质量认证）IS(英文版) AMERICAN NATIONAL STANDARDQuality management systems—RequirementsApproved as a American National Standard by:American Society for QualityAn American National Standard Approved on December 13, 2000American 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and users are cautioned to obtain the latest edition.Caution Notice:This American National Standard may be revised or withdrawn at any time.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. ANSI/ISO/ASQ 09001-2000Contents Page1 Scope 11.1 General 11.2 Application 12 Normative reference 13 Terms and definitions 14 Quality management system 24.1 General requirements 24.2 Documentation requirements 25 Management responsibility 35.1 Management commitment 35.2 Customer focus 45.3 Quality policy 45.4 Planning 45.5 Responsibility, authority and communication 45.6 Management review 56 Resource management 56.1 Provision of resources 56.2 Human resources 66.3 Infrastructure 66.4 Work environment 67 Product realization 67.1 Planning of product realization 67.2 Customer-related processes 77.3 Design and development 87.4 Purchasing 97.5 Production and service provision 107.6 Control of monitoring and measuring devices 118 Measurement, analysis and improvement 118.1 General 118.2 Monitoring and measurement 118.3 Control of nonconforming product 128.4 Analysis of data 138.5 Improvement 13AnnexesA Correspondence between ISO 9001:2000 and ISO 14001:1996 15B Correspondence between ISO 9001:2000 and ISO 9001:1994 19Bibliography 23Introduction0.1 GeneralThe adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. 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 complementary 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 organization’s ability to meet customer, regulatory and the organization’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.0.2 Process approachThis 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 organization 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 organization, together with the identification and interactions of these processes, and their management, can。