Main features and essentials of the hottest ISO900

The main characteristics and requirements of ISO9001:2000 Standard

quality is an eternal topic in social production and life, and it is also one of the themes of global economic development in this century. With the development of the times, the improvement of the level of science and technology and the deepening of human understanding of objective things, quality has been given new life and mission. Nowadays, the mutual integration of national economies, the continuous deepening of Global trade, and the increasingly perfect pursuit of quality by social members have brought great room for the development of ISO9000 standards

1987 version of ISO9000 family standards comes from British standard BS5750. In order to promote this effective management method in the field of quality management, the experts of the international organization for Standardization (ISO) and its Member States, after fruitful efforts and hard work, produced the first edition of ISO9000 family standards in 1987, namely iso9000:1987 series standards, making it a basic international standard to measure the status of quality management activities of enterprises. Since then, ISO9000 family standards, like a global best seller, have been gradually promoted in Europe, America, Asia and the world. This quality management mode not only injects new vitality and vitality into enterprise management, brings quality credibility to world trade, and provides the evaluation basis for the quality management system, but also develops and improves with the global economic integration, the improvement of objective cognition, and the needs of the standard itself. From the evolution of ISO9000 series standards, it can be seen that the 1987 ISO9001 standard pays more attention to the internal quality management and quality assurance of enterprises from the perspective of self assurance; The 1994 version of ISO9001 standard includes user requirements, regulatory requirements and quality assurance requirements into the scope of the standard through 20 quality management system elements: the 2000 version of ISO9001 standard has changed with the flavor of the times in terms of standard conception and standard purpose, and the concept of process method, consideration of customer needs, and the idea of continuous improvement run through the whole standard, The ability and degree of the organization's quality management system to meet customer requirements are reflected in the requirements of the standard

with the popularization of the application of ISO9000 family standards and the increase of standard users, the excessive number of standards in ISO9000 family standards, the difficulty of the application of standards in different economic and technological 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 arising from the use of the 1994 edition of the standard, take into account the future development of the standard and fully meet the needs of customers, iso/tc176 conducted a written survey of the global adoption of ISO9000 family standards involving 1120 users and customers in 197 to collect the opinions and suggestions of standard users, so as to understand the needs of standard users more accurately in the revision of the standard, The comprehensive function and efficiency of the quality management system are more accurately reflected in the content of the new standard. The contents of the written consultation also include the willingness to revise the standard, the respective characteristics and mutual relationship between ISO9001 standard and ISO9004 standard, and the relationship between quality management system standard and environmental management system standard. After five years and on December 15, 2000, it was officially promulgated and implemented by the international organization for standardization. ISO9000, ISO9001, ISO9004 and iso19011 constitute the core standards of the new ISO9000 family of standards

2000 ISO9001 standard has changed significantly compared with 1994 standard in terms of structure, content and conception. The new version of the standard adopts the process based quality management system organization mode, which is completely different from the organization mode based on 20 elements in the 1994 ISO9001 standard. The process based structural model is more practical than the element based structural model, and is more used in today's management activities. The use of the process mode realizes the purpose of unifying the contents of the 2000 ISO9001 standard with the PDCA cycle in the ISO14001 standard, and incorporates all the 20 elements of the 1994 ISO9001 standard into the new standard. From the perspective of change, the new version of iso2030 or so may cause the world high-tech biomaterial market to grow to ≈ us The 9001 standard with more than 50000 billion yuan mainly has the following characteristics:

first, the standard has wide applicability

as a general quality management system standard, ISO9001:2000 standard can be applied to all kinds of organizations, and is not affected and limited by the type of organization,

scale, economic and technological activity field or professional scope, and the type of products provided. This feature of the standard can be shown in four aspects:

1. The quality management system of any organization should consider four important components: first, management responsibilities, including policies, objectives, management commitments, responsibilities and authorities, planning, customer needs, quality management system and management review; The second is resource management, including human resources, information resources, facilities, equipment and working environment; The third is process management, including customer demand conversion, design, procurement, product production and service provision; The fourth is measurement, analysis and improvement, including information evaluation, internal audit of quality management system, product monitoring and measurement, process monitoring and measurement, nonconforming product control, continuous improvement, corrective and preventive measures, etc. The four important components of the quality management system are reflected in the classification in the new standard terms

2. The term "product" used in the standard has dual meanings. The term "product" can mean tangible physical products or "services"

3. The organization adopts this standard to establish a quality management system. Its main purpose is to show that the organization has the ability to continuously provide products that meet the needs of customers and the requirements of relevant laws and regulations, and to ensure that it can enhance the trust of customers through the effective operation of the quality management system

4. The contents and requirements of the standard terms use clear language and terms, comprehensively reflect the characteristics of various quality management activities, and reduce the difficulty of understanding and applying the standard terms

II. The compatibility between ISO9000 series standards and ISO14000 series standards has been significantly improved.

the new ISO9001 standard can be better compatible with iso14001:1996 environmental management system standards, which is a very important customer demand in the process of standard implementation. This demand exists in both existing and expected ways. Improving the compatibility between ISO9000 series standards and ISO14000 series standards can be seen from the structure, quality management system mode, standard content, language and terminology used in the new ISO9001 standard. When the organization's management activities and management system adopt the standards of the two systems, there are management system elements that can be used and meet the ISO9001 standard and ISO14001 standard at the same time. In the management and control of product/service quality, environmental factors and environmental impact, process mode and PDCA cycle method can be better combined to play a role. Meeting the requirements of relevant laws and regulations, customer needs and the interests of interested groups in society have become the common purpose of the two series of standards. As the necessary measures of management activities, monitoring, measurement, analysis and improvement are put forward in the same way in the two series of standards, which is more conducive to the operation of the management system and improve the effectiveness

another compatibility feature of the new version of ISO9001 standard is that it provides convenience for users of the 1994 version of ISO9001, ISO9002 and ISO9003 standards. From the comparison between the elements of the 1994 ISO9001 standard and the 2000iso9001 standard, the 20 quality management system elements of the 1994 standard are fully contained in the terms and contents of the new standard. Users of the 1994 standard need only classify and partially adjust the contents and requirements of their quality management system when they convert to the new standard

III. acceptability of standard terms and requirements

one of the principles of adopting standards is to meet all the requirements of the standards, which is a basic feature of standardization activities. Obviously, if the organization's products and product realization process are within the scope of application of quality assurance, its quality management system should serve the requirements of all clauses of ISO9001:2000 standard. However, due to the differences in organizational functions, objective characteristics of products and the scope of application of standards, in the process of standard adoption, whether the organization places all or part of its products and product realization process within the management scope of the quality management system, it may find that the standard terms are not applicable. Therefore, the ISO9001:2000 standard gives the possibility of deleting the inapplicable standard clauses and requirements through the Clause 1.2 "scope of application of the standard". This means that in the process of adopting the new standard, the organization can make trade-offs on the standard terms and requirements according to the needs and application scope of its quality management system, and delete the inapplicable standard terms. The quality management system requirements mentioned here refer to the adoption of standards for selected products and product realization processes; The scope of application refers to the use of standards for all or part of products and product realization processes. No matter whether the organization chooses the terms and requirements of the standard or not, the results of standard acquisition shall indicate the conformity of the organization's quality management system to the standard. The declaration of compliance with the standard can be completed through the organization's self declaration, second-party assessment or third-party certification. Therefore, the new version of the standard limits the deletion of the standard terms of standard durability test: repeated press test can be carried out according to the preset pressure conditions to the content of Chapter 7 "product realization". At the same time, when deleting the contents of Chapter 7 of the standard, we should also consider whether it brings difficulties to the organization's ability, responsibility, product provision and product realization

IV. effectively solve the operability of quality management system documents

users of the 1994 version of the label respect have a common feeling: establishing a quality calendar system according to the requirements of the standard requires generating at least 17 procedure documents and more than 18 quality records; The preparation of these procedure documents or quality records brings excessive document workload to the organization; Some documents or records deviate more or less from the characteristics of the organization and the data automatically collected during fast compression is very different from the data collected during slow compression or static compression; The use and management of quality management system documents have become an increasingly heavy burden; The formatting of quality management system documents is increasing. These phenomena in the use of standards reduce the efficiency and practicality of quality management system documents. The 2000 ISO9001 standard has two important purposes in quality management system documents: to establish a simple document format suitable for organizations of different sizes; The quantity and content of documents are more in line with the expected results of the organization's process activities

based on the above two aspects, the new standard simplifies the requirements of quality management system documents. As for the requirements of the quality manual, clause 4.2.1b) indicates that the contents of the manual can be determined according to the management needs of the organization. Clause 4.2.2 shows that the content of the quality manual required by the standard is the application scope of the quality management system, the deleted standard requirements and the reasons for the deletion, the procedure documents used or quoted in the quality management system, and the content describing the interrelationship and interaction between the processes contained in the quality management system. For the requirements of relevant procedure documents, the procedure documents for standard requirements in Clause 4.2.1c) include: the procedure documents for document control required in 4.2.3, the procedure documents for record control required in 4.2.4, the procedure documents for internal audit of quality management system required in 8.2.2, the procedure documents for control of nonconforming products required in 8.3 8.5.2 required procedure documents for corrective activities and 8.5.3 required procedure documents for preventive activities. Record relevant quality