Rang Dong Healthcare, a brand connecting Vietnamese products to foreign markets. News 13/05/2020
On April 22-25, 2020, the auditing team of BSI Vietnam Limited Company concluded that Rang Dong Plastic Group has successfully completed the audit and certification of its Quality Management System according to ISO 13485:2016 & EN ISO 13485:2016 for the scope of manufacturing and supplying plastic products for the medical industry. This can be considered as a joyful news for the leadership, officers, and employees of Rang Dong Plastic Group, reflecting their dedicated efforts in achieving this rigorous certification.
What is ISO 13485:2016 standard?
ISO 13485 is a standard for a safety management system for medical devices, part of the ISO 13485:2003 standard set issued by the ISO organization.
The latest version of ISO 13485:2016, specifies requirements for a quality management system applicable to organizations involved in the manufacturing and supply of medical devices and related services. It aims to ensure the ability to provide products that meet customer requirements and comply with legal regulations. The ISO 13485 standard is developed based on the foundation of the ISO 9001 standard set.
Benefits of implementing ISO 13485:2016 certification
- Satisfy and create a better impression for customers.
- Enhance competitive advantage in business, especially in bidding cases.
- Reduce operating costs by improving production efficiency, product quality, controlling risks, controlling hygiene, and contamination into products, and having specific implementation plans.
- Create the ability to penetrate international markets that require high quality and safety because ISO 13485 certification is considered the first step towards compliance with European regulatory requirements.
- Effectively control internal processes and minimize risks related to product quality and safety.
- Convenient integration with other management systems (ISO 9001, ISO/IEC 17025, ISO 14000).
Rang Dong Healthcare Corporation, a member of Rang Dong Holding Group, operates with the motto “For the health of the community” as its development foundation. Specializing in the production and export of medical plastic products such as supplies and equipment used in operating rooms and patient care, as well as patient utilities and treatment services, the ISO 13485:2016 certification holds significant importance. It serves as a prerequisite for exporting to foreign markets, particularly the European market. Currently, Rang Dong Healthcare is the sole Vietnamese entity exclusively exporting a large quantity of FDA-approved medical products to the United States, including medical clothes (PE gowns), medical hats, body bags, vomit bags, and patient file bags.
Moreover, Rang Dong Healthcare is progressively penetrating the domestic market with the aim of becoming a leading company in the provision of medical plastic products in Vietnam. This achievement is merely a matter of time.
