Quality system certification stage
First, the application and evaluation stage of certification, the main task of which is to check and evaluate the quality system of suppliers who accept the application, decide whether the certification can be approved for registration, and issue certificates of conformity.
The second is the daily supervision and management stage of the certified supplier quality system, which aims to make the certified supplier quality system continuously meet the requirements of the corresponding quality system standards within the validity period of certification.
Specific procedures for quality system certification
1. Application: (1) Submit the certification application, (2) Approve the certification application;
2. Inspection and evaluation: (3) document review, (4) preparation before on-site inspection, (5) on-site inspection and evaluation, (6) submission of inspection report;
3. Examination and approval, registration and certification: (7) Examination and approval, (8) registration and certification;
4. Supervision and management after passing the certification: (9) Supplier notification, (10) supervision and inspection, (1 1) suspension or revocation of the certification, (12) extension of the validity period of the certification.
Characteristics of quality system certification
Independent third-party quality system certification was born in the late 1970s and evolved from product quality certification. Quality system certification has the following characteristics:
The object of 1. certification is the supplier's quality system. The object of quality system certification is not the products or services of enterprises, but the quality system itself. Of course, the quality system certification will inevitably involve 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, and some applications only include the quality system certification of one or some products (or services). Although the range of products involved is large and small, 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 for suppliers to provide external quality assurance, so certification is based on relevant quality assurance model standards. In order to make the quality system certification conform to international practice, suppliers should choose one of ISO900 1, ISO9002 and ISO9003 standards.
3. Certification institutions are third-party quality system evaluation institutions. In order to make the supplier's quality system certification fair and credible, the certification must be undertaken by a third-party organization that has no economic interests and administrative affiliation with the certified unit (supplier). In addition to having experienced and well-trained personnel, qualified resources and procedures, this institution must win the support of the government and the trust of the society with its excellent certification practice, which is authoritative and fair.
4. The marks of certification and recognition are registration and issuance of certificates. For the quality system that applies for certification according to the prescribed procedures, when the evaluation result is judged to be qualified, the certification body shall register the certification enterprises and issue certificates, which shall be listed in the list of quality system certification enterprises and publicly released. Certified enterprises may use the registered mark in publicity materials, trade fairs and other promotional activities, but they may not directly use the mark on products or their packaging to avoid confusion with product certification. A registered trademark is protected by law and may not be fraudulently used or forged.
5. Certification is the independent behavior of enterprises. Product quality certification can be divided into two categories: safety certification and quality certification, among which safety certification is often mandatory. Quality system certification is mainly to improve the quality reputation of enterprises and expand sales. Generally speaking, enterprises apply voluntarily and voluntarily, which is an independent behavior of enterprises. However, enterprises that do not apply for certification are often under the pressure of distrust or natural trade barriers in the market, forcing enterprises to strive to enter the ranks of certified enterprises, but this is not the mandatory role of certification system or government decrees.
Quality system certification conditions
In order to obtain the quality system certification, enterprises should mainly do two things: one is to establish and improve the quality assurance system, and the other is to do all the work directly related to the system certification. Regarding the establishment of quality assurance system, we should start with the distribution of quality functions, compile quality assurance manuals and program documents, and implement them to ensure the integrity of quality records. The work directly related to system certification mainly includes the following contents:
1, comprehensive planning, preparation of system certification work plan;
2. Grasp the information and choose the certification body;
3. Negotiate and sign a certification contract or agreement with the selected certification institution;
4. Submit the quality assurance manual;
5. Prepare for on-site inspection;
6, accept on-site inspection, timely feedback information;
7. Organize the rectification of nonconformities;
8. Obtain the certification certificate through system certification;
9. Prevent relaxation and retrogression, and continuously improve the quality system;
10, carry out rectification to meet the follow-up inspection.
The three keys for enterprises to obtain system certification are the attention of leaders, correct planning and the active participation of departments and all employees.
Interpretation of quality system certification
The original meaning of the word "authentication" in English is the act of issuing certification documents. The definition of "certification" in ISO/IEC Guide 2: 1986 is: "The activity of a completely trusted third party to make certified products or services conform to specific standards or normative documents."
For example, for the products or services provided by Party A (supplier or seller), Party B (buyer or buyer) cannot judge whether their quality is qualified, but a third party will. The third party should be responsible and impartial to both parties, and the certificate issued should 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.
The origin of quality system certification
???????ттттттттттттттттттттт10 During World War II, the demand for weapons needed for the expansion of the war expanded sharply, and American arms dealers were limited by the size, technology and personnel of the weapons manufacturing factories at that time, and could not meet the requirements of "all for war". Therefore, the U.S. Department of Defense is faced with the realistic problem of doing everything possible to expand weapons production while ensuring quality. Enterprise analysis at that time: most of the management was NO 1, that is, the foreman directed production by experience management, and the technology was all in his head, while the number of people managed by NO 1 was very limited, and the output was of course limited, which was far from the war demand. Therefore, the Ministry of National Defense organizes technicians of large enterprises to compile technical standard documents, offer training courses, and provide a lot of training to employees of other related original machinery factories (such as hardware, tools and foundries), so that they can learn to recognize process drawings and process rules in a short time and master the key technologies needed for weapons manufacturing, thus quickly "copying" "special technologies" to other machinery factories, thus miraculously and effectively solving the war problem. After the war, the Ministry of National Defense summed up and enriched the valuable experience of "process documents", compiled more detailed standards and popularized them in factories all over the country, and achieved satisfactory results. At that time, official documents prevailed in the United States. 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 "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.
Status quo of quality system certification
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. More than 100 countries and regions in the world are actively promoting the ISO9000 international standard.
Quality system certification steps
After reading the ISO900 1 standard carefully, you will definitely have such a concept. ISO900 1 standard is really comprehensive, which regulates all the processes of an enterprise from raw material procurement to finished product delivery, involving all employees from top to bottom. You may think that such a comprehensive and complex system must be very difficult to implement!
Admittedly, it is difficult to implement ISO9000. However, as long as you sincerely take ISO9000 as an important measure to improve the company's management performance instead of just posing, take it as a long-term development strategy and make careful planning according to the company's specific situation, ISO9000 will eventually take root in your company.
In short, there are five basic processes for implementing ISO9000:
Knowledge preparation-legislation-publicity-implementation-supervision and improvement.
According to the specific situation of your company, you can plan the above five processes and follow certain implementation steps to guide your company to gradually enter the world of ISO9000.
The following are typical steps for enterprises to implement ISO9000. It can be seen that these steps completely include the above five processes:
Identification and diagnosis of the original quality system of the enterprise;
Appoint management representatives and set up ISO9000 implementation agencies;
Set goals and incentives;
Personnel at all levels receive necessary management awareness and quality awareness training;
ISO900 1 standard knowledge training;
Compilation of quality system documents (legislation);
Large-scale publicity, training, release and trial operation of quality system documents;
Internal auditors have been trained;
Several internal quality system audits;
Management review based on internal audit;
Perfection and improvement of quality management system;
Apply for certification.
Before carrying out ISO9000, enterprises should carefully plan the above implementation steps according to their own actual conditions, and make specific arrangements in time and activities to ensure more effective implementation.
After repeated internal audits and gradual correction, enterprises can apply for external certification if they think that the established quality management system has reached the requirements of the selected standards (specifically, when few nonconformities are found in internal audits).
Applicable industries for quality system certification
1, agriculture and fisheries
2. Mining and quarrying
3. Food, beverages and tobacco
4. Textiles and textile products
5. Leather and leather products
6, wood and wood products
7. Pulp, paper and paper products
8. Publishing industry
9. Printing industry
10, coke and refined petroleum products
1 1, nuclear fuel
12, chemicals, chemicals and fibers
13, drugs
14, rubber and plastic products
15, nonmetallic mineral products
16, concrete, cement, lime, gypsum and others
17, base metals and metal products
18, mechanical equipment
19, electronic, electrical and photoelectric equipment
20. Shipbuilding
2 1, aviation, aerospace
22 other transportation equipment
23. Other manufacturing industries not classified.
24. Recycling of waste materials
25, power generation and power supply
26, gas production and supply
27. Water production and supply
28.architecture
29, wholesale and retail cars, motorcycles, personal and household goods repair.
30. hotels and restaurants
3 1, transportation, storage and communication
32. Finance, real estate and leasing services
information technology
34. Science and technology service industry
35. Other services
Public administration
37.education
38, medical and health and social welfare undertakings
39. Other social services
Series standard
1, GBT 19000-ISO 9000 "Quality Management and Quality Assurance-Guide to Selection and Use"
2. GBT19001-ISO 9001"Quality System-Quality Assurance Model for Design/Development, Production, Installation and Service"
3.GBT 19002-ISO 9002 "Quality System-Quality Assurance Mode of Production and Installation"
4.GBT 19003-ISO 9003 "Quality System-Quality Assurance Mode for Final Inspection and Test"
5.GBT 19004-ISO 9004 "Elements of Quality Management and Quality System-Guide"