1、附录 F1. ISO90012008 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for
2、 which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on a
3、ll matters of electrotechnical standardization. Introduction 0.1 General The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced by a) its organizational environment, chan
4、ge in that environment, and the risks associated with the environment； b) its varying needs； c) its particular objectives； d) the products provided； e) the processes it employed； f) its size and structure of the organization. It is not the intent of this International Standard to imply uniformity in
5、 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 req
6、uirement. This International Standard can be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, statutory and regulatory requirements applicable to the product, and the organizations own requirements. The quality management pr
7、inciples stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard. 0.2 Process approach This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality m
8、anagement system, to enhance customer satisfaction by meeting customer requirements. For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activity using resources, and managed in order to enable the transformation of inputs int
9、o 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 to produce the desired the ou
10、tcome, 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 processes within the system of processes, as well as over their combination and interaction. When used within a quality management
11、 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. NOTE I
12、n addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows. Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizations policies. Do: implement
13、the processes. Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results. Act: take actions to continually improve process performance. 0.3 Relationship with ISO 9004 ISO 9001 and ISO 9004 are quality management system stand
14、ards which have been designed to complement each other, but can also be used independently. ISO9001 specifies requirements for a quality management system that can be used for internal application by organizations, or not certification, or for contractual purposes. It focuses on the effectiveness of
15、 the quality management system in meeting customer requirements. At the time of publication of this international standard, ISO9004 is under revision. The revised edition of ISO9004 will provide guidance to management for achieving sustained success for any organization in a complex, demanding, and
16、ever changing, environment. ISO9004 provides a wide focus on quality management than ISO9001； it addresses the needs and expectations of all interested parties and their satisfaction, by the systematic and continual improvement of the organization performance. However, it is not intended for certifi
17、cation, regulatory or contractual use. 0.4 Compatibility with other management systems During the development this international standard, due consideration was give to the provisions of ISO14001:2004 to enhance the compatibility of the two standards for the benefit of the user community. Annex A sh
18、ows the correspondence between ISO9001:2008 and ISO14001:2004. This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. How
19、ever, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies
20、 with the requirements of this International Standard. INTERNATIONAL STANDARD ISO 9001:2008(E) Quality management systems Requirements 4 Quality management system 4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and continually i
21、mprove its effectiveness in accordance with the requirements of this International Standard. The organization shall a) determine the processes needed for the quality management system and their application throughout the organization (see 1.2), b) determine the sequence and interaction of these proc
22、esses, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure where applicable, and anal
23、yse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organization in accordance with the requirements of this International Standard. Where an organization chooses to outsource any pro
24、cess that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system. NOTE 1 Processes needed for the quality management system
25、 referred to above should include processes for management activities, provision of resources, product realization and measurement, analysis and improvement. NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses t
26、o have performed by an external party. NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to outsourced processes can be influence
27、d by factors such as a) the potential impact of the outsourced process on the organizations capability to provide product that conforms to requirements. b) the degree to which the control for the process is shared. c) the capability of achieving the necessary control through the application of 7.4 4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures and records required by this International Standard, and
