Rhenus Hong Kong has announced that it has earned ISO certification, ISO13485:2016, after an extensive audit of its internal operations. This quality management certification covers the design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.
ISO 13485:2016 is a standard to certify quality management systems for businesses that provide medical devices and related services. ISO 13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.
Companies that achieve ISO 13485:2016 demonstrate a high standard of process and system management. Rhenus Hong Kong’s professional handling and storage of medical devices are among the key highlights of the accreditation, which saw the audit dive into resource management, monitoring and measurement processes, product and contamination control, and traceability control and measurement.
“Gaining the ISO 13485:2016 certification is a milestone for the Rhenus HK team, as we continue to work towards delivering professional and sustainable logistics services. Covid-19 has changed the lives of everyone, and medical devices have become a necessity. The certification will allow us to provide international standards of warehousing services, especially in the areas of medical device product handling, optimal storage environment and traceability for our customers,” said Dennis Mak, Director, Warehousing Solutions & Distribution – Greater China.
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