AMT obtains ISO 13485:2016 Medical Devices Quality Management Systems Certification23 Jun, 2021
AMT obtained the ISO 13485:2016 medical devices quality management systems certification this June. This credential further demonstrates that the manufacturing, assembly, and sales of AMT medical touch solutions reach the standards and provide safe and reliable medical touch products to customers with remarkable efficiency and excellent quality control.
What does ISO 13485:2016 entail?
ISO 13485:2016 is an international standard that specifies requirements for the management system of an organization involved in one or more stages of the life cycle of a medical device. ISO 13485:2016 emphasizes risk management, factual verification and strengthens the supplier's control process. It also stipulates that the scope of quality control extends to the entire life cycle of the product. It is a standard widely adopted by laws and regulations in many countries, including the United States, Canada, and many European countries. Organizations that meet the standards have much greater chances for medical devices to enter the global market in compliance with regulations and meet customer needs.
Challenges we went through to become certified
One of AMT's goals this year is to obtain ISO 13485:2016 certification. Since January, we have conducted assessments of certification bodies, prepared documents, and formulated our medical product policies and targets. We underwent a written document review in April, and the official audit by the external certification body was conducted in late May. With the efforts of everyone in the company, we successfully passed the ISO 13485:2016 certification and obtained the certificate in early June. With this certification, we believe AMT will have substantial developments in the medical market and continue to provide quality assurance for our customers in the field.
AMT’s complete dedication is certified
In addition to ISO 13485:2016 certification, AMT is also certified with ISO 9001:2015 quality management system, ISO 14001:2015 environmental management system, and ISO 45001:2018 occupational safety and health management system. These international standard certifications prove our complete dedication to product quality, environmental conservation, energy management, and safety and health. AMT is determined that our company and products must comply with laws and regulations and persists in providing customers with excellent products and quality services.
Pure Quality, Pure Satisfaction
AMT is committed to providing high-performing and exceptional touch products. Our projected capacitive (PCAP) touch products also meet the IEC 60601-1-2 medical safety test standards. They have been applied to many well-known medical products, including ventilators, physiological monitors, ultrasound equipment, electrocardiographs, blood gas analyzers, AED, ultrasonic dental scalers... etc. The special functions and advantages of our touch products make AMT an excellent choice for your medical applications!