Introduction to ISO basic knowledge

ISO is an English abbreviation for an organization. Its full name is International Organization for Standardization, translated into Chinese is "International Standardization Organization".

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 to cooperate in the fields of intelligence, science, technology and economy.

ISO currently has 117 members, including 117 countries and regions.

The highest authority of ISO is the "General Assembly" once a year, and its daily office is the Central Secretariat, located in Geneva, Switzerland. The Central Secretariat currently has 170 staff, headed by the Secretary-General.

What is ISO9000

ISO conducts technical activities through its 2856 technical institutions. There are 185 technical committees (TC), 611 sub-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 formulated more than 10,300 international standards, mainly related to the technical specifications of various products in various industries (including service products, knowledge products, etc.).

In addition to the standardized name, the international standards developed by ISO also have a number. The format of the number is: ISO standard number [bar substandard number] colon release year (the content in square brackets is optional), for example: ISO8402: 1987, ISO9000-1: 1994, etc. are the numbers of a certain standard. However, "ISO9000" does not refer to a standard, but a general term 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 and its full name is "Quality Assurance Technical Committee". In 1987, it was renamed as "Quality Management and Quality Assurance Technical Committee". TC176 is responsible for formulating standards for quality management and quality assurance technology.

One of the earliest standards developed by TC176 was ISO8402: 1986, named "Quality-Terminology", which was officially released on June 15, 1986. In March 1987, ISO officially released ISO9000: 1987, ISO9001: 1987, ISO9002: 1987, ISO9003: 1987, ISO9004: 1987, a total of 5 international standards, together with ISO8402: 1986, collectively referred to as "ISO9000 series of standards".

Since then, TC176 has issued another standard in 1990, three standards in 1991, one standard in 1992, and five standards in 1993; no additional standards were released in 1994, but for the aforementioned "ISO9000 series standards" It has been uniformly modified and changed to ISO8402: 1994, ISO9000-1: 1994, ISO9001: 1994, ISO9002: 1994, ISO9003: 1994, ISO9004-1: 1994, and the standards developed by TC176 are defined as "ISO9000 family". In 1995, TC176 released another standard, the number is ISO10013: 1995. On December 15, 2000, ISO released the 2000 version of the ISO9000 series of standards, reducing the original 9000 series of standards to the following three standards:

1. ISO9000: 2000 "Quality Management System-Foundation and Terminology";

2. ISO9001: 2000 "Quality Management System-; Requirements";

3. ISO9004: 2000 "Quality Management System-Performance Improvement Guide".

What is authentication

The original meaning of the word "authentication" in English is an act of issuing supporting documents. The definition of "certification" in ISO / IEC Guide 2: 1986 is: "The activity of a third party that can be fully trusted to verify that a certified product or service meets a specific standard or regulatory document."

For example, for the product A produced by the first party (supplier or seller), the second party (demand or buyer) cannot determine whether the quality is qualified, but is determined by a third party. The third party is responsible to both the first party and the second party. It is impartial, and the certificate issued must be able to gain the trust of both parties. Such an activity is called "certification".

This means that third-party certification activities must be open, fair and equitable in order 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 interest with the first party and the second party, or have the same interest, or Only with 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 assume the role of this third party? Obviously, there is no non-state or government. This role is directly assumed by the state or government agency, or by an organization recognized by the state or government. Such an agency or organization is called a "certification body".

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

Before the certification system came into being, the supplier (first party) usually used a "product declaration of conformity" to gain the trust of the customer (second party) in order to promote its products. This method was feasible when the product was simple at that time and the quality could be judged intuitively without special detection methods. However, with the development of science and technology, the variety of products is increasing, and the structure and performance of products are becoming more and more complicated. It is difficult to judge whether the products meet the requirements based on the knowledge and experience of the buyer; plus the "product conformity declaration" of the supplier belongs to "Wang Po" The set of "selling melons and self-proclaiming boasting" is true and false, mixed with fish and dragons, and is not always credible. The credibility and role 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, the name was changed to "Conformity Assessment Committee" (CASCO), which promoted the development of product quality certification systems in various countries.

Nowadays, product quality certifications of countries all over the world are generally certified according to international standards. 60% of the international standards are made by ISO, 20% are made by IEC, and 20% are made by other international standardization organizations. Many are also certified according to their own national standards and advanced foreign standards, see Appendix C for details.

Product quality certification includes two types of qualification certification and safety certification. Certification based on the performance requirements in the standard is called conformity certification; certification based on the security requirements in the standard is called safety certification. The former is voluntary, the latter is mandatory.

Product quality certification has developed rapidly since the 1930s. By the 1950s, all industrialized developed countries were basically popularized. The majority of countries in the third world were gradually introduced in the 1970s. China established its first certification body-"China Electronic Device 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 by Western quality assurance activities.

In 1959, the US Department of Defense proposed quality assurance requirements to military enterprises under the Department of Defense Supply Bureau, requiring contractors to "develop and maintain an effective and economical quality assurance system consistent with their management, procedures, and regulations." Fully ensure quality in all areas and processes required by the contract (eg, design, development, manufacturing, processing, assembly, inspection, testing, maintenance, boxing, storage, and installation) "and provides for two types of unification for the quality assurance system Mode: Military standard MIL-Q-9858A "Quality Outline Requirements" and military standard MIL-I-45208 "Inspection System Requirements". The contractor shall prepare the "Quality Assurance Manual" according to these two models and implement it effectively. The government should gradually check and evaluate the implementation against the documents. This is actually the prototype of the modern second-party quality system audit. 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 bodies in various countries have gradually increased the content of auditing the enterprise's quality assurance system during product quality certification, which has further promoted the development of quality assurance activities. In the late 1970s, a British certification body BSI (British Standards Association) first launched a separate quality assurance system certification business, making quality assurance activities from second-party audits to third-party certification, which has been welcomed by all parties. Promote the rapid development of quality assurance activities.

After three years of practice, BSI believes that the certification of this quality assurance system has a wide range of adaptability, flexibility, and value to promote to the international community. Therefore, a proposal was submitted to ISO in 1979. According to the recommendations of BSI, ISO decided to establish a "Quality Assurance Committee" on the basis of the "Quality Assurance Working Group" of the ISO certification committee. In 1980, ISO formally approved the establishment of the "Quality Assurance Technical Committee" (that is, TC176) to start this work, which led to the birth of the aforementioned "ISO9000 family" standard, perfected the separate quality system certification system, and expanded The scope of business of quality certification bodies, on the other hand, has led to the birth of a large number of new specialized quality system certification bodies.

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 a quality management system within the enterprise and apply for quality system certification, quickly forming a worldwide trend . At present, nearly 100 countries and regions around the world are actively promoting the ISO9000 international standard. There are about 40 quality system accreditation bodies, about 300 quality system certification bodies, and more than 200,000 companies have obtained ISO9000 quality system certification. The first international multilateral recognition agreement and regional multilateral recognition agreement were also born on January 22, 1998 and January 24, 1998 in Guangzhou, China.

A set of international standards has been adopted by so many countries in such a short period of time, and its influence is so extensive. This is a phenomenon that has never been seen in the history of international standardization and has been recognized as the "ISO9000 phenomenon".