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検索対象: 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格
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1. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

46 ISO 9001 formation necessary t0 support the operation and monitoring Of these processes, monitor, measure where applicable, and anal- yse these processes, and implement actions necessary tO achieve planned results and continual improvement Of processes. These processes shall be managed by the organi- zation in accordance with the reqmrements 0f this lnternational Standard. organization chooses tO outsource any process that affects product conformity t0 reqmre- ments, the organization shall ensure control over such processes. The type and extent 0f control tO be applied t0 these outsourced processes shall be defined within the quality management system. NOTE 1 Processes needed for the quality man- agement system referred t0 above include process- es for management activities, pr0VIS10n Of resourc- es, product realization, measurement, analysis

2. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

88 ISO 9001 and development stage(s) being reviewed. Records of the results of the revlews and any necessary ac- tions shall be maintained (see 4.2.4 ). 7.3.5 Design and development verification Verification shall be performed in accordance with planned arrangements (see 7.3.1 ) tO ensure that the design and development outputs have met the design and development input requirements. Re- cords Of the results 0f the verification and any nec- essary actions shall be maintained (see 4.2.4 ). 7.3.6 Design and development validation Design and development validation shall be per- formed in accordance With planned arrangements (see 7.3.1 ) tO ensure that the resulting product is capable 0f meeting the requlrements for the specl- fied application or intended use, where known. Wherever practicable, validation shall be complet- ed prior t0 the delivery or implementation of the product. Records 0f the results 0f validation and any necessary actions shall be maintained (see 4.2.4 ).

3. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

286 ISO 9000 3.10 Terms related to quality management for measurement processes 3.10.1 measurement management system set 0f interrelated and interacting elements nec- essary tO achieve metrological confirmation ( 3.10.3 ) and continual control of measurement processes ( 3.10.2 ) 3.10.2 measurement process set 0f operations t0 determine the value 0f a quan- tity 3.10.3 metrological confirmation set Of operations required tO ensure that measur- ing equipment ( 3.10.4 ) conforms t0 the require- ments ( 3.1.2 ) for its intended use NOTE 1 MetrologicaI confirmation generally includes calibration or verification ( 3.8.4 ) , any necessary adjustment or repair ( 3.6.9 ) , and sub-

4. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

218 3.2.8 ISO 9000 quality management coordinated activities to direct and control an or- ganization ( 3.3.1 ) with regard t0 quality ( 3.1.1 ) NOTE Direction and control with regard to qual- ity generally includes establishment 0f the qual- ity policy ( 3.2.4 ) and quality objectives ( 3.2.5 ) , quality planning ( 3.2.9 ) , quality control ( 3.2.10 ) , quality assurance ( 3.2.11 ) and quality improvement ( 3.2.12 ). 3.2.9 quality planning part 0f quality management ( 3.2.8 ) focused on setting quality objectives ( 3.2.5 ) and specifying necessary operational processes ( 3.4.1 ) and re- lated resources t0 fulfil the quality objectives NOTE Establishing quality plans ( 3.7.5 ) can be part 0f quality planning. 3.2.10 quality control

5. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

102 ISO 9001 7.6 Control of monitoring and measuring eqmpment The organization shall determine the monitor- ing and measurement t0 be undertaken and the monitoring and measurlng equlpment needed to provlde evidence Of conformity of product to deter- mined requn•ements. The organization shall establish processes to en- sure that monitoring and measurement can be carried out is consistent With the monitoring reqturements. Where necessary to ensure valid results, measur- ing equipment shall a) be calibrated or verified, or both, at specified intervals, or prior tO use, measure- ment standards traceable to international or national measurement standards•, Where no

6. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

76 ISO 9001 7.2 Customer-related processes 7.2.1 Determination of requirements relat- ed t0 the product The organization shall determine essary by the organization. any additional reqmrements considered nec- cable tO the product, and statutory and regulatory requirements appli- known , necessary for specified or intended use, where requirements not stated by the customer but post-delivery activities, cluding the requirements for delivery and reqmrements specified by the customer, ln- The organization shall revlew the requlrements product 7.2.2 Review of requirements related to the disposal. supplementary servlces such as recycling or final al obligations such as maintenance services, and ple, actions under warranty prouslons, contractu- NOTE Post-delivery activities include, for exam-

7. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

b) 70 d) ISO 9001 where applicable, provide training or take Other actions tO achieve the necessary compe- tence, evaluate the effectiveness Of the actions tak- en, ensure that its personnel are aware 0f the rel- evance and importance Of their actiV1ties and how they contribute to the achievement of the quality objectives, and maintain appropnate records Of educatlon, training, skills and experience (see 4.2.4 ). 6.3 lnfrastructure The organization shall determine, provide and malntain the infrastructure needed to achieve conformity t0 product requlrements. lnfrastruc- ture includes, as applicable, supporting sersnces (such as transport, com- ware), and process equipment (both hardware and soft- buildings, workspace and associated utilities,

8. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

68 ISO 9001 resources needed a) t0 implement and maintain the quality man- agement system and continually improve its effectiveness, and b) tO enhance customer satisfaction by meeting customer reqtllrements. 6.2 Human resources 6.2.1 General Personnel performing work affecting conformity t0 product requlrements shall be competent 0 Ⅱ the basis 0f appropriate education, training, skills and experlence. NOTE Conformity to product requirements can be affected directly or indirectly by personnel per- forming any task within the quality management system. 6.2.2 Competence, training and awareness The organization shall a) determine the necessary competence for per- sonnel performing work affecting conformity t0 product reqmrements,

9. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

288 ISO 9000 sequent recalibration, comparlson with the met- rological requirements for the intended use 0f the eqmpment, as well as any required sealing and labelling. NOTE 2 Metrolog1caI confirmation IS not achieved until and unless the fitness of the mea- surmg eqmpment for the intended use has been demonstrated and documented. NOTE 3 The requirements for intended use ⅲ - clude such considerations as range, resolution and maxlmum permissible errors. NOTE 4 Metrological requn•ements are usually distinct from, and are not specified in, product re- qmrements. 3.10.4 measuring measurmg instrument, software, measurement standard, reference material or auxiliary appara- tus or combination thereof necessary tO realize a measurement process ( 3.10.2 )

10. 対訳ISO 9001:2008(JIS Q 9001:2008)品質マネジメントの国際規格

276 ISO 9000 dent auditing organizations, such as those provld- ing certification/reglstration 0f conformity to ISO 9001 or ISO 14001. NOTE 3 When two or more management sys- tems ( 3.2.2 ) are audited together, this is termed a combined audit. NOTE 4 41e Ⅱ two or more auditing organiza- tions cooperate t0 audit a single auditee ( 3.9.8 ) , this is termed a joint audit. 3.9.2 audit programme set of one or more audits ( 3.9.1 ) planned for a specific time frame and directed towards a specific purpose NOTE An audit programme includes all activi- ties necessary for plannmg, orgamzmg con- ducting the audits. 3.9.3 audit criteria set of policies, procedures ( 3.4.5 ) or require- ments ( 3.1.2 )