Quality Assurance and Accreditation

CLIA Certification

Clinical Laboratory Improvement Amendments (CLIA) is the standard certification of laboratories in the United States. This certification system evaluates the accuracy, reliability and suitability of laboratories for performing diagnostic testing on human samples.

This certification system is required for companies conducting clinical diagnostics business in the United States because the companies can provide services they have developed in-house without an approval from the FDA (Food and Drug Administration) after obtaining CLIA certification. With CLIA certification obtained via an overseas corporation, Macrogen has entered the US clinical diagnostics market and is providing clinical services to patients in American hospitals; and by introducing CLIA certification, Macrogen is enhancing clinical diagnostic services in Korea as well as overseas.

CAP Accreditation

The College of American Pathologists (CAP) Laboratory Accreditation Program has accredited the entire spectrum of laboratory test disciplines with the most scientifically rigorous checklist requirements for high-quality management since 1961. The CAP Accreditation Program demonstrates its reliability and reputation by being recognised by the US federal government as equivalent to, or stricter than, its own program. The CAP requires laboratories to pass an accuracy test and on-site inspection conducted by inspectors.

Macrogen USA passed this strict certification process and obtained CAP accreditation for the clinical diagnostic sequencing sector using NGS technology in October 2017. It is implementing related procedures to expand the CAP certification for its headquarters and the Precision Medicine Center.

Genetic Testing Accuracy Evaluation Certification

With genetic testing becomes common in medical and research areas, the Genetic Testing Accuracy Evaluation Certificate is an evaluation system created to induce improvement in the quality of services and to create healthy competition and development by evaluating the accuracy of the testing institution. The goal of the Korea Institute of Genetic Evaluation, which controls and supervises the certification, is to prevent the confusion that can occur due to indiscreet and inaccurate genetic testing. It does this by evaluating the accuracy of test results, the adequacy of work execution, the suitability of facilities and equipment, and the adequacy of testing staff.

Receiving top-tier grades (grade A or P) every year for molecular genetic testing performed in our headquarters, Macrogen contributes to public health and developments in bioscience by providing more reliable results to customers.

NGS Clinical Laboratory Certification

The NGS Clinical Laboratory Certification was established by the MFDS (Ministry of Food and Drug Safety) in August 2016 to ensure that NGS (next generation sequencing) technology is used for diagnosis and testing of diseases such as cancer genome analysis and rare-disease testing. Certification is granted after a comprehensive inspection of the quality management system, such as equipment and facilities, staff and testing capacity, and reliability of testing results.

With NGS clinical laboratory certification by MFDS obtained in April 2017, Macrogen is now able to develop and provide various NGS-based testing services using the latest technologies such as cancer panels and liquid biopsy.

Accredited by DAkkS and KOLAS (ISO/IEC 17025)

Macrogen was accredited by DAkkS, a national accreditation agency in Germany, as an international authorised testing institution for ‘forensic genetics in the forensic sector’ in December 2016 and accredited as an international authorised testing institution by the Korea Laboratory Accreditation Scheme (KOLAS), a national accreditation agency in Korea, as an international authorised testing institution for ‘forensic science genetic relationship test’ in March 2017.

Accreditation by DAkkS and KOLAS has proven the world-class technology and reliability of Macrogen’s genetic relationship test, which means that Macrogen can provide an international authorised test certification according to the international standard ISO/IEC 17025, and our test certificate can be used internationally. It also means that the test certificate of the sector issued by Macrogen has the same effectiveness as the test certificate issued in 94 countries that have joined the International Laboratory Accreditation Corporation (ILAC) according to a mutual certification procedure.

DAKKS

KOLAS

CSP Program 

Macrogen participates in the Certified Service Provider (CSP) program provided by partners Illumina, Pacific Biosciences, Life Technologies, Thermo Fisher Scientific and Agilent Technology to provide high-quality services that customers can trust. The CSP certification program is a mutual service cooperation program created to ensure that companies providing gene analysis platforms with microarray and test-related kits, and providers of corresponding services, deliver the best possible service to customers.

Macrogen complies with the service quality standard defined by gene analysis platform providers by operating the total service quality management system it established and participating in CSP certification programs. With this, Macrogen provides high-quality services and offers benefits to customers by operating a joint marketing and support program based on cooperation with gene analysis platform providers.

Illumina (Gene expression)	Illumina (Sequencing)	Pacific Biosciences
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Agilent Technology	Life Technologies	Thermo Fisher Scientific
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PIMS (Personal Information Management System)

Personal Information Management System (PIMS) is a certification granted to companies that have met a certain standard after confirming a company’s ability to handle personal information by establishing systematic and continuous protective measures. This certification evaluates companies and public organisations’ measures to handle personal information to ensure that they conform with Korea’s Personal Information Protection Act according to the Act on the Promotion of Information and Communications Network Utilisation and Information Protection. The results are then reviewed and certified by the Korea Internet and Security Agency (KISA) and certification is granted by the Korea Communications Commission.

Macrogen obtained PIMS certification for its gene analysis and clinical diagnostic service for the first time in the gene analysis industry. In particular, by preparing a personal information protection system that complies with the Bioethics and Safety Act (which bio companies that deal with bioinformation must abide by), it has successfully established a specialised personal information protection system for gene analysis companies.