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yuank 发表于 2006-1-7 16:13:46

— processed materials (e.g. lubricant).Many products comprise elements belonging to different generic product categories. Whether the product is then calledservice, software, hardware or processed material depends on the dominant element. For example, the offered product“automobile” consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid), software (e.g. engine controlsoftware, driver's manual), and service (e.g. operating explanations given by the salesman).NOTE 2 Service is the result of at least one activity necessarily performed at the interface between the supplier (3.3.6)and customer (3.3.5) and is generally intangible. Provision of a service can involve, for example, the following:— an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);— an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a taxreturn);— the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);— the creation of ambience for the customer (e.g. in hotels and restaurants).Software consists of information and is generally intangible and can be in the form of approaches, transactions orprocedures (3.4.5).Hardware is generally tangible and its amount is a countable characteristic (3.5.1). Processed materials are generallytangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods.NOTE 3 Quality assurance (3.2.11) is mainly focused on intended product.3.4.3projectunique process (3.4.1), consisting of a set of coordinated and controlled activities with start and finish dates,undertaken to achieve an objective conforming to specific requirements (3.1.2), including the constraints oftime, cost and resourcesNOTE 1 An individual project can form part of a larger project structure.NOTE 2 In some projects the objectives are refined and the product characteristics (3.5.1) defined progressively as theproject proceeds.NOTE 3 The outcome of a project can be one or several units of product (3.4.2).NOTE 4 Adapted from ISO 10006:2003.ISO 9000:2005(E)12 © ISO 2005 – All rights reserved3.4.4design and developmentset of processes (3.4.1) that transforms requirements (3.1.2) into specified characteristics (3.5.1) or into thespecification (3.7.3) of a product (3.4.2), process (3.4.1) or system (3.2.1)NOTE 1 The terms “design” and “development” are sometimes used synonymously and sometimes used to define differentstages of the overall design and development process.NOTE 2 A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product design anddevelopment or process design and development).3.4.5procedurespecified way to carry out an activity or a process (3.4.1)NOTE 1 Procedures can be documented or not.NOTE 2 When a procedure is documented, the term “written procedure” or “documented procedure” is frequently used.The document (3.7.2) that contains a procedure can be called a “procedure document”.3.5 Terms relating to characteristics3.5.1characteristicdistinguishing featureNOTE 1 A characteristic can be inherent or assigned.NOTE 2 A characteristic can be qualitative or quantitative.NOTE 3 There are various classes of characteristic, such as the following:— physical (e.g. mechanical, electrical, chemical or biological characteristics);— sensory (e.g. related to smell, touch, taste, sight, hearing);— behavioral (e.g. courtesy, honesty, veracity);— temporal (e.g. punctuality, reliability, availability);— ergonomic (e.g. physiological characteristic, or related to human safety);— functional (e.g. maximum speed of an aircraft).3.5.2quality characteristicinherent characteristic (3.5.1) of a product (3.4.2), process (3.4.1) or system (3.2.1) related to a

yuank 发表于 2006-1-7 16:14:06

requirement (3.1.2)NOTE 1 Inherent means existing in something, especially as a permanent characteristic.NOTE 2 A characteristic assigned to a product, process or system (e.g. the price of a product, the owner of a product) isnot a quality characteristic of that product, process or system.3.5.3dependabilitycollective term used to describe the availability performance and its influencing factors: reliability performance,maintainability performance and maintenance support performanceNOTE Dependability is used only for general descriptions in non-quantitative terms..3.5.4traceabilityability to trace the history, application or location of that which is under considerationISO 9000:2005(E)© ISO 2005 – All rights reserved 13NOTE 1 When considering product (3.4.2), traceability can relate to— the origin of materials and parts,— the processing history, and— the distribution and location of the product after delivery.NOTE 2 In the field of metrology the definition in VIM:1993, 6.10, is the accepted definition.3.6 Terms relating to conformity3.6.1conformityfulfilment of a requirement (3.1.2)NOTE The term “conformance” is synonymous but deprecated.3.6.2nonconformitynon-fulfilment of a requirement (3.1.2)3.6.3defectnon-fulfilment of a requirement (3.1.2) related to an intended or specified useNOTE 1 The distinction between the concepts defect and nonconformity (3.6.2) is important as it has legal connotations,particularly those associated with product liability issues. Consequently the term “defect” should be used with extremecaution.NOTE 2 The intended use as intended by the customer (3.3.5) can be affected by the nature of the information, such asoperating or maintenance instructions, provided by the supplier (3.3.6).3.6.4preventive actionaction to eliminate the cause of a potential nonconformity (3.6.2) or other undesirable potential situationNOTE 1 There can be more than one cause for a potential nonconformity.NOTE 2 Preventive action is taken to prevent occurrence whereas corrective action (3.6.5) is taken to prevent recurrence.3.6.5corrective actionaction to eliminate the cause of a detected nonconformity (3.6.2) or other undesirable situationNOTE 1 There can be more than one cause for a nonconformity.NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action (3.6.4) is taken to preventoccurrence.NOTE 3 There is a distinction between correction (3.6.6) and corrective action.3.6.6correctionaction to eliminate a detected nonconformity (3.6.2)NOTE 1 A correction can be made in conjunction with a corrective action (3.6.5).NOTE 2 A correction can be, for example, rework (3.6.7) or regrade (3.6.8).3.6.7reworkaction on a nonconforming product (3.4.2) to make it conform to the requirements (3.1.2)ISO 9000:2005(E)14 © ISO 2005 – All rights reserved

yuank 发表于 2006-1-7 16:14:50

NOTE Unlike rework, repair (3.6.9) can affect or change parts of the nonconforming product.3.6.8regradealteration of the grade (3.1.3) of a nonconforming product (3.4.2) in order to make it conform to requirements(3.1.2) differing from the initial ones3.6.9repairaction on a nonconforming product (3.4.2) to make it acceptable for the intended useNOTE 1 Repair includes remedial action taken on a previously conforming product to restore it for use, for example as partof maintenance.NOTE 2 Unlike rework (3.6.7), repair can affect or change parts of the nonconforming product.3.6.10scrapaction on a nonconforming product (3.4.2) to preclude its originally intended useEXAMPLE Recycling, destruction.NOTE In a nonconforming service situation, use is precluded by discontinuing the service.3.6.11concessionpermission to use or release a product (3.4.2) that does not conform to specified requirements (3.1.2)NOTE A concession is generally limited to the delivery of a product that has nonconforming characteristics (3.5.1) withinspecified limits for an agreed time or quantity of that product.3.6.12deviation permitpermission to depart from the originally specified requirements (3.1.2) of a product (3.4.2) prior to realizationNOTE A deviation permit is generally given for a limited quantity of product or period of time, and for a specific use.3.6.13releasepermission to proceed to the next stage of a process (3.4.1)NOTE In English, in the context of computer software, the term “release” is frequently used to refer to a version of thesoftware itself.3.7 Terms relating to documentation3.7.1informationmeaningful data3.7.2documentinformation (3.7.1) and its supporting mediumEXAMPLE Record (3.7.6), specification (3.7.3), procedure document, drawing, report, standard.NOTE 1 The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or acombination thereof.NOTE 2 A set of documents, for example specifications and records, is frequently called “documentation”.ISO 9000:2005(E)© ISO 2005 – All rights reserved 15NOTE 3 Some requirements (3.1.2) (e.g. the requirement to be readable) relate to all types of documents, however therecan be different requirements for specifications (e.g. the requirement to be revision controlled) and records (e.g. therequirement to be retrievable).3.7.3specificationdocument (3.7.2) stating requirements (3.1.2)NOTE A specification can be related to activities (e.g. procedure document, process specification and test specification), orproducts (3.4.2) (e.g. product specification, performance specification and drawing).3.7.4quality manualdocument (3.7.2) specifying the quality management system (3.2.3) of an organization (3.3.1)NOTE Quality manuals can vary in detail and format to suit the size and complexity of an individual organization.3.7.5quality plandocument (3.7.2) specifying which procedures (3.4.5) and associated resources shall be applied by whom

yuank 发表于 2006-1-7 16:15:10

and when to a specific project (3.4.3), product (3.4.2), process (3.4.1) or contractNOTE 1 These procedures generally include those referring to quality management processes and to product realizationprocesses.NOTE 2 A quality plan often makes reference to parts of the quality manual (3.7.4) or to procedure documents.NOTE 3 A quality plan is generally one of the results of quality planning (3.2.9).3.7.6recorddocument (3.7.2) stating results achieved or providing evidence of activities performedNOTE 1 Records can be used, for example, to document traceability (3.5.4) and to provide evidence of verification(3.8.4), preventive action (3.6.4) and corrective action (3.6.5).NOTE 2 Generally records need not be under revision control.3.8 Terms relating to examination3.8.1objective evidencedata supporting the existence or verity of somethingNOTE Objective evidence may be obtained through observation, measurement, test (3.8.3), or other means.3.8.2inspectionconformity evaluation by observation and judgement accompanied as appropriate by measurement, testing orgauging3.8.3testdetermination of one or more characteristics (3.5.1) according to a procedure (3.4.5)3.8.4verificationconfirmation, through the provision of objective evidence (3.8.1), that specified requirements (3.1.2) havebeen fulfilledISO 9000:2005(E)16 © ISO 2005 – All rights reservedNOTE 1 The term “verified” is used to designate the corresponding status.NOTE 2 Confirmation can comprise activities such as— performing alternative calculations,— comparing a new design specification (3.7.3) with a similar proven design specification,— undertaking tests (3.8.3) and demonstrations, and— reviewing documents prior to issue.3.8.5validationconfirmation, through the provision of objective evidence (3.8.1), that the requirements (3.1.2) for a specificintended use or application have been fulfilledNOTE 1 The term “validated” is used to designate the corresponding status.NOTE 2 The use conditions for validation can be real or simulated.3.8.6qualification processprocess (3.4.1) to demonstrate the ability to fulfil specified requirements (3.1.2)NOTE 1 The term “qualified” is used to designate the corresponding status.NOTE 2 Qualification can concern persons, products (3.4.2), processes or systems (3.2.1).EXAMPLE Auditor qualification process, material qualification process.3.8.7reviewactivity undertaken to determine the suitability, adequacy and effectiveness (3.2.14) of the subject matter toachieve established objectivesNOTE Review can also include the determination of efficiency (3.2.15).EXAMPLE Management review, design and development review, review of customer requirements and nonconformityreview.3.9 Terms relating to audit3.9.1audit

yuank 发表于 2006-1-7 16:15:31

systematic, independent and documented process (3.4.1) for obtaining audit evidence (3.9.4) and evaluatingit objectively to determine the extent to which audit criteria (3.9.3) are fulfilledNOTE 1 Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the organization (3.3.1)itself for management review and other internal purposes, and may form the basis for an organization’s declaration ofconformity (3.6.1). In many cases, particularly in smaller organizations, independence can be demonstrated by thefreedom from responsibility for the activity being audited.NOTE 2 External audits include those generally termed second- and third-party audits. Second-party audits are conductedby parties having an interest in the organization, such as customers (3.3.5), or by other persons on their behalf. Third-partyaudits are conducted by external, independent auditing organizations, such as those providing certification/registration ofconformity to ISO 9001 or ISO 14001.NOTE 3 When two or more management systems (3.2.2) are audited together, this is termed a combined audit.NOTE 4 When two or more auditing organizations cooperate to audit a single auditee (3.9.8), this is termed a joint audit.3.9.2audit programmeset of one or more audits (3.9.1) planned for a specific time frame and directed towards a specific purposeISO 9000:2005(E)© ISO 2005 – All rights reserved 17NOTE An audit programme includes all activities necessary for planning, organizing and conducting the audits.3.9.3audit criteriaset of policies, procedures (3.4.5) or requirements (3.1.2)NOTE Audit criteria are used as a reference against which audit evidence (3.9.4) is compared.3.9.4audit evidencerecords (3.7.6), statements of fact or other information (3.7.1) which are relevant to the audit criteria (3.9.3)and verifiableNOTE Audit evidence can be qualitative or quantitative.3.9.5audit findingsresults of the evaluation of the collected audit evidence (3.9.4) against audit criteria (3.9.3)NOTE Audit findings can indicate either conformity (3.6.1) or nonconformity (3.6.2) with audit criteria or opportunities forimprovement.3.9.6audit conclusionoutcome of an audit (3.9.1) provided by the audit team (3.9.10) after consideration of the audit objectives andall audit findings (3.9.5)3.9.7audit clientorganization (3.3.1) or person requesting an audit (3.9.1)NOTE The audit client may be the auditee (3.9.8) or any other organization (3.3.1) that has the regulatory or contractualright to request an audit.3.9.8auditeeorganization (3.3.1) being audited3.9.9auditorperson with the demonstrated personal attributes and competence (3.1.6 and 3.9.14) to conduct an audit(3.9.1)NOTE The relevant personal attributes for an auditor are described in ISO 19011.3.9.10audit teamone or more auditors (3.9.9) conducting an audit (3.9.1), supported if needed by technical experts (3.9.11)NOTE 1 One auditor of the audit team is appointed as the audit team leader.NOTE 2 The audit team may include auditors-in-training.3.9.11technical expert.audit. person who provides specific knowledge or expertise to the audit team (3.9.10)NOTE 1 Specific knowledge or expertise relates to the organization (3.3.1), the process (3.4.1) or activity to be audited,

yuank 发表于 2006-1-7 16:15:55

or language or culture.NOTE 2 A technical expert does not act as an auditor (3.9.9) in the audit team.ISO 9000:2005(E)18 © ISO 2005 – All rights reserved3.9.12audit plandescription of the activities and arrangements for an audit (3.9.1)3.9.13audit scopeextent and boundaries of an audit (3.9.1)NOTE The audit scope generally includes a description of the physical locations, organizational units, activities andprocesses (3.4.1), as well as the time period covered.3.9.14competence.audit. demonstrated personal attributes and demonstrated ability to apply knowledge and skills3.10 Terms related to quality management for measurement processes3.10.1measurement management systemset of interrelated and interacting elements necessary to achieve metrological confirmation (3.10.3) andcontinual control of measurement processes (3.10.2)3.10.2measurement processset of operations to determine the value of a quantity3.10.3metrological confirmationset of operations required to ensure that measuring equipment (3.10.4) conforms to the requirements (3.1.2)for its intended useNOTE 1 Metrological confirmation generally includes calibration or verification (3.8.4), any necessary adjustment orrepair (3.6.9), and subsequent recalibration, comparison with the metrological requirements for the intended use of theequipment, as well as any required sealing and labelling.NOTE 2 Metrological confirmation is not achieved until and unless the fitness of the measuring equipment for the intendeduse has been demonstrated and documented.NOTE 3 The requirements for intended use include such considerations as range, resolution and maximum permissibleerrors.NOTE 4 Metrological requirements are usually distinct from, and are not specified in, product requirements.3.10.4measuring equipmentmeasuring instrument, software, measurement standard, reference material or auxiliary apparatus orcombination thereof necessary to realize a measurement process (3.10.2)3.10.5metrological characteristicdistinguishing feature which can influence the results of measurementNOTE 1 Measuring equipment (3.10.4) usually has several metrological characteristics.NOTE 2 Metrological characteristics can be the subject of calibration.ISO 9000:2005(E)© ISO 2005 – All rights reserved 193.10.6metrological functionfunction with administrative and technical responsibility for defining and implementing the measurementmanagement system (3.10.1)NOTE The word “defining” has the meaning of “specifying”. It is not used in the terminological sense of “defining a concept”(in some languages, this distinction is not clear from the context alone).ISO 9000:2005(E)20 © ISO 2005 – All rights reservedAnnex A(informative)

yuank 发表于 2006-1-7 16:16:21

Methodology used in the development of the vocabularyA.1 IntroductionThe universality of application of the ISO 9000 family of standards requires the use of— a technical description but without the use of technical language, and— a coherent and harmonized vocabulary that is easily understandable by all potential users of qualitymanagement systems standards.Concepts are not independent of one another, and an analysis of the relationships between concepts within thefield of quality management systems and the arrangement of them into concept systems is a prerequisite of acoherent vocabulary. Such an analysis was used in the development of the vocabulary specified in thisdocument. Since the concept diagrams employed during the development process may be helpful in aninformative sense, they are reproduced in A.4.A.2 Content of a vocabulary entry and the substitution ruleThe concept forms the unit of transfer between languages (including variants within one language, for exampleAmerican English and British English). For each language, the most appropriate term for the universaltransparency of the concept in that language, i.e. not a literal approach to translation, is chosen.A definition is formed by describing only those characteristics that are essential to identify the concept.Information concerning the concept which is important but which is not essential to its description is put in oneor more notes to the definition.When a term is substituted by its definition, subject to minor syntax changes, there should be no change in themeaning of the text. Such a substitution provides a simple method for checking the accuracy of a definition.However, where the definition is complex in the sense that it contains a number of terms, substitution is bestcarried out taking one or, at most, two definitions at a time. Complete substitution of the totality of the terms willbecome difficult to achieve syntactically and unhelpful in conveying meaning.A.3 Concept relationships and their graphical representationA.3.1 GeneralIn terminology work, the relationships between concepts are based on the hierarchical formation of thecharacteristics of a species so that the most economical description of a concept is formed by naming itsspecies and describing the characteristics that distinguish it from its parent or sibling concepts.There are three primary forms of concept relationships indicated in this annex: generic (A.3.2), partitive (A.3.3)and associative (A.3.4).A.3.2 Generic relationSubordinate concepts within the hierarchy inherit all the characteristics of the superordinate concept andcontain descriptions of these characteristics which distinguish them from the superordinate (parent) andcoordinate (sibling) concepts, e.g. the relation of spring, summer, autumn and winter to season.Generic relations are depicted by a fan or tree diagram without arrows (see Figure A.1).ISO 9000:2005(E)© ISO 2005 – All rights reserved 21A.3.3 Partitive relationSubordinate concepts within the hierarchy form constituent parts of the superordinate concept, e.g. spring,summer, autumn and winter may be defined as parts of the concept year. In comparison, it is inappropriate todefine sunny weather (one possible characteristic of summer) as part of a year.Partitive relations are depicted by a rake without arrows (see Figure A.2). Singular parts are depicted by oneline, multiple parts by double lines.A.3.4 Associative relationAssociative relations cannot provide the economies in description that are present in generic and partitiverelations but are helpful in identifying the nature of the relationship between one concept and another within aconcept system, e.g. cause and effect, activity and location, activity and result, tool and function, material andproduct.Associative relations are depicted by a line with arrowheads at each end (see Figure A.3).Figure A.1 — Graphical representation of a generic relationFigure A.2 — Graphical representation of a partitive relationFigure A.3 — Graphical representation of an associative relationISO 9000:2005(E)22 © ISO 2005 – All rights reserved

yuank 发表于 2006-1-7 16:16:37

A.4 Concept diagramsFigures A.4 to A.13 show the concept diagrams on which the thematic groupings of Clause 3 are based.Since the definitions of the terms are repeated without any related notes, it is recommended to refer to Clause 3to consult any such notes.Figure A.4 — Concepts relating to quality (3.1)ISO 9000:2005(E)© ISO 2005 – All rights reserved 23Figure A.5 — Concepts relating to management (3.2)ISO 9000:2005(E)24 © ISO 2005 – All rights reservedFigure A.6 — Concepts relating to organization (3.3)Figure A.7 — Concepts relating to process and product (3.4)ISO 9000:2005(E)© ISO 2005 – All rights reserved 25Figure A.8 — Concepts relating to characteristics (3.5)Figure A.9 — Concepts relating to conformity (3.6)ISO 9000:2005(E)26 © ISO 2005 – All rights reservedFigure A.10 — Concepts relating to documentation (3.7)Figure A.11 — Concepts relating to examination (3.8)ISO 9000:2005(E)© ISO 2005 – All rights reserved 27Figure A.12 — Concepts relating to audit (3.9)ISO 9000:2005(E)28 © ISO 2005 – All rights reservedFigure A.13 — Concepts relating to quality management for measurement processes (3.10)ISO 9000:2005(E)© ISO 2005 – All rights reserved 29Bibliography ISO 704, Terminology work — Principles and methods ISO 1087-1, Terminology work — Vocabulary — Part 1: Theory and application ISO 3534-2, Statistics — Vocabulary and symbols — Part 2: Applied statistics1) ISO 9001:2000, Quality management systems — Requirements ISO 9004:2000, Quality management systems — Guidelines for performance improvements ISO 10012, Measurement management systems — Requirements for measurement processes andmeasuring equipment ISO/TR 10013, Guidelines for quality management system documentation ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000 ISO 10019, Guidelines for the selection of quality management system consultants and use of theirservices ISO 10241, International terminology standards — Preparation and layout ISO/TR 13425, Guidelines for the selection of statistical methods in standardization and specification ISO/IEC 17000, Conformity assessment — Vocabulary and general principles ISO 19011, Guidelines for quality and/or environmental management systems auditing ISO/IEC Guide 2, Standardization and related activities — General vocabulary IEC 60050-191, International Electrotechnical Vocabulary — Chapter 191: Dependability and quality ofservice IEC 60050-191/A2:2002, International Electrotechnical Vocabulary — Chapter 191: Dependability andquality of service: Amendment 2 VIM:1993, International vocabulary of basic and general terms in metrology, BIPM/IEC/IFCC/ISO/OIML/IUPAC/IUPAP Quality Management Principles Brochure 2) ISO 9000 + ISO 14000 News (a bimonthly publication which provides comprehensive coverage ofinternational developments relating to ISO’s management system standards, including news of their

yuank 发表于 2006-1-7 16:17:00

implementation by diverse organizations around the world) 3) ISO/IEC Directives, Part 1, Part 2:2004 and Supplement1) To be published.2) Available from website: http://www.iso.org3) Available from ISO Central Secretariat (sales@iso.org).ISO 9000:2005(E)30 © ISO 2005 – All rights reservedAlphabetical indexAaudit 3.9.1audit client 3.9.7audit conclusion 3.9.6audit criteria 3.9.3audit evidence 3.9.4audit findings 3.9.5audit plan 3.9.12audit programme 3.9.2audit scope 3.9.13audit team 3.9.10auditee 3.9.8auditor 3.9.9Ccapability 3.1.5characteristic 3.5.1competence 3.1.6competence .audit. 3.9.14concession 3.6.11conformity 3.6.1continual improvement 3.2.13contract 3.3.8correction 3.6.6corrective action 3.6.5customer 3.3.5customer satisfaction 3.1.4Ddefect 3.6.3dependability 3.5.3design and development 3.4.4deviation permit 3.6.12document 3.7.2Eeffectiveness 3.2.14efficiency 3.2.15Ggrade 3.1.3Iinformation 3.7.1infrastructure 3.3.3inspection 3.8.2interested party 3.3.7Mmanagement 3.2.6management system 3.2.2measurement managementsystem 3.10.1measurement process 3.10.2measuring equipment 3.10.4metrological characteristic 3.10.5metrological confirmation 3.10.3metrological function 3.10.6Nnonconformity 3.6.2Oobjective evidence 3.8.1organization 3.3.1organizational structure 3.3.2Ppreventive action 3.6.4procedure 3.4.5process 3.4.1product 3.4.2project 3.4.3Qqualification process 3.8.6quality 3.1.1quality assurance 3.2.11quality characteristic 3.5.2quality control 3.2.10quality improvement 3.2.12quality management 3.2.8quality management system 3.2.3quality manual 3.7.4quality objective 3.2.5quality plan 3.7.5quality planning 3.2.9quality policy 3.2.4Rrecord 3.7.6regrade 3.6.8release 3.6.13repair 3.6.9requirement 3.1.2review 3.8.7rework 3.6.7Sscrap 3.6.10specification 3.7.3supplier 3.3.6system 3.2.1Ttechnical expert .audit. 3.9.11test 3.8.3top management 3.2.7traceability 3.5.4Vvalidation 3.8.5verification 3.8.4Wwork environment 3.3.4.31ISO 9000:2005(E)ICS 01.040.03; 03.120.10Price based on 30 pages© ISO 2005 – All rights reserved

品质大副 发表于 2006-1-8 12:57:49

偶很想要一份中文版的啊,楼主是不是请英语版块的哪位大侠来翻译一下子?

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