Certifications critical for managing supply chains and transporting shipments for medical device customer
DB Schenker in Malaysia is pleased to announce that it has received GDPMD and ISO 13485:2016 certifications for three of its sites: Kuala Lumpur Logistics Centre 1 & 2 (KLC1 & KLC2) located in Central, and Johor Logistics Centre 7 (JLC7) located in Southern Malaysia.
Both certifications demonstrate DB Schenker’s commitment to continuously improve our quality management system processes for our medical device customers. They not only increase the reliability of our processes, but they also improve the quality and efficiency of the logistics services we provide.
GDPMD (Good Distribution Practice for Medical Devices) is a quality management system that has been developed to meet the Malaysian medical device regulatory requirements for medical device supply-chain management as stipulated in Medical Device Act 2012 (Act 737).
ISO 13485:2016 is the medical device industry’s most common and widely used international standard that outlines the requirements for a quality management system.
“The extensive, company-wide audit was conducted during the COVID-19 pandemic. Engaging and involving so many different internal and external parties in the project, while having limited face-to-face meeting opportunities, was very challenging. We are proud to meet all the rigorous requirements. The certification clearly demonstrates our commitment to continuously improve our quality management system processes”, said Nor Azidawati, QHSSE Senior Executive at DB Schenker in Malaysia.
Other DB Schenker’s country organizations in the APAC region that are ISO 13485:2016 certified include China, and Singapore.