GBZ19036-2009 English PDF
Basic dataStandard ID: GB/Z 19036-2009 (GB/Z19036-2009)Description (Translated English): Quality management systems -- Guidelines for the application of GB/T 19001 in small businesses Sector / Industry: National Standard Classification of Chinese Standard: A00 Classification of International Standard: 03.120.10 Word Count Estimation: 49,489 Date of Issue: 2009-09-30 Date of Implementation: 2009-12-01 Quoted Standard: GB/T 19000; GB/T 19001; GB/T 19004 Regulation (derived from): ?National Standard Approval Announcement 2009 No.10 (Total No.150) Issuing agency(ies): Ministry of Health of the People's Republic of China Summary: This standard specifies the general requirements intended to apply to all types, different sizes and offer different products organization. GBZ19036-2009: Quality management systems -- Guidelines for the application of GB/T 19001 in small businesses---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. Quality management systems. Guidelines for the application of GB/T 19001 in small businesses ICS 03.120.10 A00 People's Republic of China national standardization of technical guidance documents Quality Management System GB/T 19001 in small and medium-sized organizations in the application guide 2009-09-30 released 2009-12-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China China National Standardization Administration released Directory Foreword Ⅲ Introduction IV 0.1 Overview Ⅳ 0.2 Process-based Quality Management System Model Ⅴ 1 Scope 1 2 Normative references 2 3 Terms and definitions 2 4 quality management system 5 4.1 General requirements 5 4.2 Documentation Requirements 5 5 Management responsibilities 9 5.1 Management Commitment 9 5.2 Customer Focus 9 5.3 Quality Policy 10 5.4 Planning 10 5.5 Responsibility, authority and communication 12 5.6 Management Review 13 6 Resource Management 14 6.1 Resources Available 14 6.2 Human Resources 15 6.3 Infrastructure and Working Environment 16 Product realization 17 7.1 product realization planning 17 7.2 Customer Related Processes 18 7.3 Design and Development 19 7.4 Purchasing 23 7.5 Production and service delivery 26 7.6 Monitoring and measuring device control 30 Measurement, Analysis and Improvement 8.1 General 32 8.2 Monitoring and Measurement 32 8.3 Control of nonconforming product 37 8.4 Data Analysis 38 8.5 Improvement 39 References 42 ForewordThis guidance document is based on the ISO brochure "Guidelines for the Application of ISO 9001..2000 in Small Organizations." In order to further improve the effectiveness of GB/T 19001 standards implemented by various organizations, especially small and medium-sized organizations, this Guidance Document It provides guidance on how to apply GB/T 19001 to all kinds of organizations, especially small and medium-sized organizations. In order to facilitate the application of the guidance of technical documents, the guidance of technical documents containing GB/T 19001-2000 requirements of the solid line box The relevant guidance provided for these requirements is described below. This guideline is for reference only. The suggestions and opinions on this technical document are directed to the standardization administration under the State Council Department reflected. This Guidance Document is proposed and managed by the National Quality Management and Quality Assurance Standardization Technical Committee (SAC/TC151). This guidance document is drafted by China National Institute of Standardization. The guidance of technical documents Drafted by. China National Institute of Standardization, China Certification Center Co., Ltd., China National Accreditation Qualification Center, China Certification and Accreditation Association, China Electronics Quality Management Association, Beijing Zhao Wei Electronics (Group) Co., Ltd., China Building Materials Inspection Certification Center, Jiangsu East Qiang Co., Ltd. The main drafters of this Guidance Document are Li Renliang, Li Zhao, Li Baofeng, Liang Xiaowen, Yang Zhi Bao, Zhang Xuefeng, Li Ruiping, Ma Zhen Zhu, Chen Zihong.Introduction0.1 General The adoption of a quality management system should be an organizational strategic decision. Design and implementation of an organization's quality management system Various needs, specific goals, products provided, the process followed, and the size and structure of the organization. Uniform quality control The structure or documentation of the system is not the purpose of this standard. The requirements of this standard quality management system is to supplement the product requirements. "Note" is to understand and explain the requirements guide. This standard can be used internally and externally (including certification bodies) to assess the organization to meet customers, laws and regulations and the organization's own requirements ability. The development of this standard has taken into account the quality management principles set out in GB/T 19000 and GB/T 19004. 0.1 Overview GB/T 19001 standards set forth in the quality management system requirements are internationally recognized as a good way of business management. For certification or note It is not mandatory that a quality management system can be evaluated, but customers can use this as a requirement for the organization. One of the purposes of a quality management system is to provide the organization's customers with confidence and to tell the customer that the organization is in good working order, which requires Organizations have demonstrated their ability to meet the requirements of customers and related regulations. A record of the organization's past performance that enables potential customers to organize Ability to generate full trust. Organizational management is not the only way, GB/T 19001 standard provides organizations with a good tube can be used for business management The methodological system, which sets out a series of requirements for the system but does not describe the methods to meet these requirements, GB/T 19001 standard requirements have considerable free space. The organization should establish its quality management system based on its actual business activities. Organizations need to prioritize improvements to processes that do not meet the requirements method. The organization does not have to rewrite all existing quality system documents in order to meet the GB/T 19001 standard. For small and medium-sized organizations, it refers not only to the number of employees, but also to organizing business ideas. For a few only For smaller organizations, communication is often simpler and more direct. A member should undertake a large number of various kinds of work within the organization Decisions are limited to a few individuals, or even individuals. This guideline describes how the GB/T 19001 standard is applied Small organizations, some of which also involve larger organizations, are not always appropriate for larger organizations. Organizations want to reap the benefits of time and effort by improving business processes and products, services, and sales. especially For a manager of a small and medium-sized organization, implementing a quality management system is a matter of time, effort, and money The manager should be as concerned about the establishment and implementation of a quality management system as other businesses do. 0.2 process method This standard encourages the establishment of the implementation of quality management system and improve its effectiveness when using process methods to meet customer needs Seek and enhance customer satisfaction. In order for the organization to function effectively, a number of inter-related activities should be identified and managed. Enter the conversion by using resources and management Activities for the output can be regarded as a process. Often, the output of one process directly forms the input to the next process. The application of the systems of processes within the organization, together with the identification and interaction of these processes and their management, may be referred to as the "process method". The advantage of the process approach is that it relates to the connection between the individual processes in the system of the processes and to the combination and interaction of the processes Continuous control. The use of process approaches in quality management systems emphasizes the importance of. a) understand and meet the requirements; b) The process needs to be considered from a value added perspective; c) the outcome of the process's performance and effectiveness; d) continually improve the process based on objective measurements. The process-based quality management system model shown in Figure 1 shows the process links presented in Chapters 4-8. This The presentation reflects the important role that customers play in defining input requirements. Surveillance of customer satisfaction is required for customer-related organizations The information that has satisfied its request has been evaluated. Although this model covers all the requirements of this standard, but did not reflect in detail each process. Note. In addition, a method called "PDCA" may apply to all processes. The PDCA model can be summarized as follows. P --- Planning. According to customer requirements and organizational guidelines, to provide the results to establish the necessary goals and processes; D --- implementation. implementation process; C --- Inspection. According to the guidelines, goals and product requirements, process and product monitoring and measurement, and report the results; A --- Disposal. Take measures to continuously improve the process performance. Emoticons Value-added activities Information Flow Figure 1 Process-based quality management system model 0.2 Process-based quality management system model Process-based quality management system model is a conceptual model (see GB/T 19001 of Figure 1), is GB/T 19001 The main points of the standard have an important role in understanding the standard. Because the figure highlights the main processes that are inseparable from the standards, these processes may be early Already exists within the organization, but has not previously appeared in such a unique way. The model is based on the point that all quality-related processes start with the customer and end with the customer. Therefore, the model is based on care Customer-driven. In FIG. 1, customers appear on the left and right, in most cases, the same customer, but may also be different customers. The model uses the customer's comments and requirements as input to the quality management system (circles in the figure), input into production and service Planning and product and service requirements. The main process of products and services in the lower part of the figure, identified as "product realization." This box covers the organization of manufacturing products and offers Services activities, in the form of products or services to become the organization's output. This model emphasizes the importance of obtaining customer satisfaction information (the dashed right arrow points to the measurement, analysis, and improvement section) Quantities and reviews are important feedback on organizational performance, and these measurement systems are identified as boxes for "Measurement, Analysis and Improvement." The Management Responsibility box illustrates the importance of the role of manager in a quality management system that managers need to pass through. Decommissioning system operating conditions, provide or adjust the resources needed to maintain and improve the system. The model also points out the need to maintain customer relationships in order to understand customer needs and satisfy customers. Management responsibilities need to be developed Needle, to determine the goal, according to these needs for the correct planning. Planning includes process identification to ensure proper documentation. These documents need rules Set the process of operation. To ensure that there is sufficient resources to ensure the quality of products and services. Resources include working environment, equipment, raw materials and personnel. Also make sure Training of personnel so that they have the capacity to undertake assigned tasks. These are identified as "Resource Management", to the left of the box. The data and analysis are the boxes to the right, identified as "Measurement, Analysis and Improvement" and may suggest improvements to the QMS, as indicated by the arrows The contents of the box to the top --- Continued to improve the quality management system. One of the key features of the standard is the increased use of feedback as a powerful management tool - a tool that can solidify your business. Once upon a time Process needs attention, the use of feedback as a means of monitoring for inspection, to remind operators or managers to take measures to restore To normal condition. Without such a mechanism, waste will increase and morale will falter, both of which will affect the normal production of the organization. Potential opportunities for improvement should be identified. If it turns out that it does exist, then the necessary steps should be taken to put it into practice. The process model in Figure 1 is closely linked to continuous improvement, reflecting two mechanisms that can be used for improvement. --- As part of the quality management system (referred to as the arrow in the inner ring), including control of nonconforming products, corrective measures and preventive measures. --- Review process including audit, self-assessment, management review and monitoring and measurement, these processes can improve the quality management system, The entire quality management system are very crucial. Quality Management System GB/T 19001 in small and medium-sized organizations in the application guide1 Scope1.1 General This standard specifies the quality management system requirements for organizations that have the following requirements. a) the need to demonstrate its ability to consistently provide products that meet the requirements of customers and applicable laws and regulations; b) through the effective application of the system, including the continuous improvement of the system and the assurance of conformity with customers and applicable laws and regulations Requirements, designed to enhance customer satisfaction. Note. In this standard, the term "product" applies only to products intended to be provided to customers or customers. 1.2 application All requirements specified in this standard are generic and are intended to be applicable to organizations of all types, sizes and offering different products. When any of the requirements of this standard is not applicable due to the characteristics of the organization and its products, they may be considered for deletion. Except as limited to those in Chapter 7 of this standard that do not affect the organization to provide products that meet the requirements of customers and applicable laws and regulations The ability or responsibility of the requirements, or can not claim compliance with this standard.1 ScopeThis guidance document provides guidance for the application of GB/T 19001 in small and medium-sized organizations and also for large organizations. This guidance does not set any technical requirements, nor increase or change the GB/T 19001 standard requirements. The standard 1.2 clause "Application" provides the necessary flexibility to satisfy the requirements of 1.2 to claim compliance with GB/T 19001. Standard The quorum provides that the requirements in Chapter 7 of the Standard (Chapter 7 only) can be omitted when the content in Chapter 7 does not apply to the organization (neither Chapter 7 The provisions of the activities, nor the corresponding activities of these provisions responsible for) or does not apply to the products and services provided under this condition Less such requirements will not affect the quality of products and services. The corresponding requirement in Chapter 7 of the Standard can not be deleted because of unwillingness to accept these requirements. In fact, these requirements have not been implemented in the past It does not mean that these requirements do not apply to the organization. If you do not understand a requirement, you can learn about the following. What are the concepts and principles behind this requirement? --- To meet the requirements can prevent what kind of problem? --- Meet the requirements will get the customer's trust? --- If you do not have to be responsible for this request, then who is responsible? For example. If the organization does not design (7.3), then there is no need to design any course of activity. Other possible exceptions are. --- If you do not use the device for measurement, then do not need to be calibrated (7.6). --- If there is no customer provided any property, then there is no need to implement 7.5.4. There may be situations where a sub-item in Chapter 7 may contain deletable content. For example. In the standard 7.5.3 clause, The traceability requirement can be considered as an exception, but the marking requirement can not be used as an exception. Chapter 7 of any impact on the quality of products and services requirements can not be omitted. 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