Part 1

Introduction 

• Overview on Biobanking 
• Biobanking  & Biobanks 
• Biobanking activities
• Biological Material and/or Associate Data
• Main purpose
• Types of Biobanks
•  

The use of ISO/TR 22758:2020 “Biotechnology - Biobanking - Implementation guide for ISO 20387”

• ISO 20387 vs. ISO/TR 22758
• Contents of ISO/TR 22758
• Scope
• Normative references
• Terms and definitions
• Background information for the development of ISO 20387                             
• Fitness for an intended purpose
• Process landscape
• Conformity with ISO 20387
• Guidance on the interpretation of certain ISO 20387:2018 text parts 

Part   2

The International Standard ISO 20387: 2018
Biotechnology – Biobanking - General requirements for biobanking

•  Scope 
•  Normative references
• Terms and definitions
• 4. General requirements
• 4.1 General 
• 4.2 Impartiality        
• 4.3 Confidentiality
• 5. Structural requirements
• 6. Resources requirements
• 6.1 General
• 6.2 Personnel 
• 6.3 Facilities / dedicated areas and environmental conditions 
• 6.4 External provided process, products and services  
• 6.5 Equipment
• 7. Process requirements
• 7.1 General
• 7.2 Collection of biological material and associated data 
• 7.3 Reception and distribution of biological material and associated data
• 7.4 Transport of biological material and associated data
• 7.5 Traceability of biological material and associated data 
• 7.6 Preparation and preservation of biological material
• 7.7 Storage of biological material
• 7.8 Quality control of biological material and associated data
• 7.9 Validation and verification of methods
• 7.10 Management of information and data
• 7.11 Nonconforming output
• 7.12 Report requirements
• 7.13 Sampling       
• 8. Quality Management system requirements
• 8.1Options
• 8.2 Documented information for the QMS (Option A) 
• 8.3 Control of QMS  documents (option A)
• 8.4 Control of records (option A) 
• 8.5 Actions to address risks and opportunities
• 8.6 Improvements (option A)
• 8.7 Corrective actions for nonconforming output (option A)
• 8.8 Internal audits (option A)
• 8.9 Management reviews (option A)