"O 13485" is the quality management system standard of medical device industry, and it is also the most authoritative international quality system standard of medical device industry. Medical device manufacturers who follow this standard can show that they have established a quality assurance system to protect public safety from infringement.
?13485; added the special requirements of medical equipment industry on the basis of ISO9000, and put forward stricter control requirements for product identification and process control. This certification can enhance the trust of medical workers and end users in your product. At the same time, your products can freely enter the European market through ISO 13485 certification and MDD directive of EU CE.
I SO900 1:2008 standard is the quality management department formulated by iso (international organization for standardization) TC 176, and the quality management system (QMS) ISO 900 1: 2005 standard is defined as "the management system that commands and controls the organization in terms of quality".
It usually includes the formulation of quality policies, objectives and activities, such as quality planning, quality control, quality assurance and quality improvement. To achieve the goal of quality management and effectively carry out various quality management activities, we must establish a corresponding management system, which is the quality management system.