What is it? Why is it important?

ISOs (International Standards Organisation) are international standards developed by experts using internationally recognised processes.

 

The objective of the ISO 20387 for Biobanking is to promote confidence in the set-up and management of a biobank. This is achieved by:

  • Setting standards supporting competent biobanking operations
  • Ensure that researchers are provided with Biological Material (BM) and associated data of quality

 

Standards include:

 

ISO standards have been approved by the CEN and the SNV

What do I need to do?

Access to ISO 20387 is liable to cost.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

SBP Documents

General

  • Quality Manual

External Links

  • CEN – European committee for standardization
  • SNV – Swiss Association for Standardization

References

ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking

Abbreviations
  • BM – Biological Material
  • CAPA – Corrective and Preventative Action
  • CEN – European Committee for Standardization
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • ISO – International Standards Organisation
  • QMS – Quality Management System
  • SBP – Swiss Biobanking Platform
  • SNV – Schweizerische Normen-Vereinigung / Swiss Association for Standardization
Basic ↦ Biobanking ↦ Biobanking Standards ↦ ISO Biobanking
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Basic ↦ Biobanking ↦ Biobanking Standards ↦ ISO Biobanking

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