質(zhì)量體系文件編寫規(guī)則

1、質(zhì)量體系文件編寫規(guī)則質(zhì)量體系文件編寫規(guī)則2014.03.12The copying, distribution and utilization of this document as well as the communication of its contents to others without expressed authorization is prohibited.Offenders will be held liable for the payment of damages. All rights reserved in the event of the grant of a p

2、atent, utility model or ornamental design registration.1描述質(zhì)量方針/目標(biāo)、質(zhì)量管理體系過程及過程之間的相互關(guān)系 質(zhì)量管理手冊(cè)數(shù)據(jù)與信息的載體，提供質(zhì)量體系有效運(yùn)行的符合性證據(jù) ？控制程序?yàn)橘|(zhì)量管理體系活動(dòng)提供指導(dǎo)并分配職責(zé) ？指導(dǎo)文件詳細(xì)描述具體質(zhì)量活動(dòng)的每個(gè)步驟與要求 ？個(gè)質(zhì)量記錄質(zhì)量體系文件結(jié)構(gòu)質(zhì)量體系文件結(jié)構(gòu)質(zhì)量記錄質(zhì)量記錄The copying, distribution and utilization of this document as well as the communication of its contents t

3、o others without expressed authorization is prohibited.Offenders will be held liable for the payment of damages. All rights reserved in the event of the grant of a patent, utility model or ornamental design registration.2v文件發(fā)布方式：通過IT室在公司內(nèi)部網(wǎng)發(fā)布v文件管理權(quán)限： 質(zhì)量保證部體系管理員：可讀可寫 公司所有電腦使用用戶：可讀v文件查詢目錄：Y盤/specical

4、folder/質(zhì)量體系文件/質(zhì)量手冊(cè)、程序、流程質(zhì)量體系發(fā)布路徑質(zhì)量體系發(fā)布路徑The copying, distribution and utilization of this document as well as the communication of its contents to others without expressed authorization is prohibited.Offenders will be held liable for the payment of damages. All rights reserved in the event of the gr

5、ant of a patent, utility model or ornamental design registration.質(zhì)量體系文件編制原則質(zhì)量體系文件編制原則The copying, distribution and utilization of this document as well as the communication of its contents to others without expressed authorization is prohibited.Offenders will be held liable for the payment of damage

6、s. All rights reserved in the event of the grant of a patent, utility model or ornamental design registration.4質(zhì)量體系控制程序質(zhì)量體系控制程序u 來源來源質(zhì)量體系過程分析圖（烏龜圖）u 確定確定深刻理解所負(fù)責(zé)體系過程整理現(xiàn)有質(zhì)量體系文件整合/融合 u 定義定義是涉及到質(zhì)量管理體系的一個(gè)邏輯上的獨(dú)立部分或活動(dòng)是對(duì)質(zhì)量管理體系的某項(xiàng)質(zhì)量活動(dòng)實(shí)施內(nèi)容、方法和順序要求的規(guī)定對(duì)質(zhì)量活動(dòng)應(yīng)規(guī)定目的和范圍，實(shí)施的具體步驟，實(shí)施結(jié)果的處理、反饋，以及在實(shí)施過程中與各部門的關(guān)系等是質(zhì)量手冊(cè)的支持性的文

7、件。因此，程序文件實(shí)際上是對(duì)質(zhì)量手冊(cè)規(guī)定的進(jìn)一步展 開、落實(shí)和細(xì)化?？梢允琴|(zhì)量管理體系的一個(gè)條款的一部分，或涉及多個(gè)相關(guān)的條款The copying, distribution and utilization of this document as well as the communication of its contents to others without expressed authorization is prohibited.Offenders will be held liable for the payment of damages. All rights reserved

8、 in the event of the grant of a patent, utility model or ornamental design registration.5質(zhì)量體系控制程序質(zhì)量體系控制程序u 編寫要求考慮質(zhì)量管理體系的整體性、系統(tǒng)性充分展開各項(xiàng)質(zhì)量活動(dòng)建立各個(gè)程序文件之間的關(guān)系相互作用的有機(jī)整體明確部門接口強(qiáng)調(diào)可操作性和可指導(dǎo)性描述簡(jiǎn)明、用詞準(zhǔn)確，避免贅述。可操作性可指導(dǎo)性注重方法和步驟、職責(zé) 不涉及技術(shù)細(xì) 節(jié)和工作細(xì)節(jié)The copying, distribution and utilization of this document as well as the com

9、munication of its contents to others without expressed authorization is prohibited.Offenders will be held liable for the payment of damages. All rights reserved in the event of the grant of a patent, utility model or ornamental design registration.6u 程序文件格式紙張/頁邊距A4/上：2.54cm；下：2.54cm 左： 1.91cm；下：1.91

10、cm頁眉固定板式；文件編號(hào)/版本由質(zhì)量保證部統(tǒng)一編制頁碼：總頁數(shù)及當(dāng)頁碼字體/全篇宋體字號(hào)名稱/小三大標(biāo)題/小四、加粗副標(biāo)題/小四、加粗正文/小四、不加粗章節(jié)編號(hào)阿拉伯?dāng)?shù)字，按自然順序排列最多4個(gè)數(shù)字，每個(gè)數(shù)字之間用點(diǎn)隔開每增加一個(gè)數(shù)字，整行需向后2個(gè)字節(jié)質(zhì)量體系控制程序質(zhì)量體系控制程序The copying, distribution and utilization of this document as well as the communication of its contents to others without expressed authorization is prohibi

11、ted.Offenders will be held liable for the payment of damages. All rights reserved in the event of the grant of a patent, utility model or ornamental design registration.7質(zhì)量體系控制程序質(zhì)量體系控制程序u 內(nèi)容描述1 目的為什么做？為達(dá)到什么樣的目標(biāo)？發(fā)揮什么樣的作用？2 適用范圍通常描述的是工作的主要內(nèi)容的縮寫，如XXX工作的計(jì)劃、實(shí)施與監(jiān)控等。3 術(shù)語和定義必須描述的為：采用ISO 9001：2008 質(zhì)量管理體系基本原理

12、詞匯以及ISO/TS16949：2009技術(shù)規(guī)范中相關(guān)的汽車行業(yè)術(shù)語和定義。其它：文中出現(xiàn)的不易理解、看懂的詞匯，如英文縮寫、DBTS慣用的詞語、認(rèn)為有不要特別解釋/說明的。4 職責(zé)程序中涉及部門責(zé)、權(quán)、利的描述（職責(zé)描述不須具體到部門的某類崗位/人員）通常采用主、謂、賓結(jié)構(gòu)；謂語可以為負(fù)責(zé)、支持、參與、策劃、監(jiān)控、配合、協(xié)助等動(dòng)詞。職責(zé)中的工作內(nèi)容須與正文內(nèi)容相對(duì)應(yīng)與呼應(yīng)The copying, distribution and utilization of this document as well as the communication of its contents to other

13、s without expressed authorization is prohibited.Offenders will be held liable for the payment of damages. All rights reserved in the event of the grant of a patent, utility model or ornamental design registration.8質(zhì)量體系控制程序質(zhì)量體系控制程序5 工作程序采用文字描述，層級(jí)關(guān)系采用第6頁P(yáng)PT規(guī)定的編碼規(guī)則進(jìn)行敘述采用“6問5W1H分析法”，進(jìn)行文件的構(gòu)思步驟應(yīng)脈絡(luò)清晰、邏輯關(guān)系正

14、常、不跳躍、不雜亂說明各種不同活動(dòng)實(shí)施方法，使用的文件和所進(jìn)行的控制對(duì)質(zhì)量活動(dòng)中所涉及到的責(zé)任、權(quán)力和相互關(guān)系作出規(guī)定。對(duì)于質(zhì)量活動(dòng)所涉及到 的文件應(yīng)注明文件名稱注：程序的內(nèi)容 主要是規(guī)定質(zhì)量活動(dòng)應(yīng)做什么，即實(shí)施的方法和步驟，需要而不是敘述如何做的具體細(xì)節(jié)。細(xì)節(jié)應(yīng)在三層級(jí)文件中予以規(guī)定。 6 相關(guān)支持性文件文中所描述的質(zhì)量活動(dòng)在實(shí)施/控制中需引用/參照?qǐng)?zhí)行的相關(guān)程序、流程、標(biāo)準(zhǔn)以及管理辦法等。此項(xiàng)出現(xiàn)的相關(guān)文件須在“5 工作程序”中出現(xiàn)。 7 質(zhì)量記錄完成本程序的質(zhì)量活動(dòng)需提供的具體記錄名稱主要來源于本程序以及引用的相關(guān)程序、流程、標(biāo)準(zhǔn)以及管理辦法中所涉及到的質(zhì)量記錄。記錄編號(hào)由質(zhì)量保證部統(tǒng)一

15、確定。8變更履歷The copying, distribution and utilization of this document as well as the communication of its contents to others without expressed authorization is prohibited.Offenders will be held liable for the payment of damages. All rights reserved in the event of the grant of a patent, utility model o

16、r ornamental design registration.9 8 變更履歷每變更一次，均需進(jìn)行評(píng)審和記錄；記錄中包括：批準(zhǔn)日期：體系文件評(píng)審表中的“批準(zhǔn)日期”變更內(nèi)容：明確變更前后內(nèi)容的描述變更后的版本號(hào)質(zhì)量體系控制程序質(zhì)量體系控制程序The copying, distribution and utilization of this document as well as the communication of its contents to others without expressed authorization is prohibited.Offenders will be

17、held liable for the payment of damages. All rights reserved in the event of the grant of a patent, utility model or ornamental design registration.10質(zhì)量體系三層級(jí)文件質(zhì)量體系三層級(jí)文件u 流程格式統(tǒng)一模板：頁眉、文件編號(hào)、流程名稱、輸入、工作流程、解釋/說明、輸出以及變更履歷紙張/頁邊距A4/上下左右各2個(gè)坐標(biāo)格字體/字號(hào)流程名稱：宋體/16（黑色）工作框內(nèi)：宋體/9號(hào)（黑色）箭頭與框圖的線條要求為：線型/實(shí)線；粗細(xì)/03；顏色/黑色The co

18、pying, distribution and utilization of this document as well as the communication of its contents to others without expressed authorization is prohibited.Offenders will be held liable for the payment of damages. All rights reserved in the event of the grant of a patent, utility model or ornamental d

19、esign registration.11質(zhì)量體系三層級(jí)文件質(zhì)量體系三層級(jí)文件流程流程流程符號(hào)含義引用的相關(guān)支持性文件上下頁承接對(duì)工作動(dòng)作特別的解釋/說明表示工作行進(jìn)方向流程編制要求流程名稱需被相關(guān)控制程序引用；文件編號(hào)“空”，質(zhì)量部統(tǒng)一定義輸入：工作依據(jù)、工作指令工作流程：富于邏輯的工作步驟；清晰的工作流向；明確的職責(zé)；正確的符號(hào)描述考慮工作內(nèi)容的全面性，涉及不同的工作情形，應(yīng)采用流程的“分枝”來展現(xiàn)，盡可能減少文字性的解釋/說明，充分體現(xiàn)流程圖的直觀性；進(jìn)程框內(nèi)的語言應(yīng)保持描述風(fēng)格的一致性，建議采用動(dòng)賓與偏正詞組的描述方式。如動(dòng)賓詞組“制定審核計(jì)劃”、“實(shí)施審核計(jì)劃”，或者偏正詞組“審核計(jì)

20、劃的制定”、“審核計(jì)劃的實(shí)施”等菱形判斷框內(nèi)容的描述，采用疑問句的句式進(jìn)行表達(dá)，如“評(píng)審?fù)ㄟ^了嗎？”、“合格嗎？”、“驗(yàn)證有效嗎？”等。判斷框內(nèi)的內(nèi)容是一個(gè)虛擬的語句，不需明確負(fù)責(zé)人員；但判斷的指令必由有前一進(jìn)程框發(fā)出。判斷之后，必須有判斷結(jié)果，結(jié)果為否定NO表示；結(jié)果為肯定-YES表示。The copying, distribution and utilization of this document as well as the communication of its contents to others without expressed authorization is prohib

21、ited.Offenders will be held liable for the payment of damages. All rights reserved in the event of the grant of a patent, utility model or ornamental design registration.12上下頁內(nèi)容對(duì)接時(shí)，采用上圖中的“頁面內(nèi)引用”符號(hào)，根據(jù)需對(duì)接內(nèi)容的數(shù)量，依次用“A、B、C.表示。”每一個(gè)進(jìn)程框中必須明確活動(dòng)的主體（負(fù)責(zé)部門/人員），負(fù)責(zé)人僅明確主要實(shí)施者，并且是唯一的，不允許出現(xiàn)2個(gè)以上的負(fù)責(zé)部門/人，如需要特別注釋其他的配合/協(xié)助人

22、員，可在“解釋/說明”欄中采用“批注”符號(hào)加以說明。工作的實(shí)施主體也應(yīng)統(tǒng)一，確保整個(gè)流程的標(biāo)準(zhǔn)化，如流程全篇均采用質(zhì)量部、制造部、研發(fā)部等；均采用“保全室、現(xiàn)場(chǎng)質(zhì)量室、產(chǎn)品設(shè)計(jì)室、生產(chǎn)車間”等，或者“產(chǎn)品設(shè)計(jì)人員、現(xiàn)場(chǎng)質(zhì)量工程師、現(xiàn)場(chǎng)操作工、項(xiàng)目采購工程師”等；-（部門組織機(jī)構(gòu)）流程中的工作應(yīng)是閉環(huán)的，有“開始”必須要有“結(jié)束”；特別是一些工作的分支，完成后必須有渠道與主流程會(huì)合，直至“結(jié)束”。輸出：工作證據(jù)的載體，如相關(guān)指導(dǎo)性文件、作業(yè)標(biāo)準(zhǔn)、記錄等。變更履歷變更履歷是流程的一部分，包括版本號(hào)（質(zhì)量部定義）、批準(zhǔn)日期（體系文件評(píng)審表中的“批準(zhǔn)日期” ）以及變更內(nèi)容 質(zhì)量體系三層級(jí)文件質(zhì)量體系三

23、層級(jí)文件流程流程The copying, distribution and utilization of this document as well as the communication of its contents to others without expressed authorization is prohibited.Offenders will be held liable for the payment of damages. All rights reserved in the event of the grant of a patent, utility model or ornamental design registration.13質(zhì)量體系三層級(jí)文件質(zhì)量體系三層級(jí)文件-管理標(biāo)準(zhǔn)管理標(biāo)準(zhǔn)格式同程序文件，但刪除第3條款“術(shù)語和定義”；原第5條款“工作程序”變?yōu)榈?條款“實(shí)施