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With the continuous expansion of the commodity economy and increasingly internationalized, in order to improve the product Credibility, reduce repeated testing, weakening and eliminating technical barriers to trade, and safeguard the rights and interests of producers, distributors, users and consumers, a third-party certification. This certification is not governed by the economic interests of the two sides of the production and marketing, fair and scientific work has gradually established the authority and credibility, and has become a common practice in all countries to evaluate the quality of products and enterprises and supervision. Today's economic integration of countries and the deepening of global trade, as well as members of the community on the quality of the pursuit of perfection to the ISO9000 standard has brought great space for development.
I, 2000 version of the ISO9000 family of standards structure
1, the core standard four
ISO9000: 2000 "quality management system basis and terminology"
ISO9001: 2000 "quality management system requirements" Q
ISO9004: 2000 "quality management system" performance improvement guide =
ISO19011 Audit Guidelines for Quality and Environmental Management
2, a related standard
ISO10012 Requirements for Quality Assurance of Measuring Devices,
3, the technical reports (now included in the program) are 6:
ISO/TR10006 Project Management TR10017 Guide to the Application of Statistical Techniques to ISO9001
4. There are two booklets (now planned): G
Principles of Quality Management - A Guide to Selection and Use :
Guide to the Application of ISO9001 in Small Businesses
5. In order to make the ISO9000 standard more widely and appropriately applied, ISO/TTR10015 Guide to Education and Training
ISO/TR10015 Guide to the Application of Statistical Techniques to ISO9001
5, In order to make the ISO9000 standard more widely and appropriately applied, ISO/TC176 cooperates with other committees or related industries to expand the scope of use of the ISO9000 family of standards:
ISO16949 "Quality System - Supply Side for the Automotive Industry" is an international standard for the automotive industry developed by ISO/TC176 in cooperation with the international automotive industry, replacing the U.S., German, French and Italian automotive industry standards QS9000, VS9000, and VLV. The industry standards QS9000, VDA-6.1, EAQF and AVSQ.0
ISO13485 "Quality System - Application of ISO9001 in Medical Devices" is an international standard developed by ISO/TC176 in cooperation with the medical industry has also been released.
Second, the core standard introduction
1, ISO9000: 2000X
Replaced ISO8402: 1994 and ISO9000-1: 1994, provides the terminology and basic principles of quality management system. This standard puts forward eight quality management principles, is based on the summary of the quality management experience, a clear organization in the implementation of quality management must follow the principles, but also the 2000 version of the 9000 family of standards developed by the guiding ideology and theoretical basis. The second part of this standard proposes 87 terms in 10 parts. In the language emphasizes the use of non-technical language, so that all potential users can easily understand. For ease of use, in the standard appendix, recommended to "concept map" to describe the relationship between the relevant terms. As an echo of the eight principles of quality management in the introduction to this standard, ISO 9000:2000 also proposes the basic principles of quality management systems.
2. ISO 9001:2000
Replaces ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994. The new standard adopts a "process approach" model, replacing the 20 elements of ISO 9001:1994. The new standard adopts the "process approach" model, replacing the 20 elements of the ISO9001:1994 standard. In order to meet the needs of different types of organizations, under certain circumstances, the system requirements can be deleted. The new standard name no longer appears in the word "quality assurance", which reflects the standard quality management system requirements include product quality assurance and customer satisfaction of two meanings.
3, ISO9004: 2000 V6
Provides guidance beyond the requirements of ISO9001: 2000 in order to consider improving the effectiveness and efficiency of the quality management system, with an emphasis on continual improvement, to improve the performance of the organization. ISO9004: 2000 and ISO9001: 2000 is a pair of coordinated and can be used together, the two standards use the same principles, but the two standards can be used together. The two standards use the same principles but have different scopes of application, and the ISO 9004 standard is not intended to be used as an implementation guide for the ISO 9001 standard. The ISO9004 standard can be used as a guide when managers of an organization wish to go beyond the requirements of the ISO9001 standard and pursue growth in performance improvement.
4, ISO19011
is ISO/TC176 and ISO/TC207 (Environmental Management Technical Committee) jointly developed to follow the "different management system, can *** with the management and audit" principle. In terms of terminology and content, the standard is compatible with the quality management system and environmental management system characteristics of both, for the audit of the basic principles, the management of the audit outline, the implementation of environmental and quality management systems, as well as environmental and quality management system assessor qualification requirements to provide a guide.'' 4>
Three, the new and old standards for the conversion of j=#
1, a correct and comprehensive understanding of the connotation of the new version of the standard
The new and old standards, from the form of structural and content changes, and from the essence of the concept of change. These concepts are summarized: the eight principles of quality management, quality management system of the 12 principles, as well as its inclusion of two goals and four methods. The two goals are: customer satisfaction, continuous improvement; 4 methods are: process approach, systems management approach, fact-based decision-making approach and quality management system approach. As long as the correct and comprehensive understanding of these concepts, you can better grasp the requirements of the four core standards.
2, correctly analyze the difference between the new and old versions =b--;Z
2000 version and 1994 version, in the standard structure and content have obvious differences, this difference is mainly reflected in the standard structure and concept, as well as the corresponding standard comparison. If the overall requirements from the two versions of the comparison, the existence of differences is only in the inheritance based on the need for development, is not fundamental. For example: people may feel in the ISO9001: 1994 standard does not fully emphasize the "process" concept, but in the ISO9001-1: 1994 standard, it is clearly pointed out that: "ISO9000 family of standards is based on all work is done through the process of ISO9000 is based on the understanding that all work is accomplished through processes. Four of the nine basic concepts (4.6, 4.7, 4.8, 4.9) described in the standard describe "process" and issues related to "process". In addition, ISO9001:1994, 4.1 "Management Responsibilities" has only one sentence on quality objectives: "A quality policy shall be defined, including a commitment to quality that includes quality objectives. The ISO9000-1:1994 standard states an organization's "principal quality objectives and quality responsibilities". We should note that the 1994 version of the standard also includes quality "improvement", but in fact the idea of quality improvement is implicit in "design control", "corrective and preventive action" (e.g., "corrective action"), and "quality improvement" (e.g., "quality control", "quality improvement"). Both "corrective action" and "preventive action" emphasize that these measures can include changes in, for example, procedures and systems to achieve quality improvement at any stage in the quality loop. During the changeover process, it is important to compare the differences between the two versions and understand their similarities or differences.
3, the correct analysis and use of the existing quality system
Any organization has a quality management system, especially through the certification of the organization, they have been established in accordance with the 1994 version of the standard a documented quality system. A certified organization, the need is not to rebuild a new system, but according to the requirements of the 2000 version of the standard, to improve the system has been established, and never negate the 1994 version of the standard has been established by the system.