{"id":324941,"date":"2024-10-19T22:32:23","date_gmt":"2024-10-19T22:32:23","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-203872020\/"},"modified":"2024-10-25T21:09:32","modified_gmt":"2024-10-25T21:09:32","slug":"bs-en-iso-203872020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-203872020\/","title":{"rendered":"BS EN ISO 20387:2020"},"content":{"rendered":"

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

This document does not apply to biological material intended for food\/feed production, laboratories undertaking analysis for food\/feed production, and\/or therapeutic use.<\/p>\n

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NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document.<\/p>\n<\/blockquote>\n

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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.<\/p>\n<\/blockquote>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 General requirements
4.1 General <\/td>\n<\/tr>\n
17<\/td>\n4.2 Impartiality
4.3 Confidentiality
5 Structural requirements <\/td>\n<\/tr>\n
18<\/td>\n6 Resource requirements
6.1 General <\/td>\n<\/tr>\n
19<\/td>\n6.2 Personnel
6.2.1 General
6.2.2 Competence and competence assessment
6.2.3 Training <\/td>\n<\/tr>\n
20<\/td>\n6.3 Facilities\/dedicated areas and environmental conditions
6.4 Externally provided processes, products and services <\/td>\n<\/tr>\n
21<\/td>\n6.5 Equipment <\/td>\n<\/tr>\n
22<\/td>\n7 Process requirements
7.1 General <\/td>\n<\/tr>\n
23<\/td>\n7.2 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 <\/td>\n<\/tr>\n
24<\/td>\n7.3.2 Reception
7.3.3 Distribution
7.4 Transport of biological material and associated data <\/td>\n<\/tr>\n
25<\/td>\n7.5 Traceability of biological material and associated data <\/td>\n<\/tr>\n
26<\/td>\n7.6 Preparation and preservation of biological material
7.7 Storage of biological material <\/td>\n<\/tr>\n
27<\/td>\n7.8 Quality control of biological material and associated data
7.8.1 General
7.8.2 Quality control of processes <\/td>\n<\/tr>\n
28<\/td>\n7.8.3 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
29<\/td>\n7.10 Management of information and data
7.11 Nonconforming output
7.11.1 General <\/td>\n<\/tr>\n
30<\/td>\n7.11.2 Control of nonconforming output
7.12 Report requirements
7.12.1 General
7.12.2 Content of the report <\/td>\n<\/tr>\n
31<\/td>\n7.13 Complaints <\/td>\n<\/tr>\n
32<\/td>\n8 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
33<\/td>\n8.3 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
34<\/td>\n8.6 Improvement (Option A)
8.7 Corrective action for nonconforming output (Option A) <\/td>\n<\/tr>\n
35<\/td>\n8.8 Internal audits (Option A)
8.9 Quality management reviews (Option A) <\/td>\n<\/tr>\n
37<\/td>\nAnnex A (normative) Documentation requirements <\/td>\n<\/tr>\n
39<\/td>\nAnnex B (informative) Implementation guidance for Annex A <\/td>\n<\/tr>\n
42<\/td>\nAnnex C (informative) Quality management system options <\/td>\n<\/tr>\n
43<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Biotechnology. Biobanking. General requirements for biobanking<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2020<\/td>\n46<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":324945,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-324941","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/324941","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/324945"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=324941"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=324941"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=324941"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}