With the popularization of ISO9000 family standards and the increase of standard users, the excessive number of standards in ISO9000 family standards, the difficulty of applying standards in different economic and technical fields and the effectiveness of quality management system have become the focus of general attention in the use of standards. In order to solve the problems existing in the use of the 1994 version of the standard, consider the future development of the standard, and fully meet the needs of customers, ISO/TC 176 conducted a written survey on the users of120 and 197 who adopted the ISO9000 family standard all over the world, and solicited the opinions of standard users. The written opinions also include the willingness to revise the standards, the respective characteristics and relationships of ISO900 1 and ISO9004 standards, and the relationship between quality management system standards and environmental management system standards. After five years, on February 5, 2000,16,5438+08 was officially promulgated and implemented by the International Organization for Standardization. ISO9000, ISO900 1, ISO9004 and ISO 190 165438 constitute the core standards of the new ISO9000 family standard.
Compared with the 1994 version, the 2000 version of ISO900 1 standard has obvious changes in structure, content and concept. The new version of the standard adopts the organization mode of quality management system based on process, which is completely different from the organization mode of ISO900 1 Edition 1994 based on 20 elements. The process-based structural model is more practical than the factor-based structural model, and it is used more in today's management activities. The use of process mode has achieved the purpose of unifying the PDCA cycle contents in ISO900 1 and ISO 1400 1 in 2000. All the 20 elements of ISO900 1 in 1994 are included in the new standard. In terms of changes, the new ISO900 1 standard mainly has the following characteristics: