Quality system certification
Quality system certification is also called "quality system registration".The quality system of an enterprise shall be evaluated by an impartial third-party system certification institution according to the officially issued quality system standards, and the system certification certificate and registration directory shall be issued to prove to the public that the quality system of an enterprise complies with all activities of a certain quality system standard.
The first is the application and evaluation stage of certification, whose main task is to accept and evaluate the supplier quality system that accepts the application, decide whether to approve the certification and register, and issue the certificate of conformity.
The second is the daily supervision and management stage of the supplier quality system approved for certification. The purpose is to make the supplier quality system approved for certification continue to meet the requirements of corresponding quality system standards within the valid period of certification.
The specific procedures
1. Application :(1) submission of certification application, (2) examination and approval of certification application;
2. Inspection and evaluation :(3) document review, (4) preparation before site inspection, (5) site inspection and evaluation, (6) submission of inspection report;
(7) examination and approval, (8) registration and issuance;
4. Supervision and management after approval of certification :(9) notification of supplier, (10) supervision and inspection, (11) suspension or revocation of certification, and (12) extension of validity of certification.
Independent third-party quality system certification was born in the late 1970s, and it evolved from product quality certification.Quality system certification has the following characteristics:
1. The certification object is the supplier's quality system.The object of quality system certification is not a product or service of the enterprise, but the quality system itself.Of course, the quality system certification inevitably involves the products or services covered by the system. Some enterprises apply for the certification of the overall quality system including all kinds of products or services of the enterprise, and some apply for the certification of the quality system of only one or part of products (or services).Although the range of products involved is large and small, and the object of certification is the supplier's quality system.
2. Certification is based on quality assurance standards.Quality system certification is often the need of the supplier to provide quality assurance to the external, so the certification basis is related to quality assurance model standards.In order to make the quality system certification and international practices meet mutual recognition, the supplier had better choose one of the standards of ISO9001, ISO9002 and ISO9003.
3. The certification institution is the third-party quality system evaluation institution.To ensure the impartiality and credibility of the supplier quality system certification, the certification must be undertaken by a third party organization that has no economic interest or administrative affiliation with the certified entity (supplier).In addition to having experienced, well-trained personnel, meeting required resources and procedures, the agency must win the support of the government and the trust, authority and impartiality of the society with its good certification practices.
4. The approved identification is registration and certificate issuance.The quality system applying for certification according to the prescribed procedure shall be registered and issued by the certification body to the certification enterprise after the evaluation result is judged to be qualified, which shall be included in the list of quality system certification enterprises and published publicly.An enterprise approved for certification may use the registration mark in promotional materials, trade fairs and other promotional activities, but shall not use the mark directly on the product or its packaging to avoid confusion with product certification.The registration mark shall be protected by law and shall not be used presumptuously or forged.
5. Certification is an enterprise's independent behavior.Product quality certification can be divided into two categories: safety certification and quality certification, of which safety certification is often mandatory certification.Quality system certification, mainly for the purpose of improving the enterprise's quality reputation and expanding sales volume, is generally voluntary enterprises, the initiative to put forward applications, is the enterprise's independent behavior.However, enterprises that do not apply for certification are often subject to natural market pressure of distrust or trade barriers, forcing enterprises to strive to enter the ranks of certification enterprises, but this is not a mandatory role of certification system or government decree.
ISO9000 is developed from western quality assurance activities.During the second world war, due to the expansion of the war, the demand for weapons grew rapidly. Due to the limitations on the size, technology and personnel of the weapons manufacturing factories at that time, American arms dealers failed to meet the requirement of "all for war".The us department of defense is faced with the problem of expanding the production of weapons and ensuring the quality of weapons.Analysis of the enterprise at that time: most of the management is NO1, that is, the foreman is managing by experience, directing production, and the technology is all in his head, while the number of people under the management of a NO1 is very limited, and the output is certainly limited, far from the demand for war.So, defense organization large enterprise technical personnel written technical standard file, open training classes, for employees from other related to the original machinery factory (such as hardware, tools, casting factory), a large number of training, can make it in a very short period of time in identifying process diagram and rules, master the key technologies needed for weapons, which will "proprietary technology" quickly "copy" to other mechanical factory, thus miraculously effectively solves the problem of war.After the war, the ministry of defense summarized and enriched the valuable experience of "process documentation", compiled more detailed standards to be promoted and applied in the national factories, and also achieved satisfactory results.At that time, documents were prevailing in the United States. Later, this experience of American military industry was quickly adopted by the military industry departments of other industrial developed countries and gradually extended to civil industry, which flourished in western countries.
With the rapid development of the above quality assurance activities, certification authorities in various countries have gradually increased the content of auditing the quality assurance system of enterprises, which further promoted the development of quality assurance activities.In the late 1970s, BSI (British standard association), a British certification body, first carried out the certification business of a separate quality assurance system, which enabled the quality assurance activity to develop from the second party audit to the third party certification, which was welcomed by all aspects and promoted the rapid development of quality assurance activities.
Through three years of practice, BSI believes that the certification of this quality assurance system has a wide range of adaptability, flexibility and value of promotion to the international community.A proposal was submitted to ISO in 1979.In accordance with the recommendations of the 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, the ISO formally approved the establishment of the "quality assurance technical committee" (TC176) set about this job, leading to the birth of the "ISO9000 family of standards, a sound system of a single quality system certification, on the one hand, to expand the business scope of original quality certification body, on the other hand, has led to a large number of the birth of new specialized quality system certification body.