................................................................... 29

7.3.2...... Příjem....................................................................................................................................................................................... 30

7.3.3...... Distribuce................................................................................................................................................................................. 30

7.4......... Přeprava biologického materiálu
a souvisejících dat.................................................................................................................................................................. 31

7.5......... Sledovatelnost biologického materiálu a souvisejících dat........................................................................................... 32

7.6......... Příprava a konzervace biologického
materiálu.................................................................................................................................................................................. 32

7.7......... Uložení biologického materiálu.......................................................................................................................................... 33

7.8......... Řízení kvality biologického materiálu
a souvisejících dat.................................................................................................................................................................. 34

7.8.1...... Obecně..................................................................................................................................................................................... 34

7.8.2...... Řízení kvality procesů............................................................................................................................................................ 34

Foreword...................................................................................................................................................................................................... 9

Introduction................................................................................................................................................................................................ 10

1............ Scope.......................................................................................................................................................................................... 11

2............ Normative references.............................................................................................................................................................. 11

3............ Terms and definitions.............................................................................................................................................................. 11

4............ General requirements.............................................................................................................................................................. 20

4.1......... General....................................................................................................................................................................................... 20

4.2......... Impartiality.................................................................................................................................................................................. 21

4.3......... Confidentiality........................................................................................................................................................................... 21

5............ Structural requirements........................................................................................................................................................... 21

6............ Resource requirements........................................................................................................................................................... 23

6.1......... General....................................................................................................................................................................................... 23

6.2......... Personnel................................................................................................................................................................................... 23

6.2.1...... General....................................................................................................................................................................................... 23

6.2.2...... Competence and competence assessment....................................................................................................................... 23

6.2.3...... Training....................................................................................................................................................................................... 24

6.3......... Facilities/dedicated areas and environmental conditions................................................................................................ 24

6.4......... Externally provided processes, products
and services............................................................................................................................................................................... 25

6.5......... Equipment.................................................................................................................................................................................. 26

7............ Process requirements.............................................................................................................................................................. 28

7.1......... General....................................................................................................................................................................................... 28

7.2......... Collection of biological material
and associated data................................................................................................................................................................. 28

7.2.1...... Documented information requirements............................................................................................................................... 28

7.2.2...... Pre-acquisition information.................................................................................................................................................... 29

7.2.3...... Collection procedure................................................................................................................................................................ 29

7.3......... Reception and distribution of biological
material and associated data................................................................................................................................................. 29

7.3.1...... Access principles...................................................................................................................................................................... 29

7.3.2...... Reception................................................................................................................................................................................... 30

7.3.3...... Distribution................................................................................................................................................................................. 30

7.4......... Transport of biological material
and associated data................................................................................................................................................................. 31

7.5......... Traceability of biological material
and associated data................................................................................................................................................................. 32

7.6......... Preparation and preservation of biological
material....................................................................................................................................................................................... 32

7.7......... Storage of biological material................................................................................................................................................ 33

7.8......... Quality control of biological material
and associated data................................................................................................................................................................. 34

7.8.1...... General....................................................................................................................................................................................... 34

7.8.2...... Quality control of processes................................................................................................................................................... 34

Strana

Page

7.8.3...... Řízení kvality dat..................................................................................................................................................................... 35

7.9......... Validace a verifikace metod................................................................................................................................................ 36

7.9.1...... Obecně..................................................................................................................................................................................... 36

7.9.2...... Validace................................................................................................................................................................................... 36

7.9.3...... Verifikace................................................................................................................................................................................. 36

7.10....... Management informací a dat.............................................................................................................................................. 36

7.11....... Neshodný výstup.................................................................................................................................................................... 37

7.11.1... Obecně..................................................................................................................................................................................... 37

7.11.2... Řízení neshodného výstupu................................................................................................................................................. 38

7.12....... Požadavky na zprávy............................................................................................................................................................ 38

7.12.1... Obecně..................................................................................................................................................................................... 38

7.12.2... Obsah zprávy.......................................................................................................................................................................... 38

7.13....... Stížnosti.................................................................................................................................................................................... 39

8............ Požadavky na systém managementu kvality................................................................................................................... 40

8.1......... Možnosti................................................................................................................................................................................... 40

8.1.1...... Obecně..................................................................................................................................................................................... 40

8.1.2...... Možnost A................................................................................................................................................................................ 40

8.1.3...... Možnost B................................................................................................................................................................................ 40

8.2......... Dokumentované informace pro systém managementu kvality (Možnost A)............................................................. 40

8.3......... Řízení dokumentů systému managementu
kvality (Možnost A)................................................................................................................................................................. 41

8.4......... Řízení záznamů (Možnost A)............................................................................................................................................... 42

8.5......... Opatření k zohlednění rizik a příležitostí
(Možnost A)............................................................................................................................................................................. 42

8.6......... Zlepšování (Možnost A)........................................................................................................................................................ 43

8.7......... Nápravné opatření pro neshodný výstup
(Možnost A)............................................................................................................................................................................. 43

8.8......... Interní audity (Možnost A)..................................................................................................................................................... 44

8.9......... Přezkoumávání managementu kvality
(Možnost A)............................................................................................................................................................................. 44

Příloha A (normativní) Požadavky na dokumentaci....................................................................................................................... 46

Příloha B (informativní) Návod k implementaci
přílohy A................................................................................................................................................................................... 48

Příloha C (informativní) Možnosti systému
managementu kvality............................................................................................................................................................ 53

Bibliografie.............................................................................................................................................................................................. 54

7.8.3...... Quality control of data.............................................................................................................................................................. 35

7.9......... Validation and verification of methods................................................................................................................................. 36

7.9.1...... General....................................................................................................................................................................................... 36

7.9.2...... Validation................................................................................................................................................................................... 36

7.9.3...... Verification................................................................................................................................................................................. 36

7.10....... Management of information and data.................................................................................................................................. 36

7.11....... Nonconforming output............................................................................................................................................................. 37

7.11.1... General....................................................................................................................................................................................... 37

7.11.2... Control of nonconforming output.......................................................................................................................................... 38

7.12....... Report requirements................................................................................................................................................................ 38

7.12.1... General....................................................................................................................................................................................... 38

7.12.2... Content of the report................................................................................................................................................................ 38

7.13....... Complaints................................................................................................................................................................................. 39

8............ Quality management system requirements........................................................................................................................ 40

8.1......... Options........................................................................................................................................................................................ 40

8.1.1...... General....................................................................................................................................................................................... 40

8.1.2...... Option A...................................................................................................................................................................................... 40

8.1.3...... Option B...................................................................................................................................................................................... 40

8.2......... Documented information for the quality
management system (Option A)............................................................................................................................................ 40

8.3......... Control of quality management system
documents (Option A).............................................................................................................................................................. 41

8.4......... Control of records (Option A).................................................................................................................................................. 42

8.5......... Actions to address risks and opportunities
(Option A)................................................................................................................................................................................... 42

8.6......... Improvement (Option A).......................................................................................................................................................... 43

8.7......... Corrective action for nonconforming output
(Option A)................................................................................................................................................................................... 43

8.8......... Internal audits (Option A)......................................................................................................................................................... 44

8.9......... Quality management reviews (Option A)............................................................................................................................. 44

Annex A (normative) Documentation requirements......................................................................................................................... 46

Annex B (informative) Implementation guidance
for Annex A................................................................................................................................................................................ 48

Annex C (informative) Quality management system options......................................................................................................... 53

Bibliography.............................................................................................................................................................................................. 54

Předmluva

Foreword

ISO (Mezinárodní organizace pro normalizaci) je celo-
světová federace národních normalizačních orgánů (členů ISO). Mezinárodní normy obvykle vypracovávají technické komise ISO. Každý člen ISO, který se zajímá o předmět, pro který byla vytvořena technická komise, má právo být v této technické komisi zastoupen. Práce se zúčastňují také vládní i nevládní mezinárodní organizace, s nimiž ISO navázala pracovní styk. ISO úzce spolupracuje s Mezinárodní elektrotechnickou komisí (IEC) ve všech záležitostech normalizace v elek-
trotechnice.

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.

Postupy použité při tvorbě tohoto dokumentu a postupy určené pro jeho další udržování jsou popsány
ve směrnicích ISO/IEC, část 1. Zejména se má věnovat pozornost rozdílným schvalovacím kritériím potřebným pro různé druhy dokumentů ISO. Tento dokument byl vypracován v souladu s redakčními pravidly uvedenými ve směrnicích ISO/IEC, část 2
(viz www.iso.org/directives).

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).

Upozorňuje se na možnost, že některé prvky tohoto dokumentu mohou být předmětem patentových práv. ISO nelze činit odpovědnou za identifikaci jakéhokoliv nebo všech patentových práv. Podrobnosti o jakých-
koliv patentových právech identifikovaných během přípravy tohoto dokumentu budou uvedeny v úvodu a/nebo v seznamu patentových prohlášení obdrže-
ných ISO (viz www.iso.org/patents).

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).

Jakýkoliv obchodní název použitý v tomto dokumentu se uvádí jako informace pro usnadnění práce uživatelů a neznamená schválení.

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

Vysvětlení významu specifických termínů a výrazů ISO, které se vztahují k posuzování shody, jakož i informace o tom, jak ISO dodržuje principy Světové obchodní organizace (WTO) týkající se technických překážek obchodu (TBT), jsou uvedeny na tomto odkazu URL: www.iso.org/iso/foreword.html.

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.

Tento dokument připravila technická komise ISO/TC 276, Biotechnologie.

This document was prepared by Technical Committee ISO/TC 276, Biotechnology.

Jakákoli zpětná vazba nebo otázky týkající se tohoto dokumentu mají být adresovány národnímu normalizač-
nímu orgánu uživatele. Úplný seznam těchto orgánů lze nalézt na adrese www.iso.org/members.html.

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.

Úvod

Introduction

Tento dokument byl vypracován s cílem podpořit důvěru v provozování biobank. Obsahuje požadavky, které mají umožnit biobankám prokázat jejich kompetentní fungování a schopnost poskytovat biologický materiál a související data v odpovídající kvalitě pro výzkum a vývoj.

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.

Toho má být dosaženo plánováním a implementací politik, procesů a postupů pokrývajících životní cyklus biologických materiálů a souvisejících dat. Použití tohoto dokumentu usnadňuje spolupráci, podporuje výměnu a napomáhá při harmonizaci postupů mezi biobankami, výzkumnými pracovníky a dalšími stranami.

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.

V tomto dokumentu se používají následující slovesné tvary:

In this document, the following verbal forms are used:

–    anglické „shall“ označuje požadavek („musí“);

–    “shall” indicates a requirement;

–    anglické „should“ označuje doporučení („má“);

–    “should” indicates a recommendation;

–    anglické „may“ označuje dovolení („smí“);

–    “may” indicates a permission;

–    anglické „can“ označuje možnost nebo způsobilost („může“).

–    “can” indicates a possibility or a capability.

Další podrobnosti lze nalézt ve směrnicích ISO/IEC, část 2.

Further details can be found in the ISO/IEC Directives, Part 2.

1 Předmět normy

1 Scope

Tento dokument specifikuje obecné požadavky na kom-
petenci, nestrannost a konzistentní provoz biobank, včetně požadavků na kontrolu kvality tak, aby bylo zajištěno, že soubory biologického materiálu a dat budou mít odpovídající kvalitu.

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.

Tento dokument je použitelný pro všechny organizace provozující biobanky, včetně biobank biologického mate-
riálu z mnohobuněčných organismů (např. lidí, zvířat, hub a rostlin) a mikroorganismů pro výzkum a vývoj.

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.

Uživatelé biobank, regulační orgány, organizace a pro-
gramy využívající vzájemné posouzení, akreditační orgány a další, mohou též používat tento dokument k potvrzení nebo uznání kompetence biobank.

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.

Tento dokument se nevztahuje na biologický materiál určený k výrobě potravin/krmiv, pro laboratoře prová-
dějící analýzy pro výrobu potravin/krmiv a/nebo
na terapeutické použití.

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

POZNÁMKA 1 Na konkrétní témata zahrnutá v tomto doku-
mentu se mohou také vztahovat mezinárodní, národní nebo regionální předpisy nebo požadavky.

NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document.

POZNÁMKA 2 Subjekty, které nakládají s lidským materiá-
lem získaným a používaným pro diagnostické a léčebné účely, by se měly řídit především ISO 15189 a dalšími klinickými standardy.

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.