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BS EN ISO 20387:2020

BS EN ISO 20387:2020

$189.07

Biotechnology. Biobanking. General requirements for biobanking

Published By Publication Date Number of Pages
BSI 2020 46
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
16 4 General requirements
4.1 General
17 4.2 Impartiality
4.3 Confidentiality
5 Structural requirements
18 6 Resource requirements
6.1 General
19 6.2 Personnel
6.2.1 General
6.2.2 Competence and competence assessment
6.2.3 Training
20 6.3 Facilities/dedicated areas and environmental conditions
6.4 Externally provided processes, products and services
21 6.5 Equipment
22 7 Process requirements
7.1 General
23 7.2 Collection of biological material and associated data
7.2.1 Documented information requirements
7.2.2 Pre-acquisition information
7.2.3 Collection procedure
7.3 Reception and distribution of biological material and associated data
7.3.1 Access principles
24 7.3.2 Reception
7.3.3 Distribution
7.4 Transport of biological material and associated data
25 7.5 Traceability of biological material and associated data
26 7.6 Preparation and preservation of biological material
7.7 Storage of biological material
27 7.8 Quality control of biological material and associated data
7.8.1 General
7.8.2 Quality control of processes
28 7.8.3 Quality control of data
7.9 Validation and verification of methods
7.9.1 General
7.9.2 Validation
7.9.3 ​Verification
29 7.10 Management of information and data
7.11 Nonconforming output
7.11.1 General
30 7.11.2 Control of nonconforming output
7.12 Report requirements
7.12.1 General
7.12.2 Content of the report
31 7.13 Complaints
32 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)
33 8.3 Control of quality management system documents (Option A)
8.4 Control of records (Option A)
8.5 Actions to address risks and opportunities (Option A)
34 8.6 Improvement (Option A)
8.7 Corrective action for nonconforming output (Option A)
35 8.8 Internal audits (Option A)
8.9 Quality management reviews (Option A)
37 Annex A (normative) Documentation requirements
39 Annex B (informative) Implementation guidance for Annex A
42 Annex C (informative) Quality management system options
43 Bibliography

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BS EN ISO 20387:2020
$189.07