AS ISO 20387:2020
Current
The latest, up-to-date edition.
Biotechnology - Biobanking - General requirements for biobanking
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
07-31-2020
Important note : All end users must be registered with an Account prior to user licenses being assigned.The objective of this document is to specify 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.
| Committee |
HE-032
|
| DocumentType |
Standard
|
| ISBN |
978 1 76072 941 7
|
| Pages |
36
|
| PublisherName |
Standards Australia
|
| Status |
Current
|
| Supersedes |
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.
First published as AS ISO 20387:2020.
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO/IEC 17021-1:2015 | Conformity assessment Requirements for bodies providing audit and certification of management systems Part 1: Requirements |
| ISO 8601-1:2019 | Date and time — Representations for information interchange — Part 1: Basic rules |
| ISO/IEC 17020:2012 | Conformity assessment — Requirements for the operation of various types of bodies performing inspection |
| ISO 26000:2010 | Guidance on social responsibility |
| ISO 20166-2:2018 | Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins |
| ISO 8601-2:2019 | Date and time — Representations for information interchange — Part 2: Extensions |
| ISO/IEC 20944-1:2013 | Information technology — Metadata Registries Interoperability and Bindings (MDR-IB) — Part 1: Framework, common vocabulary, and common provisions for conformance |
| ISO 27799:2016 | Health informatics Information security management in health using ISO/IEC 27002 |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 17100:2015 | Translation services — Requirements for translation services |
| ISO 20166-3:2018 | Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA |
| ISO/IEC 17025:2017 | General requirements for the competence of testing and calibration laboratories |
| ISO/TS 20658:2017 | Medical laboratories — Requirements for collection, transport, receipt, and handling of samples |
| ISO Guide 30:2015 | Reference materials — Selected terms and definitions |
| ISO 20184-2:2018 | Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins |
| ISO 17511:2003 | In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials |
| ISO 15189:2012 | Medical laboratories — Requirements for quality and competence |
| ISO 20186-3:2019 | Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma |
| ISO 17034:2016 | General requirements for the competence of reference material producers |
| ISO 15378:2017 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| ISO 20184-1:2018 | Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA |
| ISO 17364:2013 | Supply chain applications of RFID — Returnable transport items (RTIs) and returnable packaging items (RPIs) |
| ISO 20186-1:2019 | Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| ISO/IEC 17043:2010 | Conformity assessment — General requirements for proficiency testing |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 20186-2:2019 | Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA |
| ISO 19011:2018 | Guidelines for auditing management systems |
| ISO 8459:2009 | Information and documentation Bibliographic data element directory for use in data exchange and enquiry |
| ISO/IEC 17000:2004 | Conformity assessment Vocabulary and general principles |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.