AS ISO 20387 pdf download
AS ISO 20387 pdf download.Biotechnology — Biobanking — General requirements for biobanking
1 Scope
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.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https:// www .iso .org/ obp — IEC Electropedia: available at http:// www .electropedia .org/ 3.1 accessioning logging documenting the addition of a new biological material and/or associated data to a biobank 3.2 acquisition act of obtaining possession and/or custody of biological material and/or associated data 3.3 associated data any information affiliated with biological material including but not limited to research, phenotypic, clinical, epidemiologic, and procedural data 3.4 authentication process by which biological material is characterized to a defined level of specification using appropriate technology/documentation to establish a conclusive basis for accepting the material as genuine 3.5 biobank legal entity or part of a legal entity that performs biobanking (3.6) 3.6 biobanking process of acquisitioning (3.2) and storing, together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributing defined biological material as well as related information and data 3.7 biological material any substance derived or part obtained from an organic entity such as a human, animal, plant, microorganism(s) or multicellular organism(s) that is(are) neither animal nor plant (e.g. brown seaweed, fungi) 3.8 biosafety containment principles, technologies and practices that are implemented to prevent unintentional exposure to pathogens and toxins, or their accidental release [SOURCE: Laboratory Biosafety Manual, third edition, WHO, 2004] 3.9 biosecurity institutional and personal security measures and procedures designed to prevent the loss, theft, misuse, diversion or intentional/unintentional release of pathogens, genetically modified organisms, toxin-producing organisms, or parts thereof, as well as such toxins that are held, transferred and/or supplied by the biobank 3.10 catalogue systematically arranged list or record often including descriptive information 3.11 cataloguing act of creating and maintaining a systematically arranged list or record often including descriptive information 3.12 chain of custody responsibility for or control of materials and associated data as they move through each step of a process 3.13 competence ability to apply knowledge, experience, and skills to achieve intended results [SOURCE: ISO 17100:2015, 2.4.9] 3.15 conformity fulfillment of a requirement Note 1 to entry: In English the word “conformance” is synonymous but deprecated. In French the word “compliance” is synonymous but deprecated. Note 2 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1. The original definition has been modified by adding Note 1 to entry. [SOURCE: ISO 9000:2015, 3.6.11] 3.16 critical having a potential impact on the fitness for the intended purpose of biological material and/or associated data 3.17 dedicated area space containing the biological material kept by the biobank (3.5) or where the biobank activities take place 3.18 destruction process of eliminating biological material and/or deleting associated data, beyond any possible reconstruction 3.19 disposal act of removing a biological material and/or associated data usually for scrapping, destruction or returning to provider/donor 3.20 distribution process of providing selected biological material and/or associated data to recipient(s)/user(s)
