ISO INTERNATIONAL STANDARD 20387 First edition 2018-08 Biotechnology Biobanking General requirements for biobanking Biotechnologie—<Biobanking》Exigencesgenerales relatives au <biobanking Referencenumber IS020387:2018(E) Intemational Organization for Standardization tandards and Technology 9972181 @IS0 2018 IS020387:2018(E) COPYRIGHTPROTECTEDDOCUMENT @IS02018 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either IsO at the address below or Iso's member body in the country of the requester. ISO copyright office CP 401 : Ch.de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+41227490111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland Intemationaibr Drganizationfor Standardization Hicensee-Shenzhen Institute of Standards andelSg& All rights reserved ous National Standards Bodies Notfor Resale, 2018/11/27 00:50:46 No reproduction or networking permitted without license from IH IS020387:2018(E) Contents Page Foreword ..V Introduction.. ...vi 1 Scope.... 2 Normative references 3 Terms and definitions 4 General requirements. 4.1 General .8 4.2 Impartiality 4.3 Confidentiality .9 5 Structuralrequirements .9 6 Resource requirements .10 6.1 General. .10 6.2 Personnel .11 6.2.1 General. ..11 6.2.2 Competenceand competenceassessment ..11 6.2.3 Training .11 6.3 Facilities/dedicated areas and environmental conditions. ..12 6.4 Externally provided processes, products and services .12 6.5 Equipment. .13 7 Process requirements .14 7.1 General .14 7.2 Collection ofbiologicalmaterialand associated data ..15 7.2.1 Documented informationrequirements .15 7.2.2 Pre-acquisition information .15 7.2.3 Collection procedure. .15 7.3 Reception and distribution of biological material and associated data ..15 7.3.1 Accessprinciples ..15 7.3.2 Reception .15 7.3.3 Distribution .16 7.4 Transportofbiological material and associated data ..16 7.5 Traceability of biological material and associated data ..17 7.6 Preparation and preservation of biological material .18 7.7 Storage of biological material. .18 7.8 Quality control of biological material and associated data. .19 7.8.1 General ..19 7.8.2 Quality control ofprocesses. ..19 7.8.3 Quality control of data 20 7.9 Validation and verification of methods. 20 7.9.1 General. 20 7.9.2 Validation. 20 7.9.3 Verification 20 7.10 Management of information and data 21 7.11 Nonconforming output 21 7.11.1 General. 21 7.11.2 Control of nonconforming output 22 7.12 Report requirements 22 7.12.1 General. 22 7.12.2 Content of thereport. .22 7.13 Complaints. .23 8 Quality management system requirements. .24 8.1 Options. .24 emationalanizatin8All rights reserved iii icensee=Shenzhen Institute of Standards and Technology 9972181