参考文献 Customer satisfaction 197 Guideline s for dispute resolution external tO organizations [ 9 ] ISO 10005 : 2005 , QuaIity management systems ー Guidelines for quality plans [ 10 ] ISO 10007 : 2003 , Quality management Guideline s for confi guration systems management [ 11 ] ISO 10012 : 2003 , Measurement manage- ment systems ー Requirements for measure- ment processes and measurmg [ 12 ] ISO/TR 10013 : 2001 , GuideIines for quality management system documentation [ 13 ] ISO 10014 : 2006 , QuaIity management Guideline s for re alizing financial and economic benefits [ 14 ] ISO 10015 : 1999 , QuaIity management GuideIine s for training [ 15 ] ISO/TR 10017 : 2003 , Guidance on statistical techniques for ISO 9001 : 2000 [ 16 ] IEC 60300-1 : 2003 , DependabiIity manage- ment ー Part 1 : Dependability management systems [ 17 ] IEC 61160 : 2006 , Design reuew [ 18 ] ISO/IEC 90003 : 2004 , Software englneering

52 ISO 9001 b) the complexity Of processes and their interac- tions, and c) the competence of personnel. NOTE 3 The documentation can be ⅲ any form or type 0f medium. 4.2.2 QuaIity manual The organization shall establish and maintain a quality manual that includes a) b) c) the scope 0f the quality management system, including details 0f and justification for any exclusions (see 1.2 ) , the documented procedures established for the quality management system, or reference to them, and a description 0f the interaction between the processes Of the quality management system. 4.2.3 Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according t0 the reqturements given in 4.2.4.

58 ISO 9001 d) conducting management revlews, and e) ensuring the availability of resources. 5.2 Customer focus Top management shall ensure that customer re- quirements are determined and are met with the aim Of enhancing customer satisfaction (see 7.2.1 and 8.2.1 ). 5.3 QuaIity policy Top management shall ensure that the quality policy b) d) IS appropriate t0 the purpose 0f the organlza- tion, includes a commitment to comply with re- qumements and continually improve the effec- tiveness 0f the quality management system, provldes a framework for establishing and re- uewmg quality 0bJectives, IS communicated and understood within the organization, and IS reuewed for continuing suitability. 5.4 Planning

3 まえがき 品質保証の国際規格として 1987 年に制定された ISO 9000 ファミリーは , 1994 年に初めての改正が , 2000 年に は品質マネジメントシステムの国際規格としての改正 ( 2 回 目 ) が行われた . 2008 年には , ISO 9000 ファミリーのう ち , ISO 9001 : 2000 (Quality management systems—Re- quirements) に限って , ①要求事項の明確化 , ② ISO/TC 176 ( 品質管理及び品質保証 ) による公式の解釈を必要と するようなあいまいさの除去 , ③ ISO 14001 との両立性向 上の 3 点を目的とした , 追補改正版である ISO 9001 : 2008 (Quality management systems¯Requirements) カゞ 11 月 15 日に発刊された . この 2008 年版は 3 回目の改正とはいえ , 技術的内容でな く編集上の変更だけを行う追補であり , その変化は限定的で ある . このように , 2008 年 ISO 9001 追補改正版は , 実質 的には 2000 年版 IS09001 と同一なため , 適用において実 質的な変化・影響はないものとみなされている . 国内においては , 品質マネジメントシステム規格国内委 員会委員を中心に JIS 化分科会が設置され , ISO 9001 : 2008 を翻訳した JISQ9001 ( 品質マネジメントシステムー要求 事項 ) が同じく 2008 年に改正された . また , ISO 9001 : 2008 で引用されている ISO 9000(QuaIity management systems¯Fundamentals and vocabulary) は 2005 年に改正され , その完全一致の翻訳規格である JIS Q9000 ( 品質マネジメントシステムー基本及び用語 ) も 2006

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

301 quality assurance 品質保証 220 quality characteristic 品質特性 244 quality control 品質管理 218 quality improvement 品質改善 220 quality management 品質マネジメント 218 quality management system 品質マネジメントシ ステム 212 quality manual 品質マニュアル 262 quality objective 品質目標 214 quality plan 品質計画書 264 quality planning 品質計画 218 quality policy 品質方針 214 record 記録 266 regrade 再格付け release リリース 260 repair 修理 256 requirement 要求事項 204 reV1e 、・レーヒコ、、一一 272 rework 手直し 254 scrap スクラップ 256 specification 仕様書 262 supplier 供給者 228 system システム 212 254

296 手直し rework 255 < と > 等級 grade 209 特性 charactenstic 245 特別採用 concession 259 トッブマネジメント top management トレーサビリティ traceability 249 < ひ > 281 被監査者 auditee ロロ質 quality 205 ロロ質改善 qu ality improve ment 品質管理 quality control 219 品質計画 quality planning 219 品質計画書 quality plan 265 221 217 品質特性 qu ality characteristic 品質方針 quality policy 215 品質・保証 quality assurance 品質マニュアル quality manual 263 品質マネジメント quality management 219 品質マネジメントシステム quality management system 213 品質目標 qu ality obj ective < ふ > 245 221 215 不適合 nonconformity プロジェクト project 251 239

214 3.2.4 quality policy ISO 9000 overall intentions and direction Of an organiza- tion ( 3.3.1 ) related to quality ( 3.1.1 ) as formally expressed by top management ( 3.2. の NOTE 1 Generally the quality policy is consis- tent with the overall policy of the organiz ation and provldes a framework for the setting 0f qual- ity objectives ( 3.2.5 ). NOTE 2 Quality management principles pre- sented in this lnternational Standard can form a basis for the establishment 0f a quality policy. (See 0.2. ) 3.2.5 quality objective something sought, or aimed for, related tO quality ( 3.1.1 ) NOTE 1 Quality objectives are generally based 0 Ⅱ the organization's quality policy ( 3.2.4 ). NOTE 2 Quality objectives are generally speci- fied for relevant functions and levels ⅲ the orga-

220 ISO 9000 part 0f quality management ( 3.2.8 ) focused 0 Ⅱ fulfilling quality re quirem ents 3.2.11 quality assurance part 0f quality management ( 3.2.8 ) focused on providing confidence that quality reqmrements will be fulfilled 3.2.12 quality improvement part 0f quality management ( 3.2.8 ) focused 0 Ⅱ mcre asing the ability tO fulfil quality re quire - ments NOTE The requlrements can be related to any aspect such as effectiveness ( 3.2.14 ) , efficiency ( 3.2.15 ) or traceability ( 3.5.4 ). 3.2.13 continual improvement recurring activity t0 increase the ability t0 fu161 requirements ( 3.1.2 )

264 ISO 9000 document ( 3.7.2 ) specifymg the quality man- agement system ( 3.2.3 ) Of an organization ( 3.3.1 ) NOTE Quality manuals can vary ⅲ detail and format t0 suit the size and complexity of an indi- Vidual organization. 3.7.5 quality plan document ( 3.7.2 ) specifying which procedures ( 3.4.5 ) and associated resources shall be applied by whom and when to a specific proj ect ( 3.4.3 ) , product ( 3.4.2 ) , process ( 3.4.1 ) or contract NOTE 1 These procedures generally include those referring t0 quality management processes and tO product realization processes. NOTE 2 A quality plan often makes reference to parts 0f the quality manual ( 3.7.4 ) or t0 proce- dure documents. NOTE 3 A quality plan is generally one of the results of quality planning ( 3.2.9 ).