ISO 13485 Certification In Vietnam

by do ha hado

The ISO 13485:2016 quality management system (QMS) standard for medical devices was introduced in 1st March 2016, with the Accreditation enabling the transition of certified organizations from previous versions within three years. ISOCERT is an established ISO 13485 certification body in Vietnam, we can assist you in your journey towards local and international compliance. ISO 13485 certification for medical devices is an internationally recognized quality standard which affirms the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices anywhere in the world.

ISO 13485 for Medical Devices and Equipment

13485 certification in vietnam
Ensure the medical devices and equipment is made as per the international standard by achieving the ISO 13485 Certification. This certification establishes the high-quality performance of medical devices and equipment. Further, it inspires the suppliers, manufacturers and medical device industry to design quality products that ensure customers’ safety and employees’ satisfaction.

“Điều 68. Điều khoản chuyển tiếp

Cơ sở sản xuất trang thiết bị y tế, đã hoạt động trước ngày Nghị định này có hiệu lực thi hành được tiếp tục hoạt động sản xuất nhưng phải hoàn thành việc công bố đủ điều kiện sản xuất trước ngày 01 tháng 7 năm 2017. Riêng đối với quy định về hệ thống quản lý chất lượng: Cơ sở sản xuất trang thiết bị y tế phải hoàn thành việc áp dụng hệ thống quản lý chất lượng ISO 9001 trước ngày 01 tháng 01 năm 2018 và hệ thống quản lý chất lượng ISO 13485 trước ngày ngày 01 tháng 01 năm 2020.”

ISO 13485 is specifically proposed to implement the Quality Management System of the medical device industry. This globally recognized standard is applicable for all kinds of medical industries and as well as the medical device suppliers and dealers.

ISO 13485 Certification

13485 certification in vietnam
The standard ISO 13485 includes the guidelines, directives, and regulations to make high-quality medical devices and equipment. It specifies requirements to reduce low-quality products and wastes. Also, ISO 13485 provides effective measures to bring continual improvement in various sectors such as design, development, production, storage, distribution, and installation.

ISO 13485 Certification describes the quality of medical devices and ensures employees’ safety. It is one of the easy and effortless ways to achieve global recognition in your medical device industry.

How the ISO 13485 Certification benefits the organization?

The ISO 13485 Certification for medical devices is the mark of the organizations that produce well-designed, safe equipment. This certification also provides the following benefits to the organization.

Reduces the wastes and low-quality products
Helps control and manage the operational risks
Helps win more business opportunities
Enhances the sales and profit of the business

ISOCERT – the famous ISO 13485 Certification Body

ISOCERT offers management system certification on ISO 13485 and also on various ISO standards. We also issue product certifications such as ISO 9001, ISO 14001, ISO 45001 and so on.

We follow a simple yet effective auditing process to drive betterment in the management system.

ISOCERT is an international certification organization that provides ISO 13485:2016 certification services. ISOCERT is licensed by the Directorate for Standards, Metrology and Quality, is accredited by the Office of Quality Accreditation (BOA) - Under the Ministry of Science and Technology and is issued with VICAS 067.

13485 certification in vietnam
Thereby, ISOCERT has full legal capacity to carry out international certification and inspection activities. Understanding the important role, the trend of the times as well as always interested in listening from customers. We are always aiming at solutions, package procedures, reasonable prices towards "Harmony With Prosperity".