BS EN ISO 20387:2020+A11:2024

$145.44

Biotechnology. Biobanking. General requirements for biobanking

Published By	Publication Date	Number of Pages
BSI	2024	50

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PDF Catalog

PDF Pages	PDF Title
2	undefined
6	European foreword Endorsement notice
7	European foreword
8	Annex ZA (informative) Relationship between this European Standard and the requirements of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulat… Table ZA.1 — Correspondence between this European Standard and Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 [OJ L 218]
11	Foreword
12	Introduction
13	1 Scope 2 Normative references 3 Terms and definitions
20	4 General requirements 4.1 General
21	4.2 Impartiality 4.3 Confidentiality 5 Structural requirements
22	6 Resource requirements 6.1 General
23	6.2 Personnel 6.2.1 General 6.2.2 Competence and competence assessment 6.2.3 Training
24	6.3 Facilities/dedicated areas and environmental conditions 6.4 Externally provided processes, products and services
25	6.5 Equipment
26	7 Process requirements 7.1 General
27	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 7.3.2 Reception
28	7.3.3 Distribution 7.4 Transport of biological material and associated data
29	7.5 Traceability of biological material and associated data
30	7.6 Preparation and preservation of biological material 7.7 Storage of biological material
31	7.8 Quality control of biological material and associated data 7.8.1 General 7.8.2 Quality control of processes
32	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
33	7.10 Management of information and data 7.11 Nonconforming output 7.11.1 General
34	7.11.2 Control of nonconforming output 7.12 Report requirements 7.12.1 General 7.12.2 Content of the report
35	7.13 Complaints
36	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)
37	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)
38	8.6 Improvement (Option A) 8.7 Corrective action for nonconforming output (Option A)
39	8.8 Internal audits (Option A) 8.9 Quality management reviews (Option A)
41	Annex A (normative) Documentation requirements
43	Annex B (informative) Implementation guidance for Annex A
46	Annex C (informative) Quality management system options
47	Bibliography