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1、INTERNATIONAL STANDARD ISO 9001 Fourth edition 2008-11-15 Reference number ISO 9001:2008(E) ISO 2008 Quality management systems Requirements Systmes de management de la qualit Exigences ISO 9001:2008(E) ii ISO 2008 All rights reserved PDF disclaimer This PDF file may contain embedded typefaces. In a
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6、 office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ISO 9001:2008(E) ISO 2008 All rights reserved iii Contents Page 1Scope 1 1.1General . 1 1.2Application . 1 2Normative references 1 3Terms and defini
7、tions 1 4Quality management system 2 4.1General requirements . 2 4.2Documentation requirements 2 5Management responsibility 3 5.1Management commitment 3 5.2Customer focus . 4 5.3Quality policy . 4 5.4Planning . 4 5.5Responsibility, authority and communication 4 5.6Management review 5 6Resource manag
8、ement . 6 6.1Provision of resources 6 6.2Human resources 6 6.3Infrastructure . 6 6.4Work environment . 6 7Product realization . 7 7.1Planning of product realization 7 7.2Customer-related processes 7 7.3Design and development 8 7.4Purchasing . 9 7.5Production and service provision 10 7.6Control of mo
9、nitoring and measuring equipment 11 8Measurement, analysis and improvement . 12 8.1General . 12 8.2Monitoring and measurement 12 8.3Control of nonconforming product 13 8.4Analysis of data . 13 8.5Improvement 14 Annex A (informative) Correspondence between ISO 9001:2008 and ISO 14001:2004 . 15 Annex
10、B (informative) Changes between ISO 9001:2000 and ISO 9001:2008 . 20 Bibliography . 26 ISO 9001:2008(E) iv ISO 2008 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing
11、International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaiso
12、n with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of tec
13、hnical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is dra
14、wn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 9001 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2,
15、 Quality systems. This fourth edition cancels and replaces the third edition (ISO 9001:2000), which has been amended to clarify points in the text and to enhance compatibility with ISO 14001:2004. Details of the changes between the third edition and this fourth edition are given in Annex B. ISO 9001
16、:2008(E) ISO 2008 All rights reserved v Introduction 0.1General 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, changes in tha
17、t environment, and the risks associated with that environment, b)its varying needs, c)its particular objectives, d)the products it provides, e)the processes it employs, f)its size and organizational structure. It is not the intent of this International Standard to imply uniformity in the structure o
18、f 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 I
19、nternational 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 principles stated
20、in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard. 0.2Process approach This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system,
21、 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 activities using resources, and managed in order to enable the transformation of inputs into outputs, can
22、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 outcome, can be refer
23、red 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 system, such an ap
24、proach emphasizes the importance of a)understanding and meeting requirements, b)the need to consider processes in terms of added value, ISO 9001:2008(E) vi ISO 2008 All rights reserved c)obtaining results of process performance and effectiveness, and d)continual improvement of processes based on obj
25、ective measurement. The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires t
26、he evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level. NOTEIn addition, the methodology kno
27、wn 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 the processes. Check: monitor a
28、nd measure processes and product against policies, objectives and requirements for the product and report the results. Act: take actions to continually improve process performance. Figure 1 Model of a process-based quality management system ISO 9001:2008(E) ISO 2008 All rights reserved vii 0.3Relati
29、onship with ISO 9004 ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently. ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for
30、 certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements. At the time of publication of this International Standard, ISO 9004 is under revision. The revised edition of ISO 9004 will provide guidance to management f
31、or achieving sustained success for any organization in a complex, demanding, and ever changing, environment. ISO 9004 provides a wider focus on quality management than ISO 9001; it addresses the needs and expectations of all interested parties and their satisfaction, by the systematic and continual
32、improvement of the organizations performance. However, it is not intended for certification, regulatory or contractual use. 0.4Compatibility with other management systems During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance
33、 the compatibility of the two standards for the benefit of the user community. Annex A shows the correspondence between ISO 9001:2008 and ISO 14001:2004. This International Standard does not include requirements specific to other management systems, such as those particular to environmental manageme
34、nt, occupational health and safety management, financial management or risk management. However, 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 ex
35、isting management system(s) in order to establish a quality management system that complies with the requirements of this International Standard. . viii INTERNATIONAL STANDARDISO 9001:2008(E) ISO 2008 All rights reserved 1 Quality management systems Requirements 1Scope 1.1General This International
36、Standard specifies requirements for a quality management system where an organization a)needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b)aims to enhance customer satisfaction through the effective applica
37、tion of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. NOTE 1In this International Standard, the term “product” only applies to a)product intended for, or required by, a custome
38、r, b)any intended output resulting from the product realization processes. NOTE 2Statutory and regulatory requirements can be expressed as legal requirements. 1.2Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless
39、 of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable
40、 unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. 2Normative references The following referenced documents
41、are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2005, Quality management systems Fundamentals and vocabulary 3Terms and def
42、initions For the purposes of this document, the terms and definitions given in ISO 9000 apply. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”. ISO 9001:2008(E) 2 ISO 2008 All rights reserved 4Quality management system 4.1General req
43、uirements The organization 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 organization shall a)determine the processes needed for the quality management sy
44、stem and their application throughout the organization (see 1.2), 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 informatio
45、n necessary to support the operation and monitoring of these processes, e)monitor, measure where applicable, and analyse 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
46、 accordance with the requirements of this International Standard. Where an organization chooses to outsource any process 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 proces
47、ses shall be defined within the quality management system. NOTE 1Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement. NOTE 2An “outsourced process” is a pr
48、ocess that the organization needs for its quality management system and which the organization chooses to have performed by an external party. NOTE 3Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulat
49、ory requirements. The type and extent of control to be applied to the outsourced process can be influenced 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. 4.2Documentation requirements 4.2.1General The quality management system documentation shall include a)documented statemen