ISO is the abbreviation of an organization. Its full name is International Organization for Standardization, which is translated from Chinese as "International Organization for Standardization". Also known as "Economic United Nations" (with more than 120 member countries).
ISO is a non-governmental international scientific and technological organization, and it is the largest and most authoritative international standard-setting and revision organization in the world. Founded on February 23rd, 1947. The highest authority of ISO is the annual General Meeting of Members, and its daily office is the Central Secretariat, located in Geneva, Switzerland.
ISO claims that its purpose is "to formulate international standards, promote the consistency of global standards, and promote international trade and scientific and technological cooperation."
ISO has members from 120 countries and regions.
Second, what is ISO9000?
ISO standards are formulated by Technical Committee (TC). ISO*** has more than 200 technical committees and more than 2,200 sub-technical committees (SC for short).
⪔ refers to the quality management system standard, which is not a standard but a series of standards. ⪔is all international standards made by TC 176(TC 176 Technical Committee of Quality Control Department). Among more than 12000 standards issued by ISO,
Third, what is certification?
The original meaning of the word "authentication" in English is the act of issuing certification documents. 1986 defines "certification" as "the activity that the certified product or service conforms to specific standards or normative documents formulated by a completely trusted third party."
For example, for the products or services provided by Party A (supplier or seller), Party B (buyer or buyer) cannot judge whether the products or services are 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.
Fourth, the origin of ISO9000
⪔⪔⪔⪔⪔⪔⪔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 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 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.
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. At present, more than 100 countries and regions in the world are actively promoting the ISO9000 international standard.
[Edit this paragraph] Part II Benefits of Implementing ISO9000
Generally speaking, internal and external management can be well handled: internal management can be strengthened, personnel quality and corporate culture can be improved; Enhance corporate image and market share. Details are as follows:
ISO9000 1。 Strengthen quality management and improve enterprise efficiency; Enhance customer confidence and expand market share
The certification bodies responsible for ISO9000 quality system certification are all authoritative organizations recognized by national accreditation bodies, and they are very strict in auditing the quality system of enterprises. In this way, enterprises can carry out quality management according to the strictly audited international standardized quality system, truly meet the requirements of legalization and scientificity, greatly improve work efficiency and product qualification rate, and quickly improve the economic and social benefits of enterprises. For the outside of the enterprise, when customers know that suppliers are managed according to international standards, have obtained ISO9000 quality system certification, and have strict audit and regular supervision by certification bodies, they can be sure that the enterprise can stably provide qualified products or services, so as to safely conclude supply and marketing contracts with the enterprise and expand the market share of the enterprise. It can be said that both aspects have achieved immediate results.
2. Obtained the green card of international trade-"passport", and eliminated the barriers of international trade.
In order to protect their own interests, many countries have set up various trade barriers, including tariff barriers and non-tariff barriers. Among them, non-tariff barriers are mainly technical barriers, and technical barriers are mainly barriers to product quality certification and ISO9000 quality system certification. Especially in the World Trade Organization, all member countries have abolished tariff barriers and can only set up technical barriers. Therefore, obtaining certification is the main way to eliminate trade barriers. After China's entry into WTO, the strict boundary between domestic trade and international trade has been lost, and all trade may encounter the above technical barriers, which should be highly valued by the business community and prevented as soon as possible.
Third, it saves the energy and cost of the second-party audit.
In modern trade practice, the second-party audit has long been a practice, and gradually found its huge disadvantages: an organization usually supplies many customers, and the second-party audit will undoubtedly bring a heavy burden to the organization; On the other hand, customers also need to pay considerable fees, and at the same time, they should consider the experience and level of sending or hiring personnel, otherwise the fees will not reach the expected purpose. Only ISO9000 certification can eliminate this drawback. Because as Party A, after applying for the third-party ISO9000 certification and obtaining the certification certificate, there is no need for many Party B to audit Party A, so both Party A and Party B can save a lot of energy or expenses. In addition, if an enterprise applies for quality certification of products such as UL and CE after obtaining ISO9000 certification, it can also avoid the cost of repeated certification of enterprise quality management system by certification bodies.
Fourth, always be in an invincible position in product quality competition.
The means of international trade competition are mainly price competition and quality competition. Because the method of low-price sales not only greatly reduces profits, but also will be subject to trade sanctions if it constitutes dumping, and the means of price competition is increasingly undesirable. Since 1970s, quality competition has become the main means of international trade competition, and many countries regard improving the quality requirements of imported goods as an important measure of trade protectionism. Implementing the quality management of ISO9000 international standardization can steadily improve the quality of products and make enterprises invincible in the product quality competition forever.
It is beneficial to international economic cooperation and technical exchange.
According to the practice of international economic cooperation and technical exchange, the two sides must have the same language, unified understanding and * * * standards in terms of product (including service) quality before they can cooperate and exchange. The quality management system certification is to provide this kind of trust, which is beneficial for both parties to reach agreement quickly.
Six, strengthen the internal management of enterprises, stable operation, reduce the technical or quality fluctuations caused by employee resignation.
Seven, improve the corporate image.
[Edit this paragraph] Part III: Introduction to ISO 9000: 2000.
I. Eight Quality Management Principles of ISO 9000: 2000
The eight quality management principles of ISO 9000: 2000 are the most basic and universal general principles of quality management expressed in ISO/TC 176. It summarizes the practical experience of quality management, absorbs the opinions of the most respected quality management experts in the world and becomes the theoretical basis of quality management. It is the principle that organization leaders must follow to effectively implement quality management.
1. Focus on customers
Organizations depend on customers, so they should know the current and future needs of customers, so as to meet their requirements and exceed their expectations. The customer is always right; ② If the customer is wrong, execute ①.
2. Leadership
Leaders unify the purpose, direction and internal environment of the organization and create an environment that enables employees to fully participate in achieving organizational goals. 80% of quality problems are related to management and 20% to employees.
3. Full participation
Employees at all levels are the foundation of the organization's survival and development. Only with their full participation can they bring the greatest benefits to the organization. Job responsibilities include all employees (from general manager to grass-roots employees).
4. Process method
Managing related resources and activities as processes can achieve the expected results more effectively.
Flowchart method.
5. System management methods
⪔The system of target recognition, understanding and management based on the foundation is composed of interrelated processes, which is helpful to improve the effectiveness and efficiency of the organization. The principle of coaming of barrel.
6. Continuous improvement
This is the eternal development goal of the organization. PDCA cycle.
7. Fact-based decision-making method:
Logical analysis or judgment of data and information is the basis of effective decision-making. Speak with data and facts.
8. Mutually beneficial supplier relationship
Enhance the ability of the organization and its suppliers to create value through mutually beneficial relations. The management style of McDonald's.
Two. The requirements of iso 900 1: 2000
1. range
1. 1 general provisions
1.2 application
2. Reference standards
3. Terms and definitions
4. Quality management system
4. 1 General requirements
4.2 Document requirements
5. Management responsibilities
5. 1 management commitment
5.2 Pay attention to customers
5.3 Quality policy
5.4 planning
5.5 Responsibility, Power and Communication
5.6 Management review
6. Resource management
6. 1 resource provision
6.2 Human resources
6.3 Infrastructure
6.4 Working environment
7. Realization of products/services
7. 1 product/service realization planning
7.2 Customer-related processes
7.3 Design and Development
7.4 Procurement
7.5 Provision of Products/Services
7.6 Control of Monitoring and Measuring Devices
Three. Process method model:
(Cannot paste chart)
Four. File structure of ISO 9000: 2000 quality management system;
1. Quality Manual (QM):
The main function is to inform all employees or customers of the management's quality policy and objectives in the form of documents. In order to ensure the quality, write down "what work has been done to ensure the quality".
2. Program file (QP):
It is a document that guides employees how to implement and complete the policies and objectives expressed in the quality manual.
3. Work instruction (WI):
A document detailing how specific work is carried out.
4. Record Form (f):
It is a document used to prove how a product or service operates according to the specified requirements.
Verb (abbreviation of verb) ISO 9001:2000: Differences between 2000 and 94
Item 94, 2000 edition
1. Changes in terms
1. From 4. 1 to 4.20 * * *, engaged in more than 20 articles.
2. Three quality system models.
(1) There are only five articles.
(2) Integration into the quality system model.
(3) The application of technology is not required to encourage the acceptance of the technology. Any activity that accepts input and turns it into output is regarded as a process. To operate effectively, an organization must identify and manage many interrelated processes.
3. Continuous improvement requirements. Organizations that have not explicitly put forward requirements should continuously improve the quality management system according to the quality policy, objectives, evaluation results, data analysis, corrective and preventive measures.
4. Description of supply chain subcontractor-supplier-customer
Supplier-Organization-Customer
5. Quality policy and quality objectives.
The quality policy must include quality objectives.
(1) requires the quality policy to provide a framework for quality objectives.
(2) Establish measurable quality objectives at the relevant functions and levels of the organization. Requiring quality objectives refers to ensuring the realization of clear and measurable objectives required by the quality policy.
6. Change the name of the system quality management and quality assurance system quality management system: the word "quality assurance" is no longer included to reflect that it includes quality assurance and customer satisfaction.
7. The application of PDCA adopts logistics operation mode, and the writing structure adopts simple PDCA process mode.
8. The system conversion period shall not be used after three years from the date of official release of the new version in 2000. It has been used since the official release of the 2000 edition.
9. Compatibility with ISO 14000: 1996 environmental management system standard is not compatible with ISO14000:1996+0: 96, and is consistent with other international management system standards.
Changes in the new ISO900 1:2008 standard
The new standard of 1 т 090012008 will be officially released in 2008, 10 3 1,
2. The standard has hardly been revised, so there is no reason to need a "transition stage". ISO will end the use of ISO900 1:2000 within 6 ~ 12 months.
3. For most organizations, the normal transition of supervision and review is usually enough, and no extra time is needed.
4. Auditors only need to train the changes in the new version.
5. The following are the terms of change:
3.0 Terms and definitions, supply chain cancellation. (Supplier-Organization-Customer)
4. 1 added the control of outsourcing process, and used the method of 7.4. 1 to control the outsourcing mode. Outsourcing will not reduce the Organization's responsibilities.
4.2. 1 changed the requirement that a single file can contain one or more programs, and the requirement of a documented program can also be reflected in multiple files. (such as corrective and preventive management procedures)
4.2.3 4.2.3f has been added to ensure that external documents required for quality system planning and operation are identified and their distribution is controlled.
5.5.2 Management representative: that is, the new standard requires that the management representative should be a subordinate employee in the organization or a full-time employee (not part-time) stipulated in the contract.
6.2. 1 Based on education, training, skills and experience, the staff engaged in products that affect product quality compliance should be competent (in a wide range).
6.2.2 Ability, awareness and training: evaluate the effectiveness of training; Ensure that the necessary capabilities are realized (tighten the practical operation capabilities).
6.3 6.3c was added: support services (such as transportation or communication or information system /ERP system), planning, providing and maintaining all-round evaluation were added.
7.2. 1 Determination of product-related requirements: Post-delivery activities, including warranty clauses and contract performance responsibilities, such as maintenance services and auxiliary services (such as product recovery or final disposal) have been added.
7.5. 1 control of production and service provision: production and service include product protection (packaging-storage-handling-recycling manual).
7.5.2 Confirmation of production and service provision processes: explain the importance of confirmation of special processes, such as welding, training and heat treatment, and identification of special projects. (e.g. qualification confirmation of service, welder, driver, instrument school engineer and internal auditor)
7.5.4 Customer property: added a note-indicating that intellectual property and private information are customer property (such as insurance companies, banks, etc.). ).
7.6 Control of monitoring and measuring devices: requirements for measuring with computer software have been added (such as verifying the suitability and configuration management of the software used in the company's software testing station).
8.2. 1: Monitoring customer feelings may include inputs from the following sources, such as customer satisfaction survey, submitted product quality information, user opinion survey, analysis, praise, warranty statement and sales report of lost business, etc.
8.2.2 Internal audit: the storage range of audit records (such as internal audit plan, sign-in form, internal audit report, checklist, non-conformance report, etc.). ) has been increased.
8.2.3 Monitoring and measurement of process: 1. The last sentence, namely "ensure the consistency of products", was deleted. 2. The main points to be considered when adopting the process control method are added in the notes. This note hopes that organizations will consider the application value of process monitoring and measurement methods when determining them. (that is, the scope is expanded to include all processes of the quality system).
8.3 Control of nonconforming products: nonconforming products that do not meet the customer's requirements can only be released with the customer's consent, and cannot be released within the organization without the customer's consent. If the release does not meet the standard requirements, the main unqualified products should be opened.
[Edit this paragraph] Part IV Introduction to ISO9000 Quality Management System
I. Consultation Flow Chart
Professional consulting companies and their consultants have mastered a lot of professional knowledge and practical experience, accumulated relevant knowledge under various management backgrounds, and obtained the methods and skills needed to solve problems, improve functions and improve efficiency. They can provide management guidance and decision-making assistance to customers. Consulting is a kind of consulting service. Consulting companies and consultants do not manipulate enterprises, nor do they make decisions on behalf of managers. Their work is correct.