Ⅰ. What is ISO ?

ISO is the abbreviation of "International Organization for Standardization".

ISO is the biggest international standards organization in the world, which established on February 23, 1947. As a matter of fact its predecessor is ISA (i.e. International Federation of International Standardized Association founded in 1928). Compared with IEC (i.e. International Electro-technical Commission as the earliest international standards organization set up in London, U.K. in 1906) which is responsible for the standardized activities in the electro-technical and electronic field, ISO is responsible for the those in all other fields.

ISO aims to be "to promote the development of standardization and relevant activities in the world; to facilitate the international exchange of the goods and service; to launch the cooperation in the intelligence, science, technology and economic field. "

ISO has 117 members, coming from 117 countries and regions at present.

The highest authority of ISO is the annual "the convention of the whole", while the routine office is the central Secretariat, situated in Geneva, Switzerland. There are 170 employees leaded by the secretary-general in the central secretariat.

Ⅱ. What is ISO9000?

ISO launches the technological activities through 2856 technological organizations. To be more exact, there are 185 technical committees (abbreviated as TC), 611 sub-technical committee (abbreviated SC), 2022 work groups (abbreviated as WG) and 38 special work groups.

"International Standard" is the achievement/product of technological activities conducted by ISO 2856 technological organizations. Currently ISO already made the international standard as many as more than 10300, mainly covering the technical specifications for a variety of products (including service products and intellective products etc.) in all trades and professions.

The international standard ISO works out has not only the canonical name, but also the serial number. The form of serial number is: ISO + standard number + [hyphen + substandard number]+ colon + issued year number (the content in the square bracket is dispensable.), for example: ISO8402: 1987, ISO9000-1: 1994, are the serial numbers for certain standards.

However," ISO9000" is not referred to a standard, but a general designation for a group of standard. According to the definition ISO9000-1: 1994, "ISO9000 group' is referred to all international standards made by ISO/TC176."

What is TC176? TC176 is the 176th technical committee in ISO. It was established in 1980 with the full name as "Technical Committee of Quality Guarantee ", which is renamed as "Technical Committee of Quality control and guarantee" in 1987. TC176 is in charge of constituting the standard of quality control and guarantee.

The earliest standard that TC176 made is ISO8402: 1986, is called "quality-glossary", issued formally on June 15th, 1986. On March of 1987, ISO formally issued five international standards (i.e. ISO9000: 1987, ISO9001: 1987, ISO9002: 1987, ISO9003: 1987, ISO9004: 1987), which is called as "ISO9000 Series Standard" together with ISO8402: 1986.

Afterwards TC176 released one standard in 1990, three standards in 1991, one standard in 1992 and five standards in 1993. In 1994, no standard was issued, but an amendment was made on the aforesaid "ISO9000 Series Standard" in unison, which was changed to ISO8402: 1994, ISO9000-1: 1994, ISO9001: 1994, ISO9002: 1994, ISO9003: 1994, ISO9004-1: 1994, and the standard that TC176 made is defined as "ISO9000 Group" consequently. In 1995, TC176 published one standard again with the serial number ISO10013: 1995. So far, there are 17 standards altogether in the group of ISO9000. (see appendix A in detail)

The above-mentioned standards should be understood thoroughly by the expert, while it is just OK for the enterprise to select one of the following three standards.

1. ISO9001: 1994 "quality system--the mode of quality guarantee on the design, development, production, installation and service".
2. ISO9002: 1994 "quality system--the mode of quality guarantee on the production, installation and service".

3. ISO9003: 1994 "quality system--the mode of quality guarantee on the final examination and experiment".

Ⅲ. What is the authentication ?

The English original meaning of "authentication" is a kind of action to provide the documentary evidence. The definition of "authentication" in 2:1986 for ISO/IEC guide2: "the action to verify whether the product or service complies with the stipulated standard or regulatory document by the fully trustworthy third party.

For instance, the product that the first party (i.e. the supplier or seller) manufactured must be determined by the third party, because the second party (the purchaser or buyer) is unable to judge whether it is qualified. The third party should be responsible for the other two parties in an impartial position and issue the documentary evidence that can be trusted by them. The above action is named "authentication".

In other words, the authentication of the third party can not be valid without the publicity, fairness and justice. Under these circumstances the third party must have the absolute both the right and prestige, be independent outside the other two parties, have nothing to do with them financially. Or they have the equal stakes or have the duty and responsibility to safeguard the rights and interests of the other two sides. In this way can the other two sides grant the full trust.

However, who should act as the role of third party ? Obviously, nobody can do this except the state/government. Namely, they are the organ or the approved organization of the state/government, which is called "the authentication organization". (see appendix B in detail)

Presently the authentication organizations in various countries mainly offer two kinds of authentication service as follows.  

1. Quality Authentication

The modern system of quality authentication of the third party, derived from Britain in 1903, was initiated by British Project Standard Committee (i.e. the predecessor of BSI).

Before such authentication came into being, the supplier (i.e. the first party) usually adopt the system of "Qualification Declaration" to attract the trust from the customer (i.e. the second party) and promote the sale of products. This way is feasible under those circumstances that the products were made so simply that its qualification can be directly judged without any professional examination means. However, with the development of science and technology, the kinds of products increases day by day and the structure and function of products becomes complicated, it is quite hard for the buyer to judge whether the product is qualified by means of his own knowledge and experience only. In addition the "Qualification Declaration" of the supplier is mainly involved in self-glorification, regardless of whether it is true or not, which results in the distrust while the prestige and effect in this way drop gradually. In this case, the aforesaid system of quality authentication emerges as the times require.

In 1971, ISO established "the Authentication Committee"(CERTICO); In 1985, its name changed to "qualification evaluation committee"(CASCO), which promoted developing the system of qualification authentication in various countries.

Now the quality authentication is averagely conducted according to the international standard. Particularly 60% of the international standard is made by ISO while 20% is constituted by IEC and 20% was made by other international standardization organizations. On the other hand, many of them are also authenticated according to their own national and the foreign advanced standard. (see appendix C in detail)

The quality authentication includes two kinds. One is called "Eligibility Authentication", which is to make the attestation as per the performance requirement in the standard. The other is called "Safety Authentication" on basis of the security requirement in the standard. The former is voluntary whereas the latter is mandatory.

The system of quality authentication has developed at a high speed since the 1930s. In the 1950s, it is popularized in all industrially developed countries. From 1970s, it was spread gradually in major countries in the third world. It is in the April of 1981 that the first authentication organization, "China authentication committee on electronic appliances", was established in China. It made a feature of high starting point and rapid growth, although being somewhat late.

2. Quality Management System Authentication

This kind of authentication is developed from the activity of western quality guarantee.

In 1959, U.S.A. Ministry of National Defence proposed a request on the quality guarantee to the subsidiary military enterprise, requiring that the contractor "should make and keep the effective and economical system of quality guarantee in conform to its management and regulation", "should fully guarantee the quality while realizing all the fields and process required by the contract (e.g. design, development, manufacture, processing, assembly, examination, test, maintenance, loading, storage and installation), and stipulate two kinds of unified modes on the system of quality guarantee, i.e., army mark MIL-Q-9858A "Quality Outline Requirement" and army mark MIL-I-45208 "Examination System Requirement". The contractor should work out "Quality Guarantee Guide" according to the two modes, and then implement it effectively. The government will check one by one as per the documentation, evaluating the status of performance. This is the embryonic form of the modern quality verification system of the second party in fact. This kind of method impelled the contractor to carry on the overall quality control and made great success.

Later, the experience of U.S.A. military enterprise was adopted by the departments of war industry in the other industrially developed countries soon, and then gradually extended to the civil industry and flourished in western countries.

With the rapid growth of the aforesaid activities of quality guarantee, the authentication organs in various countries gradually increased the content to verify the system of quality guarantee in enterprises and promoted developing the activity of quality guarantee further, while carrying out the authentication on the quality.  In the late stage of 1970, BSI (i.e. Britain Standard Institute), an authentication organ in Britain, took the lead in separately authenticating the system of quality guarantee, develop the quality guarantee from the verification of second party to the authentication of third party. This received the acclamation from different fields and promoted the rapid development of quality guarantee activity.

Through three-year practice, BSI thought, the authentication on this system of quality guarantee was of both wide accommodation and great flexibility, particularly, had great value in popularization all over the world. As a result, they submitted a suggestion to ISO in 1979. According to suggestion of BSI, ISO determine to establish "the Quality Guarantee Committee" based on "the Quality Guarantee Workgroup" under the authentication committee of ISO in the same year. In 1980, ISO approved the establishment of "the Quality Guarantee Technical Committee"(i.e. TC176) to set about the service, which caused the birth of the aforesaid "ISO9000 group" standard, perfected the separate system of quality authentication. Furthermore this expanded the business range of the original organization of quality authentication on one hand, and brought about the naissance of a good many new professional organizations of quality authentication again on the other hand.

Since the ISO9000 series standard came out in 1987, in order to strengthen the quality management and adapt to the quality competition, more and more entrepreneurs have adopt the ISO9000 series standard and then set up the system of quality control inside enterprises and applied for the quality authentication, which formed a worldwide trend quickly. At present nearly 100 countries and regions are pursuing the ISO9000 international standard actively. Besides there are about 40 institutes of quality verification, about 300 organizations of quality authentication, more than 200,000 enterprises who got the certificate of ISO9000 quality authentication. Specially the first international multilateral recognition agreement and the first regional one were respectively signed in Guangzhou, China in January 22th and 24th, 1998.

The set of international standards is adopted by so many countries in the short time, exerting the influence so extensively, which is unprecedented in the history of international standardization and then recognized as "ISO9000 phenomenon".

However, why did the ISO9000 business grow so rapidly ? (more details in the following chapter)

Ⅳ. the Effect to Carry out ISO9000

1. Strengthen Quality Control; Improve Enterprise Benefit; build up Customer Confidence; Expand Market Share

The authentication organization responsible for ISO9000 quality authentication is the authoritative one approved by the state. They are quite strict with verifying the quality system of enterprise. In this way, the exterior of enterprise can carry on the quality control according to the international standardized and strictly verified quality system, which can comply with the requirement of the law and science, improve the working efficiency and product quality percentage greatly, and enhance the economic and social benefits of enterprise rapidly. On the other hand, the interior of enterprise can expand the share of market, as the customer will be so assured that the enterprise are the trustworthy one to firmly manufacture the qualified even first-rank product as to sign the supply and marketing contract with the enterprise when learning that the supplier conducts the management according to the international standard, possesses the certificate of ISO9000 quality authentication, and is strictly verified and regularly supervised by the authentication organization. In other words, it will get effect instantly in the two fields.

2. Obtain the "Permit" and Remove the Barrier in the International Trade 

In order to protect their own interests, a lot of states set up quite a few of trade barriers including tariff and non-tariff wall. Specially, the non-tariff wall is mainly referred to the technical barrier, which is mainly composed of the barrier in the authentication of product quality and ISO9000 system. Especially, every member state in WTO (i.e. World Trade Organization) get rid of the tariff wall each other, so there is only the technical barrier they can set up. Hence, to obtain the authentication is the main way to wipe off the trade barrier. (Since China entered WTO, the strict demarcation between the domestic and international trade fades away, while it is likely to encounter above-mentioned technological barriers in all trades, which should draw the great attention of the enterprises who ought to make the preparation as early as possible.)

3. Save the Energy and Expense of the Second Party in Verification

In the modern trade practice, the verification of the second party is conventional for a long time. However, the heavy drawbacks emerge gradually. One supplier usually supply the products for many buyers, and the verification of the second party will undoubtedly brings the heavy burden to the supplier. On the other hand, the buyer has to pay the considerable cost, taking into consideration the experience and level of the dispatched people for employees. Otherwise, the anticipated effect can not be exerted notwithstanding the cost is paid. Therefore it is the ISO9000 authentication that can eliminate such a drawback, because the second party will not verify the first party once the enterprise, as the first party, has applied for the ISO9000 authentication of the the third party and obtained the related certificate. As a result, both the first party and the second party can save lots of energy or expenses. In addition, if passing through the quality authentication, the enterprise can be exempted from the charge that the authentication organization doubly verifies the quality guarantee system, when the other products, such as UL, CE, etc., need authenticating later. 

4. Be Forever in an Invincible Position in the Quality Competition 

The means of competition in the international trade is mainly shown on the price and the quality. For the method to sell at a low price makes the profit fall sharply, even incurs the sanction if it is testified as a dumping action, the means of price competition is more and more inadvisable. Since the 1970s, the competition on the quality has already become the key means in the international trade, while many states have increased the requirement on the quality of imports as the important measure of the trade protectionism to restrict imports and encourage exports. To implement the quality control of ISO9000 international standardization can improve the quality of the products steadily, and make the enterprise remain unassailable forever in the quality competition.

5. Avoid the Liability of Product Effectively

While various states carry out the law on product quality, the complaints about the product quality is more and more frequent; The cause of accident is more and more complicated; To investigate the responsibility is stricter and stricter too. Particularly, in the latest years, the developed countries shifted the old principle "fault liability" into the new one "strictness responsibility", heightening the security requirement a lot on the manufacturers. For example, if a worker is injured at the time of operating a lathe, the principle of "strictness responsibility" requires the court not only to look into the quality of the lathe, such as the malfunction on spare parts, etc., but also investigate whether it is equipped with any safety device, or whether there is any device giving the warning to the worker, and the like. The court can adjudge that this lathe is the defective and the manufacturer will compensate for the consequence according to the above-mentioned conditions. However, according to the law of product liability in various countries, if the manufacturer offers the ISO9000 certificate of quality authentication, they can be exempted from the compensation. Otherwise, they will lose a lawsuit and then be punished severely. (With the perfection of our law, the circle of enterprises should pay great attention to "the law of product liability" in case of the problem.

6. Facilitate the Technology Exchange and the Economic Cooperation in the World