1. Identify the needs and expectations of customers and other interested parties.

2. Establish the quality policy and quality objectives of the organization.

3. Determine the processes and responsibilities required to achieve quality objectives.

4. Determine and provide the resources needed to achieve quality objectives.

5. Specify the method for measuring the effectiveness and efficiency of each process.

6. Apply these measurement methods to determine the effectiveness and efficiency of each process.

7. Determine the measures to prevent unqualified and eliminate unqualified reasons.

8. Establish and apply the continuous improvement process of quality management system.

This process is also suitable for maintaining and continuously improving the existing quality management system.

Establishing a quality management system according to the requirements of ISO 9000: 2000 is a general management model refined by the International Organization for Standardization on the basis of traditional management experience, and it is a scientific, standardized, standardized and international management method.

The establishment and implementation of quality management system can be divided into four stages: preliminary preparation, system planning, system establishment and system trial operation.

(1) Preparatory stage

1, psychological preparation

Organize leaders at all levels to unify their thinking and understanding in the implementation of standards (referred to as "standard implementation"), which is the need to implement scientific management, improve management structure and improve management ability. Only by fully unifying our understanding and making ideological preparations can we consciously and actively promote the implementation of standards, gradually establish and strengthen the supervision and restriction mechanism and self-improvement mechanism for quality management in strict accordance with standards, improve and standardize the management system of organizations, and ensure the scientific and normative nature of organizational activities or processes.

2. Organize training

(1) Select training target: the heads of relevant departments in organizing activities (processes), who are the backbone of standard implementation. What effect the implementation of standards achieves depends on the understanding of standards by top managers and department heads.

(2) Training content:

① Basic knowledge of GB/T 19000 family standards in 2000 edition,

② Understanding and implementation of standards,

③ Methods and steps of establishing quality management system

3. Establish a standard operation mechanism.

(1) Establish a standard implementation mechanism.

Generally, the top management is the person in charge of the organization involved in standardization work, the management representative is the deputy, and the person in charge of the functional department involved in standardization work is a member of the organization.

The task of the standard implementation organization is to plan and lead the implementation of standards, including formulating quality policies and quality objectives, assigning quality responsibilities to various departments according to standards, reviewing system documents, and coordinating and handling problems in system operation.

(2) Appoint management representatives and determine the competent department of quality management.

The management representative is appointed by the top management in a formal document, and his responsibilities and authority are specified. On behalf of the top management, he takes responsibility and exercises rights in quality management.

The management representative should be a member of the top management of the organization, have the ability of leadership and coordination, and have the conditions and channels to perform the duties and powers of the management representative; Familiar with the business of this institution; Can better understand GB/T 19000 family standards and their requirements, and can actually perform their duties.

The competent quality management department shall assist the management representative to organize the establishment and operation of the quality management system according to the decision of the organization that implements the standards.

(3) Establish a quality management system document writing team.

Select representatives who have been trained in document writing, have certain management experience and good writing ability from all responsible departments of the quality management system to form a standard document writing team.

4. Analyze and evaluate the existing quality management system.

The purpose of implementing the standard is to transform, integrate and improve the existing system to make it more standardized and meet the requirements of the standard. This requires people who pass the standard to analyze and evaluate the existing management system according to the standard to decide whether to accept or reject it.

(B) Quality management system planning stage

1, quality policy

Quality policy is the organization's quality goal and direction, and the procedure of quality management system, which should reflect the organization's goals and customers' expectations and needs. The formulation and implementation of quality policy is the main function of quality management, and the following requirements shall be met when formulating quality policy:

(1) The quality policy should match its quality management system, that is, it should be consistent with the quality level, management ability, service and management level of the organization. The content of this policy should be related to the functional types and characteristics of the services provided by the organization.

(2) The quality policy should make a commitment to quality, which is not an empty slogan, but reflects the expectations of customers.

(3) The quality policy can be revised through brainstorming and repeated discussions, and then the top management will approve the release in the form of documents, and indicate the release date.

(4) The quality policy should be phrased, concise, advanced and feasible, not lengthy and unconventional.

(5) The quality policy should be easy to understand, remember and publicize, and all employees should know, understand and abide by it.

2. Quality objectives

Quality goal is the concretization of quality policy, and it is "the goal pursued in quality". Quality objectives shall meet the following requirements:

(1) needs to be quantified, which is a measurable evaluation and an achievable indicator;

(2) It should be advanced and reasonable, and play a positioning role in the quality management level;

(3) Be able to evaluate and adjust regularly to adapt to the changes of internal and external environment;

(4) In order to ensure the realization of the objectives, the quality objectives should be decomposed layer by layer and implemented in every department and employee.

3, organization and responsibility design

The quality management system is coordinated and operated by the organization. The operation of the quality management system involves the activities of all departments covered by the internal quality management system, and the division of labor, order, methods and interfaces of these activities are realized through the division of responsibilities of the organization. Therefore, it is necessary to establish an organizational structure that is compatible with the quality management system. To do this, you need to complete the following tasks:

(1) Analyze the existing organizational structure and draw the "administrative organization chart" of the organization.

(2) Analyze the organization's quality management levels, responsibilities and relationships, and draw a "quality management system organization chart" to explain the organization's quality management system.

(3) Assign all elements of the quality management system to relevant functional departments respectively, and prepare a "Quality Responsibility Distribution Table".

(4) stipulate the quality responsibilities of the department; Quality responsibilities of management, implementation and verification personnel.

(5) Specify the responsibilities and authority of the responsible personnel who have decision-making power over all elements of the quality management system and process.

4. Resource allocation,

Resources are the guarantee for the effective implementation of quality management system. Including the allocation of all kinds of personnel and infrastructure according to the standard requirements, and the procedures and methods for obtaining, transmitting and managing work information on the basis of planning all quality activities.

(3) the establishment stage of quality management system

1, preparation of quality management system documents

The implementation and operation of the quality management system is realized by establishing documents to carry out the quality management system. Implement quality policy through quality management system documents; Maintain the consistency and continuity of the quality management system and its requirements when the situation changes; As the basis of organizing quality activities, quality management system documents provide evidence for internal audit and external audit; Quality management system documents can be used to show the quality management system and prove that it meets the requirements of customers and third parties.

Quality management system documents generally consist of four parts: quality manual, procedure document, work instruction, quality record form, etc.

The quality management system documents are written by a special writing team, and the writing order can be:

(1) is carried out from top to bottom, that is, it is written in the order of quality manual-procedure document-supporting document and record form;

(2) proceeding from bottom to top;

(3) Take the middle breakthrough method, that is, write the program file first.

Firstly, the members of the document writing team are trained, then the writing plan is made, and relevant materials are collected. The writing team discusses the interface between documents, and then the first draft of the documents is submitted to the consulting experts for review. After consulting experts give feedback to the writing team and * * * discuss the revision opinions with them, the writing team will revise the document until it meets the requirements.

2. Review, approval and release of quality management system documents

Quality management system documents should be graded for approval. The quality manual shall be approved by the top management; Program documents are approved by the management representative, work instructions are generally approved by the head of the document business department, and cross-departmental/multi-professional documents are approved by the management representative. After the document is approved, it will be officially released and the implementation date will be specified. Through publicity and training, all personnel in the organization can understand the relevant contents stipulated in the quality policy and quality management system documents, and know and understand the relevant contents through examination before the quality management system is put into operation.

(4) Trial operation stage of quality management system

1, trial operation of quality management system

After the quality management system documents are completed, it is necessary to test the applicability and effectiveness of these quality management system documents through trial operation. Organize the effective operation of the quality management system through continuous coordination, quality monitoring, information management, quality management system audit and management review.

There are many factors that affect the effectiveness of quality activities, such as old habits, traditional concepts, insufficient understanding, misunderstanding of documents, etc. Therefore, it is necessary to continuously monitor procedures, methods, resources, personnel, processes, records and products (services). If deviation from the standard is found, corrective measures should be taken in time. If necessary, the number of internal quality audits can be increased, and the quality management system can be continuously improved through the self-improvement mechanism of internal quality audit and management review.

2, internal quality audit and management review

Internal quality audit and management review are important means to verify the suitability, adequacy and effectiveness of the quality management system.

(1) The internal audit is aimed at whether the activities and related results of the quality management system conform to the relevant standard documents and whether the provisions of the quality management system documents are effectively implemented.

The characteristics of internal audit lie in its objectivity, systematicness and independence. Internal audit is divided into two stages: document audit and on-site audit: document audit is the need to evaluate whether the quality manual and procedure documents compiled by the organization meet the requirements of standards and work objectives. On-site audit is to evaluate whether the actual quality activities conform to the provisions of standards, quality manuals, procedure documents and other related documents, and whether these provisions are effectively implemented. The contents of internal audit include: organizational structure and suitability of activities carried out; The implementation and operation of the quality management system and the implementation of working procedures; Implementation of relevant quality systems, systems and measures; Suitability of personnel, equipment and equipment; Integrity of quality management system documents, compliance with standards, etc. During the trial operation, the internal audit frequency can be more according to the situation, which needs 2-3 times a year; After the normal operation of the system, the internal audit mode can be divided into centralized audit or rolling audit. The former is a centralized and comprehensive audit, at least once a year, while the latter is carried out one after another as planned, covering one or several departments or activities at a time, at least once a year.

The following steps of internal audit shall be clearly specified in the internal audit procedure:

(1) Planning audit (determine the task, purpose and scope);

(2) Prepare the audit (form an audit team, prepare the audit plan, checklist, on-site audit record, nonconformity report and other work forms);

③ On-site audit (first meeting, on-site collection of objective evidence, evaluation and final meeting);

(4) Write an audit report;

⑤ Conduct on-site rectification, and formulate and implement rectification measures;

⑥ Tracking and verification of corrective measures.

⑦ Prepare the annual summary analysis report of the quality management system;

(2) Management review is the top management's timely evaluation of the sustainability, effectiveness, suitability and adequacy of the organization's quality management system.

Management review includes the following main contents:

(1) Achieve the quality policy and objectives;

② Evaluate the completion and effectiveness of internal audit and corrective measures, as well as special measures for weak links;

(3) the completion of quality indicators and trend analysis;

(4) customer comments and handling, analysis of major problems and preventive measures;

⑤ Adaptability of organization and resources;

⑥ Quality improvement plan;

⑦ Suggestions on further improving and perfecting the quality management system.

3. Adjustment and improvement of quality management system

Internal audit and management review are helpful to find that the quality management system planning is not up to standard or inoperable. On the one hand, we should correct the unqualified items in the system, on the other hand, we should modify the documents.

4. Preparation for qualification certification of quality management system

There are four main aspects in the preparation of quality management system qualification certification:

(1) mock audit. The consulting experts independently conduct a comprehensive audit of the quality management system of the organization, clearly put forward the unqualified items, and make a conclusive evaluation. The evaluation contents include

(1) is the process determined? Is the process procedure properly documented?

(2) Is the process formulated and implemented in full accordance with the document requirements?

③ Is the process effective in providing expected results?

(2) Organize to draw inferences about non-conformities, draw up a corrective action plan from point to area, and make rectification within a time limit.

(3) Apply for qualification certification, submit the quality management manual and determine the qualification certification time.

(4) consulting experts to guide the preparatory work before qualification certification, including the following guidance:

① Conduct self-inspection on key projects:

(2) Re-train and assess all employees to further understand the quality policy and quality objectives; Related responsibilities, authorities, my position and role in the quality management system; The contents and implementation of relevant program documents and other documents;

(3) Provide relevant witness materials for the operation of the quality system, such as internal audit of the quality management system, management review plan, internal and meeting minutes; Extract some typical vocational skill appraisal examination cases, etc.

5. Quality management system qualification certification.