We’re thrilled to share that Taizhou Shuoshi Medical Testing, a subsidiary of BioPerfectus, has been awarded ISO 15189 accreditation from CNAS. This recognition marks a milestone, highlighting the commitment of BioPerfectus to achieving international standards in medical laboratory quality management and service capabilities.
Global Standards, Local Excellence
ISO 15189 is a globally recognized standard issued by the International Organization for Standardization (ISO), which sets out the criteria for medical laboratory quality and competence. It covers various aspects, including organizational management, quality systems, personnel, facilities and environment, and testing procedures. The goal of this standard is to ensure that laboratories deliver accurate, reliable, and timely test results, providing high-quality medical services for patients and clinicians alike. The updated ISO 15189 emphasizes risk management and patient-centered care, ensuring that laboratories design quality management systems and processes with a focus on patient risk.
CNAS is the sole official body in China authorized to grant ISO 15189 accreditation, with strict standards and high application thresholds. The certification is widely recognized globally, and obtaining it demonstrates that the laboratory meets the highest standards in management systems, technical proficiency, and service quality.
Validated Excellence, Global Impact
From November 22 to 24, 2024, an assessment team from the China National Accreditation Service for Conformity Assessment (CNAS) conducted a three-day on-site review of Shuoshi Medical Testing.The team of experts rigorously assessed Shuoshi Medical Testing's management processes, quality and technical standards, personnel competence, service capabilities, biosafety measures, and information systems in accordance with CNAS's accreditation guidelines. Achieving this certification confirms that Shuoshi Medical Testing meets international standards across key areas, including laboratory management, testing procedures, quality control, staff training, biosafety, information systems, and resource allocation.This accreditation ensures that the laboratory's test reports are mutually recognized by accreditation bodies in countries and regions worldwide, significantly enhancing the credibility and international recognition of its testing results.
