LABORATORY

QUALITY CERTIFICATIONS AND ACCREDITATIONS OF OUR ASSOCIATED LABORATORY

Quality Management System

ISO 9001

They obtained ISO 9001 certification from the British Standards Institution (BSI) to increase customer trust and satisfaction. Thanks to this certification, company-wide quality objectives and policies have been established, as well as detailed regulations for our work processes. This has allowed not only to improve the efficiency of management practices, but also to achieve cost savings, higher profits and greater competitiveness.

Quality Management System for Clinical Diagnostics

GCLP Accreditation

Accredited as a clinical sample analysis institution by the Ministry of Food and Drug Safety in May 2019. As the first institution to be able to test samples through NGS technology, it is committed to strengthening the competitiveness of national clinical trials by providing reliable testing services.

CAP Accreditation

Its 3 international locations have received CAP accreditation for clinical diagnostic sequencing using NGS technology.

CLIA Certification

CLIA Certification for its headquarters. Backed by this CLIA certification, it offers various clinical diagnostic services as well as patient sample inspections.

 
Certification of Accuracy Evaluation of Genetic Testing

Molecular genetic testing services are certified Grade A (Grade P if non-insurance coverage is included). By providing your customers with reliable results, you contribute to national health and progress in the life sciences.

 Internationally accredited testing laboratory

DAkkS and KOLAS accreditation (ISO/IEC 17025)

It received international accreditation as a testing laboratory for "forensic genetics" from the German national accreditation body DAkkS in December 2016. In March 2017, it acquired international testing laboratory accreditation for "forensic DNA type analysis tests" from KOLAS (Korea Laboratory Accreditation Scheme), the accreditation body operating under the Korea Technology and Standards Agency. DAkkS and KOLAS accreditation certifies that DNA type analysis tests (relationship genetic testing) are recognized for their world-class reliability and advanced technology. Thanks to this accreditation, it can provide internationally certified test reports in accordance with the international standard ISO/IEC 17025. Based on cross-accreditation procedures among the 94 member states of the International Laboratory Accreditation Cooperation (ILAC), the test reports issued are equivalent to the test reports issued locally in each member state.

CSP Program

To provide quality services that inspire customer confidence, it is a member of the CSP (Certified Service Provider) program along with Illumina, Pacific Biosciences, Life Technologies, Thermo Fisher Scientific, Agilent Technology, and Ion Torrent.

Information Management System

ISO27701 Certification

ISO27701 is the most prestigious international standard privacy certification established by the International Organization for Standardization (ISO) in August 2019. The only company in the sector that has acquired the three best information protection certificates at an international level.

 ISMS-P Certification

ISMS-P certification to establish a comprehensive management system for all the information needed in precision medicine, an objective indicator that demonstrates the security of customer information and genomic data. ISMS-P. It is the best security management system, jointly announced by the Ministry of Science and ICT and the Privacy Commission.

 ISO/IEC 27001:2013 Certification

First biotechnology company to successfully achieve Personal Information Management System (PIMS) and International Information Security (ISO/IEC 27001) certifications.