ISO is an international standardization organization, and its members are composed of national standardization organizations from more than 65,438+000 countries in the world. The national organization representing China in ISO is CSBTS in China. ISO is closely related to the International Electrotechnical Commission (IEC), and China's national institution participating in IEC is also the State Bureau of Technical Supervision. As a whole, ISO and IEC are responsible for formulating internationally recognized standards. ISO and IEC are non-governmental organizations, and their standards are voluntary in nature, which means that these standards must be excellent and they will bring benefits to industry and service industry, so they consciously use these standards. ISO and IEC are not un agencies. However, they maintain technical ties with many specialized agencies of the United Nations. ISO and IEC have about 65,438+0,000 professional technical committees and subcommittees, and all member countries participate in the activities of these technical committees and subcommittees on a national basis. ISO and IEC also have about 3,000 working groups, and ISO and IEC formulate and revise 1000 international standards every year. The standard covers a wide range, from basic fasteners and bearings to semi-finished products and finished products, and the technical fields involve information technology, transportation, agriculture, health care and environment. Each work organization has its own work plan, which lists the standard items (test methods, terminology, specifications, performance requirements, etc. ) needs to be formulated. The main function of ISO is to provide a mechanism for people to reach an agreement on the formulation of international standards. Its main organization and operation rules are stipulated in a document called ISO/IEC Technical Work Guide. Its technical structure in ISO is 800 technical committees and subcommittees. Each committee has a chairman and a secretariat, and each member country provides services. At present, 30 member groups undertake the work of secretariat countries, and each secretariat maintains direct contact with the ISO Central Secretariat in Geneva.

Through these institutions, ISO has issued 9200 international standards, such as ISO metric thread, ISO A4 paper size, ISO container series (95% of the world's shipping containers meet ISO standards at present), ISO film speed code, ISO Open System Interconnection (OS2) series (widely used in the information technology field) and the famous ISO9000 quality management series standards. In addition, ISO has established contacts with 450 international and regional standards organizations, especially with the International Telecommunication Union (ITU). There are 28 international standards bodies besides ISO/IEC system. Every institution sets some international standards in a certain field, which are usually under the control of the United Nations. A typical example is the 85% international standard set by the World Health Organization (WHO). ISO/IEC, the remaining 65,438+05% is formulated by these 28 other international standards bodies.

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Origin of ISO9000 Quality System Certification

Any standard is produced to meet the needs of the development and changes of objective factors such as science, technology, society and economy, and so is ISO9000.

With the progress of science and technology and the development of society, customers need to put their safety, health and daily life under the protection of quality levee. In order to avoid huge compensation due to product quality problems, enterprises should establish a quality assurance system to improve their reputation and market competitiveness; With the rapid development of world trade, different countries and enterprises are required to have the same language, unified understanding and the same norms in technical cooperation, experience exchange and trade. The scale of internal cooperation in modern enterprises is getting larger and larger, which makes procedural management a requirement of productivity development itself. These reasons make ISO9000 standard inevitable.

1979, ISO established Technical Committee for Quality Management and Quality Assurance TC 176, which was responsible for formulating quality management and quality assurance standards.

1979 BSI submitted a proposal to ISO, proposing to learn international standardized quality assurance technology and management experience. In the same year, ISO approved the establishment of Technical Committee for Quality Management and Quality Assurance TC 176, which was responsible for formulating quality management and quality assurance standards. TC 176 mainly refers to the British BS5750 standard and the Canadian CASZ299 standard, and pays attention to connecting the standards formulated by it with those of many countries from the beginning.

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The birth of ISO9000

People didn't wait long. On the basis of the efforts of experts from various countries, the International Organization for Standardization officially promulgated the first edition of ISO9000 series standards (9000~9004) in 1987. By the end of 1994, it has been adopted by more than 70 countries, including all EU and EFTA countries, Japan and the United States. More than 50 countries have established national quality system certification/registration institutions and carried out third-party certification and registration. In some countries, companies waiting for registration take a long time, and it takes months or even 1 year to get certification. EOTC, the European testing and certification organization, refers to ISO9000 standard in some areas, such as the legislation of medical devices, and suppliers must obtain ISO9000 registration in some areas. Many companies have come to the conclusion that it is absolutely beneficial to get ISO9000 registration if they want to do business with a unified European market. Many national and international product certification systems, such as British BSI kite logo and Japanese JIS logo, take ISO9000 as the primary requirement for obtaining product certification, and incorporate ISO9000 into the product certification plan.

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What is ISO9000 quality system certification?

ISO carries out technical activities through its 2856 technical organizations. There are * *185 Technical Committee (TC), * SC) * * 61+0 Technical Committee (SC), 2022 working groups (WG) and 38 special working groups.

The technical activities (products) of 2856 technical institutions of ISO are "international standards". ISO has formulated more than *** 10300 international standards, mainly involving the technical specifications of various products (including service products and knowledge products) in all walks of life.

In addition to standardized names, international standards formulated by ISO also have numbers. The numbering format is: ISO+ standard number+[article+sub-standard number]+colon+publication year number (contents in square brackets are optional), for example: ISO 8402: 1987, ISO 9000- 1: 65438.

However, "ISO9000" refers not to one standard, but to a series of standards. According to the definition of ISO 9000- 1: 1994: "ISO 9000 family is all international standards formulated by ISO/TC 176."

What is TC 176? TC 176 is the technical committee of 176 in ISO. Established in 1980, the full name is "Quality Assurance Technical Committee". 1987 was renamed as "Technical Committee for Quality Management and Quality Assurance". TC 176 is responsible for formulating standards for quality management and quality assurance technology.

One of the earliest standards formulated by TC 176 is ISO 8402: 1986, named Quality-Terminology, which was officially released on June 1986. 1987 In March, ISO officially released ISO9000: 1987, ISO 900 1: 1987, ISO 9002: 1987, and ISO 9003:/kloc-0.

Since then, TC 176 has published another standard in 1990, three standards in 199 1, one standard in 1992 and five standards in 1993. 1994 did not publish other standards, but revised the above-mentioned "ISO9000 series standards" uniformly. Change them to ISO 8402: 1994, ISO9000- 1: 1994, ISO 9001:/994, ISO 9002: 1994, ISO 9002. In 1995, TC 176 issued another standard with the number of ISO10013:1995.

In 2000, TC 176 completely revised the 94th edition of the standard. On June 5438+February 65438+May 2000, ISO9000:2000 Quality Management System Fundamentals and Terminology, ISO900 1:2000 Quality Management System Requirements and ISO9004:2000 Quality Management System Performance Improvement Guide were promulgated. In 2002, ISO/KOOC-0/90/KOOC-0//KOOC-0/:2002 "Guidelines for Auditing Quality and/or Environmental Management Systems" was promulgated, and another standard ISP/KOOC-0/90/KOOC-0/2 is currently being formulated.

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Brief introduction of ISO9000 standard

In recent years, the IS09000 family standard is being vigorously promoted throughout the country, and the quality system consultation and certification based on the S09000 family standard is being carried out. The release of "Quality Revitalization Plan" in the State Council has aroused the attention and attention of enterprises and quality workers to IS09000 family standards.

According to the definition given by IS09000- 1, IS09000 family refers to "all international standards formulated by technical committee of ISO/TC 176". So how many standards have been formulated by ISO/TC 176 Technical Committee? The crowd is different. The accurate statement should be that there are four international standards formulated by ISO/TC 176 Technical Committee and officially promulgated by ISO (National Organization for Standardization), and there are 1 international standards that have not been promulgated by ISO/TC 176 Technical Committee. ISO officially promulgated four international standards of IS09000 family, and all of them were transformed into national standards of China. Other 1 international standards that are still in the draft stage are also being studied in China. Once officially promulgated, China will promptly convert it into a national standard. The officially promulgated IS09000 family standards are as follows:

Fundamentals and Terminology of O9000:2000 Quality Management System

т120000 Quality Management System Requirements:

O9004:2000 Quality Management System Performance Improvement Guide:

Iso19011:2002 quality and/or environmental management system audit guide.

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The New Trend of IS09000 Family Standards Development

According to the future development vision put forward by ISO/TCl76, the structure of IS09000 family standards will probably undergo major changes in the future development, so as to improve the flexibility in the use of standards, better adapt to organizations of all sizes and properties, and expand the application of standards in different industries. For example, IS0900 1 and IS09003 are merged into IS0900 1 1S09000-2, IS09000-3, IS09004-2, 1S09004-3, which belong to is09004-3 respectively. 11s010013-is010016 belongs to IS09004/ 1 or as technical report is0100/. In a word, the new structure of IS09000 family standards will be based on IS0900 1 and IS09004, including a few supporting standards.

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Introduction to ISO9000 standard

The Technical Committee on Quality Management and Quality Assurance of the International Organization for Standardization (ISO/TC 176) put forward the implementation strategy of international quality standards in the 1990s at the ninth annual meeting held in 1990, which is internationally called Outlook 2000. Its goal is: "let the world accept and use ISO9000 family standard, and provide effective methods to improve the operation ability of the organization;" Strengthen international trade and promote global prosperity and development; So that any organization or individual can have the confidence to obtain any desired products from all over the world and successfully sell their own industries to all over the world. "As a reader, do you understand the meaning of ISO9000 family standard from this passage? Do you feel the effect of introducing ISO9000 family standard from this passage?

After the prescribed procedures, many discussions and revisions at different levels, the 2000 version of ISO9000 standard will be released soon. The remarkable feature of the 2000 edition of ISO9000 family standard is to fully integrate eight quality management principles generally accepted by the global quality community into the ISO9000 family quality management standard. These eight quality management principles are: customer-centered, leading role, full participation, process method, system management method, continuous improvement, fact-based decision-making method and mutually beneficial supplier relationship.

"O9000 series standards can help organizations of all types and sizes to implement and run effective quality systems. For many enterprises in Zhongguancun, which are at the forefront of China's high-tech and technological development in the new century, it should be an important consideration to introduce a quality management system in line with international standards, which is one of the important contents of enterprise management.

In the process of development, some enterprises deeply feel that the quality management of our organization can not meet the requirements of domestic and foreign markets and customers. After careful consideration, they introduced the ISO9000 standard.

Some enterprises have recognized the necessity and introduced ISO9000 family standard at the request of higher authorities and industry authorities. In the market operation, some enterprises have met the requirements of quality management system put forward by customers. In order to meet the requirements and open up the market, ISO9000 series standards were introduced.

Compared with other enterprises in the same industry, some enterprises have been promoted and influenced by other aspects, and have also introduced ISO9000 family standards.

No matter what consideration, it is a very correct choice and decision to introduce ISO9000 family standard.

The𚧈family standard, especially the "Quality Management System-Requirements" of ISO900 1, does not tell the enterprise what to do, but only puts forward the requirements of the quality management system that is in harmony with international communication. Therefore, the introduction of ISO9000 family standard is the first step, and how to realize effective quality management and establish a suitable and lasting quality management system according to the requirements of the standard requires energy, time and resources.

Entrepreneurs and managers are invited to spend some time and energy to understand the ISO9000 standard. I hope you can introduce ISO9000 standard as soon as possible, and I hope you can establish an effective quality management system that conforms to ISO9000 standard.

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Basic requirements of ISO9000 family

Product quality is the key to the survival of enterprises. There are many factors that affect the quality of products. Simply relying on inspection only selects qualified products from the products produced. It is impossible to continuously and stably produce qualified products at the best cost.

The quality system established and implemented by the organization should be able to meet the quality objectives set by the organization. Ensure that the technical, management and human factors affecting product quality are under control. Whether it is hardware, software, process materials or services, all controls should aim at reducing and eliminating nonconformities, especially preventing nonconformities. This is the basic guiding ideology of the ISO9000 family, which is embodied in the following aspects:

First, control the quality of all processes.

The O9000 family standard is based on the understanding that "all work is done through processes". The quality management of an organization is realized by managing various processes within the organization, which is the theoretical basis of ISO9000 family on quality management. When an organization carries out quality system planning in order to implement the quality system, it should first determine which processes should be carried out according to the specific situation of the organization, and then analyze the quality activities needed in each process to determine the effective control measures and methods that should be taken.

Second, the starting point of the control process is to prevent nonconformity.

At all stages of the product life cycle, the control of all processes from the initial identification of market demand to the final satisfaction of demand embodies the idea of prevention first. For example:

-control the quality of market research and marketing, develop new products on the basis of accurately determining market demand, and prevent blind development from causing unsalable sales that do not meet market demand and wasting manpower and material resources.

-Control the quality of the design process. Through design review, design verification, design confirmation and other activities, ensure that the design output meets the input requirements and the products meet the needs of users. Prevent product quality from being unqualified and defective due to design quality problems, or cause losses to subsequent processes.

-Control the purchasing quality. Select qualified suppliers and control their supply quality, so as to ensure that the raw materials, purchased parts and cooperative parts needed to produce products meet the specified quality requirements and prevent the use of unqualified purchased parts from affecting the quality of finished products.

-Control the quality of the production process. Determine and implement appropriate production methods, use appropriate equipment, maintain the normal working capacity and required working environment of the equipment, control the parameters and personnel skills that affect the quality, ensure that the manufacturing meets the quality requirements specified in the design, and prevent the production of unqualified products.

-Control inspection and testing. Carry out incoming inspection, process inspection and finished product inspection according to the quality plan and documented procedures to ensure that the product quality meets the requirements, prevent unqualified purchased products from being put into production, prevent unqualified process products from being transferred to the next process, and prevent unqualified finished products from being delivered to customers.

-Control handling, storage, packaging, protection and delivery. Take effective measures to prevent product damage and deterioration in all these links.

-Control the quality of inspection, measuring and experimental equipment, ensure that qualified testing means are used for inspection and test, ensure the effectiveness of inspection and test results, and prevent misjudgment of product quality due to unqualified testing means.

-Control documents and materials, ensure that all documents and materials used in the site are up-to-date and effective, and prevent the use of expired or invalid documents, resulting in unqualified products or quality system elements.

-Corrective and preventive measures. When nonconformities (including products or quality systems) or customer complaints occur, the reasons should be found out and corrective measures should be taken to prevent the recurrence of the problems. Through the analysis of various quality information, potential problems are actively found and prevented, thus improving product quality.

-All-staff training, that is, training all personnel engaged in work that has an impact on quality, so as to ensure that they are competent for their jobs and prevent products or quality systems from being unqualified due to lack of knowledge or skills.

Three, the central task of quality management is to establish and implement a documented quality system.

Quality management runs in the whole quality system, so the implementation of quality management must establish a quality system. The ISO9000 family believes that the quality system is an influential system with strong operability and inspection. The quality system required to be established by the organization shall be documented and maintained. Typical quality system documents are divided into three levels, namely, quality manual, quality system procedures and other quality documents. The quality manual is a document describing the quality system according to the quality policy stipulated by the organization and the applicable ISO9000 series standards. The quality manual can include the quality system procedures or indicate the specific location of the quality system procedures. Quality system procedure is a document used by relevant functional departments to control the quality of each process and stipulate effective measures and methods for how to carry out various quality activities. Other quality documents, including work instructions, reports and forms, are more detailed working documents used by workers. The basic requirements of the contents of quality system documents are: what should be written, what should be done, and the results should be recorded, that is, what needs to be written, what should be done, and the nine-character mantra should be remembered.

Fourth, continuous quality improvement:

Quality improvement is an important part of quality system. GB/T 19004. 1 Standard stipulates that the managers of an organization should ensure that their quality system can promote and promote continuous quality improvement when implementing the quality system. Quality improvement includes product quality improvement and work quality improvement. Striving for customer satisfaction and realizing continuous quality improvement should be the eternal goal pursued by managers at all levels of the organization. A quality system without quality improvement can only maintain quality. Quality improvement aims at improving quality. Quality improvement is achieved by improving the process, with the aim of pursuing higher process efficiency and effectiveness.

5. An effective quality system should meet the needs and interests of customers and organizations.

In other words, for customers, the organization should not only have the ability to deliver the expected quality, but also maintain the quality continuously and pursue the ultimate satisfaction of customers; For an organization, the expected quality can be achieved and maintained at an appropriate cost. That is to meet the needs and expectations of customers and protect the interests of the organization.

Six, regularly evaluate the quality system.

Its purpose is to ensure that the implementation of various quality activities and their results conform to the planned arrangements, and to ensure the continued suitability and effectiveness of the quality system. When evaluating, we must ask the following three basic questions for each evaluated process:

A. has the process been determined? Is the process procedure properly documented?

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

C. is the process effective in providing the expected results?

Seven, the key to do a good job in quality management is leadership.

—— The top management of the organization should do the following five things in quality management:

First, determine the quality policy. The quality policy, including quality objectives and commitment to quality, shall be stipulated by the manager responsible for implementation.

B, determine the responsibilities and authority of each position.

C. allocating resources. Including financial and material resources (including manpower).

Designate a management representative to be responsible for the quality system.

E, responsible for management review. Ensure the continuous suitability and effectiveness of the quality system.

Looking back on history, ISO9000 family standards originated from the progress of science and the development of technology. Looking forward to the future, the development of high technology needs the guidance of ISO9000 family standards. The application of mature ISO9000 series standards in the field of science and technology provides endless power for scientific and technological progress.

Characteristics and benefits of ISO9000 certification

1 and ISO9000 are systematic standards, covering a wide range of fields and contents, emphasizing the clear division, planning and coordination of responsibilities and powers of various departments, so that enterprises can carry out various activities effectively and orderly and ensure the smooth progress of work.

2. Emphasize the intervention of management, clearly formulate quality policies and objectives, and through regular management review, achieve the purpose of understanding the operation of the company's internal system and taking timely measures to ensure the good operation of the system.

3. Emphasize corrective and preventive measures, eliminate unqualified products or potential causes of unqualified products, and prevent unqualified products from happening again, thus reducing costs.

4. Emphasize constant auditing and supervision, so as to achieve the purpose of constantly revising and improving enterprise management and operation.

5. Emphasize full participation and training to ensure that the quality of employees meets the job requirements, so that every employee has a strong sense of quality.

6. Emphasize cultural management to ensure the regularity and continuity of the management system. If enterprises effectively implement this management standard, they can improve the quality of products (or services), reduce the cost of production (or services), establish customers' confidence in enterprises, improve economic benefits, and ultimately greatly improve the competitiveness of enterprises in the market.

Characteristics and functions of ISO900 1

It is one of ISO9000 quality assurance model standards, which is used for external quality assurance in contract environment. It can be used as a basis for supplier quality assurance and evaluation of supplier quality system.

It can be used as the basis for enterprises to apply for ISO9000 quality system certification.

It is a quality assurance model for development/design, production, installation and service. It is used to ensure that suppliers meet the specified requirements at all stages of development, design, production, installation and service.

The requirements of quality assurance are the most comprehensive, and the evidence providing the elements of quality system is the most. From contract review to final after-sales service. It is required to provide a basis for strict control of the whole process. Suppliers are required to implement the principle of "prevention first, combining inspection with assessment", improve the quality system, have complete quality system documents and ensure its effective operation.

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ISO9000 certification principle

Customer-oriented leadership

Full participation process method

The systematic method of management has been continuously improved.

Relationship between fact-based decision-making method and supplier's mutual benefit

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The significance of ISO9000

1. Strengthen quality management and improve enterprise efficiency: enhance customer confidence and expand market share. The certification bodies responsible for ISO9000 quality system certification are all authoritative organizations recognized by national accreditation bodies, and they are very strict in auditing the quality system of enterprises. In this way, enterprises can carry out quality management according to the strictly audited international standardized quality system, truly meet the requirements of legalization and scientificity, greatly improve work efficiency and product qualification rate, and quickly improve the economic and social benefits of enterprises. For the outside of the enterprise, when customers know that suppliers are managed according to international standards, have obtained ISO9000 quality system certification, and have strict audit and regular supervision by certification bodies, they can be sure that the enterprise is a trustworthy enterprise that can stably produce qualified products or even excellent products, so as to safely conclude a supply and marketing contract with the enterprise and expand the market share of the enterprise. It can be said that both aspects have achieved immediate results.

2. Obtained a "passport" for international trade and eliminated international trade barriers. In order to protect their own interests, many countries have set up various trade barriers, including tariff barriers and non-tariff barriers. Among them, non-tariff barriers are mainly technical barriers, and technical barriers are mainly barriers to product quality certification and ISO9000 quality system certification. Especially in the World Trade Organization, all member countries have abolished tariff barriers and can only set up technical barriers. Therefore, obtaining certification is the main way to eliminate trade barriers. After China's entry into WTO, the strict boundary between domestic trade and international trade has been lost, and all trade may encounter the above technical barriers, which should be highly valued by the business community and prevented as soon as possible. )

3. Save the energy and cost of the second-party audit. In modern trade practice, the second-party audit has long been a routine, and gradually found its huge disadvantages: a supplier usually has to supply multiple demanders, and the second-party audit will undoubtedly bring a heavy burden to the supplier; On the other hand, the demand side also needs to pay a considerable amount of expenses, and at the same time, it should also consider the experience and level of sending or hiring personnel, otherwise the expenses will not reach the expected purpose. Only ISO9000 certification can eliminate this drawback. Because as a production enterprise of Party A, after applying for the third-party ISO9000 certification and obtaining the certification certificate, there is no need for many second parties to audit Party A, so both Party A and Party B can save a lot of energy or expenses. In addition, if an enterprise applies for quality certification of products such as UL and CE after obtaining ISO9000 certification, it can also avoid the cost of repeated certification of enterprise quality assurance system by certification bodies.

4. Always be in an invincible position in the product quality competition. The main means of international trade competition are price competition and quality competition. Because the method of low-price sales not only greatly reduces profits, but also will be subject to trade sanctions if it constitutes dumping, and the means of price competition is increasingly undesirable. Since 1970s, quality competition has become the main means of international trade competition, and many countries regard improving the quality requirements of imported goods as an important measure of trade protectionism. Implementing the quality management of ISO9000 international standardization can steadily improve the quality of products and make enterprises invincible in the product quality competition forever.

5. Effectively evade product liability In the practice of implementing product quality law in various countries, due to more and more frequent complaints about product quality, the causes of accidents are more and more complicated, and the accountability is becoming more and more strict. Especially in recent years, developed countries are changing the original "negligence liability" into "strict liability", and the safety requirements for manufacturers are also much higher. For example, if a worker is injured while operating a machine tool, according to the legal principle of "strict liability", the court should not only look at the quality problems such as the failure of machine tool parts, but also whether there are safety devices and devices to warn the operator. The court can judge that the machine tool is defective according to any of the above problems, and the factory is responsible for the consequences. However, according to the product liability laws of various countries, if the manufacturer can provide ISO9000 quality system certification, it can be exempted from compensation, otherwise it will lose the case and be severely punished. With the improvement of the rule of law in China, the business community should attach great importance to the Product Liability Law and take precautions as soon as possible. )

6. Conducive to international economic cooperation and technical exchanges According to the practice of international economic cooperation and technical exchanges, both sides must have the same language, unified understanding and * * * norms in terms of product (including service) quality before they can cooperate and communicate. 𚧈 The quality system authentication is to provide this kind of trust, which is beneficial to the quick agreement between the two parties.

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ISO9000 certification steps

After reading the ISO900 1 standard carefully, you will definitely have such a concept. ISO900 1 standard is really comprehensive, which regulates all the processes of an enterprise from raw material procurement to finished product delivery, involving all employees from top to bottom. You may think that such a comprehensive and complex system must be very difficult to implement!

Admittedly, it is difficult to implement ISO9000. However, as long as you sincerely take ISO9000 as an important measure to improve the company's management performance instead of just posing, take it as a long-term development strategy and make careful planning according to the company's specific situation, ISO9000 will eventually take root in your company.

In short, there are five basic processes for implementing ISO9000:

Knowledge preparation-legislation-publicity-implementation-supervision and improvement.

According to the specific situation of your company, you can plan the above five processes and follow certain implementation steps to guide your company to gradually enter the world of ISO9000.

The following are typical steps for enterprises to implement ISO9000. As you can see, the above five processes are completely contained in the middle:

○ Identification and diagnosis of the original quality system of the enterprise;

○ Appoint management representatives to form an ISO9000 implementation organization;

○ Setting goals and incentives;

○ Personnel at all levels receive necessary management awareness and quality awareness training;

○ ISO900 1 standard knowledge training;

○ Preparation of quality system documents (legislation);

Large-scale publicity, training, release and trial operation of quality system documents;

○ Internal auditors are trained;

○ Multiple internal quality system audits;

○ Management review based on internal audit;

○ Perfection and improvement of quality management system;

○ Apply for certification.

Before carrying out ISO9000, enterprises should carefully plan the above implementation steps according to their own actual conditions, and make specific arrangements in time and activities to ensure more effective implementation.