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1

GENTIS is pleased to receive ISO 13485:2016 Quality Management System Certification

Created date : 06-03-2023

Updated date: 02-11-2023

Author: Gentis

After the ISO 9001:2015 certification, GENTIS is pleased to continue to receive the ISO 14385:2016 quality management system certificate on November 8, 2022.

ISO 13485:2016 is a management system standard applied in the field of manufacturing and trading in medical instruments and supplies. With ISO 9001 as its foundation, the importance of continuous improvement is replaced by meeting statutory and customer-specific requirements, managing risk, and maintaining efficient processes, namely the design, manufacture and safe distribution of medical devices.

After more than 12 years of operation, GENTIS achieved ISO 9001:2015 certification for genetic testing and genetic analysis services in 2015, then in 2019, GENTIS achieved ISO 15189:2012 certification for services. GenEva prenatal test. And until most recently, on February 1, 2023, GENTIS was officially granted the ISO 9001: 2015 certificate at both Hanoi and Ho Chi Minh facilities after a period of rigorous assessment and inspection.

However, it does not stop there, GENTIS is very pleased to have also obtained the quality management system certification for the field of medical equipment since November 8, 2022.

All as an affirmation in maintaining the service quality as well as the reputation of GENTIS in the domestic and international markets.

As a companion in GENTIS's ISO standardization stages, Ms. Pham Thi Thuy (GENTIS Quality Management Specialist) said: “Achieving ISO 13485:2016 is proof of our satisfaction. harmonize quality management system requirements with regulatory requirements for the medical device industry. This is an important standard, a must have in the current period if GENTIS wants its products and services to be widely recognized around the world.”

Accordingly, the ISO 13485:2016 standard brings practical benefits not only to businesses but also to customers, such as:
• Activities are managed according to the system, helping to control product quality and safety
• Improve the ability to meet customer requirements. Meet national and international regulations for medical products
• Improve the efficiency of the current management system. Convenient in integration with other management systems.
In the future, GENTIS promises to constantly develop and expand in the international arena, bringing the best products, services and experiences to customers, fulfilling the mission of improving the physical and mental health of Vietnamese people.