Standards touch almost every part of our daily lives. They ensure that products and services work the way we expect them to, making life both safer and more enjoyable. BGI Group understands the importance of maintaining the highest standards in healthcare, and that commitment is reflected in our laboratories, devices, data security, compliance management, and more aspects, worldwide.
On October 14th every year, the world celebrates World Standards Day as a global community to recognize the power of standardization. The theme for 2023 is "Shared Vision for A Better World: Incorporating SDG 3."
UN Sustainable Development Goal 3 (SDG 3) is a vital part of this vision, focusing on ensuring healthy lives and promoting well-being for all. Achieving SDG 3 and the broader 2030 Agenda for Sustainable Development requires rigorous adherence to international standards. In this regard BGI Group stands out as committed to safeguarding human health and the well-being of global society.
Adherence to Global Top-Tier Medical Laboratory Standards
The College of American Pathologists (CAP) accreditation is considered the “gold standard” for medical laboratory quality systems.
BGI’s laboratories in Denmark, Australia, Hong Kong, Shenzhen, and Tianjin participate in the CAP PT programs every year and achieved "Good" ratings performance, while the Genalive Medical Laboratory, an independent joint venture clinical laboratory between BGI and its Saudi Arabian partner, has passed a CAP audit recently, demonstrating its excellence in clinical laboratory testing and management practices.
Another critical standard in healthcare is ISO 15189, which regulates the management and technical requirements for the quality and capability of medical laboratories on an international level. BGI Group's laboratories in Denmark and Australia have obtained ISO 15189 accreditation. The accreditation for BGI Australia lab allows it to perform clinical whole exome sequencing (cWES). The accreditation helps BGI Australia to provide services to clinical labs, hospitals, and other partners to detect changes in the exome that contribute to rare genetic and paediatric diseases.
These certifications underline BGI’s commitment to meeting international standards and top-tier medical laboratory quality.
Medical Devices Qualifications Ensure Highest Quality Management
For medical devices, ISO 13485 is a crucial quality management system standard that applies to the design, production, storage, distribution, and installation of medical devices.
BGI Group's commitment extends to in vitro diagnostic (IVD) products, including fertility, oncology, and infectious disease testing kits. BGI Group sites in six cities in China and overseas locations in Singapore, Denmark, Latvia, and Ethiopia have all achieved ISO 13485 certification, reinforcing BGI's dedication to ensuring the highest quality in medical devices.
Paramount Importance for Data Security and Personal Privacy
In today's digital age, personal privacy protection is of paramount importance. BGI Group has demonstrated its commitment to data security and personal privacy by obtaining certifications such as BS 10012 and ISO/IEC 27001.
BS 10012, issued by the British Standards Institute, aligns with the stringent General Data Protection Regulation (GDPR) in the European Union, providing a robust framework for personal information protection in data governance. BGI has obtained BS 10012 certification in Hong Kong and Denmark and is actively pursuing similar certifications in various other regions.
Multiple branches of BGI Group in China and overseas locations have also obtained ISO/IEC 27001 Certification, one of the most common information security management systems globally. These certifications underscore BGI's dedication to safeguarding data and personal privacy.
Comply Strictly with Global Standards for Compliance Management
Recently, BGI Genomics, a subsidiary of BGI Group, successfully passed the rigorous review of British Standards Institution (BSI) and obtained the GB/T 35770-2022 / ISO 37301:2021 Compliance Management System Certification, which signifies the company’s compliance management level has reached the requirements of international standards.
Committed to Standards Establishment
BGI Group's commitment to standards goes beyond compliance; it actively participates in the establishment of standards.
Recent contributions include the release of "ISO/TS 23511:2023 Biotechnology - General requirements and considerations for cell line authentication," "ISO/TS 8392:2023 Genomics informatics - Description rules for genomic data for genetic detection products and services," and "ISO/TS 24420:2023 Biotechnology - Massively parallel DNA sequencing - General requirements for data processing of shotgun metagenomic sequences." These standards are the first of their kind in their respective fields and are pivotal in advancing genetic technology and ensuring its responsible use.
Today, BGI Group holds more than 100 international quality system accreditation certificates worldwide, meeting international requirements. These certificates reassure customers about BGI's commitment to laboratory quality management, data security, personal privacy, environmental protection, and more.
BGI Group's unwavering commitment to global standards not only benefits their customers but also contributes to the broader vision of a better, healthier world outlined in SDG 3 and the 2030 Agenda for Sustainable Development. In the words of Dr. Fu Wei, BGI Genomics Director of Quality Management, "It is the mission and vision of BGI to benefit mankind through genetic technology, and quality is the lifeline that BGI firmly adheres to."