Abstract: On 15 December 2000, ISO officially released the 2000 version of ISO9000 national standard. From June 1, 2001, the 2000 version of the ISO9000 family standard will be fully replaced to implement the 1994 version of the 1994. We need to understand the previous version of ISO9000 knowledge, we must understand the ISO9000 version that is now applicable, especially the relationship between new and old versions (this knowledge point is examined in 2002). I believe that these knowledge will be able to expand your knowledge while expanding your thinking, making the foundation for the competent project supervisors, project managers, CIOs. At the same time, I hope that the provision of these materials can be helpful to your review, and they will be helpful, thank you. Keywords: System Analyst Department Counseling ISO 9000-2000 Basic References December 15, 2000, ISO officially released the 2000 version of ISO9000 national standard. From June 1, 2001, the 2000 version of the ISO9000 family standard will be fully replaced to implement the 1994 version of the 1994. The National Quality and Technical Supervision Bureau has used the 2000 version of the ISO9000 standard equivalent to China's national standards, its standard number and the corresponding relationship with ISO standards are: GB / T19000-2000 "Quality Management System Foundation and Terminology" ID ISO9000-2000 . I. 2000 version ISO9000 standard structure 1, 2000 version ISO9000 national file structure (1) core standard 4 · ISO9000: 2000 basic principle and term · ISO9001: 2000 quality management system - Requirements · ISO9004: 2000 Quality Management System - Performance Improvement Guide · ISO19011 Quality and Environmental Management Audit Guide (2) Other Standards 1 ISO10012 "Quality Guarantee Requirements" for Measurement Equipment "(3) Delivery, now included: · ISO / TR10006 Project Management Guide · ISO / TR10007 Technology Status Management Guide · ISO / TR10013 Quality Management System Document Guide · ISO / TR10014 Quality Economic Guide · ISO / TR10015 Education and Training Guide · ISO / TR10017 Statistical Technology In ISO9001 Application Guide Booklet Some Series, now included The planned: · Quality Management Principle · Selection and Use Guide · ISO9001 Application Guide in Small Enterprises In order to prevent the development of ISO9000 national standards from "quality management encyclopedia" ISO / TC176 will cooperate with other committees or related industries To expand the range of use of ISO9000 national standards. For example: ISO / TC176 cooperates with the international automotive industry to formulate international standards in the automotive industry: ISO / DTR16949 "Quality System - Automotive Supply Party" (draft) to replace the US, Germany, France and Italy's automotive industry standard QS9000, VDA-6.1, EAQF and AVSQ. International standards such as ISO / FDIS13485 "Quality System-ISO9001 in medical equipment" in ISO / TC176 and medical industries are will be released. 2. Introduction to the core standard (1) ISO9000: 2000 This standard specifies the terminology and basic principles of the quality management system, replacing the 1994 ISO8402 and ISO9000-1 standards. The eight quality management principles proposed by this standard is based on quality management experience, which clarifies that an organization must follow the principles that must be followed in quality management, and the guiding ideology and theoretical basis for the 2000 version of the 9000 national standard. The second part of this standard proposes 87 terms. In the language, it emphasizes non-technical language to make all potential users to understand. In order to facilitate use, in the standard appendix, it is recommended to describe the relationship of related terms in "conceptual map" mode. The third key content of ISO / DIS9000: 2000 is to put forward the basic principles of the quality management system. As an echo of the eight principles of quality management in this standard.
(2) ISO9001: 2000 This standard replaced the 1994 version of three quality assurance standards (ISO9001: 1994, ISO9002: 1994 and ISO9003: 1994). The new version of the quality management system requires "process mode model" to replace 20 elements in the 1994 ISO9001 standard. In order to adapt to different types of organizations, in a certain case, the system requires to allow deletion (tailoring). The word "Quality Assurance" no longer appears in the new version, which reflects the quality management system requirements for standards, including product quality assurance and customer satisfaction. (3) ISO9004: 2000 This standard gives the application guide for quality management, describing the process of quality management system, emphasizing the performance of the organization through improvement processes. This standard is a replacement standard of 1994 ISO9004-1. ISO9004: 2000 and ISO9001: 2000 is a quality management system standard for coordination and can be used together. Two standards use the same principles, but it should be noted that the scope of application is different, and ISO9004 standard does not intend to use the implementation guidelines for ISO9001 standards. Under normal circumstances, when organizers want to exceed the minimum requirements of ISO9001 standards, the performance improvements are pursuing growth, often as a guide with ISO9004 standards. ⑷ ISO19011 This standard is the principle of ISO / TC176 and ISO / TC207 (Environmental Management Technology Commission) to follow the principles of "different management systems, can manage and review". The new ISO19011 standard will be combined with several standards such as ISO10011-1, ISO10011-2, ISO10011-3 and ISO14010, ISO14011, ISO14012. This standard is compatible with both terms and content, compatible with both quality management systems and environmental management systems. This standard is the basic principle of reviewing the basic principles, the implementation of the audit outline, and provides guidelines for the qualification requirements for environmental and quality management system reviewers. Second, 2000 version of the standard relative to the 1994 version of the change 1, the overall structure change (1) Process Mode Model '94 version of the criteria proposed 20 requirements in the way, where the product quality formation process is basically in the quality of hardware manufacturing Preparation, the service and software organizations are not very versatile. The 2000 version of ISO9001 has a large adjustment, comprehensive application process method, proposes the process method of four large sectors structure: management responsibilities, resource management, product implementation and measurement, analysis, improvement of 4 process, reflecting planning P - Implement D-Check C-improvement a cycle. Make a piece of sector in different industries, product implementation or service providing processes, allowing deletion according to the actual situation of different industries, allowing 2000 version of ISO9001 standard to be organized for 4 products, 3 Quality Assurance Mode Standard ISO9001, 9002 and 9003 merged into a standard. Avoid the past service industry, the software industry implements the "94 version of ISO9001 standard" once a manifestation of the hard-moving hard sleeve, the cutting process, blindly meets the requirements of the standard provisions, which helps the ISO9000 national standard in these behavioral industries. (2) rationally returning and, in the inheritance basis, the 2000 version of the standard is considered a major change in structure, but considers the standard inheritance, the content of the 94 version should be maximized in order to obtain only the organization In the original basis, the adjustment can meet the requirements of the 2000 version of the standard and achieve a smooth transition.
The new standard made a reasonable return, putting the document control, quality record of various product organizations, and returns the resources, and returning to resource management after further development of resources, and tests, unqualified product control, correctment and preventive measures. , Internal quality audit and statistics are all incorporated into measurement, analysis, and improvement, all of the elements related to product quality formation are all incorporated into the product implementation process, and different types of product organizations are allowed to be appropriately deducted according to their actual operation. 2. Changes in the content (1) The main supplementation of 2000 criteria is based on the implementation of the eight quality management principles, which makes an important supplement in the content to further improve the effectiveness of the quality system to adapt to market competition. Its main changes are: 1 The quality management of the organization is clearly submitted to the principle of the organization's focus on the principles of the organization's attention to the principles of the organization. 2 Leadership enhances the leadership requirements for the highest administrator to give full play to the leadership of the highest administrator. 3 Quality Policy and the new standard for the goal have put forward specific requirements for quality policy and it is recommended to use 8 principles as the basis for formulating quality policy. Quality objectives should include satisfying the content required for product requirements and consistent with the quality policy. The quality goal is to be measurable, and the quality goals are established in the relevant functions and levels of the organization, that is, the requirements of the requirements, the goal of development and implementation. 4 Continuous improvement of the new version of the "Continuous Improvement" requirement. The '94 version reflects the thoughts of continuous improvement through "unqualified control", "corrective and precautions", "internal audit and management review". The new standard has improved on this basis, but continuous improvements not only refer to the discovery or potential unqualified, but also the qualified part also requires continuous improvement with the changes in the demand of the outside world to adapt to the environment of the market competition. (5) Inside, the new standards of external communication require the company to carry out internal communication and external communication activities, which facilitates strengthening mutual understanding and cooperation, mobilizing the enthusiasm of employees, achieving the purpose of "all participation". At the same time, through communication with customers, accurately understand the customer's request, customers are satisfied by implementing the process. The new standard makes up for the '94 version of the standard is not suitable for the shortcomings of the service industry. (6) Data analysis requires enterprise to determine, collect and analyze appropriate data to clearly continue to improve the direction of main attack. This is an important part of measurement, analysis and improvement involving all measurements, results of monitoring, data analysis, and data that find problems, more focused objects, in order to identify main problems, and clearly improve the direction. (7) Strengthening resource management has strengthened the enterprise leaders to provide the human resources, infrastructure, and work environments required to achieve product compliance. In addition to the requirements of "Capacity and Consciousness", it is clear that people who are not enough, and it is necessary to "provide training or adopt other measures to meet the needs" and require "evaluation. Effectiveness. At the same time, "ensuring that employees' awareness of the correlation and importance of activities, and how to contribute to realize quality goals", reflecting the specific application of "all participation" principles. (8) The effectiveness of strengthening quality activities is compared with the '94 version of the standard, the new standards provide corresponding evidence for the effectiveness of various evaluation activities, not only the records of reservation activities. 2. Deleting or Weakening Requirements The new version of the standard in order to be able to fit the four-class products, combined with its actual effective quality system, delete or weaken the '94 version of the standard, and the standard requirements are flexible and principled. Its main changes are: (1) Weakened the mandatory program file '94 version ISO9001 proposes for the mandatory requirements of 17 written procedures, which apply to the hardware manufacturing industry, which is not applicable to the service or software industry, simple small enterprises for products Not applicable.
To this end, the new version of the standard only retains 6: file control, quality record, internal audit, unqualified product control, correction, precautions, etc., and the control of the quality activities of the product implementation process The program document has taken a flexible principle, and the business activities, the business activities, the business activities needed to be carried out, and the complexity of the company is flexible, and the real-purpose program documentation and operation instructions are prepared. It must be noted that the requirements of the mandatory program file are less, and it is not necessary to reproduce the program file required to control the product to be controlled by the process. All aspects of the product implementation process have proposed corresponding control requirements. Enterprises must confirm the meeting. These control requirements, but satisfaction methods are flexible. (2) It is no longer distinguishing between the import, process, and final inspection of the '94 version of the standard for the purchase, process and final test, including exceptional release requirements. The new standard has become a principled control requirement in the monitoring and measurement of the product, no longer use the filling, process and final test, so that it can be used in the four-class products. (3) The service is no longer single-column terms '94 version of the standard, "In the case where there is a service requirements, the supplier should establish and maintain the procedure for the implementation of the implementation, verification, and reporting of the service to satisfy the service to meet the requirements. "The new version of the standard is no longer single-column terms, while weaken to control" release, delivery, and post-delivery activities ", and the delivery activities are determined by" Planning of Product Implementation ". (4) Handling, storage, packaging, and protection are weakened to "Protection" '94 version of the standard for handling, storage, and packaging have separate control requirements, which apply to the hardware manufacturing industry. The new version of the standard is taken into account, simplifying processing, becoming "product protection", requiring "organizations should provide protection against product compliance, such protection should include identification, handling, packaging, storage and protection. Protection should also apply Component part of the product. " It emphasizes that the purpose of protection should be achieved is to "product compliance" methods can be diverse to adapt to different enterprises. ISO9000 confirmed eight principles ISO9000 family quality management system in the introduction of ISO9000: 2000 and ISO9004: 2000, all mentioned a concept called "Eight Management Principles". Although the standards are simply elaborated in the standards, this eight management principles is the essence of the ISO9000 quality management system standard, and implemented in the requirements and applications of all quality management systems. . Since there are not many instructions in the ISO9000 standard, there are not many instructions in the ISO9000 standard, which further introduces the benefits and methods of using these principles to facilitate management to guide the performance improvements. The eight management principles is to be responsible and involved in the ISO9000 standard development and maintenance through a wide range of customer investigations, ultimately in accordance with the knowledge of customer requirements and experts, and have been summarized, with this as a formula ISO9000: 2000 The basic principle. These eight principles are: 1. Centers centers; 2. Leadership; 3. All members participate; 4. Process method; 5. Manage system method; 6. Continuous improvement; 7. Decision method based on facts; 8. Mutually beneficial supplier relationship. The main benefits of the eight management principles: Principles L - Organizations are contained in their customers as a central organization, so organizations should understand the current and future needs of customers to meet customer needs and strive to exceed customers. Main benefits: Advent revenue and market share by flexible market opportunities. Improve the effectiveness of organizational resource use to enhance customer satisfaction. Strengthen the loyalty of the customer, recruit back. Application example: Comprehensively study and understand customer needs and expectations. Ensure the organization's goals in line with customers' needs and expectations.
Communicate the needs and expectations of customers to the entire organization. Measure the customer satisfaction and guide the operation of the organization based on the results. Systemically manages the relationship between customers. Ensure that the benefits of satisfied customers and other related parties (such as owners, employees, suppliers, financial institutions, communities and the whole society). Principle 2 - Leadership The leadership of leadership establishes a consistent organizational purpose and direction. They should create and maintain a suitable internal environment, enabling employees to fully participate in the implementation of organizational goals. Main benefits: Employees can understand organizational goals and pursue the success of the organization. Assess, arrange and implement activities in a unified way. The inclination of internal communication will be minimized. Application example: Considering the needs of all stakeholders, including customers, owners, employees, suppliers, communities and the whole society. Clearly outline the future of the organization. Set challenging objectives. Establish value sharing and moral ethics at all levels of the organization. Establish trust and eliminate fear. Provide the employee to the resource, legalization, given the freedom of performing responsibilities and obligations. Inspire, reward and recognize employee contributions. Principles 3 - The whole staff participates in all levels of staff are the fundamental, only they participate fully, their talent will bring gains for the organization. Main interest: employees within the organization have been incentive, faithful, and actively participate. Further promote the innovation and creativity of the organization goals. Employees are responsible for their performance. Employees have actively contributed to the continuous improvement of the organization. Application example: Let employee understand the importance of their contribution and role in the organization. Make employees to identify restrictions on their performance. Employees take responsibility for solving problems. Enable employees to assess their performance according to individual objectives. Enable employees to actively seek opportunities to strengthen their skills, knowledge and experience. Make employees to share knowledge and experience in the team. Make employees discuss issues and perspectives. Principle 4 - Process Methods Activities Related resources are managed as a process, which can achieve the expected results more efficiently. Main benefits: reduce cost and shortening cycles by effectively use resources. The result of continuous improvement, coordination, and predictable. Provide an improved opportunity for priorities. Application example: Systematically determines the activities necessary to achieve the desired result. Clearly manage critical activities responsibilities and obligations. Analyze and measure the ability of critical activities. Identify the interface between key activities between long functions in the organization's functions. Pay attention to factors such as resources, methods, and materials, to improve the key activities of the organization. Evaluate the risk, consequences and impact on customers, suppliers and other stakeholders. Principle 5 - Manage system methods help to improve the effectiveness and efficiency of the organization for the development of the goals, identify, understand and manage the system. Main interest: The coordination of the process can achieve the maximum results of the expected results. It has the ability to focus on key processes. Establish confidence in the coordination, effectiveness and efficiency of the stakeholders. Application example: Constructing a system to achieve the organization's goals in the most effective and most efficient manner. Understand the intrinsic relevance between the various processes of the system. The use of structured methods to coordinate and integrate processes. Better understanding as the role and responsibility necessary to achieve a common goal, thereby reducing obstacles with intersection of functions. Understand the ability of the organization, determine the limitations of resources before action. Set the target and define how specific activities operate within the system. Continuous improvement system by measuring and assessing. Principles 6 - Continuous improvement of the overall performance of the organization should be an eternal goal. Main benefits: Strengthen competitive advantage by improving organizational capabilities. Coordinate the improvement activities at all levels based on the organization's strategic intention. Rapid and flexible reactions to opportunities. Application example: A consistent way of consistently improved the performance of the organization within the organization. Provide employees to provide continuous improvement methods and tool training. Continuous improvement of products, processes, and systems as the goal of each member of the organization. Establish guidance and measurement of continuous improvement goals. Recognize and recognize improvements. Principles 7 - Reliverative decisions based on facts are based on the analysis of data and information. Main interest: there is a decision of information basis. Enhance the ability to prove the effectiveness of the past decision-making through referring to actual records.
