iso9000-2000(doc28)英文版-iso9000(编辑修改稿)

iso9000-2000(doc28)英文版-iso9000(编辑修改稿)内容摘要：

aces the term “subcontractor”. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”. 4 Quality management system General requirements The anization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The anization shall a) identify the processes needed for the quality management system and their application throughout the anization (see ), b) determine the sequence and interaction of these processes, 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 and analyze these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the anization in accordance with the requirements of this International Standard. Where an anization chooses to outsource any process that affects product conformity with requirements, the anization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. Documentation requirements 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 required by this International Standard, d documents needed by the anization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see ). NOTE I Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. ANSI/ISO/ASQ Q90012020 3 NOTE 2 The extent of the quality management system documentation can differ from one anization to another due to a) the size of anization and type of activities, b) the plexity of processes and their interactions, and c) the petence of personnel. NOTE 3 The documentation can be in any form or type of medium. Quality manual The anization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of and justification for any exclusions (see ), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system. Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in . A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue, b) to review and update as necessary and reapprove documents, C) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. Control of records Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 5 Management responsibility Management mitment Top management shall provide evidence of its mitment to the development and implementation of the quality management system and continually improving its effectiveness by a) municating to the anization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, ANSI/ISO/ASQ Q90012020 4 d) conducting management reviews, and e) ensuring the availability of resources. Customer focus Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see and ). Quality policy Top management shall ensure that the quality policy a) is appropriate to the purpose of the anization, b) includes a mitment to ply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is municated and understood within the anization, and e) is reviewed for continuing suitability. Planning Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product a)], are established at relevant functions and levels within the anization. The quality objectives shall be measurable and consistent with the quality。