BS ISO 20387:2018
$189.07
Biotechnology. Biobanking. General requirements for biobanking
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 46 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National 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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Biotechnology. Biobanking. Implementation guide for ISO 20387 Published By Publication Date Number of Pages BSI…
