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ISO9001 Quality Certification
Quality of social production and life of an eternal topic, but also concerned about the global economic growth this century one of the themes. With the development of the times, raising the level of science and technology and human cognition of objective things better, the quality has continually been given new life and mission. Today the mutual blending of national economies and the deepening of global trade, as well as members of society, the pursuit of perfection of the quality of the growing family to the ISO 9000 standard a huge space for development.
    1987 edition of ISo 9000 Family Standards from the British Standard BS5750. In order to promote the effective management of quality management methods, International Organization for Standardization (1So) experts and a member of the organization through the fruitful efforts and hard work, in 1987 produced the first version of IS09000 family standards, that is, ISo 9000 : 1987 series of standards, making enterprise quality management activities to measure the status of a basic international standards. Since then, ISo 9000 Family of Standards is like a global best-seller in Europe, the Americas, Asia, and gradually spreads throughout the world. This quality management model for enterprise management inject new vigor and vitality to the world trade has brought quality and credibility, to provide basis for evaluation of quality management at the same time, but also as the global economic changes, the objective of raising awareness and standards of their need to constantly develop and improve. IS09000 series of standards from the evolution can be seen, 1987 version of ISO 9001 standard from the perspective of self-assurance, more concerned about internal quality management and quality assurance; 1994 edition of ISo 9001 standards for quality management system through the 20 elements of the user requirements, regulatory requirements and quality assurance requirements into the standard range; 2000 ISo 9001 standards and criteria for the purpose of the standard idea of areas where there are a flavor of the times change, the concept of process approach, consideration of customer needs, continuous improvement thinking throughout the standards, the organization's quality management system the ability to meet customer needs and level of expression in the standard appeals.
    ISo 9000 family standard applications with the popularity and the increase in standard user, ISo 9000 family of standards for the excessive number of standards, standards in different areas of economic and technical ease of application of quality management system of universal concern the effectiveness of a standard user focus. 1994 edition of the standard used to resolve the problems in the process and taking into account the future development of the standard and fully meet customer needs, ISo/TCl76 carried out in 1997 with a 1120 users and customers to participate in the global adoption of ISo 9000 Family Standards of a written survey, collecting a standard user comments and recommendations for the revision in the standard more accurate understanding of the standard user needs, the content in the new version of the standard more accurately reflects the quality management system, integrated functionality and performance. The content of the written comments will also include revised standards, ISo 9001 standards and ISo 9004 standards for their respective characteristics and the relationship between the quality management system standards and environmental management system standard of relationships. After five years of the standard revision process, ISo 9000:2000 series of standards on December 15, 2000 formally promulgated and implemented by the International Organization for Standardization, ISo 9000, ISo 9001, ISO 9004, and ISo19011 four standards form the new core of 1.509 million Family Standards standard.
    2000 ISo 9001 standard in structure, content, ideas, etc. Compared with the 1994 edition of significant changes have taken place. Adopted the new standard process-based quality management system and structural model, which is 1994 version of ISO 9001 standards to 20 elements based on structural model is entirely different. Process-based model than by the structural elements of the structural model based on a more realistic, is more used in today's management activities. Process model used to achieve the 2000 version of IS09001 and IS014001 standard content standards of the PDCA cycle of the unity of purpose and ISo 9001 to 1994 version of the standard 20 to accommodate all the elements into the new standard. From the change in perspective, the new version of ISo 9001 standard has the following characteristics.
    1, the standard has broad applicability
    ISo 9001:2000 standard as a common standard of quality management system applicable to all types of organizations are not subject to histological type, size, economic and technological activity area or areas of expertise, providing the impact of product categories and limitations. This feature of the standard can be shown in four aspects:
    1. Any organization's quality management system should take into account four important components: first, management responsibilities, including the principles, objectives, management commitment, responsibility and authority, planning, customer needs, quality management system and review the content of Deng Xiang; followed by resource management , including human resources, and information resources, facilities and equipment and the working environment Dengxiang content; third is a process management, including customer conversion, design, procurement, production and service provision Dengxiang content; Fourth, measurement, analysis and improvement, including information evaluation, quality management system and internal audit, product monitoring and measurement, process monitoring and measurement, control of nonconforming product, continuous improvement, corrective and preventive measures Dengxiang content. Quality management system of the four important part of the provisions embodied in the new version of the standard classification.
    2. The terminology used in the standard term "product" has two meanings. The term "product" means tangible or physical products could also be means "services."
    3. Organizations to adopt the standard set up quality management system, its main purpose is to show organizations have the capacity to meet customer demand and continue to provide the relevant laws and regulations of the products, to ensure that their quality management system through the effective operation of enhanced customer confidence.
    4. Standard terms of content and require the use of a clear language and terminology, a comprehensive reflection of the characteristics of various types of quality management activities, reducing the need for standard terms difficult to understand and use.
    Second, significant improvement in IS09000 series of standards
    Compatibility with the IS014000 series of standards
    A new version of ISO 9001 standard can be better with ISo14001: 1996 environmental management system standard compatibility, which is the standard process of implementing a very important customer demands. This demand and expectations of the existing presence in two ways. 1.509 million to improve the family standard and IS014000 series of standards of compatibility from the new structure of ISO 9001 standards, quality management system model, standard content, the standard language and terminology so apparent. Management activities of the organization and management system in the use of two series of standards, there can be used at the same time comply with ISo 9001 standard and IS014001 standard management system elements. In the right product / service quality, environmental factors and environmental impact management and control, process model and the PDCA cycle method can work better together play a role. To meet the relevant laws and regulatory requirements, customer demand and interest groups in the interests of the community into two series of standards of common purpose. Monitoring, measurement, analysis and improvement of management activities, as a necessary measure in the two series of standards in the same manner more conducive to the operation and management system to improve effectiveness.
    Another new version of the standard ISo 9001 compatibility feature for the 1994 edition of ISo 9001, ISo 9002, ISo 9003 standard provides the convenience of the conversion. From the 1994 version of ISO9001 standard elements ISo 9001 and 2000 comparison of the standard clauses of view, 1994 edition of the standard 20 elements of quality management system, fully inclusive in the new version of the standard terms and content. 1994 edition of the standard user to the new standard conversions, simply for its quality management system, contents and requirements of classification, and some adjustments accordingly.
    3, standard terms and requirements can be trade-offs of
    One of the principles standard is in line with all the requirements of the standard, which is a basic feature of standardization activities. Clearly, if the organization's products and product realization process within the scope of quality management system, its quality management system should comply with all the provisions of ISo 9001:2000 standard requirements. However, as the organizational functions, products, and standards for application of objective characteristics of the differences in the standard adoption process, both organizations are in whole or in part of its products and product realization process placed the management of quality management system within the standard may be found, provisions do not apply to the situation. To this end, ISo9001: 2000 standard through the 1.2 "standard the scope of application" clause does not apply is given on the standard terms and requirements of the possibility of deletion. This means that organizations that have adopted new standard in the process can be based on its quality management system requirements and scope of application of the standard terms and conditions and requirements to make trade-offs, cut does not apply standard terms and conditions. Are talking about here refers to the quality management system requirements for the selected products and product realization process of a standard situation; application refers to all or part of products and product realization process of a standard situation. Regardless of whether the organization of the standard terms and requirements of trade-offs, the results should indicate the organization to adopt the subject of quality management system standard compliance. A standard declaration of conformity through the organization of self-declaration, second party assessment, or third-party certification to complete. Therefore, the new standards will be limited to standard terms and conditions of the deletion of Chapter 7, "product realization" content. At the same time, the standard contents of Chapter 7 deletion, you should also consider whether the capacity of the organization, functions, products and product realization to influence.
    Fourth, an effective solution to quality management system documents operability
    1994 edition of the standard users have a common feeling: In accordance with standard quality management system needs to generate at least 17 program files and 18 more than the quality of records; these program files, or the preparation of quality records to bring to the organization too much paper work ; some of the documents or records more or less deviate from the characteristics of the organization and management of live; quality management system documents the use and management of an increasingly heavy burden; quality management system documents formatted unabated. Standards for the use of these phenomena arise in the process, reducing the effectiveness of quality management system documents and practicality. 2000 ISo 9001 standards in quality management system documentation to achieve two important objectives are: to establish a simple file format to apply to three different scales of organization and content of the volume of documentation more in line with the process of organizing the activities of the desired results.
    Based on the above two aspects, the new standards in quality management system documentation requirements were simplified. The quality manual requirements, terms 4.2.1b) shows that the contents of the manual can be determined according to the organization's management needs. Terms of 4.2.2 shows that the standard requirements of quality manual content is the application of quality management system, was deleted and the deletion of the reasons for standards, quality management system in use or referenced documents and describe the quality management system by includes the process of inter-relationships and the role of content. Documentation requirements of the relevant procedures, terms 4.2.1c) that the standard procedures required documents are: 4.2.3 the requirements for document control program file, 4.2.4 required for recording control procedures files, 8.2.2 required for quality management system internal audit of the program file, 8.3 required for controlling non-conforming product program files, 8. 5.2 requirements for corrective action program documents and 8.5.3 the requirements for prevention activities in program files. Records relating to the quality requirements, standards were made in terms of the different 21 for quality management systems quality records. These records are: management review records; members of the education, training, skills and experience records; used to prove that products meet requirements and product realization process of the record; reflect the product requirements and the results and measures of records; design, development input records; reflect the design, development, and the results and measures of the records; reflect the design, development, validation results and the measures taken to record; reflect the design, development, confirmation of results and measures of records; reflect the design, development, validation results and the measures taken to record; reflection for the side the results of evaluation and self-evaluation records; monitoring and measurement results fail to reflect the process of verification to confirm the records; right product can be traced back to establish unique identification of the record; customer asset management and use of records; no benchmarks to reflect the measurement of equipment calibration and verification of records; measurement results deviate from the requirements of the pre-verification records; measuring equipment calibration and verification of records; reflect the results of quality management system internal audit records; prove that the products comply with standards and contract requirements of the records; right unqualified Goods to take corrective measures, records; reflect the correct results of the records and records of the results of prevention activities.
    Streamlined quality management system documents, allowing organizations to use a more flexible and effective way to construct its quality management system, but also to enable organizations to a small number of documentation requirements in the most comprehensive show of its process of effective planning, operation and control, and quality management effectiveness of the system and continuous improvement of the situation.
    ISo 9001 overview 2000 edition of the standard content can be found, the standard highlights the process of identification, the factors affecting the control, continuous improvement and system operation effectiveness of the four requirements. Process-model-based quality management system, the primary problem is effective identification of quality management system included in the process. As a prerequisite, standard clauses 0.2 process approach, expressed the basic characteristics of the process, a standard clause 4. 1a) raised the quality management system included in the process of identification requirements.
    It is worth mentioning that the process of identifying the content to be considered are: the application of quality management system, the organization's functions and objectives, organizational structure and quality management activities. Characteristics to be considered are: the course along with input and output exist; the process may be one or more of the same goal with different functional activities of combinations.
    The process can be divided into coarse to fine, coarse division of the process consists of a number of small process. Standards on the thickness of the process of division does not make a specific request, but the standard proposed by the implementation of effective control of the process requirements, will be detailed breakdown of the process to better reflect the superiority of the process of division.
    As the process contains a number of affected product or service quality factors, the standard terms put forward from different factors affecting the process of implementation of the management and control requirements. These include control of documents and records, principles and objectives of management, resource management, responsibilities and authority of management, organization of internal and external information management, product formation and service delivery process management, product quality, performance and control requirements, the product Factors Affecting the Quality of control.
    The standard set forth in the articles 8.5.1 Quality Management System requirements of continual improvement, and the provisions of the Agreement related to all aspects of quality management system. As mentioned in the terms of the quality policy and objectives, internal quality management system audits and management reviews, product realization process of quality control and influencing factors on product quality control, customer needs and relevant laws and regulations requirements. Continuous improvement activities, a key component, is the customer needs and expectations from the current perspective, this requires the organization in quality management activities, should provide the ability to predict future demand. Quality management system, the purpose of continuous improvement is in the organization demonstrated its ability to continually meet customer requirements and relevant laws and regulations required by the product while maintaining the effectiveness of quality management system in a timely manner. This is also the 2000 edition of ISo 9001 standards emphasize an important aspect. Standards on quality management system model calls for changes to the quality management system to streamline the documentation of inappropriate deletion of the provisions and requirements are given the possibility of its final day, once the organization decided to use their quality management activities in the 2000 version of IS09001 establish a quality management system standard, we must ensure that the effectiveness of quality management system in a timely manner.
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