Immetech Awarded ISO 13485:2016 Certification
ISO 13485:2016 Certification for Medical Devices – Quality Management Systems confirmed
The R&D and production of medical devices requires high specifications and strict quality and safety standards since these are, after all, industries that secure the livelihood of the population and which each country supports and develops vigorously. In the 21st century, global control of disease outbreaks and epidemics is becoming increasingly serious. Greater attention is paid to corporate R&D and the production of medical equipment, as well as to the quality and production control systems of the medical industry. ISO 13485 is an internationally recognized standard that medical device manufacturers and R&D enterprises must obtain and which requires strict and full participation and control of execution.
In order to meet the requirements of laws and regulations of various countries, customers’ expectations and to better explore the international market, Immetech Industrial, as a manufacturing company, started planning the ISO 13485:2016 certification two years ago. After 300 days and nights of continuous improvement, full participation in training, repetition and with the introduction and improvement of various production control systems and quality assurance mechanisms, we finally passed the examination by the international certification institution SGS on May 30, 2020, and obtained the certification ISO 13485:2016, Medical devices — Quality management.
What is ISO 13485:2016? It is all about bringing your medical equipment to the global market and proving that your products are safe, effective, stable, and compliant. Medical products must meet a high standard.
- Full name: ISO 13485 Medical devices — Quality management systems
- Who develops the ISO 13485? International Organization for Standardization
- Current version: ISO 13485:2016 version (2020)
Relevant standards: ISO 13485 contains some professional requirements for medical devices. Medical equipment is a specific range of products for healing the injured and rescuing the dying, and to prevent and treat diseases. Applying to the ISO9000 standard for general requirements only is not enough, therefore the ISO organization issued ISO13485:1996 edition standard (YY/T0287 and YY/T0288). This standard puts forward special requirements for the quality management system of medical device manufacturers which ensures the quality of medical devices to be safe and effective.
Immetech Industrial Co., Ltd has maintained a steady growth since its establishment over 10 years ago, and has always persisted in continuous improvement and innovation. Together with our customers and through upgrading and improving our systems, mechanisms, management and quality, the Immetech team has successfully obtained ISO 9001:2015 Quality Certification + ISO 13485:2016 Medical Device – Quality Management System certification and + SMETA 6.1 certification. These certifications ensure that management processes within the organization are regularly reviewed and improved internally to enhance efficiency and reduce costs, and that all our products, whether medical, automotive, home appliances or smart devices, are safe, effective and durable.