ISO 25720 Certification Service

ISO 25720:2009 Certification – Quality Asia Certification

Overview
ISO 25720:2009 is an international standard that outlines the requirements for the content and structure of labels for blood and blood components. This standard plays a vital role in ensuring traceability, safety, and accuracy in transfusion medicine and blood banking. It is specifically designed for use by blood establishments, transfusion services, and organizations involved in the labeling, processing, or distribution of blood and its components.

What is ISO 25720:2009?
ISO 25720:2009 sets out a globally harmonized labeling system for blood and blood components, using machine-readable barcodes along with human-readable text. The primary goal is to facilitate reliable identification and reduce errors in blood transfusion procedures. This standard helps in improving patient safety by ensuring that the correct product is delivered to the right recipient. It defines essential label content, formatting, data structures, and barcode symbology to support automated data capture and error reduction across healthcare systems.

Why ISO 25720:2009 Certification?
Organizations involved in collecting, processing, or distributing blood products must maintain high standards of traceability and safety. ISO 25720:2009 provides a structured framework to meet these expectations through standardized labeling practices. Certification to this standard demonstrates that the organization complies with internationally recognized best practices in blood product labeling, improving overall system integrity and public health outcomes.

Benefits of ISO 25720:2009 Certification

• Ensures globally harmonized labeling of blood and blood components

• Reduces the risk of transfusion-related errors through standardized barcoding

• Enhances patient safety by supporting correct identification and tracking

• Improves interoperability among healthcare and blood banking systems

• Enables faster, automated data capture for efficient inventory management

• Reinforces trust among stakeholders including hospitals, blood banks, and patients

• Aligns with regulatory expectations for safe handling and distribution of blood products

Certification Process

1. Application Review: Submit your organization 's details and scope of activities related to blood labeling.

2. Document Evaluation: Assess the label design, content format, and barcode implementation based on ISO 25720:2009 requirements.

3. On-Site Audit: Conduct an audit to verify compliance with labeling standards, documentation, and operational practices.

4. Corrective Actions: Address any non-conformities identified during the audit.

5. Certification Decision: Upon successful verification, the certification is granted.

6. Surveillance Audits: Periodic audits ensure continued compliance and improvement.