It is suitable for all walks of life to standardize and program the quality system management of the organization. This is a very practical and popular film, which meets international management standards.
At present, all walks of life in our country are adopting it, and the answer of "Pippi, little darling" is no longer in line with the current standard. Here, the 94 version of the standard is also publicized, which is backward. ISO version 2000 has been used for a long time, and it will be misleading to talk about version 94.
I am the old standard of ISO9000. The GB/T 1987 standard began to learn contact, and the ISO9000——94 standard was implemented in the early 1990s, until today's ISO 9000-2000: GB/T 19000 standard.
I helped various industries to implement ISO9000 and participated in the audit.
2. What is ISO900 1? ISO (International Organization for Standardization) and IAF (International Accreditation Forum) issued a joint communique on August 20, 2008, unanimously agreeing to smoothly transform the most widely used quality management system standards in the world and implement ISO900 1:2008 certification.
Logo [1ISO9000]: The 2008 standard is based on eight years' practice of 170 countries and about1million organizations certified by ISO900 1, which more clearly expresses ISO 900/kloc. At present, the 2008 edition of ISO900 1 quality management system requirements is scheduled to be released together with the GB/T 1900 1-2008 quality management system requirements at the end of 2008.
After the release of ISO900 1:2008 standard 1 year, all certificates issued by recognized certification bodies are ISO900 1:2008 certificates; The full name of internal auditor is internal quality system auditor, who is usually familiar with ISO900 1:2008 international standards and enterprise management. According to the requirements of the new ISO900 1:2008 standard, any organization implementing the new ISO900 1:2008 standard needs to conduct internal quality audit at least once a year. Therefore, any organization that implements ISO900 1:2008 usually needs to train a group of internal auditors.
Internal auditors can be held by people from all departments, so internal auditors play an important role in the normal operation and improvement of an organization's quality system. Implementing ISO9000 quality is the key to success.
The research of different countries, international organizations and trade associations shows that the survival, development and continuous progress of enterprises depend on the effective implementation of quality assurance system. The quality system of tapir O 9000 series has been widely adopted by many developed and developing countries in the world 1 10, which makes the market competition more intense and the quality of products and services increasingly improved.
Facts have proved that effective quality management is one of the means to win in the fierce market competition. Today, ISO9000 series management standards have been accepted and recognized by all walks of life providing goods and services, and having a quality management system widely recognized by countries and society all over the world has great market advantages.
In the next few years, when the market economy at home and abroad develops further and trade barriers are eliminated, it will become more important. The establishment of ISO9000 quality assurance system can make enterprises and organizations realize the following benefits: 1) A well-structured quality management system can make the operation of organizations produce greater benefits and higher efficiency.
2) Better training and higher productivity. 3) Reduce customers' rejection and complaints, thus saving a lot of expenses and finally enjoying a larger market share; 4) Customers trust the enterprise and its products/services more.
5) it can be unimpeded in the market that needs ISO9000 certification.
Three. What is the specific content of ISO9000 quality management and quality assurance system? After more than ten years of development, there are more than 20 standards in three series, namely ISO8000, ISO9000 and ISO 10000, which are called "quality management and quality assurance family standards".
More than 70 countries in the world directly adopt or convert it into national standards word by word; More than 50 countries have established quality system certification/registration institutions, forming a worldwide "fever" for implementing standards and certification. The birth and development of 1.ISO9000 quality management and quality assurance standards. Technical Committee of ISO/TC 176 SC2 issued a series of ISO9000 quality management and quality assurance standards in 1987.
This series of standards is the main standard in quality management and quality assurance standards, * * including "standard selection, quality assurance and quality management" five standards. The birth of the Five Standards is a new era of quality management and quality assurance in the world, which has played a very good role in promoting the quality management of industrial enterprises and the quality assurance of supply and demand sides in the world and promoting international trade exchanges.
In recent years, with the development of international trade and problems in the implementation of standards, this series of standards has been comprehensively revised, and the 94th edition, 1994, was officially released in July. Subsequently, the development of standards progressed rapidly, and the ISO9000 standard developed into ISO9000- 1, ISO9000-2, ISO9000-3 and ISO9000-4.
The following are the features of each version. Two. The composition and characteristics of ISO9000: 1987 quality management and quality assurance standards-a guide to selection and use; 109002:19877 quality system-quality assurance mode of production and installation; 109003:19877 quality system-the quality assurance mode of the final inspection and test; Wang O9000: 1987 quality management and quality system elements guide.
Among the above five standards, ISO9000: 1987 provides the principle guidance for the selection and use of this series of standards; Wango9001:1987, ISO9002: 1987 and ISO9003: 1987 are a set of three quality assurance model standards compiled by Britain on the basis of British BS5750 and referring to the relevant standards of other countries. O9004: 1987 is a document to guide enterprises to establish quality system, which is formulated by American standard ANSIZ 1. Based on 15 and referring to some relevant standards of other countries, it was compiled by the United States.
Three. Composition and characteristics of quality management and quality assurance clauses in ISO8402: 1994, 94th edition; Han O9000- 1: 1994 Quality Management and Quality Assurance Standards Part I: Selection and Guidance; Quality assurance mode of design, development, production, installation and service of quality system; 109002:19940 quality assurance mode for mass system production, installation and service; 109003:19940 The final inspection and experimental quality assurance mode of mass system; 10904-1:1994quality management and quality system elements Part1Guide: (1) Hierarchical structure analysis among various standards (1) Basic level-ISO8402 ISO8402 is a quality terminology standard.
Summarize the related concepts used in quality management from the experience theory of quality management. It is undoubtedly the theoretical basis and the most basic reference for the implementation of ISO9000 standards, and has a guiding role for all the standards in this series.
2) Guidance level-ISO 9000-1ISO 9000-1is a guide for selecting and using quality management and quality assurance standards. Choosing a standard as a guide illustrates the complexity of the standard itself.
"Use" actually adds another layer of explanation to the standard: it introduces each method and specific requirements of "use". This standard has a guiding role in the selection and application of quality standards, and has an important guiding role for beginners to be familiar with the standard, get started quickly and take the overall situation into consideration.
Undoubtedly, it should be placed in the initial guiding position of learning selection criteria. 3) Core levels-ISO 9001-ISO 9003 and ISO 9000-2, ISO 9004-1ISO 900/-ISO 9003 are the core of this series of standards.
The tangible goal of the implementation of enterprise standards is to obtain certification as one of the quality assurance modes. In fact, most enterprises regard obtaining certification as the primary purpose of implementing standards.
It is understandable that ISO 9001-9003-9003 is the core of a series of standards, instead of ISO9004, which some experts insist on. т 9000-2Quality Management and Quality Assurance Standards Part 20: General guide to the application of ISO 9001-90030: Compared with ISO 900 1-9003 standard, the application scope of various quality requirements of ISO 900 1-9003, the meanings of various concepts and the operation methods are further explained.
Wango9004-1quality management and quality system element Part 1: Guide, which is almost equivalent to ISO900 1 in a series of standards, is a requirement for quality system, and is more detailed and in-depth than ISO900 1. It can be completely implemented as a complete quality system, but at present, ISO 9004- 1 has become the most powerful auxiliary standard when ISO 9001-9003-9003 is used in hardware products.
These two standards are most closely related to ISO 900 1-ISO 9003 and can be regarded as the core standards of ISO9000. 4) Support levels1-ISO1001,ISO10013 ISO1001,quality system audit guide, ISO 660.
The compilation of quality manual and the audit of quality system are both practical operations that must be carried out during the implementation of standards, which are far from other quality assurance principles introduced by standards. Without specific instructions, it is very difficult and arbitrary to complete these tasks, so it is very necessary to provide some auxiliary tools.
5) Support level 2-ISO9004-4ISO9000-4-ISO65438ISO9004-8+00012. The standards at this level are placed at the bottom of figure 1 and connected with the core standards by dotted lines. These standards are quality technologies adopted only when necessary, or supporting and guiding quality standards, which are adopted only according to the requirements of the enterprise's own management.
In general, it is not certified.
Four. What is ISO9000? ISO is the abbreviation of international standardization, a global non-organization, and a very important organization in the field of international standardization.
Its members are composed of national standardization organizations from more than 100 countries in the world, and the national organization representing China in ISO is China National Bureau of Technical Supervision (CSBTS). ISO is closely related to the International Electrotechnical Commission (IEC), and China's national institution participating in IEC is also the State Bureau of Technical Supervision.
As a whole, ISO and IEC are responsible for formulating international standards with global consensus. ISO and IEC are non-organizations, and their standards are voluntary in nature, which means that these standards must be excellent and will bring benefits to industry and service industry, so they use them consciously. ISO and IEC are not UN agencies, but they maintain technical ties with many UN specialized agencies.
ISO and IEC have about 1000 professional technical committees and subcommittees, and all member countries participate in the activities of these technical committees and subcommittees on a national basis. ISO and EC also have about 3,000 working groups, and ISO and IEC formulate and revise 1000 international standards every year.
The standard covers a wide range, from basic fasteners and bearings to semi-finished products and finished products, and the technical fields involve information technology, transportation, agriculture, health care and environment. Each work organization has its own work plan, which lists the standard items (test methods, terminology, specifications, performance requirements, etc. ) needs to be formulated.
The main function of ISO is to provide a mechanism for people to reach an agreement on the formulation of international standards. Its main organization and operation rules are stipulated in a document called ISO/IEC Technical Work Guide. Its technical structure is 800 technical committees and subcommittees of ISO. Each committee has a chairman and a secretariat, and each member country provides services. At present, 30 member groups undertake the work of secretariat countries, and each secretariat maintains direct contact with the ISO Central Secretariat in Geneva.
Through these institutions, ISO has issued 9200 international standards, such as ISO metric thread, ISO A4 paper size, ISO container series (95% of the world's shipping containers meet ISO standards at present), ISO film speed code, ISO Open System Interconnection (OS2) series (widely used in the information technology field) and the famous ISO9000 quality management series standards. In addition, ISO has established contacts with 450 international and regional standards organizations, especially with the International Telecommunication Union (ITU).
There are 28 international standards bodies besides ISO/IEC system. Every institution sets some international standards in a certain field, which are usually under the control of the United Nations.
A typical example is the World Health Organization (WHO). 85% of international standards are formulated by ISO/IEC, and the remaining 15% are formulated by these 28 other international standards bodies.
The quality system established according to ISO9000 family standards can give full play to the actual effect of enterprise quality management, and at the same time lay a solid foundation for the recognition of customers and third parties and provide recognition.
ISO was founded in 1946, headquartered in Geneva, and has more than 100 member countries.
There are more than 200 technical committees (TC) under ISO, which are specialized in the formulation and promotion of international standards. On the basis of British standard BS5750, Canadian standard Z299 and other national defense and nuclear industry standards, ISO Technical Committee TC 176(ISO/ TC 176) specialized in quality management and quality assurance began to formulate ISO9000 family standards in 1979, and in 1987.
The ISO9000 series standard was revised for the first time in 1994. At present, the commonly used standard is ISO9000: 1994. This standard clarifies the differences and interrelationships between basic quality concepts.
This standard stipulates a set of basic elements of quality system for enterprises to choose and use according to their respective markets, product categories, production processes, customers and consumers' needs.
The goal of ISO9002 is to prevent the production and incorrect installation of unqualified products (services). It also provides a feedback mechanism to take corrective and preventive measures when problems arise.
In addition to the requirements of various elements consistent with ISO9002, the standard also adds design elements.
т 900190020 and 9003contain some similar requirements. Such as: regularly calibrating test and measuring equipment, using appropriate statistical techniques, keeping records of product identification and traceability system, systematic product handling, storage, packaging, protection and transportation system, inspection and test system and system for handling unqualified products, and adequate personnel training. -ISO9000 series standards include five standards. They are: ISO9000- 1: 1994 Quality Management and Quality Assurance Standards Part I: Guidelines for Selection and Use ISO900 1:.
Verb (abbreviation of verb) iso9000 management system introduction management system standard-ISO 9000 ISO 9000 family standard is a series of standards on quality management and quality assurance issued by the International Organization for Standardization, which has been adopted by more than 80 countries. This series of standards has had a wide and profound impact on the world, and some people call it ISO 9000 phenomenon.
The release of the standards of the O9000 family is mainly to promote international trade, which is a kind of recognition of quality by buyers and sellers, and is the cornerstone of building mutual trust in trade activities. As we all know, product standards that require product performance and indicators include many enterprise standards and national standards.
However, these standards can not fully meet the requirements and needs of customers. The products that customers want not only need to pass the inspection at that time, but also put forward clear requirements for people, equipment, methods and documents during the whole production and use of the products, so as to ensure the physical quality of the products through the quality of work and minimize its hidden defects.
At present, many countries have transformed the ISO9000 family standard into their own national standards, encouraging and supporting enterprises to organize production and sales according to this standard. As a buyer and seller, especially as a product buyer, I hope that the quality of the product at that time is good and its failure rate can be minimized during the whole use process.
Even if there are defects, it can provide timely service for users. In these aspects, ISO9000 family standards have specific requirements.
Conforming to ISO9000 family standards has become the minimum requirement for buyers and sellers in international trade. That is to say, to do business, you must first look at your quality assurance ability, that is, whether your level has reached the internationally recognized ISO9000 quality assurance system level, and then continue negotiations. A modern enterprise, in order to make its products occupy and consolidate the market, in order to make its products impact the international market, must improve the quality management level anyway.
At the same time, based on the requirements of customers, many enterprises take the initiative to standardize their work on the scale of ISO9000, and gradually improve the physical quality. As the ISO9000 system is a market mechanism, many countries encourage consumers to give priority to purchasing ISO9000-certified enterprise products to protect their own consumer markets.
It can be said that passing ISO9000 certification has become a passport for enterprises to prove their product quality and work quality. There are three standards related to quality system assurance in ISO9000 family standards: ISO900 1, ISO9002, ISO9003 ISO900 1 are quality assurance modes for design, development, production, installation and service; ⪖is the quality assurance mode of production, installation and service; The quality system standard is the quality assurance mode of the final inspection and test. There are 19 international standards formulated by ISO/TC 176 Technical Committee and officially promulgated by ISO (National Organization for Standardization), and there are 7 international standards not promulgated by ISO/TC 176 Technical Committee.
ISO, as the international standard of IS09000 family 19, has been officially promulgated and all of them have been translated into China's national standards. China is also studying seven other international standards that are still in the draft stage. Once officially promulgated, China will promptly convert it into a national standard.
The quality management and quality assurance clauses of the formally promulgated IS09000 family standard (1) GB/t65831994 (IDT is08402:1994). (2)GB/T 19000 .
1-1994 (id tls09000-1:1994) quality management and quality assurance standards-part1selection guide. (3)GB/ 19000 .
2-1994 (IDTIS 09000-2:1993) Quality Management and Quality Assurance Standards Part II GB/T 1900 1, GB/T 19002 and GB/T/kl. (4) GB/T19000.3-1994 (ID TLS 09000-3:1994) Quality Management and Quality Assurance Standard Part 3 GB/T 1900 1 Software Development.
(5) GB/T19000.4-1994 (IDTIS 09000-4:1993) Quality Management and Quality Assurance Standards-Part IV: Guidelines for the Management of Credibility Outline. (6) The quality assurance mode of serial design, development, production, installation and service of GB/T19000-1994 (ID TLS 09001:1994).
(7) Production, installation and service quality assurance mode of GB/T19002-1994 (ID TLS 09002:1994) quality system. (8) Quality assurance mode for final inspection and test of GB/T190031994 (IDTIS 09003:1994) quality system.
(9) GB/T 1 9004.1-Kloc-0/994 (ID TLS 09004-1:1994) Guide to Quality Management and Quality System Elements Part1. (10) GB/T19004.2-1994 (ID tls09004-2:1991) Quality management and quality system elements Part 2 service guide.
(11) GB/t19004.3-1994 (IDTIS 09004-3:1993) Quality management and quality system elements Part 3: Guide to process materials. (12) GB/T19004.4-1994 (ID TLSO-4:1993) Quality management and quality system elements Part 4 Quality improvement guide.
(13) GB/t19015-1996 (id tisol 0005:1995) quality management quality plan guide. (14) GB/T19017-1996 (ID tls010007:1995) Technical Requirements Management Guide for Quality Management.
(15) GB/t19021.1993 (idtlsol001-1:1990 (16) GB/t19021.2-1993 (IDTIS 01001-2:/kloc-0
(17) GB/T19021.3-1993 (IDTIS 0100LL-3:1991) quality system. (1 8) GB/t19022.1994 (IDTIS 010012:1992) Quality assurance of measuring equipment.
(19) GB/T19023-1996 (idtlsol0013:1995) Guidelines for compiling quality manuals. The quality principle of ISO/IS09000-8, which is still in the drafting stage, and its application in quality management practice.
(2)ISO/DISl0006 Quality Management Project Management Guide. (3) Quality Assurance Requirements of ISO/FDIS L0012-2 Measuring Equipment Part 2 Measurement Process Control.
(4)ISO/FDISl00 14 Quality and Economic Management Guide. (5)ISO/CDl00 15 Continuing education and training.
(6)ISO/WDl00 16 Guide for the expression of inspection and test record results. (7) The application of ISO/WDL0017 statistical technology in quality management.
The new trend of IS09000 family standard development is based on ISO/TCl.