The establishment of a quality system

I. Quality Management Terminology There are 67 terms in the GB/T6583-ISO8402 "Quality Management and Quality Assurance - Terminology" standard. The purpose of these terms is to clarify the meaning of the quality terminology used in the quality management field. Its standardization. Some of these terms are also often used in their fields, but they may have different meanings...
Second, establish the basic point of quality system:
According to the requirements of the ISO9000 family standards and the experience of companies that have obtained qualification assurance, we must obtain consensus from the following points in the process of establishing, maintaining, and improving the quality system...
Third, the establishment of quality system requirements (a) emphasis on system optimization (b) emphasis on prevention (c) emphasis on meeting customer requirements for products to meet customer and other beneficiaries of product demand is the core of the establishment of a quality system. Therefore, whether the established quality system is effective should first be reflected in product quality. The GB/T19004.1 standard sets general requirements for products produced by a company:
a) The need, purpose or purpose of meeting the appropriate regulations.
b) Meet customer expectations.
c) Meet the appropriate standards and specifications.
d) Meet the social needs. (laws, regulations, etc.)
e) reflect the needs of the environment.
f) should have competitive prices and timely deadlines.
g) Economically provided.
(4) Emphasizing the concept of the process The ISO 9000 family of standards is based on the understanding that "all work is done through the process." The GB/T 19000.1 standard states that when evaluating quality systems, each process must be evaluated and three basic questions should be raised:
a) Is the process determined?
b) Is the process fully developed and implemented as required by the document?
c) Is the process effective in providing the expected results?
The audit of the quality system is based on the above three aspects and draws conclusions for effective evaluation. (5) Emphasizing the unification of quality and efficiency.
Fourth, the quality system to establish the steps and requirements:
The establishment and improvement of the quality system generally involves four stages: the planning and design of the quality system, the preparation of the quality system documentation, the trial operation of the quality system, and the review and evaluation of the quality system. Each stage is divided into specific steps.
A. Planning and design of quality system B. Preparation of quality system documentation C. Test run of quality system.
D. Audit and review of quality system The audit of quality system is very important in the initial stage of system establishment. At this stage, the focus of the quality system review is mainly to verify and confirm the validity, conformity and adaptability of the system documentation.
1. The main content of the audit and review:
1 Whether the stipulated quality policy and quality goal are feasible 2 Whether the system documentation covers all quality activities, and whether the interfaces between the documents are clear;
3 Whether the organizational structure can meet the needs of the quality system operation, and whether the quality responsibilities of various departments and positions are clear;
4 whether the choice of quality system elements is reasonable;
5 Whether the stipulated quality record serves as a witness;
6 Are all employees operating according to the system documents and how are they implemented?
2. Features of the quality system audit...
It should be emphasized that the quality system is perfected through constant improvement. After the quality system has entered normal operation, it still needs to adopt various means such as internal auditing, management review, etc. so that the quality system guarantee can be continuously improved.
3. Comparison of quality system audit and management review