Quality management system = quality management system
The following is an introduction of his professional knowledge, I hope it will help you!
Quality management system (QMS) ISO 900 1: 2008 is defined as "the management system that commands and controls the organization in terms of quality", which usually includes activities such as formulating quality policies and objectives, quality planning, quality control, quality assurance and quality improvement. To achieve the goal of quality management and effectively carry out various quality management activities, we must establish a corresponding management system, which is the quality management system.
catalogue
Quality management system eight principles of quality management system
The quality management system shall conform to.
The quality management system should be unique.
The quality management system should be systematic.
The quality management system should be fully effective.
The quality management system should be preventive.
The quality management system should be dynamic.
The quality management system should be continuously controlled.
Characteristics of quality management system
Companies that implement selective certification
Write a quality manual
Establish supporting documents
Implement your quality management system.
Pre-audit service
Obtain certification
Subsequent audit
Steps to establish a quality management system
Planning and design, education, training and unified understanding of quality system
Organize the implementation and draw up the plan.
Determine the quality policy and set the quality objectives.
Investigation and analysis of current situation
Adjust the organizational structure and allocate resources.
Compilation of quality system documents
Trial operation of quality system
Audit and review of quality system
Quality management system certification procedure 1. Application for quality system certification
2. Preparation before on-site audit
3. On-site audit
4. Certification and approval
5. Changes in the scope and standards of certification
Maintenance-continuous improvement
Classification and function of quality management system audit
Steps to establish a quality management system
Eight principles of laws related to quality management system.
The quality management system shall conform to.
The quality management system should be unique.
The quality management system should be systematic.
The quality management system should be fully effective.
The quality management system should be preventive.
The quality management system should be dynamic.
The quality management system should be continuously controlled.
Characteristics of quality management system
Companies that implement selective certification
Write a quality manual
Establish supporting documents
Implement your quality management system.
Pre-audit service
Obtain certification
Subsequent audit
Steps to establish a quality management system
Planning and design, education, training and unified understanding of quality system
Organize the implementation and draw up the plan.
Determine the quality policy and set the quality objectives.
Investigation and analysis of current situation
Adjust the organizational structure and allocate resources.
Compilation of quality system documents
Trial operation of quality system
Audit and review of quality system
Quality management system certification procedure 1. Application for quality system certification
2. Preparation before on-site audit
3. On-site audit
4. Certification and approval
5. Changes in the scope and standards of certification
Maintenance-continuously improve the classification and function of quality management system audit; Steps to establish a quality management system; Formulate and edit relevant laws; Editor of quality management system in this paragraph.
Quality management system is a systematic quality activity established within an enterprise, which is necessary to ensure product quality or quality objectives. It combines several system elements according to the characteristics of enterprises, strengthens quality management activities from design, development, production, inspection, sales and use, and makes it institutionalized and standardized, which has become the requirements and activity procedures of internal quality work of enterprises. Quality management system
In modern enterprise management, the latest standard of quality management system is ISO900 1:2008, which is widely adopted by enterprises. However, it should be pointed out that ISO 900 1 is not the only quality management system. In addition to ISO900 1, there are TS 16949 automobile parts quality management system and ISO 13485 medical device quality management system. т 90012008standard is one of the standards of quality management system made by ISO (International Organization for Standardization) TC1760.
Eight principles of quality management system
The eight principles mainly refer to the quality management system icons involved in ISO900 1:2008.
(1) Pay attention to customers; (2) leadership; (3) full participation; (4) technological method; (5) Management methods of the system; (6) continuous improvement; (7) Decision-making method based on facts; (8) mutually beneficial relationship with suppliers.
The quality management system shall conform to.
In order to effectively implement quality management, we must design, establish, implement and maintain the quality management system. The top management of the organization is responsible for the decision of designing, establishing, implementing and maintaining the quality management system according to ISO900 1 international standards, and for establishing the quality management system certification.
Responsible for a reasonable organizational structure and provide appropriate resources; Management representatives and quality functional departments are directly responsible for the formulation and implementation of documented procedures and the establishment and operation of processes.
The quality management system should be unique.
The design and establishment of quality management system should be combined with the organization's quality objectives, product categories, process characteristics and practical experience. Therefore, different organizations' quality management systems have different characteristics.
The quality management system should be systematic.
Quality management system is a combination of interrelated functions, including quality management system certification.
: ① organizational structure-reasonable organizational structure and clear responsibilities, authorities and their coordination; (2) Procedures-The documented procedures and work instructions specified in place are the basis of process operation and activities; ③ The effective implementation of the process quality management system is realized by the effective operation of the required processes; ④ Resources-Necessary, sufficient and suitable resources include personnel, funds, facilities, equipment, materials, energy, technology and methods.
The quality management system should be fully effective.
The operation of the quality management system should be comprehensive and effective, which can not only meet the requirements of internal quality management of the organization, but also meet the contract requirements between the organization and customers, and also meet the requirements of second-party identification, third-party authentication and registration.
The quality management system should be preventive.
The quality management system should be able to take appropriate preventive measures and have certain ability to prevent important quality problems.
The quality management system should be dynamic.
Top management regularly approves internal quality management system audits and conducts management reviews to improve the quality management system; It is also necessary to support quality functional departments (including workshops) to take corrective and preventive measures to improve the process and thus improve the system.
The quality management system should be continuously controlled.
The processes and activities required by the quality management system should be continuously controlled. The quality management system should be optimized, and the organization should comprehensively consider the benefits, costs and risks and optimize it through the continuous and effective operation of the quality management system.
Characteristics of quality management system
(1) It represents a view that modern enterprises or government agencies think about how to really play the role of quality and how to make quality decisions optimally; (2) It is the basis of in-depth and meticulous quality documents; (c) Quality system is the process method of quality management system, which enables the company to implement a wider range of quality activities.
The basis of management; (4) The quality system is the basis for improving the main quality activities of the whole company in a planned and step-by-step order. Any organization needs management. When management is related to quality, it is quality management. Quality management is the coordination activity of commanding and controlling organizations in quality, which usually includes activities such as formulating quality policies and objectives, quality planning, quality control, quality assurance and quality improvement. To achieve the goal of quality management and effectively carry out various quality management activities, we must establish a corresponding management system, which is the quality management system. Can effectively improve the quality. O 9000 is a universal quality management system in the world.
Realization of editing this paragraph
Purchasing Standards Before you are ready to implement, you need a standard. You need to read and understand. Refer to related literature and software. There are many quality publications and software tools that can help you understand, implement and register the quality management system. Set up a team to formulate a strategy. By working out strategies with top management, you organize and plan the overall implementation of the system. The responsibility of quality management system lies with top managers, so top managers need to participate in the implementation of the system. It is necessary to improve the overall understanding of ISO 900 1:2000 in order to consider training quality management personnel and senior management personnel to implement the system. Group activities, seminars and training courses will help. By choosing consultants, you can get advice from neutral consultants on how to better implement the quality management system. They have rich experience in implementing QMS, so you can avoid detours.
Select a certification company
Certification companies are third-party organizations, such as BSI, DNV, TUV, CQC, etc. You can effectively audit your company's quality management system, and if it meets the standards, these institutions will issue certificates. Due to various market reasons, choosing a certification company may be a complicated process. Factors considered include: factory experience, geographical scope, price and service level. The key is to find the certification body that best suits your needs.
Write a quality manual
The quality manual is a high-level document, which should list your quality management points. What is quality management system, why and how to implement it in enterprises.
Establish supporting documents
Establish program documents supporting the quality manual. Concise and to the point, list the main points of a job, who did it, what did it and how.
Implement your quality management system.
The key to implementation is communication and training. In the implementation stage, all personnel who carry out the procedures should collect records to prove that the regulations have been implemented and meet the requirements.
Pre-audit service
Pre-audit services are usually carried out 6 weeks after the implementation of the system. The purpose is to find out which regional quality management system certification certificates.
Not up to standard. This will enable you to consider the direction of improvement before the initial review.
Obtain certification
You and your certification body arrange a preliminary inspection. At this stage, the certification body will review your quality management system and make suggestions on whether to issue certificates.
Subsequent audit
Once you pass the certification and get the certificate, you can publicize (but follow the principle of use) that your enterprise certification is successful. In order to ensure certification, you need to continue to implement all quality systems. Certification bodies should regularly check (supervise and audit) the implementation of standards. Certification is valid for 3 years, and needs to be re-evaluated (re-evaluated) after 3 years. If the re-evaluation is qualified, the certification certificate will be renewed.
Edit the steps of establishing quality management system in this paragraph.
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.
Planning and design of editing quality system.
The planning and design stage of quality system is mainly to do all kinds of preparatory work, including education and training, unified understanding, organization and implementation, and drawing up plans; Determine the quality policy and set the quality objectives; Investigation and analysis of current situation; Adjust the organizational structure and allocate resources.
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: 1. By introducing the development of quality management and quality assurance and the experience and lessons of our unit, the urgency and importance of establishing and perfecting quality system are explained. 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. The personnel at this level are the backbone of establishing and perfecting the quality system, 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.
Organize the implementation and draw up the plan.
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 system construction leading group (or committee) attended by top managers (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 is to establish 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 organization and responsibilities are implemented, work plans should be made at different levels. Note: 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.
Determine the quality policy and set the 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 establishing quality policy are: 1. Coordinate with the 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.
Investigation and analysis of current situation
The purpose of current situation investigation and analysis is to reasonably select system elements, including: 1. System situation 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.
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 in 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.
Edit the preparation of quality system documents in this paragraph.
From the perspective of quality system construction, the contents and requirements of quality system documents should emphasize several issues: 1. System documents should generally be formally formulated after the completion of the first stage of work, and can be crossed if necessary. If the preliminary work is not done well, it is easy to produce systematic, incomplete and divorced from reality by directly compiling system documents; 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, carry out quality activities (including direct quality activities and indirect quality activities) one by one, and assign quality functions to all 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.