NEWSROOM

NEWSROOM

2019.12.17
[Press Release] LSK Global PS becomes the first CRO that obtained ‘ISO 37001’ certification

- LSK Global PS obtained the certification for the first time as a CRO to participate in promoting an environment of ethical management in the pharmaceutical industry

- Korea Compliance Certification Assurance (KCCA) requested, “The culture of ethical management should be spread in the CRO business world starting from LSK Global PS that has taken the initiative and set an example”

- Integrated certification along with ISO 9001, which means recognition for the service quality complying with international standards


 

 


Photo] Lee, Young Jack, President of LSK Global PS (left) and Lee, Won-ki, Head of the KCCA (right) are taking a commemorative photo in the ceremony awarding ISO 37001 certificate.


LSK Global Pharma Services Co., Ltd. (LSK Global PS) which is a leading contract research organization (CRO) in Korea announced on December 16, 2019 it had become the first CRO obtaining ‘ISO 37001’ certification which is the international standard for anti-bribery management system from the International Organization for Standardization.


 


ISO 37001 introduced into Korea in 2017 is an international standard prescribing the requirements applicable to prevent bribery that may arise in all kinds of organizations, and its introduction has been particularly accelerated to build anti-bribery culture in the pharmaceutical industry. LSK Global PS has become the first and only CRO obtaining the ISO 37001 certification to join the voluntary commitment of pharmaceutical industry and to keep pace with the creation of environment for ethical management.


 


The main requirements of the ISO 37001 standard consist of anti-bribery policy, procedures, and regulation within the organization, training for anti-corruption, due diligence, internal audit and management review, corrective action and continuous improvement, etc., and the certification is granted through the strict screening process. In addition, continuous efforts are required for maintenance even after the certification is granted. Since a certification holder has to go through the post-certification audit twice each year and the screening for renewal in the 3rd year of certification to maintain its certified status, continuous management such as training or internal audit, and corrective action should be implemented.


 


Lee, Won-ki who is the head of the KCCA said, “While a lot of pharmaceutical companies are obtaining the certification to establish a transparent culture in the pharmaceutical industry, it is very encouraging a CRO company consisting of the core infrastructure has taken the initiative in obtaining the certification”. He continued to say, “LSK Global PS which is a leading CRO in Korea has shown an example of obtaining the ISO 37001 certification for the first time as a CRO passing the strict screening criteria”. He said he desired based on this, the move toward ethical management would also be spread in the CRO business world.


 


Meanwhile, with the introduction of ISO 37001, LSK Global PS obtained an integrated certification of ISO 37001 and ‘ISO 9001(quality management system)’ which had been previously granted. The ISO 9001 was a recognition that LSK Global PS obtained in March, 2017 for the first time as a CRO for its service quality throughout entire service areas relevant with clinical trials, and LSK Global PS has been acknowledged once again through this integrated certification it is maintaining the service quality in compliance with international standards.