Management System Certification

ISO13485 medical device industry quality management system certification

ISO13485 "Medical Device Quality Management System for Regulatory Requirements", because medical devices are special products for life-saving, disease prevention and treatment, it is not enough to standardize only according to the general requirements of ISO9000. For this reason, ISO organization has promulgated ISO13485 international standard. It has put forward special requirements for the quality management system of medical device manufacturers, which has played a very good role in promoting the safety and effectiveness of medical devices.

ISO13485 standard is developed by the SCA/TC221 Medical Device Quality Management and General Requirements Standardization Technical Committee. It is an independent standard based on ISO9001 and specifies the quality management system requirements for relevant organizations. Since its publication in 1996, the standard has been widely implemented and applied worldwide. Unlike the ISO9001 standard, ISO13485 is a management standard applicable to the regulatory environment. It is clearly defined as the quality management system requirements for the regulations. In the international arena, medical devices are not only the general listed products operating in the commercial environment, but also subject to the supervision of national and regional laws and regulations, such as the US FDA, the EU MDD (EU Medical Device Directive), and the Chinese medical Equipment Supervision and Management Regulations. Therefore, the standard must be legally bound to operate in a regulatory environment, and must fully consider the risks of medical device products, and require risk management throughout the process of implementing medical device products. Therefore, in addition to the special requirements, it can be said that ISO13485 is actually ISO9001 under the medical device regulatory environment.

The United States, Canada and Europe generally use ISO9001, EN46001 or ISO13485 as the requirements of the quality assurance system, and the establishment of medical device quality assurance systems are based on these standards. Medical devices must enter the markets of North America, Europe or different countries in Asia and comply with the relevant regulatory requirements.

Meaning of ISO13485 certification

• Improve and enhance  the management level of  organizations, avoid legal risks, and increase reputation of  organizations

• Improve and ensure the quality level of products so that enterprises can obtain greater economic benefits

• It is conducive to eliminating trade barriers and obtaining passes to enter the international market

• It is conducive to enhancing the competitiveness of products and increasing the market share

• Effectively reduce the risk of product quality accidents or adverse events through effective risk management

• Improve  responsibility, enthusiasm and dedication of the employees