(1) Preliminary stage: investigation and diagnosis, assisting enterprises in rational adjustment and utilization of resources.   1. On-site visit, talk with business leaders and quality management personnel to understand the current situation of the company;   2. According to ISO13485, formulate practical and feasible rectification plans based on the current situation of the enterprise;   3. Assist enterprises to establish or optimize the quality management organization structure;   4. Assist the company to establish an internal certification team; (II) Implementation stage: Initial training: 1. Tell the basic knowledge of the quality system and the significance of the enterprise implementation quality system. 2. Assist the enterprise in hardware transformation: Provide the company with standardized and feasible hardware transformation opinions; 3. Supervise and inspect the transformation process and evaluate the transformation effect; 4. The establishment and implementation o