[下载]9000：2005吐血奉献

yuank 发表于 2006-1-7 15:42:05

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<DIV>ISO 9000:2005新版本标准

日前，国际标准化组织（ISO）发布ISO 9000:2005新版本标准,在国际标准9000族的基础上对质量管理体系定义术语词作了新的描述与编辑。　</DIV>
<DIV>　ISO 9000:2005，质量管理体系-基础和术语，ISO 9000:2005，质量管理体系的基本原理如ISO 9000：2000版标准所述，未做任何改变，只是增加了一些定义，对解释的条款的内容已做了进一步扩充。例如:技术专家，要求，能力，合同，审核员，审核组，审核计划和审核范围等。</DIV>
<DIV>　　ISO技术委员会ISO/TC 176工作组负责ISO 9000标准的解释：这个新版本的主要内容是提供各种各样的管理体系标准所使用的关键术语和单个术语的明确解释，特别是国际标准组织9001:2000，质量管理系统-要求和ISO19011:2002质量及/或环境的管理系统审核的指南。</DIV>
<DIV>　　重编的ISO 2000：2005得到了IEC (国际电工委员会)的认可。</DIV>
<DIV>　　ISO 2000：2005版本出现了许多图表，所发生的这些变化证明标准已经被提高。</DIV>
<DIV>　　ISO9000族ISO 9000:2005的标准将对所有的用户是有用的，特别是下列方面:</DIV>
<DIV>　　-对供方、消费者和调整者提供质量管理的术语的解释；</DIV>
<DIV>　-评审质量管理体系（QMS）的人，或接受ISO9001:2000标准符合性审核的人，例如内审员，审核员，或调整者；</DIV>
<DIV>　　-咨询师或QMS培训人员。</DIV></DIV></TD></TR></TABLE>
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<Palign=left>INTERNATIONAL ISO
<Palign=left>STANDARD 9000
<Palign=left> 
<Palign=left>Third edition
<Palign=left>2005-09-15
<Palign=left>Reference number
<Palign=left>ISO 9000:2005(E)
<Palign=left>© ISO 2005
<Palign=left>Quality management systems —
<Palign=left>Fundamentals and vocabulary
<Palign=left>Systèmes de management de la qualité — Principes essentiels et
<Palign=left>vocabulaire
<Palign=left>ISO 9000:2005(E)
<Palign=left>ii © ISO 2005 – All rights reserved
<Palign=left>PDF disclaimer
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<Palign=left>unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
<Palign=left>© ISO 2005
<Palign=left>All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
<Palign=left>electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
<Palign=left>ISO's member body in the country of the requester.
<Palign=left>ISO copyright office
<Palign=left>Case postale 56 • CH-1211 Geneva 20
<Palign=left>Tel. + 41 22 749 01 11
<Palign=left>Fax + 41 22 749 09 47
<Palign=left>E-mail copyright@iso.org
<Palign=left>Web www.iso.org
<Palign=left>Published in Switzerland
<Palign=left>ISO 9000:2005(E)
<Palign=left>© ISO 2005 – All rights reserved iii
<Palign=left>Contents Page
<Palign=left>1 Scope .................... 1
<Palign=left>2 Fundamentals of quality management systems ............................................................................... 1
<Palign=left>2.1 Rationale for quality management systems ..................................................................................... 1
<Palign=left>2.2 Requirements for quality management systems and requirements for products ........................ 1
<Palign=left>2.3 Quality management systems approach ........................................................................................... 2
<Palign=left>2.4 The process approach ........................................................................................................................ 2
<Palign=left>2.5 Quality policy and quality objectives ................................................................................................ 2
<Palign=left>2.6 Role of top management within the quality management system ................................................. 3
<Palign=left>2.7 Documentation .... 4
<Palign=left>2.8 Evaluating quality management systems ......................................................................................... 4
<Palign=left>2.9 Continual improvement ...................................................................................................................... 5
<Palign=left>2.10 Role of statistical techniques ........................................................................................................... 6
<Palign=left>2.11 Quality management systems and other management system focuses ..................................... 6
<Palign=left>2.12 Relationship between quality management systems and excellence models ............................ 6
<Palign=left>3 Terms and definitions .......................................................................................................................... 6
<Palign=left>3.1 Terms relating to quality ..................................................................................................................... 7
<Palign=left>3.2 Terms relating to management .......................................................................................................... 8
<Palign=left>3.3 Terms relating to organization ........................................................................................................... 9
<Palign=left>3.4 Terms relating to process and product ........................................................................................... 11
<Palign=left>3.5 Terms relating to characteristics ..................................................................................................... 12
<Palign=left>3.6 Terms relating to conformity ............................................................................................................ 13
<Palign=left>3.7 Terms relating to documentation ..................................................................................................... 14
<Palign=left>3.8 Terms relating to examination ......................................................................................................... 15
<Palign=left>3.9 Terms relating to audit ...................................................................................................................... 16
<Palign=left>3.10 Terms relating to quality management or measurement processes .......................................... 18
<Palign=left>Annex A (informative) Methodology used in the development of the vocabulary ................................ 20
<Palign=left>Bibliography ............... 29
<Palign=left>Alphabetical index ..... 30
<Palign=left>ISO 9000:2005(E)
<Palign=left>iv © ISO 2005 – All rights reserved
<Palign=left>Foreword
<Palign=left>ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
<Palign=left>(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
<Palign=left>technical committees. Each member body interested in a subject for which a technical committee has been
<Palign=left>established has the right to be represented on that committee. International organizations, governmental and
<Palign=left>non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
<Palign=left>Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
<Palign=left>International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
<Palign=left>The main task of technical committees is to prepare International Standards. Draft International Standards
<Palign=left>adopted by the technical committees are circulated to the member bodies for voting. Publication as an
<Palign=left>International Standard requires approval by at least 75 % of the member bodies casting a vote.
<Palign=left>Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
<Palign=left>rights. ISO shall not be held responsible for identifying any or all such patent rights.
<Palign=left>ISO 9000 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance,
<Palign=left>Subcommittee SC 1, Concepts and terminology.
<Palign=left>This third edition cancels and replaces the second edition (ISO 9000:2000). It includes the changes accepted in
<Palign=left>the Draft Amendment ISO/DAM 9000:2004.
<Palign=left>Annex A includes concept diagrams that provide a graphical representation of the relationships between terms
<Palign=left>in specific fields relative to quality management systems.
<Palign=left>ISO 9000:2005(E)
<Palign=left>© ISO 2005 – All rights reserved v
<Palign=left>Introduction
<Palign=left>0.1 General
<Palign=left>The ISO 9000 family of standards listed below has been developed to assist organizations, of all types and
<Palign=left>sizes, to implement and operate effective quality management systems.
<Palign=left>— ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality
<Palign=left>management systems.
<Palign=left>— ISO 9001 specifies requirements for a quality management system where an organization needs to
<Palign=left>demonstrate its ability to provide products that fulfil customer and applicable regulatory requirements and
<Palign=left>aims to enhance customer satisfaction.
<Palign=left>— ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the quality management
<Palign=left>system. The aim of this standard is improvement of the performance of the organization and satisfaction of
<Palign=left>customers and other interested parties.
<Palign=left>— ISO 19011 provides guidance on auditing quality and environmental management systems.
<Palign=left>Together they form a coherent set of quality management system standards facilitating mutual understanding in
<Palign=left>national and international trade.
<Palign=left>0.2 Quality management principles
<Palign=left>To lead and operate an organization successfully, it is necessary to direct and control it in a systematic and
<Palign=left>transparent manner. Success can result from implementing and maintaining a management system that is
<Palign=left>designed to continually improve performance while addressing the needs of all interested parties. Managing an
<Palign=left>organization encompasses quality management amongst other management disciplines.
<Palign=left>Eight quality management principles have been identified that can be used by top management in order to lead
<Palign=left>the organization towards improved performance.

yuank 发表于 2006-1-7 16:08:08

a) Customer focusOrganizations depend on their customers and therefore should understand current and future customerneeds, should meet customer requirements and strive to exceed customer expectations.b) LeadershipLeaders establish unity of purpose and direction of the organization. They should create and maintain theinternal environment in which people can become fully involved in achieving the organization's objectives.c) Involvement of peoplePeople at all levels are the essence of an organization and their full involvement enables their abilities to beused for the organization's benefit.d) Process approachA desired result is achieved more efficiently when activities and related resources are managed as aprocess.e) System approach to managementIdentifying, understanding and managing interrelated processes as a system contributes to theorganization's effectiveness and efficiency in achieving its objectives.ISO 9000:2005(E)vi © ISO 2005 – All rights reservedf) Continual improvementContinual improvement of the organization's overall performance should be a permanent objective of theorganization.g) Factual approach to decision makingEffective decisions are based on the analysis of data and information.h) Mutually beneficial supplier relationshipsAn organization and its suppliers are interdependent and a mutually beneficial relationship enhances theability of both to create value.These eight quality management principles form the basis for the quality management system standards withinthe ISO 9000 family.INTERNATIONAL STANDARD ISO 9000:2005(E)© ISO 2005 – All rights reserved 1Quality management systems — Fundamentals and vocabulary1 ScopeThis International Standard describes fundamentals of quality management systems, which form the subject ofthe ISO 9000 family, and defines related terms.This International Standard is applicable to the following:a) organizations seeking advantage through the implementation of a quality management system;b) organizations seeking confidence from their suppliers that their product requirements will be satisfied;c) users of the products;d) those concerned with a mutual understanding of the terminology used in quality management (e.g.suppliers, customers, regulators);e) those internal or external to the organization who assess the quality management system or audit it forconformity with the requirements of ISO 9001 (e.g. auditors, regulators, certification/registration bodies);f) those internal or external to the organization who give advice or training on the quality management systemappropriate to that organization;g) developers of related standards.2 Fundamentals of quality management systems2.1 Rationale for quality management systemsQuality management systems can assist organizations in enhancing customer satisfaction.Customers require products with characteristics that satisfy their needs and expectations. These needs andexpectations are expressed in product specifications and collectively referred to as customer requirements.Customer requirements may be specified contractually by the customer or may be determined by theorganization itself. In either case, the customer ultimately determines the acceptability of the product. Becausecustomer needs and expectations are changing, and because of competitive pressures and technical advances,organizations are driven to improve continually their products and processes.The quality management system approach encourages organizations to analyse customer requirements,

yuank 发表于 2006-1-7 16:09:15

define the processes that contribute to the achievement of a product which is acceptable to the customer, andkeep these processes under control. A quality management system can provide the framework for continualimprovement to increase the probability of enhancing customer satisfaction and the satisfaction of otherinterested parties. It provides confidence to the organization and its customers that it is able to provide productsthat consistently fulfil requirements.2.2 Requirements for quality management systems and requirements for productsThe ISO 9000 family distinguishes between requirements for quality management systems and requirementsfor products.Requirements for quality management systems are specified in ISO 9001. Requirements for qualitymanagement systems are generic and applicable to organizations in any industry or economic sectorregardless of the offered product category. ISO 9001 itself does not establish requirements for products.ISO 9000:2005(E)2 © ISO 2005 – All rights reservedRequirements for products can be specified by customers or by the organization in anticipation of customerrequirements, or by regulation. The requirements for products and in some cases associated processes can becontained in, for example, technical specifications, product standards, process standards, contractualagreements and regulatory requirements.2.3 Quality management systems approachAn approach to developing and implementing a quality management system consists of several steps includingthe following:a) determining the needs and expectations of customers and other interested parties;b) establishing the quality policy and quality objectives of the organization;c) determining the processes and responsibilities necessary to attain the quality objectives;d) determining and providing the resources necessary to attain the quality objectives;e) establishing methods to measure the effectiveness and efficiency of each process;f) applying these measures to determine the effectiveness and efficiency of each process;g) determining means of preventing nonconformities and eliminating their causes;h) establishing and applying a process for continual improvement of the quality management system.Such an approach is also applicable to maintaining and improving an existing quality management system.An organization that adopts the above approach creates confidence in the capability of its processes and thequality of its products, and provides a basis for continual improvement. This can lead to increased satisfactionof customers and other interested parties and to the success of the organization.2.4 The process approachAny activity, or set of activities, that uses resources to transform inputs to outputs can be considered as aprocess.For organizations to function effectively, they have to identify and manage numerous interrelated and interactingprocesses. Often, the output from one process will directly form the input into the next process. The systematicidentification and management of the processes employed within an organization and particularly theinteractions between such processes is referred to as the “process approach”.The intent of this International Standard is to encourage the adoption of the process approach to manage anorganization.Figure 1 illustrates the process-based quality management system described in the ISO 9000 family ofstandards. This illustration shows that interested parties play a significant role in providing inputs to theorganization. Monitoring the satisfaction of interested parties requires the evaluation of information relating tothe perception of interested parties as to the extent to which their needs and expectations have been met. Themodel shown in Figure 1 does not show processes at a detailed level.2.5 Quality policy and quality objectivesQuality policy and quality objectives are established to provide a focus to direct the organization. Bothdetermine the desired results and assist the organization to apply its resources to achieve these results. Thequality policy provides a framework for establishing and reviewing quality objectives. The quality objectivesneed to be consistent with the quality policy and the commitment to continual improvement, and theirachievement needs to be measurable. The achievement of quality objectives can have a positive impact onproduct quality, operational effectiveness and financial performance and thus on the satisfaction and confidenceof interested parties.ISO 9000:2005(E)

yuank 发表于 2006-1-7 16:09:51

© ISO 2005 – All rights reserved 32.6 Role of top management within the quality management systemThrough leadership and actions, top management can create an environment where people are fully involvedand in which a quality management system can operate effectively. The quality management principles (see0.2) can be used by top management as the basis of its role, which is as follows:a) to establish and maintain the quality policy and quality objectives of the organization;b) to promote the quality policy and quality objectives throughout the organization to increase awareness,motivation and involvement;c) to ensure focus on customer requirements throughout the organization;d) to ensure that appropriate processes are implemented to enable requirements of customers and otherinterested parties to be fulfilled and quality objectives to be achieved;e) to ensure that an effective and efficient quality management system is established, implemented andmaintained to achieve these quality objectives;f) to ensure the availability of necessary resources;g) to review the quality management system periodically;h) to decide on actions regarding the quality policy and quality objectives;i) to decide on actions for improvement of the quality management system.NOTE Statements in parentheses do not apply to ISO 9001.Figure 1 — Model of a process-based quality management systemISO 9000:2005(E)4 © ISO 2005 – All rights reserved2.7 Documentation2.7.1 Value of documentationDocumentation enables communication of intent and consistency of action. Its use contributes toa) achievement of conformity to customer requirements and quality improvement,b) provision of appropriate training,c) repeatability and traceability,d) provision of objective evidence, ande) evaluation of the effectiveness and continuing suitability of the quality management system.Generation of documentation should not be an end in itself but should be a value-adding activity.2.7.2 Types of document used in quality management systemsThe following types of document are used in quality management systems:a) documents that provide consistent information, both internally and externally, about the organization'squality management system; such documents are referred to as quality manuals;b) documents that describe how the quality management system is applied to a specific product, project orcontract; such documents are referred to as quality plans;c) documents stating requirements; such documents are referred to as specifications;d) documents stating recommendations or suggestions; such documents are referred to as guidelines;e) documents that provide information about how to perform activities and processes consistently; suchdocuments can include documented procedures, work instructions and drawings;f) documents that provide objective evidence of activities performed or results achieved; such documents arereferred to as records.Each organization determines the extent of documentation required and the media to be used. This depends onfactors such as the type and size of the organization, the complexity and interaction of processes, thecomplexity of products, customer requirements, the applicable regulatory requirements, the demonstratedability of personnel, and the extent to which it is necessary to demonstrate fulfilment of quality managementsystem requirements.2.8 Evaluating quality management systems2.8.1 Evaluating processes within the quality management systemWhen evaluating quality management systems, there are four basic questions that should be asked in relationto every process being evaluated.a) Is the process identified and appropriately defined?b) Are responsibilities assigned?c) Are the procedures implemented and maintained?d) Is the process effective in achieving the required results?

yuank 发表于 2006-1-7 16:10:17

The collective answers to the above questions can determine the result of the evaluation. Evaluation of a qualitymanagement system can vary in scope and encompass a range of activities, such as auditing and reviewing thequality management system, and self-assessments.ISO 9000:2005(E)© ISO 2005 – All rights reserved 52.8.2 Auditing the quality management systemAudits are used to determine the extent to which the quality management system requirements are fulfilled.Audit findings are used to assess the effectiveness of the quality management system and to identifyopportunities for improvement.First-party audits are conducted by, or on behalf of, the organization itself for internal purposes and can form thebasis for an organization's self-declaration of conformity.Second-party audits are conducted by customers of the organization or by other persons on behalf of thecustomer.Third-party audits are conducted by external independent organizations. Such organizations, usuallyaccredited, provide certification or registration of conformity with requirements such as those of ISO 9001.ISO 19011 provides guidance on auditing.2.8.3 Reviewing the quality management systemOne role of top management is to carry out regular systematic evaluations of the suitability, adequacy,effectiveness and efficiency of the quality management system with respect to the quality policy and qualityobjectives. This review can include consideration of the need to adapt the quality policy and objectives inresponse to changing needs and expectations of interested parties. The review includes determination of theneed for actions.Amongst other sources of information, audit reports are used for review of the quality management system.2.8.4 Self-assessmentAn organization's self-assessment is a comprehensive and systematic review of the organization's activitiesand results referenced against the quality management system or a model of excellence.Self-assessment can provide an overall view of the performance of the organization and the degree of maturityof the quality management system. It can also help to identify areas requiring improvement in the organizationand to determine priorities.2.9 Continual improvementThe aim of continual improvement of a quality management system is to increase the probability of enhancingthe satisfaction of customers and other interested parties. Actions for improvement include the following:a) analysing and evaluating the existing situation to identify areas for improvement;b) establishing the objectives for improvement;c) searching for possible solutions to achieve the objectives;d) evaluating these solutions and making a selection;e) implementing the selected solution;f) measuring, verifying, analysing and evaluating results of the implementation to determine that theobjectives have been met;g) formalizing changes.Results are reviewed, as necessary, to determine further opportunities for improvement. In this way,improvement is a continual activity. Feedback from customers and other interested parties, audits and review ofthe quality management system can also be used to identify opportunities for improvement.ISO 9000:2005(E)6 © ISO 2005 – All rights reserved2.10 Role of statistical techniquesThe use of statistical techniques can help in understanding variability, and thereby can help organizations tosolve problems and improve effectiveness and efficiency. These techniques also facilitate better use of availabledata to assist in decision making.Variability can be observed in the behaviour and outcome of many activities, even under conditions of apparentstability. Such variability can be observed in measurable characteristics of products and processes, and may beseen to exist at various stages over the life cycle of products from market research to customer service andfinal disposal.Statistical techniques can help to measure, describe, analyse, interpret and model such variability, even with arelatively limited amount of data. Statistical analysis of such data can help to provide a better understanding of

yuank 发表于 2006-1-7 16:10:46

the nature, extent and causes of variability, thus helping to solve and even prevent problems that may resultfrom such variability, and to promote continual improvement.Guidance on statistical techniques in a quality management system is given in ISO/TR 10017.2.11 Quality management systems and other management system focusesThe quality management system is that part of the organization's management system that focuses on theachievement of results, in relation to the quality objectives, to satisfy the needs, expectations and requirementsof interested parties, as appropriate. The quality objectives complement other objectives of the organizationsuch as those related to growth, funding, profitability, the environment and occupational health and safety. Thevarious parts of an organization's management system might be integrated, together with the qualitymanagement system, into a single management system using common elements. This can facilitate planning,allocation of resources, definition of complementary objectives and evaluation of the overall effectiveness of theorganization. The organization's management system can be assessed against the organization's managementsystem requirements. The management system can also be audited against the requirements of InternationalStandards such as ISO 9001 and ISO 14001. These management system audits can be carried out separatelyor in combination.2.12 Relationship between quality management systems and excellence modelsThe approaches of quality management systems given in the ISO 9000 family of standards and inorganizational excellence models are based on common principles. Both approachesa) enable an organization to identify its strengths and weaknesses,b) contain provision for evaluation against generic models,c) provide a basis for continual improvement, andd) contain provision for external recognition.The difference between the approaches of the quality management systems in the ISO 9000 family and theexcellence models lies in their scope of application. The ISO 9000 family of standards provides requirements forquality management systems and guidance for performance improvement; evaluation of quality managementsystems determines fulfilment of those requirements. The excellence models contain criteria that enablecomparative evaluation of organizational performance and this is applicable to all activities and all interestedparties of an organization. Assessment criteria in excellence models provide a basis for an organization tocompare its performance with the performance of other organizations.3 Terms and definitionsA term in a definition or note which is defined elsewhere in this clause is indicated by boldface followed by itsentry number in parentheses. Such a boldface term may be replaced in the definition by its complete definition.For example:ISO 9000:2005(E)© ISO 2005 – All rights reserved 7product (3.4.2) is defined as “result of a process (3.4.1)”;process is defined as “set of interrelated or interacting activities which transforms inputs into outputs”.If the term “process” is replaced by its definition, as follows:product then becomes “result of a set of interrelated or interacting activities which transforms inputs intooutputs”.A concept limited to a special meaning in a particular context is indicated by designating the subject field inangle brackets, . ., before the definition.EXAMPLE In the context of an audit, the term entry for technical expert is:3.9.11technical expert.audit. person who provides specific knowledge or expertise to the audit team (3.9.10)3.1 Terms relating to quality3.1.1qualitydegree to which a set of inherent characteristics (3.5.1) fulfils requirements (3.1.2)NOTE 1 The term “quality” can be used with adjectives such as poor, good or excellent.NOTE 2 “Inherent”, as opposed to “assigned”, means existing in something, especially as a permanent characteristic.3.1.2requirementneed or expectation that is stated, generally implied or obligatoryNOTE 1 “Generally implied” means that it is custom or common practice for the organization (3.3.1), its customers (3.3.5)

yuank 发表于 2006-1-7 16:12:19

and other interested parties (3.3.7), that the need or expectation under consideration is implied.NOTE 2 A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality managementrequirement, customer requirement.NOTE 3 A specified requirement is one that is stated, for example in a document (3.7.2).NOTE 4 Requirements can be generated by different interested parties (3.3.7).NOTE 5 This definition differs from that provided in 3.12.1 of ISO/IEC Directives, Part 2:2004.3.12.1requirementexpression in the content of a document conveying criteria to be fulfilled if compliance with the document is to beclaimed and from which no deviation is permitted3.1.3gradecategory or rank given to different quality requirements for products (3.4.2), processes (3.4.1) or systems(3.2.1) having the same functional useEXAMPLE Class of airline ticket and category of hotel in a hotel guide.NOTE When establishing a quality requirement, the grade is generally specified.3.1.4customer satisfactioncustomer's perception of the degree to which the customer's requirements (3.1.2) have been fulfilledNOTE 1 Customer complaints are a common indicator of low customer satisfaction but their absence does not necessarilyimply high customer satisfaction.ISO 9000:2005(E)8 © ISO 2005 – All rights reservedNOTE 2 Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarilyensure high customer satisfaction.3.1.5capabilityability of an organization (3.3.1), system (3.2.1) or process (3.4.1) to realize a product (3.4.2) that will fulfilthe requirements (3.1.2) for that productNOTE Process capability terms in the field of statistics are defined in ISO 3534-2.3.1.6competencedemonstrated ability to apply knowledge and skillsNOTE The concept of competence is defined in a generic sense in this International Standard. The word usage can bemore specific in other ISO documents.3.2 Terms relating to management3.2.1systemset of interrelated or interacting elements3.2.2management systemsystem (3.2.1) to establish policy and objectives and to achieve those objectivesNOTE A management system of an organization (3.3.1) can include different management systems, such as a qualitymanagement system (3.2.3), a financial management system or an environmental management system.3.2.3quality management systemmanagement system (3.2.2) to direct and control an organization (3.3.1) with regard to quality (3.1.1)3.2.4quality policyoverall intentions and direction of an organization (3.3.1) related to quality (3.1.1) as formally expressed bytop management (3.2.7)NOTE 1 Generally the quality policy is consistent with the overall policy of the organization and provides a framework forthe setting of quality objectives (3.2.5).NOTE 2 Quality management principles presented in this International Standard can form a basis for the establishment ofa quality policy. (See 0.2.)3.2.5quality objectivesomething sought, or aimed for, related to quality (3.1.1)

yuank 发表于 2006-1-7 16:12:46

NOTE 1 Quality objectives are generally based on the organization's quality policy (3.2.4).NOTE 2 Quality objectives are generally specified for relevant functions and levels in the organization (3.3.1).3.2.6managementcoordinated activities to direct and control an organization (3.3.1)NOTE In English, the term “management” sometimes refers to people, i.e. a person or group of people with authority andresponsibility for the conduct and control of an organization. When “management” is used in this sense, it should always beused with some form of qualifier to avoid confusion with the concept “management” defined above. For example,“management shall…” is deprecated whereas “top management (3.2.7) shall…” is acceptable.ISO 9000:2005(E)© ISO 2005 – All rights reserved 93.2.7top managementperson or group of people who directs and controls an organization (3.3.1) at the highest level3.2.8quality managementcoordinated activities to direct and control an organization (3.3.1) with regard to quality (3.1.1)NOTE Direction and control with regard to quality generally includes establishment of the quality policy (3.2.4) andquality objectives (3.2.5), quality planning (3.2.9), quality control (3.2.10), quality assurance (3.2.11) and qualityimprovement (3.2.12).3.2.9quality planningpart of quality management (3.2.8) focused on setting quality objectives (3.2.5) and specifying necessaryoperational processes (3.4.1) and related resources to fulfil the quality objectivesNOTE Establishing quality plans (3.7.5) can be part of quality planning.3.2.10quality controlpart of quality management (3.2.8) focused on fulfilling quality requirements3.2.11quality assurancepart of quality management (3.2.8) focused on providing confidence that quality requirements will be fulfilled3.2.12quality improvementpart of quality management (3.2.8) focused on increasing the ability to fulfil quality requirementsNOTE The requirements can be related to any aspect such as effectiveness (3.2.14), efficiency (3.2.15) or traceability(3.5.4).3.2.13continual improvementrecurring activity to increase the ability to fulfil requirements (3.1.2)NOTE The process (3.4.1) of establishing objectives and finding opportunities for improvement is a continual processthrough the use of audit findings (3.9.5) and audit conclusions (3.9.6), analysis of data, management reviews (3.8.7) orother means and generally leads to corrective action (3.6.5) or preventive action (3.6.4).3.2.14effectivenessextent to which planned activities are realized and planned results achieved3.2.15efficiencyrelationship between the result achieved and the resources used3.3 Terms relating to organization3.3.1organizationgroup of people and facilities with an arrangement of responsibilities, authorities and relationshipsEXAMPLE Company, corporation, firm, enterprise, institution, charity, sole trader, association, or parts or combinationthereof.NOTE 1 The arrangement is generally orderly.NOTE 2 An organization can be public or private.ISO 9000:2005(E)

yuank 发表于 2006-1-7 16:13:06

10 © ISO 2005 – All rights reservedNOTE 3 This definition is valid for the purposes of quality management system (3.2.3) standards. The term“organization” is defined differently in ISO/IEC Guide 2.3.3.2organizational structurearrangement of responsibilities, authorities and relationships between peopleNOTE 1 The arrangement is generally orderly.NOTE 2 A formal expression of the organizational structure is often provided in a quality manual (3.7.4) or a quality plan(3.7.5) for a project (3.4.3).NOTE 3 The scope of an organizational structure can include relevant interfaces to external organizations (3.3.1).3.3.3infrastructure.organization. system (3.2.1) of facilities, equipment and services needed for the operation of an organization(3.3.1)3.3.4work environmentset of conditions under which work is performedNOTE Conditions include physical, social, psychological and environmental factors (such as temperature, recognitionschemes, ergonomics and atmospheric composition).3.3.5customerorganization (3.3.1) or person that receives a product (3.4.2)EXAMPLE Consumer, client, end-user, retailer, beneficiary and purchaser.NOTE A customer can be internal or external to the organization.3.3.6supplierorganization (3.3.1) or person that provides a product (3.4.2)EXAMPLE Producer, distributor, retailer or vendor of a product, or provider of a service or information.NOTE 1 A supplier can be internal or external to the organization.NOTE 2 In a contractual situation, a supplier is sometimes called “contractor”.3.3.7interested partyperson or group having an interest in the performance or success of an organization (3.3.1)EXAMPLE Customers (3.3.5), owners, people in an organization, suppliers (3.3.6), bankers, unions, partners or society.NOTE A group can comprise an organization, a part thereof, or more than one organization.3.3.8contractbinding agreementNOTE The concept of contract is defined in a generic sense in this International Standard. The word usage can be morespecific in other ISO documents.ISO 9000:2005(E)© ISO 2005 – All rights reserved 113.4 Terms relating to process and product3.4.1processset of interrelated or interacting activities which transforms inputs into outputsNOTE 1 Inputs to a process are generally outputs of other processes.NOTE 2 Processes in an organization (3.3.1) are generally planned and carried out under controlled conditions to addvalue.NOTE 3 A process where the conformity (3.6.1) of the resulting product (3.4.2) cannot be readily or economically verifiedis frequently referred to as a “special process”.3.4.2productresult of a process (3.4.1)NOTE 1 There are four generic product categories, as follows:— services (e.g. transport);— software (e.g. computer program, dictionary);— hardware (e.g. engine mechanical part);

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