Summary: Sysmex’s CAP accreditation and ISO certification, reinforces its commitment to delivering high-quality liquid biopsy diagnostics.

Takeaways:

  1. Industry Gold Standards: CAP accreditation and ISO 15189 certification highlight Sysmex Inostics’ adherence to rigorous international standards for accuracy, precision, and patient safety.
  2. Quality and Reliability: These achievements enhance the lab’s quality management system, ensuring consistent, reproducible results that support critical healthcare decisions in oncology and beyond.
  3. Global Impact: The accreditations position Sysmex Inostics as a trusted leader in precision medicine, enabling innovations that improve patient outcomes worldwide.

Sysmex Inostics, a provider of liquid biopsy solutions, announced its recent accreditation by the College of American Pathologists (CAP) as well as its certification under ISO 15189 standards. 

These recognitions reaffirm Sysmex Inostics’ commitment to delivering the highest level of quality and reliability in its clinical diagnostics and laboratory services, the company says.

Sysmex’s New Accreditation and Certification

CAP accreditation, considered the gold standard in laboratory quality assurance, signifies that Sysmex Inostics has met or exceeded rigorous industry standards for accuracy, precision, and patient safety, the company says. Meanwhile, the ISO 15189 certification further underscores the laboratory’s dedication to quality management and technical competence, ensuring the reliability and integrity of test results that support critical healthcare decisions.

“Achieving both CAP accreditation and ISO 15189 certification represents a significant milestone in our commitment to delivering diagnostic excellence,” says Aaron J. Lizee, VP, commercial operations of Sysmex Inostics. “These accomplishments reflect the hard work and dedication of our team and demonstrate our unwavering focus on quality and patient outcomes.”

The addition of CAP and ISO 15189 to the Sysmex Inostics quality system strengthens the laboratory’s ability to meet international standards and ensures a robust framework for continuous improvement. These accreditations provide confidence to clinicians, researchers, and partners by reinforcing the accuracy and reproducibility of results across a wide range of diagnostic applications, the company says.


Further Reading


“Our enhanced quality system empowers us to meet the highest regulatory and operational standards,” added Takeisha Wright, sr. director, regulatory affairs and quality assurance. “This achievement is not just about compliance; it is about setting the bar for excellence in diagnostics and ensuring our clients and patients receive the most reliable data to guide life-saving decisions.”

By integrating these accreditations into its quality system, Sysmex Inostics solidifies its position as a trusted partner in advancing precision medicine, supporting innovations in oncology, and delivering diagnostic solutions that improve patient care worldwide.