ISO 13485
QAMERCERT
What is ISO 13485 Quality Management System for Medical Devices?
ISO 13485, one of the ISO certifications, is a highly important Quality Management System specifically designed for medical devices. It is a system that parallels the ISO 9001 Quality Management System. ISO 13485 is the international standard adapted from ISO 9001 for medical devices. It is one of the necessary requirements for medical device manufacturers to obtain the CE mark and serves as a module for quality assurance.
What is ISO 13485 Quality Management System for Medical Devices?
The primary goal of this certification is to ensure that customer and regulatory requirements are met to the highest standards and to define the rules that companies must follow to demonstrate their capabilities. Shaped within the framework of ISO 9001, these rules include the specific requirements for quality management systems. This ensures that medical devices, which are crucial for human health, can be produced and used in a high-quality and reliable manner.
