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AS ISO 20387:2020

[Current]

Biotechnology — Biobanking — General requirements for biobanking

The objective of this document is to specify 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.
Published: 31/07/2020
Pages: 36
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 General
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
4.1.6
4.1.7
4.1.8
4.2 Impartiality
4.2.1
4.2.2
4.2.3
4.2.4
4.2.5
4.3 Confidentiality
4.3.1
4.3.2
4.3.3
4.3.4
5 Structural requirements
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
6 Resource requirements
6.1 General
6.1.1
6.1.2
6.2 Personnel
6.2.1 General
6.2.1.1
6.2.1.2
6.2.1.3
6.2.1.4
6.2.1.5
6.2.2 Competence and competence assessment
6.2.2.1
6.2.2.2
6.2.2.3
6.2.2.4
6.2.2.5
6.2.3 Training
6.2.3.1
6.2.3.2
6.2.3.3
6.3 Facilities/dedicated areas and environmental conditions
6.3.1
6.3.2
6.3.3
6.3.4
6.3.5
6.3.6
6.3.7
6.4 Externally provided processes, products and services
6.4.1.1
6.4.1.2
6.4.1.3
6.4.1.4
6.4.1.5
6.4.1.6
6.5 Equipment
6.5.1
6.5.2
6.5.3
6.5.4
6.5.5
6.5.6
6.5.7
6.5.8
6.5.9
6.5.10
6.5.11
6.5.12
7 Process requirements
7.1 General
7.1.1
7.1.2
7.1.3
7.2 Collection of biological material and associated data
7.2.1 Documented information requirements
7.2.1.1
7.2.1.2
7.2.2 Pre-acquisition information
7.2.2.1
7.2.3 Collection procedure
7.2.3.1
7.2.3.2
7.2.3.3
7.2.3.4
7.3 Reception and distribution of biological material and associated data
7.3.1 Access principles
7.3.1.1
7.3.2 Reception
7.3.2.1
7.3.2.2
7.3.2.3
7.3.2.4
7.3.2.5
7.3.2.6
7.3.3 Distribution
7.3.3.1
7.3.3.2
7.3.3.3
7.3.3.4
7.4 Transport of biological material and associated data
7.4.1
7.4.2
7.4.3
7.4.4
7.4.5
7.4.6
7.4.7
7.5 Traceability of biological material and associated data
7.5.1
7.5.2
7.5.3
7.6 Preparation and preservation of biological material
7.6.1
7.6.2
7.6.3
7.7 Storage of biological material
7.7.1
7.7.2
7.7.3
7.7.4
7.7.5
7.7.6
7.7.7
7.7.8
7.8 Quality control of biological material and associated data
7.8.1 General
7.8.1.1
7.8.1.2
7.8.1.3
7.8.2 Quality control of processes
7.8.2.1
7.8.2.2
7.8.2.3
7.8.2.4
7.8.2.5
7.8.2.6
7.8.2.7
7.8.2.8
7.8.2.9
7.8.2.10
7.8.3 Quality control of data
7.8.3.1
7.8.3.2
7.9 Validation and verification of methods
7.9.1 General
7.9.1.1
7.9.2 Validation
7.9.2.1
7.9.2.2
7.9.2.3
7.9.3 ​Verification
7.9.3.1
7.9.3.2
7.9.3.3
7.10 Management of information and data
7.10.1
7.10.2
7.10.3
7.10.4
7.10.5
7.10.6
7.11 Nonconforming output
7.11.1 General
7.11.1.1
7.11.1.2
7.11.1.3
7.11.1.4
7.11.1.5
7.11.1.6
7.11.2 Control of nonconforming output
7.11.2.1
7.11.2.2
7.11.2.3
7.12 Report requirements
7.12.1 General
7.12.1.1
7.12.1.2
7.12.1.3
7.12.2 Content of the report
7.12.2.1
7.12.2.2
7.13 Complaints
7.13.1
7.13.2
7.13.3
7.13.4
7.13.5
7.13.6
7.13.7
8 Quality management system requirements
8.1 Options
8.1.1 General
8.1.2 Option A
8.1.3 Option B
8.2 Documented information for the quality management system (Option A)
8.2.1
8.2.2
8.2.3
8.2.4
8.2.5
8.2.6
8.3 Control of quality management system documents (Option A)
8.3.1
8.3.2
8.4 Control of records (Option A)
8.4.1
8.4.2
8.4.3
8.5 Actions to address risks and opportunities (Option A)
8.5.1
8.5.2
8.5.3
8.6 Improvement (Option A)
8.6.1
8.6.2
8.7 Corrective action for nonconforming output (Option A)
8.7.1
8.7.2
8.7.3
8.8 Internal audits (Option A)
8.8.1
8.8.2
8.9 Quality management reviews (Option A)
8.9.1
8.9.2
8.9.3
Annex A
A.1 General
A.2 Acquisition
A.3 Transport
A.4 Preparation/preservation
A.5 Testing
A.6 Storage
A.7 Distribution and disposal
Annex B
B.1 General
B.2 Acquisition
B.3 Transport
B.4 Preparation/preservation
B.5 Testing
B.6 Storage
B.7 Distribution and disposal
Annex C
C.1
C.2
C.3
C.4
Bibliography
Cited references in this standard
Content history
DR AS ISO 20387:2020