The establishment and improvement of quality system generally go through four stages: the planning and design of quality system, the compilation of quality system documents, the trial operation of quality system and the audit and review of quality system, and each stage can be divided into several specific steps.

I. Planning and design of quality system

This stage is mainly to do all kinds of preparations, including education and training, unified understanding, organization and implementation, drawing up plans, etc. Determine the quality policy and set the quality objectives; Investigation and analysis of current situation; Adjust the organizational structure and allocate resources.

(A) education and training, unified understanding

The process of establishing and perfecting the quality system is a process from education to education, and it is also a process of improving and unifying understanding. Education and training should be carried out step by step.

The first level is the decision-making level, including party, political and technical (technical) leaders. Main training:

2. Through the general introduction of ISO9000 family standards, improve the understanding of establishing quality system according to national (international) standards.

3. By explaining the elements of the quality system (focusing on the overall elements such as "management responsibilities"), the key position and leading role of decision-making leaders in the construction of the quality system are clarified.

The second level is management, focusing on the heads of management, technology and production departments, as well as the staff related to the establishment of quality system.

These two levels of personnel are the backbone of the quality system construction and improvement, and play a connecting role. In order to make them fully receive the training of ISO9000 family standard, the method of combining explanation and discussion can be adopted.

The third level is the executive level, that is, the operators related to the whole process of product quality formation. The personnel at this level mainly receive content training related to the quality activities of this post, including the tasks that should be undertaken in quality activities, the authority that should be given to complete the tasks, and the responsibilities that should be borne for quality faults.

(2) Organizing the implementation and making plans.

Although the construction of quality system involves all departments and employees of an organization, it may be necessary for most units to establish a lean work team. According to the practice of some units, this team can also be divided into three levels.

The first level: set up a quality department construction leading group (or committee) headed by the top manager (factory director, general manager, etc.). ) as the team leader and the quality supervisor as the deputy team leader. Its main tasks include:

1. Overall planning of system construction;

2. Formulate quality policies and objectives;

3. Decomposition of quality functions by functional departments.

The second level, the establishment of a working group attended by leaders (or representatives) of various functional departments. This working group is generally led by the leaders of the quality department and the planning department, and its main task is to organize and implement according to the overall plan of system construction.

The third level: set up a factor working group. According to the division of labor of various functional departments, the responsible units of quality system elements are defined. For example, the design department is generally responsible for "design control" and the material procurement department is responsible for "procurement" elements.

After the implementation of the organization and responsibility, the work plan should be formulated at different levels, and attention should be paid to:

1. The goal should be clear. What tasks should be accomplished, what major problems should be solved and what purpose should be achieved?

2. Control the process. The main stage of establishing the quality system should stipulate the timetable for completing the task, the main responsible persons and participants, as well as their division of responsibilities and mutual cooperation.

3. Get to the point. The focus is mainly on the weak links and key minorities in the system. This minority may be one or several elements, or it may be some activities in elements.

(three) to determine the quality policy and quality objectives.

Quality policy embodies an organization's pursuit of quality and its commitment to customers, and it is the guideline of employees' quality behavior and the direction of quality work.

The requirements for formulating the quality policy are:

1. Coordinate with major policies;

2. Quality objectives should be included;

3. Combining the characteristics of the organization;

4. Ensure that people at all levels can understand and stick to it.

(4) Investigation and analysis of current situation

The purpose of current situation investigation and analysis is to reasonably select system elements, including:

1. system analysis. That is, analyze the quality system of the organization, so as to select the elements of the quality system according to the quality system.

2. Analysis of product characteristics. In other words, analyze technical strength, users, product safety characteristics, etc. To determine the degree of adoption of elements.

3. Organizational structure analysis. Whether the management organization of the organization meets the needs of the quality system. Establish an organizational structure that is compatible with the quality system, and establish the affiliation and contact information between institutions.

4. Production equipment and testing equipment can meet the relevant requirements of the quality system.

5. Composition, structure and level analysis of technical, management and operating personnel.

6. Analysis of basic management. Namely standardization, metrology, quality responsibility system, quality education and quality information analysis.

The above contents can be compared with the requirements of quality system elements specified in the standard.

(5) Adjust the organizational structure and allocate resources.

Because there are other kinds of management besides quality management in an organization. Due to the historical evolution, most organizational structures have not set corresponding functional departments according to the objective law of quality formation. After completing the implementation of quality system elements and developing into corresponding quality activities, the corresponding work responsibilities and authorities in the activities must be assigned to each functional department. On the one hand, it is an objective quality activity, on the other hand, it is an artificial functional department. Generally speaking, a quality functional department can be responsible for or participate in multiple quality activities, but don't let multiple functional departments be responsible for a quality activity.

At present, the responsibilities and functions of the existing functional departments of Chinese enterprises for quality management activities are generally unsatisfactory, and should be strengthened as a whole.

In the process of activities, there must be corresponding hardware, software and personnel involved, and appropriate deployment and enrichment according to needs.

Second, the preparation of quality system documents

From the perspective of quality system construction, the contents and requirements of quality system documents should emphasize several issues:

1. System documents shall generally be formally formulated after the completion of the first stage work, and may be crossed if necessary. If the preliminary work is not done well, directly compiling the system documents is prone to the disadvantages of being systematic, incomplete and divorced from reality.

2. Except for the quality manual, other system documents should be formulated by the centralized functional department according to the division of labor, and the draft should be put forward first, and then the audit should be organized, which is conducive to the implementation of the documents in the future.

3. The preparation of quality system documents should be combined with the distribution of quality functions of the unit. According to the requirements of the selected quality system, quality activities (including direct quality activities and indirect quality activities) are carried out one by one, and the distribution of quality functions is implemented in various functional departments. The quality activity items and distribution can be expressed in the form of matrix diagram, and the quality function matrix diagram can also be attached to the quality manual as an attachment.

4. In order to coordinate and unify the compiled quality system documents, a "List of Quality System Documents" should be compiled before compilation, and the existing quality manuals (if compiled), enterprise standards, rules and regulations, management methods, record forms, etc. should be collected together and compared with the quality system elements to determine the items of newly compiled, added or revised quality system documents.

5. In order to improve the efficiency of writing quality system documents and reduce rework, the coordination between documents at different levels and between documents should be strengthened in the process of writing documents. Nevertheless, a set of quality system documents should be repeated from top to bottom and from bottom to top.

6. The key to writing quality system documents is practicality rather than formalization. It is necessary to conform to the ISO9000 family standard in general and principle, and to conform to the reality of the unit in terms of methods and specific practices.

Third, the trial operation of the quality system

After the quality system documents are compiled, the quality system will enter the trial operation stage. Its purpose is to test the effectiveness and coordination of quality system documents through trial operation, and take improvement measures and corrective measures for the exposed problems, so as to further improve the quality system documents.

During the trial operation of the quality system, we should focus on the following work:

1. Publicize the quality system documents in a targeted manner. Make all employees realize that the newly established or improved quality system is a change from the previous quality system and is in line with international standards. In order to adapt to this change, we must seriously study and implement the quality system documents.

2. Practice is the only criterion for testing truth. Through trial operation, there are bound to be some problems in the system documents, and all employees will truthfully reflect the problems in practice and suggestions for improvement to the relevant departments so as to take corrective measures.

3. Coordinate and improve the problems exposed in the trial operation of the system, such as imperfect system design and incomplete projects.

4. Strengthening information management is not only the need of system debugging itself, but also the key to ensure the success of debugging. All personnel related to quality activities shall collect, analyze, transmit, feedback, process and file quality information according to the requirements of system documents.

Fourth, the quality system audit and review

Quality system audit is often more important in the initial stage of system establishment. At this stage, the focus of quality system audit is mainly to verify and confirm the applicability and effectiveness of system documents.

1. The main contents of audit and review generally include:

Whether the quality policy and quality objectives specified in (1) are feasible;

(2) Whether the system documents cover all major quality activities and whether the interfaces between the documents are clear;

(3) Whether the organizational structure can meet the needs of the operation of the quality system, and whether the quality responsibilities of various departments and positions are clear;

(4) Whether the selection of quality system elements is reasonable;

(5) Whether the specified quality records can play a witness role.

(6) Whether all employees have developed the habit of operating or working according to system documents, and how is the implementation.

2. The characteristics of system audit at this stage are:

(1) During the normal operation of the system, the system audit focuses on compliance, and in the trial operation stage, compliance and applicability are usually combined;

(2) In order to expose the problems in the trial operation stage as much as possible, in addition to organizing an audit team to conduct a formal audit, employees should also participate and encourage them to find and raise problems through the trial operation practice;

(3) After the trial operation of each stage, an audit should be arranged formally in order to correct the problems found in time, and some major problems can also be organized in time according to the needs;

(4) In the trial operation, all elements should be audited and covered again;

(5) Give full consideration to the protection of products;

(6) On the basis of internal audit, top management shall organize system review.

It should be emphasized that the quality system is improved through continuous improvement. After the quality system enters normal operation, various means such as internal audit and management review should still be taken to maintain and continuously improve the quality system.