BS EN ISO 9001-2008 Quality management systems – Requirements.pdf

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1、raising standards worldwide NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BSI British Standards Quality management systems Requirements BS EN ISO 9001:2008BS EN ISO 9001:2008 BrItISh StaNdard National foreword t his British Standard is the UK implementation of EN ISO 9001:20

2、08. It supersedes BS EN ISO 9001:2000 which is withdrawn. t he UK participation in its preparation was entrusted to technical Committee QS/1, Quality management and quality assurance procedures. a list of organizations represented on this committee can be obtained on request to its secretary. t his

3、publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. BSI 2008 ISBN 978 0 580 59471 7 ICS 03.120.10 Compliance with a British Standard cannot confer immunity from legal obligations. t his British Standard was published

4、under the authority of the Standards Policy and Strategy Committee on 30 November 2008. Amendments issued since publication Amd. No. Date Text affected EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9001 November 2008 ICS 03.120.10 Supersedes EN ISO 9001:2000 English Version Quality manage

5、ment systems - Requirements (ISO 9001:2008) Systmes de management de la qualit - Exigences (ISO 9001:2008) Qualittsmanagementsysteme - Anforderungen (ISO 9001:2008) This European Standard was approved by CEN on 8 November 2008. CEN members are bound to comply with the CEN/CENELEC Internal Regulation

6、s which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This Europ

7、ean Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the nat

8、ional standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and

9、 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9

10、001:2008: EForeword This document (EN ISO 9001:2008) has been prepared by Technical Committee ISO/TC 176 “Quality management and quality assurance“. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by

11、 May 2009, and conflicting national standards shall be withdrawn at the latest by May 2009. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This docu

12、ment supersedes EN ISO 9001:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,

13、Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 9001:2008 has been approved by CEN as EN ISO 9001:2008 without any modific

14、ation. BBBBS EN ISO 9001:2008 INTERNATIONAL STANDARD ISO 9001 Fourth edition 2008-11-15 Reference number ISO 9001:2008(E) Quality management systems Requirements Systmes de management de la qualit ExigencesBBBBS EN ISO 9001:2008 ii BS EN ISO 9001:2008iii Contents Page 1 Scope 1 1.1 General . 1 1.2 A

15、pplication . 1 2 Normative references 1 3 Terms and definitions 1 4 Quality management system 2 4.1 General requirements . 2 4.2 Documentation requirements 2 5 Management responsibility 3 5.1 Management commitment 3 5.2 Customer focus . 4 5.3 Quality policy . 4 5.4 Planning . 4 5.5 Responsibility, a

16、uthority and communication 4 5.6 Management review 5 6 Resource management . 6 6.1 Provision of resources 6 6.2 Human resources 6 6.3 Infrastructure . 6 6.4 Work environment . 6 7 Product realization . 7 7.1 Planning of product realization 7 7.2 Customer-related processes 7 7.3 Design and developmen

17、t 8 7.4 Purchasing . 9 7.5 Production and service provision 10 7.6 Control of monitoring and measuring equipment 11 8 Measurement, analysis and improvement . 12 8.1 General . 12 8.2 Monitoring and measurement 12 8.3 Control of nonconforming product 13 8.4 Analysis of data . 13 8.5 Improvement 14 Ann

18、ex A (informative) Correspondence between ISO 9001:2008 and ISO 14001:2004 . 15 Annex B (informative) Changes between ISO 9001:2000 and ISO 9001:2008 . 20 Bibliography . 26 BS EN ISO 9001:2008iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national s

19、tandards 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 which a technical committee has been established has the right to be represented on that committee. International

20、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 all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules gi

21、ven in the ISO/IEC Directives, Part 2. The main task of technical 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

22、 75 % of the member bodies casting a vote. Attention is drawn 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, Q

23、uality management and quality assurance, Subcommittee SC 2, 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 edi

24、tion and this fourth edition are given in Annex B. BS EN ISO 9001:2008v 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 organiza

25、tional environment, changes in that 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

26、 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 clarif

27、ying the associated requirement. 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. Th

28、e 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 approach This International Standard promotes the adoption of a process approach when developing, implementing and improving the effec

29、tiveness of a quality management 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 activities using resources, and managed in order to enable the tra

30、nsformation 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 to p

31、roduce the desired outcome, 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

32、 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, BS EN ISO 9001:2008vi c) obtaining results of process performance and effectiveness, and d) continual improvement of proce

33、sses based on objective measurement. The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in Clauses4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfa

34、ction requires the 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. NOTE In addition, th

35、e 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 the processes.

36、 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. Figure 1 Model of a process-based quality management system BS EN ISO 9001:2008vii 0.3 Relationship wi

37、th 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 certific

38、ation, 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 for achiev

39、ing sustained success for any organization in a complex, demanding, and ever changing, environment. ISO9004 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 improvemen

40、t of the organizations performance. However, it is not intended for certification, regulatory or contractual use. 0.4 Compatibility with other management systems During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the comp

41、atibility 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 management, occup

42、ational 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 existing ma

43、nagement system(s) in order to establish a quality management system that complies with the requirements of this International Standard. BS EN ISO 9001:2008BS EN ISO 9001:20081 Quality management systems Requirements 1S c o p e 1.1 General This International Standard specifies requirements for a qua

44、lity 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 application of the system, including processes

45、 for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. NOTE 1 In this International Standard, the term “product” only applies to a) product intended for, or required by, a customer, b) any intended output resulting f

46、rom the product realization processes. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. 1.2 Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provide

47、d. 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 unless these exclusions are limit

48、ed 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. 2 Normative references The following referenced documents are indispensable for the applica

49、tion 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 3 Terms and definitions 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”.BS EN ISO 9001:20082 4 Quality management system 4.1 General requirements The organiza