Selection and Implementation of the ISO9001 Standard to Support Biobanking Research Infrastructure Development

Area of Science:

• Biobanking and Genetic Epidemiology
• Quality Management Systems in Research

Background:

• The UK DNA Banking Network (UDBN) aims to add scientific value to its biobanking resources.
• Enabling appropriate access to biobanking resources is crucial for research.
• A robust Quality Management System (QMS) is essential for ensuring consistency in sample management.

Purpose of the Study:

• To implement a certified QMS for biobanking operations within UDBN.
• To achieve external certification for the QMS to validate operational consistency.
• To explore the challenges and benefits of implementing a QMS in an academic biobanking setting.

Main Methods:

• UDBN selected and implemented the ISO 9001 QMS.
• The QMS implementation encompassed both UDBN and its host academic department.
• Specialized software, a Quality Manual, SOPs, and dedicated training were utilized.
• An external certification body approved the QMS for the ISO 9001:2000 standard.

Main Results:

• UDBN successfully achieved ISO 9001:2000 certification, marking a first for an academic genetic epidemiology lab.
• QMS Standard Operating Procedures (SOPs) were found to be non-transferable between labs, highlighting the need for joint QMS adoption in biobank networks.
• QMS implementation required the inclusion of the host university department, not just the biobanking unit itself.

Conclusions:

• ISO 9001 certification validates the consistency of biobanking operations.
• Implementing a QMS is vital for improving access to biobanking research infrastructure.
• ISO 9001 serves as both a management and research tool for biobanking infrastructure development and longitudinal data accrual.