(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