With the establishment and development of China's socialist market economic system, quality revitalization has become the key to the sustained, rapid and healthy development of China's economy. Speed ​​is a strategic issue and quality is also a strategic issue. 1. The origin and development of quality system certification
Quality system certification has been gradually developed as a means of external quality assurance with the needs of modern industrial development and market trade.
Customer purchases need to understand the quality of the supplier's products to determine qualified suppliers. At first, this quality assurance requirement only appeared as a way for the supplier to self-declare. Then there was a way for the customer to personally inspect and evaluate the product, that is, the “second-party assessment†method, which became more and more complicated with the structure and performance of the product. With the increasing technical content, in the face of specialized international production and developed international trade markets, customers are not only concerned about the evaluation of suppliers' product quality, but also the quality assurance ability of suppliers to provide stable products to qualified products.
At the same time, due to the lack of sufficient professional inspection and evaluation capabilities, suppliers are tired of receiving second-party assessments of a large number of customers. This is a modern quality certification system that confirms product quality by third parties.
The modern quality certification system includes product quality certification and quality system certification. The former is based on the inspection of product samples and subsequent sampling supervision and inspection. However, due to the complexity of the process, the cost is high, and the cycle of product renewal is becoming shorter and shorter. The selection evaluation has turned more to the evaluation of the supplier's design, production, installation, and service quality assurance capabilities, that is, the supplier's quality system to prove the supplier's ability to continuously and stably produce products that meet the standard requirements. In the quality assurance activities in recent years, the third-party certification registration of the quality system has been increasingly carried out.
2. The meaning of quality system certification and the significance of carrying out quality system certification
The provision of quality-qualified products by enterprises depends on the overall control of the product quality formation process such as design and production, and the system capability of the entire organization management, that is, the coordination of the organizational structure, processes, procedures and resources for implementing quality management. A unified organic whole - the quality system. The quality system exists objectively, but whether it is established in a sound and sound manner according to the principles of scientific quality management and operates effectively is the fundamental guarantee for the stable and continuous supply of qualified products.
Quality system certification means that the quality system of the supplier (enterprise) is audited independently, impartially and scientifically by a third-party organization in accordance with recognized standards, and whether it is capable of ensuring that the products provided meet the standards and is qualified or not. The conclusion. For suppliers (enterprise) who have passed the conclusion, the certification body issues a certificate and publishes a system certification registration notice in the public media to confirm the customers and the market.
The quality system certification is the quality system of the supplier (enterprise), and the products covered may be hardware or process products, software or a certain service, or a combination thereof, such as hardware plus services.
The means of quality system certification is auditing and evaluation. In order to regulate the behavior of third-party certification and the acceptability of audit evaluation, ISO has established corresponding standards and guidelines. The basis for the quality system conformity assessment is the widely accepted ISO 9000 standard worldwide.
The significance of carrying out quality system certification is: it can promote the construction of enterprise quality system, enable enterprises to maintain and improve the quality management level, thus ensuring the stability and improvement of product quality; can improve the quality reputation of enterprises, and effectively enhance the enterprises in the international and domestic markets. The ability to compete; can guide customers to choose the right market, choose the reliable suppliers that provide qualified products; help prevent international trade barriers, and facilitate the development of foreign international trade. Under the market economy, it is also the state's indirect control of product quality. Effective mechanism. Therefore, the quality system certification has become more and more recognized by people and has formed a worldwide trend.
3. Quality system certification system and international mutual recognition
Quality system certification is derived from the quality assurance needs of market trade. In the era of trade globalization, quality system certification should be an international standardization behavior. Currently, it is being standardized by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). The largest international standardization organization has vigorously promoted the international mutual recognition of quality system certification, established the "Quality System Assessment International Recognition System (QSAR)", and received support and cooperation from the GATT and the WTO.
The QSAR system is based on the national quality certification and accreditation system. China has established a national accreditation system in accordance with international practices and recognized standards.
CNACR is the national accreditation body of the China Quality System Certification Body recognized by the International Organization for Standardization (ISO). It is responsible for implementing the national accreditation system for quality system certification bodies. Currently, CNACR has authorized 28 certification bodies. China Machinery Industry Quality System Certification Center (CCMQS) is the first accredited certification body (accredited registration number SCII).
At the same time, in order to strengthen the management of quality system auditors engaged in certification work, the state has implemented a national registration system for certification personnel, and authorized the National Registration Committee (CRBA) of Chinese certification personnel to be responsible for the assessment of certification auditors and to assess the supervision and management of registration qualifications. CRBA currently has registered thousands of national registered auditors.
International mutual recognition has entered a substantive stage. In 1997, the international peer assessment of certification bodies was carried out in 14 major industrial countries in Asia and Europe. China has successfully passed the assessment of the assessment team. It is expected that after the completion of all assessments, it is expected to sign the ISO/IEC QSAR multilateral mutual recognition agreement to finally realize the purpose of QSAR: “If a supplier's quality system is registered by a certification body of ISO/IEC QSAR, then The location of this institution, this supplier or its customers is anywhere in the world and its customers should acknowledge the validity of this registration." For identification purposes, such certificates will carry the ISO/IEC QSAR logo, thus Realize international certification of quality system. At the same time, the registration system for certified personnel in China is also in line with international standards, and the national registration auditors are switching to the registered auditors of the International Auditors and Training Accreditation Committee (IATCA). At that time, China Machinery Industry Quality System Certification Center (CCMQS) will also join the ranks of international certification.
At present, certificates issued by nationally recognized certification bodies are highly authoritative internationally. The first batch of accredited certification bodies in the country has been listed in the ISO certification body list, and the certificates issued by them have played an effective role in ensuring quality assurance in international trade. The certification issued by China Machinery Industry Quality System Certification Center has been accepted as a valid confirmation document for quality assurance in international bidding projects.
4. Quality system certification procedures and corporate certification standards
The procedures for quality system certification are based on internationally accepted practices and are governed by the National Accreditation System. The general procedures are:
(1) The enterprise voluntarily applies, and the certification body decides whether to accept it after review;
(2) After entering the audit, enter the initial assessment stage of the quality system certification. The certification body shall conduct a quality system document review on the applicant and send it to the audit team for on-site audit after the examination. The audit team submits an audit report and makes a proposed conclusion on whether or not to pass the certification. The audit report shall be reviewed by the certification body. If approved, the accredited enterprise shall be registered and certified;
(3) Within the validity period of the approved certification (3 years), the certification body shall supervise and manage the enterprise quality system, mainly supervision and inspection (at least once a year) and certificate management. After the expiration of the validity period, a re-evaluation will be carried out based on the application of the enterprise to determine whether the validity period of the certificate can be extended.
The conditions for an enterprise to apply for certification are:
First, it has considerable legal status and holds relevant registration certificates;
Second, the quality system was established according to the ISO9000 standard (China's equivalent use is GB/T19000 standard).
Especially the second condition, this is the main work of enterprise certification preparation work. Generally speaking, enterprises should first pass the training standard, mobilize and train the backbone; the leadership layer develops the enterprise quality policy and implements it to all employees; carries out the quality management diagnosis and quality system design; and compiles the quality system documents, such as the quality manual. And program documents; implement the system documents, and constantly improve in the implementation; carry out internal audit and management review, identify problems, and carry out rectification. After the business leaders build confidence in their own quality system, the timing of certification audits is ripe.
5, on the ISO9000 standard
ISO9000 is a family of standards, mainly composed of quality management guidelines and quality assurance model standards. The former is mainly ISO9004 standard and its supporting standards, which are used to guide enterprises to establish quality system; the latter is ISO9001~9003 standard and its supporting standards, ISO9001, ISO9002, ISO9003 standards are the basis for certification audit. In addition, this family of standards includes terminology, general guidelines, and a set of quality technical guidelines.
Talking about the Relationship between Enterprise Quality System and Standard System
With the development of social productivity, the advancement of science and technology, and the increasing competition in global trade, users have placed increasingly stringent requirements on quality. In order to win in the fierce market competition, we must rely on the strength and responsibility of the whole society to improve product quality and quality management, and ultimately form a social quality assurance network, and the standard system is the most reliable technology for quality assurance. Base
Quality management must be based on standards, and standards can only be truly implemented through quality management practices. The quality system of an enterprise must be compatible with the enterprise standard system. They have a close relationship of mutual dependence, mutual influence and complementation. Only by closely combining quality management and standardization can we achieve the purpose of improving product quality and improving economic efficiency.
The following describes the relationship between the quality system and the standard system in five aspects.
1. The quality system and the standard system are systems built around the company's quality objectives or business objectives. Both have the same scientific and economical nature.
The company's business objectives are the reflection of quality objectives, which is to steadily improve product quality, continuously develop marketable products, provide users with affordable products, and obtain the best benefits for enterprises.
In order to ensure the realization of the quality policy and quality objectives, the enterprise shall, in accordance with the GB/T19004-ISO9004 quality management and quality assurance series standards, select the applicable factors and the degree of adoption of the decision factors, and establish a quality system suitable for the enterprise, that is, the organization The overall composition of responsibilities, levels, activities, capabilities and resources. It revolves around the implementation of the quality function and its effectiveness, using quality management tools and tools, and summarizing experience, formulating and implementing standards to make it systematic, scientific, standardized and orderly, thus establishing a quality management order. So that the business activities around the core of improving product quality.
In order to achieve operational or quality objectives, enterprises should carry out standardization activities that focus on setting and implementing standards around the business objectives and establishing an enterprise standard system, so that the production technology and operation management of the enterprise are rationalized, orderly and standardized.
The enterprise standard system is based on technical standards, product standards are the leading, work standards and management standards as means to improve the conformity of processes and products, to ensure that product quality meets the standard requirements, and the object of management is products.
The quality system is based on the production, formation and realization of product quality. According to market research, design specifications, procurement, process preparation, manufacturing, inspection and testing, packaging and storage, sales and shipping, installation and operation, technology. The process of forming product quality through service and maintenance, post-disposal and other 11 links has been established. The establishment and operation of the quality system are closely related to product quality.
Both the standard system and the quality system emphasize comprehensive, full-time and full-process control of the production and operation process. And from the beginning to the end, the motivation and important role of people in completing various activities are required to make scientific, reasonable and clear objectives on the quality, qualifications, qualifications, tasks, responsibilities, authorities, activities and objectives of the activities. Provide for verification, evaluation, and incentives for the results of their activities.
2. The enterprise standard system is an important basis for the implementation of the quality system.
At present, the main goal of China's enterprise standardization work is to improve product quality and economic benefits.
The quality system consists of 11 work processes that form the product, as well as the various departments and personnel of the company. In order for this system to function properly, it is necessary to make specific requirements for each process, link, process operation, and each department and each member included in this work system, and set standards as the basis for implementing GB/T19000. Guide the activities of the entire work system to achieve the most economical way to produce products that meet user requirements.
The quality system is an organic whole consisting of six sub-systems such as the quality system document. The quality system document is a system of quality requirements and measures adopted in the system, and the documents include quality manuals, procedure documents, operation documents, quality plans and quality records. The quality manual is the programmatic document of the quality system, and the program document is the supporting document of the quality system document, which is the main basis for the operation of the quality system. That is, the operation of the quality system relies on the implementation of various management standards, work standards and technical standards.
Therefore, the enterprise standard system provides the objectives and basis for quality management and is an important basis for the implementation of the quality system.
3. The enterprise standard system is the basis for implementing the quality system.
The beginning of all work is the development of standards, the implementation process is the implementation of standards. The establishment of the quality system, the formation of the system documentation, the preparation of the quality manual, the control of the quality system elements, the responsibilities of the department and the individual responsibilities, work procedures, work content, work contacts, etc. must be standardized, standardized, and in standard form. Provisions are granted and approved by the Standardization Committee. Therefore, the establishment and operation of the system is also a process of standardization, and the review of the system is consistent with the standardization assessment.
The basic work of GB/T1900 mainly includes five aspects: quality education, quality responsibility system, standardization, measurement, information, etc., all of which involve standards or standardization. For example, the measurement is combined with the technical system and the legal system, and the quantity is uniformly measured to ensure that the quantity is accurate and consistent, and the provisions on the quantity are all standard scales determined by the legal system. It can be said that the measurement work is inseparable from the technical standards. For example, to establish and improve the quality responsibility system, it should be based on the work standards of all departments and personnel of all enterprises, standardize the scope of work of various functional departments and personnel according to the standards, continue to improve according to the standardization cycle, and improve the departments and personnel at all levels. The quality function can make the quality responsibility system be implemented and constantly improved. In a certain sense, strict work standards are not only the basis for perfecting the quality responsibility system, but also the deepening of the quality responsibility system. Therefore, the standard system is the basis for implementing the quality system.
4. The quality system is the guarantee for the implementation of the enterprise standard system.
The quality management work method is a plan-implementation-inspection-summary four-cycle cycle. From the planning stage, according to user requirements and business objectives, and based on this, a set of standards for quality activities as the basis for future work. In the implementation stage, it is implemented according to the established standards, so that the design, production and operation activities are planned according to the predetermined guidelines and objectives. After two stages of inspection and summary, check according to the standard, find out the problem, and take corresponding measures according to the inspection results. This shows that the quality management process is the process of setting standards, implementing standards and summarizing and raising standards.
The quality system is the ex ante control in the production process and the pre-control in the production process. The negative management is the active control, and the result is transformed into the management factor, so that every department and every employee of the production process participate in the management system. Production and management are in the overall coordination of standardized operation. Each link of the system is based on standardization. It effectively organizes the human resources, material resources and financial resources of the enterprise to further play the system function. In addition, the quality system can control the five factors that affect quality, raw materials, equipment, methods and the environment through standard methods. First of all, with product quality assurance as the center, we must establish and improve a set of perfect and advanced technical standards that can meet the needs of product quality. Secondly, it is necessary to establish a complete set of management standards and working standards, so that all activities of the enterprise can be highly unified and coordinated, and carried out in an orderly manner in order to achieve the purpose of ensuring product quality. The enterprise standard system is an important pillar of the quality system. Therefore, the implementation of the enterprise quality system is also the process of implementing the enterprise standard system. The quality system is the guarantee for the implementation of the standard system.
5. The quality system is the main component of the standard system.
Since the standardization infiltration enterprise manages all parts of the entire system, a management system is formed. Quality management standards are an important subsystem of the enterprise management standards system.
The enterprise standard system can be described as the largest subsystem in the enterprise management system. It covers almost all aspects of the enterprise and penetrates into various management. The quality system is established to implement quality management, quality assurance and quality objectives. The content and scope are only limited to all aspects related to product quality. Its function only implements quality management internally and carries out quality assurance. The establishment of quality system only supplements technical specifications, and its coverage is mainly related to product quality. Technology, management and people, but this content is also in the scope of technical standards, work standards, management standards, are covered by the standard system. Therefore, the enterprise standard system is inclusive of various management tasks within the quality system.
In the past, when quality management was not carried out, it was not closely integrated with standardization work, so quality management could not be further penetrated. Standards are therefore not subject to quality management practices, and it is difficult to play their role in standardization, and product quality is difficult to guarantee. Practice has proved that quality management and standardization work are closely combined to achieve the goal of quality assurance.
Overview of China's implementation of ISO9000 standards
In order to meet the needs of international economic cooperation and trade development, in accordance with the provisions of the Commodity Inspection Law and the Implementation Regulations of the Commodity Inspection Law, the State Administration of Commodity Inspection and the Ministry of Economy and Trade jointly issued a notice in October 1991, deciding to export in China’s export commodity production enterprises. Based on the quality licensing system, the ISO9000 series of standards will be further promoted. Export commodity production enterprises may apply to the commodity inspection authorities for quality system review according to foreign trade needs. In the first quarter of 1992, the State Administration of Commodity Inspection issued the “Measures for the Administration of the Quality System of Export Commodity Production Enterprises†and the “Administrative Measures for the Quality System Reviewers of Export Commodity Production Enterprises†as the relevant laws and regulations for conducting quality system assessment.
In order to implement the joint notice of the two ministries and bureaus, the State Commodity Inspection Bureau conducts a large number of standard learning and publicity activities in the national commodity inspection system and export commodity production enterprises, and organizes translation, preparation, and issuance of ISO9000 standard publicity materials and reviewer training materials. Intensify the training quality system reviewers, carry out the evaluation and pilot work, and actively establish cooperative relations with the more influential review institutions in the world. So far, the local commodity inspection bureaus have publicized and trained nearly 20,000 person-times for commodity inspection systems and export enterprises. The State Administration of Commodity Inspection also invited the British Standards Association BSI to China to hold two training courses for directors and judges. 40 students received the certificate of the chief judge of the BSI; and a self-developed teaching material was held to hold a training course for the directors. . The commodity inspection authorities have conducted 38 evaluations in Shenzhen, Shanghai, Hubei, Shandong, Chongqing, Zhejiang, Xiamen, Fujian, Gansu, Yunnan, Guizhou and other places, and carried out consultations on the establishment of quality systems for 35 export production enterprises. And 22 companies have submitted applications for review to the Commodity Inspection Bureau.
In order to further strengthen the guidance and coordination of this work, the State Administration of Commodity Inspection is in conjunction with the State Council Mechanical and Electrical Products Export Office, the Ministry of Economic and Trade, the Ministry of Electrical and Mechanical Services, the Ministry of Aeronautics and Astronautics, the Ministry of Light Industry, the Ministry of Textiles, the State Administration of Medicine, and the China National Automotive Industry Corporation. Beijing jointly established the “Working Committee on the Quality System of Export Commodity Production Enterprises (ISO9000)â€. The main duties of the working committee are to coordinate, supervise, guide and serve the implementation of ISO9000 series standards and quality system review in export production enterprises, formulate relevant policies, policies and management methods, and conduct qualifications for institutions and personnel engaged in quality system assessment. Evaluate and coordinate the external certification work.
After the establishment of the working committee, the formulation and approval methods for the work committee's charter and quality system review institutions and reviewers were issued. Organize translation of foreign quality system review works and organize the preparation of "Director's Reviewer Course", intended as a unified recommendation textbook for training quality system reviewers. Cooperated with the Information Center of the State Administration of Commodity Inspection and Shenzhen News Film and Television Center to produce the ISO9000 series standard TV teaching film "Modern Enterprise and ISO9000" to promote the further promotion and implementation of ISO9000 standards in export production enterprises.
The work committee will carry out further work this year according to its purpose. The accredited institutions and reviewers who have passed the assessment may undertake the review of the quality system of the export commodity manufacturing enterprises after being approved and registered. Adopt a unified organization and combine the self-organization of each department to further carry out the training of the reviewers. On the basis of unified work, the various departments of the working committee organize self-sponsored training courses for the judges and establish a team of judges. Partially completed the review of the pilot enterprises, and on the basis of summing up the experience, expand the application for review of the accepted enterprises. Further strengthen the contact and cooperation with foreign system review and certification institutions, in addition to continuing to cooperate with British BSI, Canadian CSA, Hong Kong Quality Assurance Agency, and focus on strengthening contacts with the European Community, the United States, Asia and other relevant international organizations. Strengthen publicity and accelerate the implementation of the ISO9000 standard. Make full use of television, newspapers, lectures and other forms of propaganda, publish relevant publications and publicity materials, timely report on domestic and international dynamic information, and provide guidance materials for the work of various departments and departments.
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