Biomedic received ISO 13485: 2016 certificate – Quality Management System for Medical Equipment

On May 19, 2020, Biomedic Scientific Materials Joint Stock Company was awarded ISO 13485: 2016 certificate by BSI Evaluation Organization. Attending the ceremony, there were: General Director of Biomedic – Mr. Cao Tien Dung, BSI representative – Ms. Nguyen Thi Minh Tam – Director of BSI Hanoi office, representatives from Military Bank – MB Bank and Biomedic’s managers.

ISO 13485 is a standard that specifies the requirements for quality management systems applied for facilities that provide medical equipment and/or related services to ensure the ability to deliver products that meet the requirements of customers and the rule of law.

The highlight of ISO 13485 is that most of the provisions require businesses that, in addition to meeting the manufacturer’s standards, must comply with statutory and regulatory requirements to ensure medical equipment and devices to ensure that the supplies to the market always meet customer requirements and the provisions of law. Additionally, with a risk-based process approach, applying ISO 13485 will minimize risks and ensure the best quality of each process, thereby bringing the best products and services to customers.

When decided to construct the ISO 13485, Biomedic had invested in quality management system, investing in facilities such as building and perfecting a spacious and modern goods storage system. The company has organized personnel training activities with standard professional skills required by the goods to ensure that the installation, technology transfer activities are carried out in accordance with ISO 13485.

Although it has been difficult to apply a specific quality management system for medical equipment with a lot of stringent requirements not only from the manufacturer but also the statutory requirements from the completion. document system to regular training and validation of the system through internal audit. However, all Biomedic staff have tried their best to contribute to the standardization of the system.

Speaking at the ceremony, the General Director of Mr. Cao Tien Dung expressed his thanks to BSI, the MB Bank, who has accompanied Biomedic since Biomedic was still a small startup. ISO 13485 certification confirms Biomedic’s commitment to product and service quality. The General Director also pledged that Biomedic will carry out continuous improvement of the system to maintain ISO 13485 certification.

BSI representative said Biomedic is one of the first companies in the field of distribution of medical equipment products to receive ISO 13485 certification. Currently, it is not required by law for companies. The distribution is ISO 13485, however, the implementation of the system by Biomedic followed by the evaluation and certification has shown the company’s commitment and desire to always provide a good service to customers.

With the efforts and determination of the entire company, Biomedic is proud to be an ISO 13485: 2016 certificate holder. This again shows the spirit of cooperation with suppliers and the commitment of product quality and service quality to the customers of Biomedic.