CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and medical devices, recently received EN ISO 13485 certification for its U.S.-based facilities.
Two of CorDx’s ISO-certified facilities are in San Diego, Calif. The third is in Atlanta, Ga. The certifications were awarded in August 2022. The certification was performed by TÜV Rheinland.
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ISO certification provides tangible assurance that a business conforms to the latest quality process standards set by the International Organization for Standardization (ISO). ISO certification helps to maintain consistency and quality across international industries and ensure safety and efficiency in products, services, and systems. While ISO sets the standards, certification is granted only after review by an independent certifying body.
ISO certification is a critical step that directly supports CorDx’s proprietary diagnostic supply chain development and is expected to further enable CorDx’s source of diagnostics products in the U.S. market.
The ISO certification process is rigorous and comprehensive, and typically takes from six months to a year to complete. In order to become ISO certified, CorDx was required to:
- Develop a Quality Management System (QMS): This includes identification of core business processes, documentation of the processes, and review, approval, and distribution of the documents to stakeholders.
- Implement the QMS: CorDx was required to ensure its procedures were performed as described in the documentation, ensure its employees were trained properly for the tasks in question, create effective reporting systems, monitor process effectiveness, and improve areas with deficiencies.
- Verify the effectiveness of the QMS: CorDx conducted an internal process audit for compliance and effectiveness, identified and reported the strengths and weaknesses of its system, and took corrective action when necessary.
Register the QMS: CorDx selected an auditing body for its external registration, submitted its documentation for review, and facilitated the inspection by the external auditor.
“CorDx is honored to receive EN ISO 13485 certification for its U.S.-based facilities,” said Jeff Yufeng Li, CorDx’s founder & CEO. “This certification is a proud reminder of, and a testament to, CorDx’s commitment to quality around the world as we develop, manufacture, and distribute reliable, affordable diagnostic products that protect health and save lives.”
CorDx is the contract or OEM manufacturer for more than 100 diagnostics companies, including for multiple EUA-authorized COVID lateral flow tests. Its over 700 diagnostic products are sold worldwide.