1. The content and inspection methods of internal audit of medical devices.
A management organization suitable for the production of medical devices should be established, with an organizational chart.
Check the quality manual provided, whether it includes an organizational chart of the company, and whether it is clear about the interrelationships of the various departments.
2. Reference of the results of internal audit self-inspection of medical devices.
The Quality Manual (No. xxx) includes an organizational chart that clarifies the relationship between each department.
3. Implementation plan for the integrated deployment of GMP ERP OA for medical devices.
1.1. Organizational framework.
First, rely on communication software to complete the construction of the enterprise organization. Then, under the enterprise organization of communication software, according to the structure of "Quality Manual" or "Organization Chart", a customized "Department Table" and a customized "Roster" can be added.
1.2. Organizational chart.
The organizational chart can be combined with OA performance to design a first-class display form, and the more conventional organizational chart can be displayed directly.
Fourth, the implementation method of integrated deployment of GMP ERP OA for medical devices.
1.1. Organizational framework.
1.1.1. How to build the actual organization of the enterprise based on communication software.
You can refer to the basic knowledge of communication software such as DingTalk, WeChat, and Feishu to complete the construction of an enterprise organization. Note that this should be the actual organization of the enterprise. What is the actual organization?If the system specialist or manager who has worked in the medical device industry for many years should be able to understand, it is actually a management organization. In fact, it is the same as the conventional traditional industry.
1.1.2. Establish the organizational structure of GMP quality system.
Combined with the requirements in the "Quality Manual" or "Organization Chart", customize a "Department Table" and "Roster" in OA, and the detailed fields are generally real organizational information and the position structure of the system.
Why is there such a job result of the system, which is only suitable for some small and medium-sized enterprises, because for example, [quality manager], [production manager], [R&D manager] these positions, may be some temporary or fictitious positions, there is no actual management value, but in order to meet the GMP system, the "department table" and "roster" must be consistent with the GMP document system.
Therefore, in the process of structuring the organization, it can actually be understood that the construction of a "department table" and "roster" that meet the requirements of GMP requirements is satisfied.
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