【正文】 c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance。企業(yè) ()大量管理資料下載 ANSI/ISO/ASQ Q90012020 AMERICAN NATIONAL STANDARD Quality management systems— Requirements Approved as a American National Standard by: American Society for Quality An American National Standard Approved on December 13, 2020 American National Standards: An American National Standard implies a consensus of those substantially concerned with its scope and provisions. An American National Standard is intended as a guide to aid the manufacturer, the consumer, and the general public. The existence of an American National Standard does not in any respect preclude anyone, whether he or she has approved the standard or not, from manufacturing, purchasing, or using products, processes, or procedures not conforming to the standard. American National Standards are subject to periodic review and users are cautioned to obtain the latest edition. Caution Notice:This American National Standard may be revised or withdrawn at any time. The procedures of the American National Standards Institute require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Purchasers of American National Standards may receive current information on all standards by calling or writing the American National Standards Institute. v ANSI/ISO/ASQ 090012020 Contents Page 1 Scope 1 General 1 Application 1 2 Normative reference 1 3 Terms and definitions 1 4 Quality management system 2 General requirements 2 Documentation requirements 2 5 Management responsibility 3 Management mitment 3 Customer focus 4 Quality policy 4 Planning 4 Responsibility, authority and munication 4 Management review 5 6 Resource management 5 Provision of resources 5 Human resources 6 Infrastructure 6 Work environment 6 7 Product realization 6 Planning of product realization 6 Customerrelated processes 7 Design and development 8 Purchasing 9 Production and service provision 10 Control of monitoring and measuring devices 11 8 Measurement, analysis and improvement 11 General 11 Monitoring and measurement 11 Control of nonconforming product 12 Analysis of data 13 Improvement 13 Annexes A Correspondence between ISO 9001:2020 and ISO 14001:1996 15 B Correspondence between ISO 9001:2020 and ISO 9001:1994 19 Bibliography 23 ANSI/ISO/ASQ Q90012020 ix Introduction General The adoption of a quality management system should be a strategic decision of an anization. The design and implementation of an anization’s quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the anization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are plementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. This International Standard can be used by internal and external parties, Including certification bodies, to assess the anization’s ability to meet customer, regulatory and the anization’s own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard. Process approach This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. For an anization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs Into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. The application of a system of processes within an anization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”. An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processe s within the system of processes, as well as over their bination and interaction. When used within a quality management system, such an approach emphasizes the importance of a) understanding and meeting requirements, b) the need to consider processes in terms of added value, C) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement. The model of a processbased quality management system shown in Figure 1 illustrates the process linkages