ISO13485 Medical Device Quality Management System
2021-05-07
ISO13485 is called "Medical Device Quality Management System" in Chinese. Since medical devices are special products that save lives, heal the wound, prevent and treat diseases, it is not enough to standardize the general requirements of the ISO9000 standard. For this reason, the ISO organization issued the ISO13485: 1996 version of the standard (YY /T0287 and YY/T0288), put forward special requirements for the quality management system of medical device manufacturers, and played a very good role in promoting the quality of medical devices to achieve safety and effectiveness.
Registration conditions for applying for ISO13485 medical device quality management system certification:
1. The applicant organization should hold a legal person business license or a document proving its legal status.
2. Has obtained a production license or other qualification certificates (when required by national or departmental regulations);
3. The products covered by the quality management system for certification should comply with relevant national standards, industry standards or registered product standards (enterprise standards), and the products should be finalized and produced in batches.
4. The applicant organization should establish a management system that meets the certification standards to be applied for, and meet the requirements of the YY/T 0287 standard for medical device production and operation companies. For companies that produce three types of medical devices, the quality management system should run for no less than 6 hours. For companies that produce and operate other products, the quality management system should run for no less than 3 months. At least one comprehensive internal audit and one management review have been conducted.
5. In the one year before the certification application, the product of the applicant organization has no major customer complaints or quality accidents.
Significance of ISO13485 certification:
1. Improve and improve the management level of the company, avoid legal risks, and increase the company's reputation;
2. Improve and guarantee the quality level of products, so that the enterprise can obtain greater economic benefits;
3. It is conducive to eliminating trade barriers and obtaining a permit to enter the international market;
4. It is conducive to enhancing the competitiveness of products and increasing the market share of products.
5. Through effective risk management, effectively reduce the risk of product quality accidents or adverse events.
6. Improve employees' sense of responsibility, enthusiasm and dedication.
