ISO TR 22758-2020 PDF

Full title and description

ISO/TR 22758:2020 — Biotechnology — Biobanking — Implementation guide for ISO 20387. A technical report providing practical guidance and illustrative examples to help biobanks implement the management, quality and technical requirements set out in ISO 20387.

Abstract

This technical report offers guidance to biobanks on implementing the quality management, managerial and technical requirements of ISO 20387. It expands on selected aspects of ISO 20387, provides examples for illustration, and aims to assist biobanks (new and existing) in addressing personnel competency and ensuring appropriate quality of biological material and associated data collections. The report is applicable to organizations performing biobanking across multicellular organisms and microorganisms, but it does not apply to biological material intended for feed/food production or to laboratories undertaking analysis for food/feed production or therapeutic use.

General information

• Status: Published.
• Publication date: May 2020 (published 29 May 2020).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 07.080 (Biology. Botany. Zoology).
• Edition / version: Edition 1 (2020-05).
• Number of pages: 23.

Scope

ISO/TR 22758:2020 functions as a companion implementation guide to ISO 20387. It provides interpretative guidance, examples and explanatory material to help biobanks determine and meet requirements for competence, impartiality, consistent operation, quality control, and fitness for the intended purpose of biological material and associated data. The guidance applies broadly to organizations performing biobanking (human, animal, plant, fungal and microbial materials) for research and development, but explicitly excludes material intended for food/feed production and work intended primarily for therapeutic/diagnostic laboratory purposes.

Key topics and requirements

• Guidance on implementing ISO 20387 clauses (general, structural and resource requirements) and interpretation of selected text.
• Fitness for the intended purpose (FIP) concepts and how to apply them across the biological material and associated data lifecycle.
• Quality management aspects specific to biobanking: QC procedures, data quality, traceability and documentation.
• Competency and resource requirements for personnel, facilities and equipment.
• Conformity assessment considerations, scopes of conformity and applicability for accreditation.
• Confidentiality, impartiality and ethical considerations in biobanking operations.
• Process landscape: acquisition, processing, storage, distribution and long‑term stewardship of biological material and data.

Typical use and users

Primary users are biobank managers and staff, quality and laboratory managers, research institutions, biorepository administrators, and organizations seeking accreditation or conformity assessment to ISO 20387. Secondary users include accreditation bodies, regulatory authorities, funders and researchers who rely on the quality and traceability of biobanked material and data. The report supports both newly established and existing biobanks in implementing ISO 20387 requirements.

Related standards

ISO/TR 22758:2020 is an implementation guide for ISO 20387 (Biotechnology — Biobanking — General requirements for biobanking, 2018) and is intended to be used alongside ISO 20387 when planning accreditation or quality programs. Other relevant standards and guidance often referenced in the biobanking context include ISO 15189 (medical laboratories) where clinical diagnostic uses are involved, and general quality-management standards such as ISO 9001; accreditation program documents and sector best‑practice guidance (e.g., ISBER) are also commonly used in tandem.

Keywords

biobanking, biobank, biological material, associated data, ISO 20387, implementation guide, quality management, fitness for intended purpose, accreditation, conformity assessment.

FAQ

Q: What is this standard?

A: ISO/TR 22758:2020 is a technical report (implementation guide) published by ISO in May 2020 to help biobanks implement the requirements of ISO 20387 (the international standard for biobanking). It is edition 1 and comprises 23 pages.

Q: What does it cover?

A: It provides explanatory guidance, examples and interpretation to support implementation of ISO 20387 clauses — covering management and technical requirements, fitness for the intended purpose of biological material and data, personnel competence, quality control, process flows and considerations for conformity assessment and accreditation.

Q: Who typically uses it?

A: Biobank managers and technical staff, quality managers, accreditation bodies, regulatory authorities, and researchers who rely on biobanked samples and associated data. The guide is designed for both new and established biobanks.

Q: Is it current or superseded?

A: As published in May 2020, ISO/TR 22758:2020 is a current technical report; ISO’s lifecycle information indicates standards are reviewed every five years and that the document is scheduled for review (to be revised) in the standard review cycle. Users should check the latest ISO catalog or national bodies for any updates or replacement documents.

Q: Is it part of a series?

A: It is a companion implementation guide to ISO 20387 (the principal standard for biobanking). Both documents were developed by ISO/TC 276 (Biotechnology) and are intended to be used together to improve biobanking quality and trust.

Q: What are the key keywords?

A: Biobanking, implementation guide, ISO 20387, fitness for intended purpose, quality control, accreditation, biological material, associated data.