As a manufacturer, the company establishes a quality management system in accordance with the requirements of EN ISO13485:2016 (ISO13485:2016) and MDD 93/42/EEC, documents it, implements and maintains it, and continues to maintain its effectiveness. At the same time, these processes are managed according to standard requirements.
The management representative shall assist the top management to organize the relevant departments to establish the quality management system:
a) Consider the company's role to determine the process required by the quality management system and its application in the organization;
b) Apply a risk-based approach to control the processes required by the quality management system;
c) Determine the sequence of these processes and their interactions. The company's product trade and service realization flow chart is shown in Annex 1.
d) The company manages all processes that have been identified and documented in accordance with the ENISO13485:2016 (ISO13485:2016) standard and the requirements of the MDD directive. In order to make the entire operation meet the requirements of the standards, the requirements of the standards and the quality management system documents established accordingly are necessary items for employee training. In order to effectively implement and maintain the standard requirements and implement the standard clauses to the relevant departments, see 0.7 "Quality Management System Process Function Allocation Table". When the standard is revised, this manual and related documents are also revised accordingly.