Medical device manufacturers quality management system related documents

According to the International Organization for Standardization (ISO9000) developed quality management system certification requirements, any organization should develop quality manuals, procedural documents and operational documents. Therefore, the medical device manufacturer quality management system related documents should also be in accordance with the requirements of the development of medical device manufacturers of quality manuals, program documents and operating documents.

The quality manual of the medical device manufacturer is the main document for the quality system to make a general statement, explain and guide the practice of the quality system, which is the programmatic document that the enterprise quality management and quality assurance activities should follow for a long time. To make an analogy, the quality manual of the enterprise is equivalent to a national constitution, is the quality management of the entire enterprise to do a general, comprehensive description;

Medical device manufacturers of procedural documents in the quality management system is the quality manual of the quality of the next level of documentation level, the provisions of the general process of a certain work. Procedure document is the method for completing an activity, is the supporting document of the quality manual, should contain the requirements and provisions of all the elements adopted in the quality system;

The operation document of the medical device manufacturer is the supporting document of the quality manual and the procedure document, which is different from the procedure document is that the operation document is usually not directly related to the provisions or elements of the ISO9000 quality management standard, and is a comprehensive description of a specific task of the enterprise;

The operation document is the next level of document in the quality management system. The first step in the process is to make sure that you have a good understanding of what is going on in your organization and how it works.

As different enterprises in the preparation of quality management system documents due to the size of the organization is different, different departmental settings, departmental duties and responsibilities of the scope of different factors, the enterprise prepared by the quality management system related documents there is a great deal of difference between the two enterprises is not the preparation of quality management system documents, need to be combined with the actual situation of the development of the enterprise.