82 ISO 9001 During the design and development planning, the organization shall determlne a) the design and development stages, b) the revlew , verific ation and validation that are appropriate t0 each design and develop- ment stage, and c) the responsibilities and authorities for design and development. The organization shall manage the interfaces be- tween different groups involved in design and de- velopment tO ensure effective clear asslgnment 0f responsibility. Planning output shall be updated, as appropriate, as the design and development progresses. NOTE Design and development review, verifica- tion and validation have distinct purposes. They can be conducted and recorded separately or 1 Ⅱ any combination, as suitable for the product and the organization. 7.3.2 Design and development inputs

240 ISO 9000 several units of product ( 3.4.2 ). NOTE 4 Adapted from ISO 10006 : 2003. 3.4.4 design and development set Of processes ( 3.4.1 ) that transforms require- ments ( 3.1.2 ) int0 specified characteristics ( 3.5.1 ) or into the specification ( 3.7.3 ) of a prod- uct ( 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 different stages of the overall de- S1gn and development process. NOTE 2 A qualifier can be applied to indicate the nature 0f what is being designed and devel- oped (). g. product design and development or pro- cess design and development).

84 ISO 9001 lnputs relating t0 product requirements shall be determined and records maintained (see 4.2.4 ). These inputs shall include d) functional and performance reqmrements, applicable statutory and regulatory require- ments, where applicable, information derived from preuous similar designs, and Other requlrements essential for design and development. The inputs shall be reviewed for adequacy. Re- qmrements shall be complete, unambiguous and not in conflict with each other. 7.3.3 Design and development outputs The outputs of design and development shall be 1 Ⅱ a form suitable for verification against the de- sign and development input and shall be approved prior tO release. Design and development outputs shall

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 ).

80 ISO 9001 are amended and that relevant personnel are made aware 0f the changed requlrements. NOTE ln some situations, such as internet sales, a formal resnew IS lmpractical for each or- der. lnstead the revlew can cover relevant prod- uct information such as catalogues or advertising material. 7.2.3 Customer communication The organization shall determine and implement effective arrangements for communicating with customers 1 Ⅱ relation tO plaints. customer feedback, including customer com- lng amendments, and enqumies, contracts or order handling, includ- product inform ation , and development 0f product. The organization shall plan and control the design 7.3.1 Design and development planning 7.3 Design and development

90 ISO 9001 7.3.7 ControI of design and development changes Design and development changes shall be identi- fied and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The revlew of design and development changes shall include evaluation of the effect of the changes 0 Ⅱ constitu- ent parts and product already delivered. Records of the results of the revlew of changes and any necessary actions shall be maintained (see 4.2.4 ). 7.4 Purchasing 7.4.1 Purchasing process The organization shall ensure that purchased product conforms t0 specified purchase require- ments. The type and extent Of control applied to the supplier and the purchased product shall be dependent upon the effect 0f the purchased prod- uct on subsequent product realization or the final

86 b) d) ISO 9001 meet the input requirements for design and develop ment , provlde appropriate information for purchas- lng, production and servlce pr0VISIon, contain or reference product acceptance crite- rla, and specify the characteristics Of the product that are essential for itS safe and proper use. NOTE lnformation for production and servlce prouslon can include details for the preservation 0f product. 7.3.4 Design and development review At suitable stages, systematic revlews of design and development shall be performed ⅲ accordance with planned arrangements (see 7.3.1 ) a) t0 evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose neces- sary actions. Particip ants in such revlews shall include repre - sentatives Of functions concerned with the design

14 3.9 Terms relating to audit 3.10 Terms related to quality management A (lnformative) MethodoIogy used ⅲ the Annex ( 省略 ) for measurement processes ・ 274 286 development 0f the vocabulary Biliography ( 省略 ) AIphabeticaI index ( 省略 )

299 corrective action 是正処置 252 customer 顧客 226 customer satisfaction 顧客満足 208 defect 欠陥 250 dependability デイベンダビリティ design and development 設計・開発 deviation permit 逸脱許可 258 document 文書 260 effectiveness 有効性 222 efficiency 効率 222 240 246 grade 等級 208 information 情報 260 infrastructure インフラストラクチャー inspection 検査 268 interested party 利害関係者 228 226 management management management 運営管理 216 運用管理 216 マネジメント 216

実現能力 capability 修正 correction 255 理 repair 257 仕様書 specification 263 211 情報 information スクラップ scrap 261 くす > 257 < せ > 製品 product 233 是正処置 corrective action 253 設計・開発 design and development < そ > 289 測定機器 measuring equipment 295 241 287 測定プロセス measurement process 組織 organization 223 組織構造 organizational structure < た > 271 妥当性確認 validation < て > dependability 247 225 デイベンダビリティ 適格性確認プロセス 適合 conformity 手順 procedure qualific ation proce s s 249 243 271