ISO is the English abbreviation of an organization. Its full name is International Organization for Standardization, which is translated into Chinese as "International Organization for Standardization". ISO declares that its purpose is "to promote the development of standardization and related activities in the world to facilitate the international exchange of goods and services and cooperation in the intellectual, scientific, technical and economic fields." ISO currently has 117 members, including 117 countries and regions. The highest authority of ISO is the annual "General Assembly", and its daily office is the Central Secretariat, located in Geneva, Switzerland. The Central Secretariat currently has 170 staff members, headed by the Secretary-General. What is ISO9000 ISO carries out technical activities through its 2856 technical institutions. Among them, there are 185 technical committees (TC), 611 sub-technical committees (SC), 2022 working groups (WG), and 38 special working groups. The results (products) of the technical activities of ISO's 2856 technical institutions are "international standards". ISO has now developed more than 10,300 international standards, which mainly involve technical specifications for various products in various industries (including service products, knowledge products, etc.). In addition to the standardized names, the international standards formulated by ISO also have numbers. The format of the numbers is: ISO+standard number+[bar+standard number]+colon+release year number (the content in square brackets is optional) ), for example: ISO8402:1987, ISO9000-1:1994, etc., which are the numbers of a certain standard. However, "ISO9000" does not refer to a standard, but a collective name for a family of standards. According to the definition of ISO9000-1:1994: "The ISO9000 family is all international standards formulated by ISO/TC176." What is TC176? TC176 is the 176th technical committee in ISO. It was established in 1980. Its full name is "Technical Committee on Quality Assurance". In 1987, it was renamed "Technical Committee on Quality Management and Quality Assurance". TC176 is specifically responsible for setting standards for quality management and quality assurance technology. One of the earliest standards formulated by TC176 was ISO8402:1986, named "Quality - Terminology", which was officially released on June 15, 1986. In March 1987, ISO officially released five international standards: ISO9000:1987, ISO9001:1987, ISO9002:1987, ISO9003:1987, ISO9004:1987, which together with ISO8402:1986 are collectively referred to as the "ISO9000 series standards". After that, TC176 released another standard in 1990, three standards in 1991, one standard in 1992, and five standards in 1993; no other standards were released in 1994, but the aforementioned "ISO9000 series standards" Unified revisions were made to ISO8402:1994, ISO9000-1:1994, ISO9001:1994, ISO9002:1994, ISO9003:1994, ISO9004-1:1994, and the standards developed by TC176 were defined as the "ISO9000 family". In 1995, TC176 released another standard, numbered ISO10013:1995. On December 15, 2000, ISO released the 2000 version of the ISO9000 series of standards, simplifying the original 9000 series of standards into the following three standards: 1. ISO9000 : 2000 "Quality Management System - Fundamentals and Terminology"; 2. ISO9001: 2000 "Quality Management System - Requirements"; 3. ISO9004: 2000 "Quality Management System - Performance Improvement Guide". What is certification? The original English meaning of the word "certification" is an action of issuing certification documents.

The definition of "certification" in ISO/IEC Guide 2:1986 is: "The activity of confirming by a fully trusted third party that an authenticated product or service conforms to a specific standard or normative document." For example, for the first For product A produced by one party (supplier or seller), the second party (demand party or buyer) cannot determine whether its quality is qualified, but a third party will determine it. The third party must be responsible to both the first party and the second party, be impartial, and issue certificates that can gain the trust of both parties. Such an activity is called "certification." This means that third-party certification activities must be open, fair and fair to be effective. This requires that the third party must have absolute power and prestige, must be independent of the first party and the second party, and must have no economic interests with the first and second parties, or have equal interests, or Only by having the obligation and responsibility to safeguard the rights and interests of both parties can we gain the full trust of both parties. So, who should play the role of this third party? Obviously, none other than the state or the government. This role is directly played by national or government agencies, or this role is played by organizations recognized by the state or government. Such agencies or organizations are called "certification agencies". See Appendix B for details.

At present, certification agencies in various countries mainly carry out the following two aspects of certification business: 1. Product quality certification The modern third-party product quality certification system originated in the United Kingdom as early as 1903 and was established by the British Engineering Standards Committee ( The predecessor of BSI) was pioneered. Before the certification system came into being, suppliers (the first party) usually used "product conformity statements" to promote their products to gain the trust of customers (the second party). This method was feasible when the products at that time were simple and the advantages and disadvantages could be visually distinguished without the need for special detection methods. However, with the development of science and technology, product varieties are increasing day by day, and the structure and performance of products are becoming increasingly complex. It is difficult to judge whether a product meets the requirements based on the buyer's knowledge and experience alone; in addition, the supplier's "Product Conformity Statement" belongs to the "Wang Po" The "selling melons, selling and boasting" approach is a mixture of true and false, good and bad, and is not always credible. The credibility and effect of this method gradually decline. In this case, the aforementioned product quality certification system came into being. In 1971, ISO established the "Certification Committee" (CERTICO). In 1985, it was renamed "Conformity Assessment Committee" (CASCO), which promoted the development of product quality certification systems in various countries. Nowadays, product quality certification in various countries around the world is generally certified based on international standards. 60% of international standards are developed by ISO, 20% by IEC, and 20% by other international standardization organizations. There are also many certifications based on each country's own national standards and advanced foreign standards. See Appendix C for details. Product quality certification includes two types: conformity certification and safety certification. Certification based on the performance requirements in the standard is called conformity certification; certification based on the safety requirements in the standard is called safety certification. The former is voluntary and the latter is mandatory. Product quality certification work has developed rapidly since the 1930s. By the 1950s, it was basically popularized in all industrially developed countries. Most countries in the third world gradually implemented it in the 1970s. Our country only established its first certification agency, the "China Electronic Devices Quality Certification Committee" in April 1981. Although it started late, it has a high starting point and rapid development. 2. Quality management system certification This certification was developed from Western quality assurance activities. In 1959, the U.S. Department of Defense proposed quality assurance requirements to military-industrial enterprises affiliated to the Department of Defense Supply Agency, requiring contractors to "develop and maintain an effective and economical quality assurance system that is consistent with their business management and procedures." "Adequately ensure quality in all areas and processes to achieve contract requirements (such as design, development, manufacturing, processing, assembly, inspection, testing, maintenance, packing, storage and installation)" and stipulates two unified quality assurance systems Model: Military standard MIL-Q-9858A "Quality Program Requirements" and military standard MIL-I-45208 "Inspection System Requirements". The contractor must prepare a "Quality Assurance Manual" based on these two models and implement it effectively. The government should gradually check and evaluate the implementation status against the documents. This is actually the prototype of modern second-party quality system auditing. This approach prompted the contractor to conduct comprehensive quality management with great success.

With the rapid development of the above-mentioned quality assurance activities, certification agencies in various countries have gradually increased the content of auditing the quality assurance system of enterprises when conducting product quality certification, further promoting the development of quality assurance activities. In the late 1970s, BSI (British Standards Institution), a British certification body, first launched the certification business of a separate quality assurance system, which developed the quality assurance activities from second-party auditing to third-party certification. It was welcomed by all parties and became even more popular. Promoted the rapid development of quality assurance activities. After three years of practice, BSI believes that the certification of this quality assurance system has wide adaptability and flexibility, and has the value of being promoted to the international community. As a result, a proposal was submitted to ISO in 1979. Based on the recommendations of BSI, ISO decided to establish a "Quality Assurance Committee" based on the "Quality Assurance Working Group" of the ISO Certification Committee that year. In 1980, ISO officially approved the establishment of the "Quality Assurance Technical Committee" (TC176) to start this work, which led to the birth of the aforementioned "ISO9000 family" standards, improved the independent quality system certification system, and on the one hand expanded the original The business scope of quality certification agencies has, on the other hand, led to the birth of a large number of new specialized quality system certification agencies. Since the advent of the ISO9000 series of standards in 1987, in order to strengthen quality management and meet the needs of quality competition, entrepreneurs have adopted the ISO9000 series of standards to establish quality management systems within their companies and apply for quality system certification. This has quickly formed a worldwide trend. . At present, nearly 100 countries and regions around the world are actively promoting ISO9000 international standards. There are about 40 quality system accreditation agencies and have recognized about 300 quality system certification agencies. More than 200,000 companies have obtained ISO9000 quality system certification certificates. , the first international multilateral recognition agreement and regional multilateral recognition agreement were also born in Guangzhou, China on January 22, 1998 and January 24, 1998. A set of international standards has been adopted by so many countries in such a short period of time and has had such a wide impact. This is an unprecedented phenomenon in the history of international standardization and has been recognized as the "ISO9000 phenomenon." The role of implementing ISO9000 1. Strengthen quality management and improve corporate efficiency; enhance customer confidence and expand market share. The certification agencies responsible for ISO9000 quality system certification are authoritative agencies accredited by national accreditation agencies, and the audit of the company's quality system is very strict. of. In this way, for internal enterprises, quality management can be carried out in accordance with the internationally standardized quality system that has been strictly reviewed, truly meeting the requirements of legalization and science, greatly improving work efficiency and product qualification rate, and rapidly improving the economic benefits and economic benefits of the enterprise. social benefits. For the outside of the company, when customers know that the supplier implements management in accordance with international standards, has obtained the ISO9000 quality system certification, and has strict audits and regular supervision by the certification body, they can be confident that the company can stably produce qualified products and even As a trustworthy company with excellent products, we can confidently enter into supply and sales contracts with the company and expand the company's market share. It can be said that immediate results have been achieved in both aspects. 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. Among technical barriers, they are mainly barriers to product quality certification and ISO9000 quality system certification. In particular, within the "World Trade Organization", member states have excluded mutual tariff barriers and can only set up technical barriers. Therefore, obtaining certification is the main way to eliminate trade barriers. (After my country's "entry into the WTO", the strict boundaries distinguishing domestic trade and international trade were lost. All trade may encounter the above technical barriers, which should attract the attention of the business community and take precautions as soon as possible.) 3. Save on second-party audits In modern trade practice, second-party auditing has long been a common practice, and it has gradually been discovered that it has major drawbacks: a supplier usually has to supply products to many demanders, and second-party auditing will undoubtedly give the supplier Bringing a heavy burden; on the other hand, the demander also needs to pay a considerable fee, and at the same time, the experience and level of the personnel sent or hired must also be considered. Otherwise, the expected purpose will not be achieved even if the money is spent.

Only ISO9000 certification can eliminate such disadvantages. Because as the first-party manufacturer, after applying for the third-party ISO9000 certification and obtaining the certification certificate, many second parties no longer need to audit the first party. In this way, whether it is the first party or the second party It can save a lot of effort or cost. In addition, if an enterprise applies for product quality certification such as UL and CE after obtaining ISO9000 certification, the certification body can also be exempted from the expense of repeated certification of the enterprise's quality assurance system. 4. Always remain invincible in product quality competition. The main means of international trade competition are price competition and quality competition. Since low-price sales will not only reduce profits sharply, but will also be subject to trade sanctions if it constitutes dumping, price competition is becoming increasingly undesirable. Since the 1970s, quality competition has become the main means of international trade competition. Many countries have taken improving the quality requirements of imported goods as an important trade protectionist measure to limit inputs and outputs. Implementing ISO9000 international standardized quality management can steadily improve product quality and enable enterprises to remain invincible in product quality competition. 5. Effectively avoid product liability. In the practice of implementing product quality laws in various countries, as complaints about product quality become more and more frequent, the causes of accidents become more and more complex, and accountability becomes more and more strict. Especially in recent years, developed countries have been transforming the original "negligence liability" into "strict liability" legal theory, and the safety requirements for manufacturers have increased a lot. For example, if a worker is injured while operating a machine tool, according to the "strict liability" legal theory, the court will not only look at the quality issues such as machine parts failure, but also whether it has safety devices and whether it has issued a warning to the operator. devices, etc. The court can determine that the machine tool is defective based on any of the above issues, and the manufacturer will be responsible for compensation for the consequences. However, according to the product liability laws of various countries, if the manufacturer can provide an ISO9000 quality system certification, it will be exempt from compensation. Otherwise, it will lose the lawsuit and be severely fined. (With the improvement of the rule of law in our country, 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 technological exchanges. According to the practice of international economic cooperation and technological exchanges, both parties must Cooperation and communication can only occur if there is a common language, a unified understanding and abiding by standards in terms of product (including service) quality. ISO9000 quality system certification provides just this kind of trust, which is conducive to both parties reaching an agreement quickly. ISO9000 quality certification - the key to the world! The Product Quality Certification System is a product of the development of the commodity economy. With the continuous expansion and increasing internationalization of the commodity economy, in order to improve product credibility, reduce repeated inspections, weaken and eliminate technical barriers to trade, and protect producers, distributors, users and consumers The rights and interests of famous parties have given rise to third-party certification. This kind of certification is not dominated by the economic interests of both producers and sellers. It gradually establishes authority and credibility through fair and scientific work. It has now become a common practice in various countries to evaluate and supervise the quality of products and enterprises. . The UK is the earliest country to carry out quality certification. As early as 1903, the British Engineering Standards Committee used a "kite mark", that is, the "BS" mark to indicate railway rails that meet size standards. In 1919, the British government formulated the Trademark Law, stipulating that Goods are inspected, and qualified products are also marked with the "Kite Mark". From then on, this mark began to have the meaning of "certification" and is still used today and enjoys a high reputation internationally.

Influenced by the United Kingdom, developed industrial countries around the world also rushed to adopt quality certification systems and paid great attention to them. The International Organization for Standardization (ISO) established the professional technical committee ISO/TC176 in 1980. After 7 years, the committee Through hard work, the first management standard---ISO9000 quality management and quality assurance standard was officially released in 1987. It is applicable to different enterprises, including manufacturing, service industry, commerce, construction industry, etc. Therefore, Its emergence has greatly promoted the development of quality certification in various countries. Currently, there are more than 70 countries among the 104 member countries of the International Organization for Standardization, including the European Union, the United States, Canada, Australia, Japan and other almost all industrially developed countries. With the adoption of the ISO9000 series of standards as their own national standards, companies from various countries have also adjusted their operating mechanisms based on these standards, and obtained certification qualifications. To date, nearly 100,000 certification certificates have been issued around the world. In recent years, more and more people have recognized the role and importance of the ISO9000 series of standards. The application scope of the ISO9000 series of standards has been expanding day by day. Based on summarizing the excellent quality management of many large companies and groups in the world, ISO/TC176 released ISO90004-2 in August 1991: "Quality Management and Quality System Elements - -Part 2: Service Guidelines" seeks to promote various units and companies to manage the quality of their various service activities in a more effective way to ensure that customers' specified or implicit needs are understood and met. All these show that in international trade, it is a trend to require proof of quality system certification in accordance with ISO900 series standards as a condition for signing a contract, and all enterprises should comply with the trend of international trade. Proactively carry out quality system certification based on GB/TI9000 series standards to improve the competitiveness of products in the international and domestic markets. Since the reform and opening up, our country has begun to implement a planned commodity economy, and both the domestic market and international trade have developed rapidly. However, because our country has not established a certification system that conforms to international practices, some of our own product supervision forms have not been recognized internationally. recognition. In international trade, we face economic losses and are restricted by technical barriers. Because our industrial enterprises do not understand the requirements of various countries' certification systems, many export commodities cannot enter the international market. Even if they do, their prices are far lower. Lower than products certified by the host country. Some companies that understand certification also have to spend a lot of foreign exchange every year to apply for foreign certification and have inspection reports issued by foreign certification agencies. Therefore, establishing my country's certification system and carrying out product quality certification and system certification are top priorities for my country's quality certification work, and are the fundamental way to ultimately eliminate the technical barriers that exist between my country and other countries. my country has officially launched certification work in 1991. In May 1991, the State Council issued the "Regulations of the People's Republic of China and Domestic Product Certification Administration", marking that my country's product quality certification work has entered the legal track. On January 1, 1993, my country officially changed from equivalent adoption to equivalent adoption of ISO900 series standards, and established a certification system in line with international practice. Our quality certification work has made considerable progress. For Chinese enterprises, obtaining a quality certification certificate through fair and independent third-party certification is a trustworthy proof of product quality and a passport for products and services to enter the international market. After the enterprise obtains the certification certificate, it will be announced at home and abroad.

Quality certification can bring the following benefits: It can stably provide products that meet customer requirements and enhance customer satisfaction.

Provide products or services that meet the general or specific needs of customers, expand and occupy the market, and make full use of non-price factors to improve competitiveness.

Expand sales channels and sales volume, achieve high quality and low prices, and obtain greater profits.

It helps to establish global economic awareness, improve the basis of the development strategies of enterprises and institutions, seize opportunities and win the future, which is in line with the choice of the times and the interests of the nation.

Promote the establishment of a systematic and rigorous business management model, optimize the organizational structure, improve business management, and establish a mechanism to reduce, eliminate, and especially prevent quality defects.

Responsibilities are further clarified and the work process is clearer, so that everyone truly takes responsibility and avoids the phenomenon of kicking the ball.

Drive the structural adjustment of services and products, promote technological transformation, and enhance its own strength.

Show respect for consumers and social responsibility, improve the credibility of enterprises, products and services, and establish a good corporate image.

Break technical barriers in international trade, enter the international market, and expand exports.

It helps to form a famous brand, and at the same time, it also protects the legitimate rights and interests of some enterprises and institutions.

Avoid repeated spot checks and inspections, and save time, manpower, material and reasonable financial resources used for inspections.

Enables continuous improvement of corporate performance.

Dr. Zhu Lan, a well-known quality management expert, proposed in 1995 that "the 21st century is the century of quality." 1999 is the last year of the 20th century, facing the rapid development of our quality certification industry. situation, this cause has a bright future. Since the International Organization for Standardization ISO launched the ISO9000 series of standards in 1987, it has been adopted by more than a hundred countries and regions. This series of standards has such a wide and profound impact around the world that some people call it the ISO9000 phenomenon. The fundamental reason for the emergence of the ISO9000 phenomenon is that buyers and suppliers from various countries generally recognize the standards and regard compliance with the requirements of the ISO9000 standards as the cornerstone of establishing mutual trust relationships in trade activities. Our country adopted equivalent standards as early as 1988 and switched to equivalent adoption of ISO9000 standards in 1992. According to statistics, as of December 31, 1998, a total of 8,117 companies held 8,245 quality system certification certificates (valid certificates) with national recognition marks, including 1,153 companies in Jiangsu Province, accounting for 14.20%; 1,051 companies in Guangdong Province Enterprises, accounting for 12.95%; Shanghai, 675, accounting for 8.32%; Beijing, 673, accounting for 8.29%. There are 34 nationally recognized certification agencies in our country, accounting for about one-tenth of the total number of certification agencies in the century. In January 1998, 17 countries including China, the United States, the United Kingdom, and Japan signed the International Accreditation Forum Multilateral Mutual Recognition Agreement (IAF/MLA), and China’s national accreditation system for quality system certification agencies officially joined the international mutual recognition; in August 1998, China The National Registration Board for Certification Personnel (CRBA) signed the International Auditor Training and Registration Association Mutual Recognition Agreement (IATCA/MLA) with the United Kingdom, the United States, Australia, New Zealand, etc., and joined the international mutual recognition system. So far, the two major systems that determine the level of my country's quality system certification have been in line with international standards and have gained international mutual recognition. *ISO——International Organization for Standardization. *ISO was founded in 1947 and is composed of representatives of international organizations from supplier governments (P member countries, O member countries). China is an official (P) member of ISO. *To date, about 90 member countries of the International Organization for Standardization (ISO) have adopted the ISO9000 family of international standards. Member States and other countries may adopt these standards on a voluntary basis. *European Union or the European Free Trade Association have made regulations requiring the existing 18 member countries to adopt these standards, while ISO member countries and other countries can adopt these standards on a voluntary basis. *Although some countries have not adopted the ISO9000 family numbering system, most adopting countries are currently working hard to maintain consistency with the ISO9000 family numbering system. *The UK has changed their BS5750, Part 1 (the equivalent adopted standard of ISO9001) to BSEN ISO9001:1994 and the existing BS9000 standard is a standard whose content has nothing to do with quality. Some countries have adopted the following numbering system: - Denmark: DS/EN ISO9001:1994 - Norway: NS-EN ISO9001:1994 - Sweden: SS-EN ISO9001:1994 - United States: ANSI/ASQCQ9001:1994 - Switzerland: SN/ EN ISO9001: 1994 Since the standard numbering system of each country is not static, all adopted standard numbers need to be listed here.

1. Formulation of international standards The ISO (International Organization for Standardization)/TC176 technical committee formulates quality system standards through the working groups (WG) in its sub-technical committees (SC). The sub-technical committees are composed of representatives from national technical committees. Standard formulation has the following main stages: 1. Determine new work items The National Technical Committee may propose the establishment of new work items. All tasks of ISO/TC176 are registered in ISO's annual report. 2. Develop draft recommendations The working group develops a standard draft recommendation and brings together experts to submit all documents (working group document, WD). 3. Committee Approval of the Draft When voting on the ISO/CD draft, members of each P member country (P - participating) have the right to vote on the draft body. ISO/TC176*** has 50 P member countries, and when 2/3 of the member countries vote, it indicates that the draft standard has been approved. The approved draft is called a committee document (ISO/CD). 4． Voting period ISO members vote on the ISO/CD draft for a period of 6 months. All ISO members vote on submitted ISO/CD drafts. Voting takes the form of hearings and voting in various countries, and national committees publicly express their opinions on the draft standards. The draft approved by voting is called the ISO draft international standard (ISO/DIS draft). National committees will give formal feedback to ISO/TC176. If comments are made that significantly change the draft, a re-vote should be held. 5． Release of the ISO standard After the voting ended, the relevant working groups in TC176 completed the editing of the standard, and finally, it was printed and published in English in Geneva. 6. Publication of Standards in Other Languages ??National committees will be responsible for translating international standards into national languages ??and numbering them. Then it is published as a national standard. It is necessary to emphasize that the 18 member states of the European Community or the European Free Trade Association have taken the following measures when adopting the ISO9000 family of international standards: - Use standards to replace mandatory technical documents; - Various Member states have the right to use EN standards; - All member states must obtain the corresponding European standards within the same time (European standards = EN = ISO standards); - Use the same number as the ISO standard, "EN" will be used as a component of the number Part is completed. Before the above measures were adopted, ISO10011 was coded as EN30011 and ISO9004-2 was coded as EN29004-2. I believe this situation will change in the Tianyi version (standards are usually revised every 5 years). When converting the 1987 version of the ISO9000 series standards into European standards, 20000 was added to the original number to become the European standard number (for example, Denmark compiled ISO9001:1987 as DS/ISO9001:1988 and DS/EN29001:1998). 2. ISO9000 family of international standards The ISO9000 family of international standards is divided into the following parts: 1. The ISO9000-X Guidelines provide guidance for the selection and use of standards in the entire ISO9000 family, and also cover certain single topics (such as trustworthiness). Safety: ISO9000-4). It is particularly emphasized that the numbering of ISO9000-3 is inappropriate. According to its content, it should be included in the ISO9004-X group. 2. ISO9001, ISO9002, ISO9003 quality assurance models These models put forward requirements for the quality system of product suppliers and are applicable to contract situations and third-party certification. Note in particular that ISO/TC176 only establishes basic standards. ISO, CEN or technical committees of various countries have developed some branch standards based on these basic standards, such as: - EN46001: 1993 - quality system; medical devices; implementation requirements of EN29001. —EN46002:1993—Quality system; medical devices; implementation requirements of EN29002. 3. ISO9004-X Guide provides guidance for various industries to implement appropriate quality management or implement appropriate system elements in the quality system.

4.ISO100x x; Requirements Guide provides supporting tools and techniques for implementing quality systems. ISO10012-1 and ISO10012-2 put forward requirements for measuring equipment. Other standards provide guidance. 5. ISO8402 Quality Management and Quality Assurance - Terminology, 1994 as the only terminology standard, ISO8402 defines terms related to quality management.