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- 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”
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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.
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