The ISO 13485 medical device quality management system certification started again. Therefore, our company specially organized a one-day training on ISO 13485 medical device quality management system. Our general manager, personnel of the procurement department, personnel of the sales department and the our internal auditors responsible for ISO 13485 medical device quality system certification participated in the training, The purpose of this training is to let our employees understand what ISO 13485 medical device quality management system certification is? What does it apply to? What's the meaning? Why should the company pass the certification of this system. The boss and internal auditors of our company will interpret these problems one by one.

What is ISO 13485 medical device quality management system certification?

A: Since 2000, European, American and Asian countries have adopted ISO13485 / 88 medical device manufacturing quality management system as their legal basis. After the promulgation of ISO9001:2000 standard, ISO / TC210 issued a new ISO13485:2003 standard, requirements for the application of medical device quality management system in regulations. Enterprises can design, develop, produce, install and serve medical devices according to the standards in turn, and design, develop and provide relevant services. At the same time, this standard can also be used internally and externally (including certification bodies) to evaluate the organization's ability to meet the requirements of customers and regulations.

This is very important for medical device companies / manufacturers producing class II medical devices, because if the company's products want to pass CE certification, they must first obtain ISO 9001 + ISO 13485 medical device quality management system certification, and first pass ISO 13485 medical device quality management system certification. Before that, a lot of data must be prepared. For example, an enterprise must first submit an application to the certification authority. The certification body will then provide the quotation to the enterprise that needs certification, and the enterprise will sign the contract to confirm it; The enterprise shall submit the previous ISO9000 + ISO13485 quality system documents, i.e. quality manual and procedure documents, to the certification authority for system document review; Before the quality system audit, the enterprise shall have a quality system operation record for at least three months, and complete a series of problems such as 1-2 internal quality system audits.

Where does this system apply?

A: All general medical devices, in vitro diagnostic medical devices, active implantable medical devices and other fields, that is, as long as the manufacturer or company producing these medical devices must be certified by ISO 13485 quality management system.

What is its meaning and purpose?

A: It can improve the management level of the company and increase the popularity of the enterprise; 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 a pass to enter the international market; It is conducive to enhance the competitiveness of products and improve the market share of products. For medical device companies or manufacturers, this system certification is essential if their business wants to go out of Asia and rush to the world.

This training on ISO 13485 quality management system aims to make our employees understand that these are very important. It is not only the business of the internal auditor of the company's quality management system, but also the business of all colleagues of the company. Only by effectively operating the quality management system can the company develop and grow better and for a long time.

We hope that through this meeting, it can strengthen the system theoretical knowledge of the company's management personnel, apply these theoretical knowledge to practical work, drive all employees to do a good job in the quality management system, effectively improve the problems encountered in the operation of the quality management system, and improve the operation level of our quality management system.