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Support documents

Our Documents support Swiss biobanks in harmonization, standardization, and accreditation readiness.
Supporting quality and interoperability in Swiss biobanking. Our comprehensive set of documents, policies, templates, and datasets provides a practical framework that helps biobanks develop and maintain state-of-the-art operations. By using these resources, biobanks contribute to national process harmonization, foster standardization, and generate traceable evidence that procedures are effectively implemented. All resources have been reviewed and approved by Swiss field experts.

More information about our key documents

Describes the organization of the biobank and defines its purposes, governance (i.e. organizational structures and rules) and operational processes.

Based on: Art. 43 HRAArt. 5 HRO and §21 Taipeiart. 16 ch. 2 CM/Rec(2016)6

Defines the rights and obligations of the provider and recipient with respect to the use of the biological resources and other related issues, such as confidentiality or intellectual property rights.
Based on: §21 Taipei

Quality Manual (for OPTIMA label) or European Quality Handbook for biobanks (for ISO accreditation)
Explains how a Quality Management System (QMS) is implemented, operated, and maintained within a biobank. It also provides an overview of operational procedures, defines the requirements and helps identify potential gaps.
Based on: ISO 20387

Define the essential data associated with samples to support the goal of making samples from different biobanks comparable and searchable, while promoting their exchange and enhancing visibility.
Read more →

The Cost Calculator allows biobanks to bill a project by splitting costs per process, distinguishing labor from material expenses. A separate document lists potential indirect costs, helping raise awareness of the broader expenses involved in biobanking.
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Filters:

BIMS Guidelines

Guideline

Biobank regulation

Nov. 2019

VITA

Template
English — Download
German — Download
French — Download

Biological Material Management SOP

1.0

NORMA

SOP
Biological Material Management SOP — Download
Sample tracking form — Download
Sample Acceptance Criteria — Download
Shipping Log — Download

Cost Calculator

1.1

Calculator
Cost Calculator — Download
User Guide — Download
Appendix — Download

Data Quality SOP

1.0

VITA

SOP
Data Quality SOP — Download
Annex 1: Data Management Plan Template — Download
Participant iD log — Download

Datasets Bacteria

2.0

NORMA

Dataset
CORE Dataset for Bacteria (pdf) — Download
CORE + EXTENDED Dataset for Bacteria (xls) — Download

Datasets Human

2.0

NORMA

Dataset
CORE Dataset for Liquid (pdf) — Download
CORE + EXTENDED Dataset for Liquid (xls) — Download
CORE Dataset for Tissue (pdf) — Download
CORE + EXTENDED Dataset for Tissue (xls) — Download

Datasets Veterinary

2.0

NORMA

Dataset
CORE Dataset for Vet Liquid (pdf) — Download
CORE + EXTENDED Dataset for Vet Liquid (xls) — Download
CORE Dataset for Vet Tissue (pdf) — Download
CORE + EXTENDED Dataset for Vet Tissue (xls) — Download

Documentation management SOP

1.0

OPTIMA

SOP
Documentation management SOP — Download
Standard document — Download
Standard SOP — Download
List of essential documents — Download

Equipment Management SOP

1.0

NORMA

SOP
Equipment Management SOP — Download
Equipment calibration records — Download
Equipment maintenance records — Download
Expiring Consumables Inventory — Download
Equipment Inventory — Download

Ethical legal and professional compliance list

July 2025

VITA

Guideline

Glossary

1.2

Glossary
English — Download

Improvement Management SOP

1.0

OPTIMA

SOP
Improvement Management SOP — Download
Management Review Report — Download
Quality Policy — Download

Internal audit SOP

1.0

OPTIMA

SOP
Internal audit SOP — Download

MTA 2.0

2.0

VITA

Template
Introduction — Download
Master Legal Instrument — Download
Project Agreement — Download

The MTA 2.0 Project Agreement is an interactive form and is to be opened and edited exclusively using Acrobat Reader.

MTA 3.0

3.0

VITA

Template
Introduction — Download
Master Legal Instrument — Download
Project Agreement — Download

MTA Veterinary

1.0

VITA

Template
pdf (editable) — Download
docx — Download

Nagoya Protocol applied to Swiss Biobanks

Guideline
Analysis and recommendations — Download
Examples of Application in Switzerland — Download
SBP Nagoya Dataset — Download

Nagoya Protocol Dataset

Non-Human Genetic Resources

1.0

Dataset

Non-conformity management SOP

1.0

OPTIMA

SOP
Non-conformity management SOP — Download
Non-Conformity Report — Download
Non-Conformity Log — Download

Obtaining consent SOP

1.0

VITA

SOP

Participant Identification log

1.0

VITA

Template

Personnel management SOP

1.0

NORMA

SOP
Personnel management SOP — Download
Personnel File — Download

Preanalytical conditions to prepare human DNA from FFPE Tissue for NGS

Guideline

Preanalytical conditions to prepare human DNA from whole blood

Guideline

Preanalytical conditions to prepare human RNA from whole blood

Guideline

Quality control strategy implementation SOP

1.0

NORMA

SOP
Quality control strategy implementation SOP — Download
Quality Control results — Download

Quality Manual

1.0

OPTIMA

Template
Quality manual (OPTIMA Label) — Download
Quality Handbook for Biobanks (ISO 20387) — Link

Responsibilities SOP

1.0

VITA

SOP

Risk Management SOP

1.0

OPTIMA

SOP
Risk Management SOP — Download
Annex — Download

Safety and Complaint SOP

1.0

VITA

SOP

Service Level Agreement Template

1.0

OPTIMA

Template
Service Level Agreement Template — Download

Validation of methods SOP

1.0

NORMA

SOP
Validation of methods SOP — Download
Validation method record — Download
Method List — Download

Contact expert

Josephine Uldry
Quality Officer — Human and non-human
josephine.uldry@swissbiobanking.ch

Lou Ferraton-Walder
Project & Operations Officer — Human
lou.ferraton@swissbiobanking.ch

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