• Shopping Cart
    There are no items in your cart

AS ISO 20387:2020

Current

Current

The latest, up-to-date edition.

Biotechnology - Biobanking - General requirements for biobanking

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

31-07-2020

€92.72
Excluding VAT

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.