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Quality Management System (QMS) is defined by the ISO9001:2005 standard as "a management system for directing and controlling an organization with respect to quality," and usually includes activities such as setting quality policy and objectives, as well as quality planning, quality control, and quality improvement. Including the development of quality policy, objectives and quality planning, quality control, quality assurance and quality improvement activities. Realize the quality management policy objectives, effectively carry out various quality management activities, must establish a corresponding management system, this system is called quality management system.
Table of Contents
Quality Management SystemThe eight principles of quality management system
Quality management system should have the conformity
Quality management system should have the uniqueness
Quality management system should have the systematic
Quality management system should have the comprehensive validity
Quality management system should have the prevention
Quality management system should be dynamic
Quality management system should be continuously controlled
Characteristics of quality management system
Implementation of selecting a certification company
Writing a quality manual
Establishment of supporting documents
Implementation of your quality management system
Pre-audit services
Getting certified
Follow-up audits
Steps in establishing a quality management systemEducation and training to unify understanding
Organization and implementation, drawing up plans
Determination of the quality policy and formulation of the quality objectives
Status quo surveys and analyses
Adjustment of the organizational structure, equipped with resources
Preparation of the quality system documents
Trial run of the quality system
Audit and review of the quality system
Quality management system certification procedures 1. Application for quality system certification
2. Preparation for on-site audit
3. On-site audits
4. Approval of the certification
5. Changes in the scope of the certification and certification standards
Maintenance --Continuous Improvement
Categorization and Role of Quality Management System Audit
Steps in Establishing a Quality Management System
Related Laws Quality Management System Eight Principles of a Quality Management System
Quality Management System Should Have Conformity
Quality Management System Should Uniqueness
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 continually controlled
Characteristics of the quality management system
Implementation Selection of a certification Company
Writing a quality manual
Establishing supporting documents
Implementing your quality management system
Pre-audit services
Acquiring certification
Follow-up audits
Steps in establishing a quality management system Education and training, unified understanding
Organize and implement the preparation of the plan
Determine the quality policy, set quality objectives
Survey and analysis of the current situation
Adjustment of the organizational structure, equipped with resources
The preparation of the quality system documents
Trial run of the quality system
Quality System Audit and Review
Quality Management System Certification Procedures 1.Application for Quality System Certification
2. Preparation before on-site audit
3. On-site audit
4. Approval of certification
5. Changes in the scope of certification and certification standards
Maintenance - Continuous Improvement
Classification and Role of Quality Management System Audit
Quality Management System Establishment Steps
Related Laws
Expand Edit this section of the quality management system
Quality management system is established within the enterprise, to ensure product quality or quality objectives necessary, systematic quality activities. It is based on the characteristics of the enterprise to choose a number of system elements to be combined to strengthen the quality management activities from the design and development, production, inspection, sales, the use of the whole process, and institutionalized, standardized, and become the internal quality requirements and activities of the enterprise program. Quality management system
In modern enterprise management, quality management system of the latest version of the standard is ISO9001:2008, is the enterprise commonly used quality management system. However, it should be noted that ISO 9001 is not the only quality management system, in addition to ISO 9001, there are also TS 16949 quality management system for automobile parts and ISO 13485 quality management system for medical devices. The ISO 9001:2008 standard is one of a series of quality management standards developed by ISO (International Organization for Standardization) TC176.
Eight Principles of Quality Management Systems
The eight principles mainly refer to (1) customer focus; (2) leadership; (3) full participation; (4) process approach; (5) systematic approach to management; (6) continuous improvement; (7) fact-based decision-making approach; and (8) mutually beneficial relationship with suppliers, which are addressed in ISO 9001:2008.
Quality management system should be compliant
To effectively carry out quality management, it is necessary to design, establish, implement and maintain a quality management system. The organization's top management of the ISO9001 international standard design, establishment, implementation and maintenance of quality management system decision-making is responsible for the establishment of quality management system certification
Reasonable organizational structure and the provision of appropriate resources is responsible for; management representatives and quality functions on the development and implementation of documented procedures, the establishment and operation of the process is directly responsible for.
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 have different characteristics of quality management system.
Quality management system should be systematic
Quality management system is a combination of interrelated and role, including Quality Management System Certification
: ① Organizational structure - reasonable organizational structure and clear responsibilities, authority and its coordination of the relationship between the ② Procedures --provided in place to form documented procedures and operating instructions, is the process of operation and the basis for activities; ③ process -- the effective implementation of the quality management system, is through the effective operation of its required processes to achieve; ④ resources --Necessary, adequate and appropriate resources including personnel, funds, facilities, equipment, materials, energy, technology and methods.
Quality management system should be fully effective
Quality management system operation should be fully effective, both to meet the organization's internal quality management requirements, as well as to meet the organization's contractual requirements with customers, but also to meet the requirements of the second-party certification, third-party certification and registration.
The quality management system should be preventive
The quality management system should be able to use appropriate preventive measures and have a certain ability to prevent the occurrence of important quality problems.
The quality management system should be dynamic
The top management regularly approves internal quality management system audits and conducts regular management reviews to improve the quality management system; it should also support the quality function (including workshops) to improve the process by adopting corrective and preventive measures, so as to improve the system.
Quality management system should be continuously controlled
Quality management system needs process and its activities should be continuously controlled. Quality management system should be optimized , the organization should take into account the benefits, costs and risks, through the continuous and effective operation of the quality management system to make it optimal.
Characteristics of a quality management system
(1) It represents a modern view of how a business or government organization thinks about how to make a real difference to quality and how to make optimal decisions about quality; (2) It is the basis for in-depth quality documentation; (3) The quality system is the basis for enabling a wider range of quality activities within a company to be managed effectively Quality management system process methodology
; (4) The quality system is the basis for enabling a wider range of quality activities within a company to be managed effectively Quality management system process methodology
. >(c) The quality system is the basis for enabling the wider quality activities within the company to be effectively managed; (d) The quality system is the basis for the planned and systematic improvement of the major quality activities throughout the company in order of importance. Management is needed in any organization. When management is related to quality, it is quality management. Quality management is the coordinated activity of directing and controlling an organization with respect to quality, and usually includes the development of quality policy, objectives, and activities such as quality planning, quality control, quality assurance, and quality improvement. To realize the policy and objectives of quality management and effectively carry out various quality management activities, it is necessary to establish a corresponding management system, which is called quality management system. It can effectively carry out quality improvement. ISO 9000 is the international common quality management system.
Edit Implementation
Procurement Standards You need a copy of the standard before you are ready to implement it. You need to read and understand it. Refer to relevant literature and software There are many publications on quality, and software tools to help you understand, implement, and register your quality management system. You organize and plan for the full implementation of the system by developing a strategy with top management. The responsibility for the QMS rests with senior management, so senior managers need to be involved when you begin to implement the system. Whether the quality manager or the senior manager is responsible for implementing the system, there is a need to raise general awareness of ISO 9001:2000. Group activities, seminars and training sessions can help. Choose a consultant You can get advice from consultants who are neutral on how best to implement a QMS. They have a lot of experience in implementing a QMS and will make sure that you go the extra mile.
Choosing a certification company
A certification company is a third party organization such as BSI that can visit and effectively audit your company's QMS and if it meets the standards, BSI will issue a certificate. Choosing a certification company can be a complex process for a variety of market reasons. Factors to consider include: plant experience, geographic scope, price and service level. The key is to find the certification body that best suits your needs. With BSI you may stand a little taller.
Writing a quality manual
A quality manual is a high-level document that lays out the key points of your quality management. The what, why and how of implementing a quality management system in your business.
Creating Supporting Documents
Create procedure documents to support the quality manual. Clear and concise, listing the essentials for getting a job done, who does it, what and how.
Implementing your QMS
The key to implementation is communication and training. During the implementation phase, all those who carry out the procedures collect records to prove: what is specified is done and what is done is in compliance.
Pre-audit services
Pre-audit services are usually performed 6 weeks after the system is implemented. The purpose is to find out which areas Quality Management System Certification
are not meeting the standards. This will allow you to consider directions for improvement prior to the initial audit.
Getting certified
You schedule an initial audit with your certification body. At this stage the certification body will review your quality management system and recommend whether to issue a certificate.
Follow-up audits
Once you are certified and have received your certificate, you can advertise to the public (subject to the principles of use) that your business has been successfully certified. In order to ensure the qualification of certification you need to continue to implement all quality systems. The certification body regularly on the implementation of standards to check (supervision and audit). Certification is valid for three years, three years after the need to re-evaluate (reassessment), reassessment of qualified replacement of the certificate of certification.
Edit this section of the quality management system to establish the steps
Establishment and improvement of the quality system in general to go through the quality system planning and design, the preparation of the quality system documentation, quality system trial run, quality system audit and review of the four stages, each stage can be divided into a number of specific steps. Quality system planning and design phase is mainly to do a variety of preparatory work, including education and training, unified understanding, organization and implementation, the development of plans; determine the quality policy, develop quality objectives; status quo survey and analysis; adjust the organizational structure, equipped with resources and so on.
Education and training, unity of understanding
The process of establishing and improving the quality system is to start with education, and finally the process of education, but also to raise awareness and unity of understanding of the process of education and training should be divided into levels, step by step. The first level for the decision-making level, including the party, government, technology (technology) leaders. The main training: 1. through the introduction of quality management and quality assurance development and the unit's experience and lessons learned, the urgency and importance of the establishment and improvement of the quality system; 2. through the overall introduction of the ISO9000 family of standards, to enhance the understanding of the establishment of a quality system in accordance with national (international) standards; 3. through the quality system elements to explain (the focus of which should be to explain the "management responsibility" and other general elements), and to improve the quality system, and to enhance the understanding of the quality system. "and other general elements), clear decision-making leadership in the quality system construction of the key position and leading role. The second level is the management level, focusing on the heads of management, technology and production departments, as well as staff related to the establishment of the quality system. This level of personnel is to build and improve the quality system of the backbone of the force, plays the role of the top and bottom, to make them fully accept the ISO9000 family of standards related to the content of the training in the method can be taken to explain the combination of seminars. The third level for the implementation of the layer, that is, with the formation of product quality of the whole process related to the operating personnel. This level of personnel training and the quality of the main activities related to the post content, including the quality of the activities should be undertaken in the task, the completion of the task should be given the authority, as well as cause the quality of faults should be responsible for.
Organization to implement, draw up plans
Although the quality system construction involves all departments of an organization and all workers, but for most units, the establishment of a competent work team may be needed, according to the practice of some units, this team can also be divided into three levels. The first level: the establishment of the highest level of management (plant manager, general manager, etc.) for the leader, quality leaders in charge of the quality system for the vice-chairman of the construction of the leading group (or committee). Its main tasks include: 1. overall planning for the construction of the system; 2. development of quality policy and objectives; 3. decomposition of quality functions by functional departments. The second level, the establishment of the leadership of the functional departments (or representatives) to participate in the work team. This work team is generally led by the quality department and planning department leaders *** with the lead, its main task is to build the system in accordance with the overall plan for the specific organization and implementation. The third level, the establishment of elements of the working group. According to the division of labor of each functional department to clarify the quality system elements of the responsible unit, for example, "design control" should be generally responsible for the design department, "procurement" elements of the material procurement department is responsible for. After the implementation of the organization and responsibility, according to the different levels of work plan, in the development of the work plan should pay attention to: 1. The goal should be clear. What tasks to be accomplished, what are the main issues to be resolved, to achieve what purpose? 2. To control the process. Establishment of the main stages of the quality system to provide a timetable for the completion of the task, the main person in charge and the participants, as well as their division of responsibilities and the relationship between the collaboration. 3. To focus. The focus is mainly on the weak links in the system and the key few. This minority may be a certain element or a few elements, but also may be some of the activities of the elements.
Determine the quality policy, the development of quality objectives
Quality policy reflects an organization's pursuit of quality, commitment to customers, is the guidelines for quality behavior of workers and the direction of quality work. The requirements for the development of quality policy are: 1. Coordinate with the general policy; 2. Should contain quality objectives; 3. Combined with the characteristics of the organization; 4. Ensure that all levels of personnel can understand and adhere to the implementation.
Survey and analysis of the current situation
Survey and analysis of the current situation is to rationally select the elements of the system, including: 1. System situation analysis. That is, the analysis of the organization's quality system, in order to select the requirements of the quality system elements according to the quality system situation. 2. Analysis of product characteristics. That is, to analyze the degree of technology-intensive products, the use of objects, product safety features, in order to determine the extent of the adoption of elements. 3. Organizational structure analysis. Whether the organization's management structure to adapt to the needs of the quality system. Should be established with the quality system to adapt to the organizational structure and establish the affiliation between institutions, contact methods. 4. Production equipment and testing equipment to adapt to the relevant requirements of the quality system. 5. Technical, management and operational personnel composition, structure and level of analysis. 6. Analysis of the management infrastructure. That is, standardization, measurement, quality accountability, quality education and quality information and other work. The above can be taken with the standard requirements of the quality system elements specified in the comparative analysis.
Adjustment of organizational structure, equipped with resources
Because in an organization in addition to quality management, there are a variety of other management. Organizational setup due to the historical evolution of the majority is not according to the quality of the formation of the objective law to set up the corresponding functional departments, so in the completion of the implementation of the quality system elements and the development of quality activities into the corresponding, it is necessary to activities in the corresponding duties and responsibilities of the work and authority assigned to the various functional departments. On the one hand, the objective development of quality activities, on the one hand, the existing man-made functional departments, the relationship between the two to deal with, in general, a quality function can be responsible for or involved in a number of quality activities, but do not let a quality activity by a number of functional departments to be responsible for. At present, the existing functional departments of Chinese enterprises on quality management activities undertaken by the responsibility, the role played by the general lack of ideal in general should be strengthened. In the process of the activities carried out, must involve the appropriate hardware, software and staffing, according to the need for appropriate deployment and enrichment.
Quality System Documentation
Quality System Documentation and requirements for the preparation of the quality system from the point of view of the construction of the quality system, should emphasize a few issues: 1. System documentation should be completed in the first phase of the work is completed before the formal development of the system can also be cross-cutting, if necessary. If the preliminary work is not done, straight