{"id":465228,"date":"2024-10-20T10:39:27","date_gmt":"2024-10-20T10:39:27","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-203872020a112024\/"},"modified":"2024-10-26T19:40:18","modified_gmt":"2024-10-26T19:40:18","slug":"bs-en-iso-203872020a112024","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-203872020a112024\/","title":{"rendered":"BS EN ISO 20387:2020+A11:2024"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | 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 \u2014 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] <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 4 General requirements 4.1 General <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 4.2 Impartiality 4.3 Confidentiality 5 Structural requirements <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 6 Resource requirements 6.1 General <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | 6.2 Personnel 6.2.1 General 6.2.2 Competence and competence assessment 6.2.3 Training <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | 6.3 Facilities\/dedicated areas and environmental conditions 6.4 Externally provided processes, products and services <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | 6.5 Equipment <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | 7 Process requirements 7.1 General <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | 7.3.3 Distribution 7.4 Transport of biological material and associated data <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | 7.5 Traceability of biological material and associated data <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | 7.6 Preparation and preservation of biological material 7.7 Storage of biological material <\/td>\n<\/tr>\n | ||||||
31<\/td>\n | 7.8 Quality control of biological material and associated data 7.8.1 General 7.8.2 Quality control of processes <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | 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 \u200bVerification <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | 7.10 Management of information and data 7.11 Nonconforming output 7.11.1 General <\/td>\n<\/tr>\n | ||||||
34<\/td>\n | 7.11.2 Control of nonconforming output 7.12 Report requirements 7.12.1 General 7.12.2 Content of the report <\/td>\n<\/tr>\n | ||||||
35<\/td>\n | 7.13 Complaints <\/td>\n<\/tr>\n | ||||||
36<\/td>\n | 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) <\/td>\n<\/tr>\n | ||||||
37<\/td>\n | 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) <\/td>\n<\/tr>\n | ||||||
38<\/td>\n | 8.6 Improvement (Option A) 8.7 Corrective action for nonconforming output (Option A) <\/td>\n<\/tr>\n | ||||||
39<\/td>\n | 8.8 Internal audits (Option A) 8.9 Quality management reviews (Option A) <\/td>\n<\/tr>\n | ||||||
41<\/td>\n | Annex A (normative) Documentation requirements <\/td>\n<\/tr>\n | ||||||
43<\/td>\n | Annex B (informative) Implementation guidance for Annex A <\/td>\n<\/tr>\n | ||||||
46<\/td>\n | Annex C (informative) Quality management system options <\/td>\n<\/tr>\n | ||||||
47<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Biotechnology. Biobanking. General requirements for biobanking<\/b><\/p>\n |