ISO is the abbreviation of an organization. Its full name is International Organization for Standardization, which is translated from Chinese as "International Organization for Standardization".

ISO is the largest international standardization organization in the world. It was founded on February 23rd, 1947 at/kloc-0. Its predecessor was the International Federation of Standardization Associations (ISA), which was founded at 1928. He is older than IEC. IEC, the International Electrotechnical Commission, 1906 was established in London, England, and it is the earliest international standardization organization in the world. IEC is mainly responsible for standardization activities in the fields of electrician and electronics. ISO is responsible for standardization activities in all other fields except electrical and electronic fields.

ISO claims that its purpose is to "promote the development of standardization and related activities worldwide, thereby promoting the international exchange of goods and services and cooperation in the fields of intelligence, science, technology and economy."

ISO has 1 17 members, including 1 17 countries and regions.

The highest authority of ISO is the annual General Meeting of Members, and its daily office is the Central Secretariat, located in Geneva, Switzerland. At present, the Central Secretariat has 65,438+070 employees and is headed by the Secretary-General.

Second, what is ISO9000?

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 ISO9000- 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. Up to now, ISO9000 family * * * has 17 standard. See appendix a for details.

As an expert, you should be familiar with the above standards. As an enterprise, you only need to choose one of the following three criteria:

1т 9001:19940 quality assurance model for mass system design, development, production, installation and service;

2. т 9002:1994 "Quality assurance mode of mass system production, installation and service";

3. 10903:1994 "Quality assurance mode of the final inspection and test of mass system".

Third, what is certification?

The original meaning of the word "authentication" in English is the act of issuing certification documents. In ISO/IEC Guide 2: 1986, the definition of "certification" is: "The activity that certified products or services conform to specific standards or normative documents formulated by completely trusted third parties."

For example, for product A produced by Party A (supplier or seller), Party B (buyer or buyer) cannot judge whether its quality is qualified, but a third party will. The third party should be responsible to both parties, be impartial and issue a certificate that can win the trust of both parties. Such an activity is called "authentication".

In other words, third-party certification activities must be open, fair and just in order to be effective. This requires that the third party must have absolute power and prestige, must be independent of the first and second parties, must have no economic interests with the first and second parties, or have equal interests, or have the obligation and responsibility to safeguard the rights and interests of both parties, in order to gain the full trust of both parties.

So, who should play the role of this third party? Obviously, it is not a country or a government. This role is played directly by an organ of the state or government, or by an organization recognized by the state or government. Such an organ or organization is called. Quot Certification Authority ",see Appendix B for details.

At present, certification bodies 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 Britain as early as 1903 and was initiated by the British Engineering Standards Committee (the predecessor of BSI).

Before the certification system came into being, suppliers (Party A) usually used "product conformity statement" to win the trust of customers (Party B) and promote their products. This method was feasible when the product was simple at that time and the advantages and disadvantages could be judged intuitively without special testing means. However, with the development of science and technology, there are more and more kinds of products, and the structure and performance of products are becoming more and more complicated. It is difficult to judge whether the product meets the requirements only by the knowledge and experience of the buyer. In addition, the supplier's "product conformity statement" belongs to the set of "the old lady sells melons and boasts herself", which is mixed with truth and falsehood and is not always credible, so the credibility and function of this method will gradually decline. In this case, the aforementioned product quality certification system came into being.

197 1 year, ISO established CERTICO, and in 1985 CERTICO was renamed as "Conformity Assessment Committee" (CASCO), which promoted the development of product quality certification systems in various countries.

At present, the product quality certification of all countries in the world is generally based on international standards. 60% of international standards are formulated by ISO, 20% by IEC and 20% by other international standardization organizations. Many of them are certified according to their own national standards and advanced foreign standards. See appendix c for details.

Product quality certification includes qualification certification and safety certification. Certification according to the performance requirements in the standard is called conformity certification; According to the safety requirements in the standard, the certification is called safety certification. The former is voluntary and the latter is compulsory.

Product quality certification has developed rapidly since 1930s. By the 1950s, it was basically universal in all industrialized countries. Most countries in the third world gradually implemented it in the 1970s. The first certification body in China, China Electronic Device Quality Certification Committee, was established in April 198 1. Although it started late, it has a high starting point and rapid development.

2. Quality management system certification

This kind of certification is developed from western quality assurance activities.

In 1959, the U.S. Department of Defense put forward quality assurance requirements to military enterprises under the Department of Defense Supply Bureau, requiring contractors to "establish and maintain an effective and economical quality assurance system consistent with their management and procedures" and "implement contract requirements in all fields and processes (such as design, development, manufacturing, processing, assembly, inspection, testing, maintenance, packaging, storage and installation). There are two unified models of quality assurance system: the quality outline requirements of military standard MIL-Q-9858A and the inspection system requirements of military standard MIL-I-45208. The contractor shall prepare the "Quality Assurance Manual" according to these two modes and implement it effectively. The government should check and evaluate the implementation step by step according to the documents. This is actually the embryonic form of modern second-party quality system audit. This method has prompted the contractor to carry out total quality management and achieved great success.

Later, the experience of American military enterprises was quickly adopted by the military departments of other industrialized countries, and gradually extended to civilian industries, which flourished in western countries.

With the rapid development of the above-mentioned quality assurance activities, certification bodies in various countries have gradually increased the content of auditing the quality assurance system of enterprises when conducting product quality certification, which further promoted the development of quality assurance activities. At the end of 1970s, BSI (British Standards Institute), a British certification body, launched a separate quality assurance system certification business for the first time, which made the quality assurance activities develop from second-party audit to third-party certification, which was welcomed by all parties and further promoted the rapid development of quality assurance activities.

After three years of practice, BSI believes that this quality assurance system has wide adaptability and great flexibility, and it is worth popularizing to the international community. Therefore, 1979 submitted a proposal to ISO. According to BSI's suggestion, ISO decided to set up the Quality Assurance Committee on the basis of the Quality Assurance Working Group of ISO Certification Committee. 1980, ISO officially approved the establishment of "Technical Committee for Quality Assurance" (TC 176) to start this work. On the one hand, it gave birth to the aforementioned "ISO9000 family" standards, improved the independent quality system certification system, expanded the business scope of the original quality certification institutions, and on the other hand, it gave birth to a large number of new specialized quality system certification institutions.

Since the release of 1987 ISO9000 series standards, in order to strengthen quality management and meet the needs of quality competition, entrepreneurs have adopted ISO9000 series standards to establish quality management systems within enterprises and applied for quality system certification, which has quickly formed a worldwide trend. At present, nearly 65,438+000 countries and regions in the world are actively promoting ISO9000 international standards, about 40 quality system accreditation bodies and about 300 quality system certification bodies have been accredited. More than 200,000 enterprises have obtained the ISO9000 quality system certification.15438+on June 22, 5438+ 10 and the first international multilateral accreditation agreement and regional multilateral accreditation agreement were held on June 5438.

A set of international standards has been adopted by so many countries in such a short time and has such a wide influence, which is unprecedented in the history of international standardization and is recognized as "ISO9000 phenomenon".

So, why is ISO9000 developing so rapidly? Please see the next section.

Fourth, the role of implementing ISO9000

1. Strengthening quality management and improving enterprise benefits: enhancing customer confidence and expanding 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 people gradually find that there are great disadvantages: a supplier usually has to supply many buyers, 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 means of international trade competition are mainly 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 avoid 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 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 exchange, the two sides must have the same language, unified understanding and * * * standards in terms of product (including service) quality before they can cooperate and exchange. 𚧈 The quality system authentication is to provide this kind of trust, which is beneficial to the quick agreement between the two parties.