手袋廠質(zhì)量手冊(中英文)

1、深圳培訓(xùn)網(wǎng) 質(zhì)量手冊QUALITY MANUAL修訂日期修訂單號(hào)修訂內(nèi)容摘要頁次版次修訂審核批準(zhǔn)2011/03/30/系統(tǒng)文件新制定4A/0/更多免費(fèi)資料下載請進(jìn)：好好學(xué)習(xí)社區(qū)批準(zhǔn)：審核：編制：質(zhì)量手冊QUALITY MANUAL0. 范圍Scope0.1 產(chǎn)品范圍Product scope 手袋及其它縫紉制品。 Bags and other sewing products.0.2 場所范圍Location scope 0.3 刪節(jié)說明CancellationA. 本手冊 “第7.3條-設(shè)計(jì)和開發(fā)”只適用于xxxxx,不適用于xx .The elements “7.3 design and d

2、evelopment” is only applicable for xxxL but not applicable for xx.B. 因?yàn)閤x依據(jù)xxxxx的樣板、技術(shù)圖紙進(jìn)行制作樣板, 在樣板得到xxxxx的承認(rèn)之后進(jìn)行產(chǎn)品生產(chǎn), 故本要素不適用于xxxxx.The cause of not applicable: because xx carries out sample making based on benchmarking samples or specification provided by xx, and xx commence mass production only a

3、fter sample has been approved by xxx1. 引用標(biāo)準(zhǔn)Normative reference1.1 ISO9000: 2005質(zhì)量管理體系基礎(chǔ)和術(shù)語 ISO9000: 2005 Quality Management System-Fundamentals and vocabulary 1.2 ISO9001: 2008質(zhì)量管理體系-要求 ISO9001: 2008 Quality Management System-Requirements 2. 術(shù)語和定義Terms2.1 質(zhì)量Quality一組固有特性滿足要求的程度. Degree to which a se

4、t of inherent characteristics fulfills requirements 注1: 術(shù)語“質(zhì)量”可使用形容詞如差、好或優(yōu)秀來修飾Note 1: the term “quality” can be used with adjectives such as poor, good or excellent注2: “固有的”(其反義是“賦予的”)就是指在某事或某物中本來就有的, 尤其是那種永久的特性Note 2: “Inherent”, as opposed to “assigned”, means existing in something, especially as

5、a permanent characteristics 2.2 顧客滿意Customer satisfaction顧客對(duì)其要求已被滿足的程度的感受Customers perception of the degree to which the customers requirements have been fulfilled 注1: 顧客投訴是一種滿意程度低的最常見的表達(dá)方式, 但沒有投訴并不一定表明顧客很滿意Note 1: customer complaint are a common indicator of low customer satisfaction but their abse

6、nce dose not necessarily imply high customer satisfaction 注2: 即使規(guī)定的顧客要求符合顧客的愿望并得到滿足, 也不一定確保顧客很滿意Note 2: even when customers requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction 2.3 顧客Customer接受產(chǎn)品的組織或個(gè)人Organization or person that r

7、eceives a product 2.4 供應(yīng)商/供方Supplier提供產(chǎn)品的組織或個(gè)人Organization or person that provides a product 2.5 過程Process一組將輸入轉(zhuǎn)化為輸出的相互關(guān)聯(lián)或相互作用的活動(dòng)Set of interrelating or interacting activities which transforms inputs into outputs 2.6 產(chǎn)品Product過程的結(jié)果Result of a process2.7 合格Conformity滿足要求Fulfillment of a requirement 2

8、.8 不合格Nonconformity未滿足要求Non-fulfillment of a requirement 2.9 預(yù)防措施Preventive action 為消除潛在不合格或其他潛在不期望情況的原因所采取的措施Action to eliminate the cause of a potential nonconformity or other potential undesirable situation2.10 糾正Correction為消除已發(fā)現(xiàn)的不合格所采取的措施Action to eliminate detected nonconformity2.11 糾正措施Correct

9、ive action 為消除已發(fā)現(xiàn)的不合格或其他不期望情況的原因所采取的措施Action to eliminate the cause of a detected nonconformity or other undesirable situation 2.12 文件Document 信息及其承載媒體Information and its supporting medium 2.13 記錄Record 闡明所取得的結(jié)果或提供所完成活動(dòng)的證據(jù)的文件Document stating results achieved or providing evidence of activities perfo

10、rmed 3. 質(zhì)量管理體系Quality management system3.1 總要求General requirements 本公司將按照本質(zhì)量手冊的要求建立質(zhì)量管理體系, 形成文件, 加以實(shí)施和保持, 并持續(xù)改進(jìn)其有效性.Our company shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this Quality

11、Manual A. 本公司將:Our company shall a. 識(shí)別質(zhì)量管理體系所需的過程及其在公司內(nèi)的應(yīng)用;Identify the processes needed for the quality management system and their application throughout our companyb. 確定這些過程的順序和相互作用(見附件1: 質(zhì)量管理體系流程圖);Determine the sequence and interaction of these processes (see attachment 1: QMS Flowchart)c. 確保為這

12、些過程的有效運(yùn)作和控制所需的準(zhǔn)則和方法;Determine criteria and methods needed to ensure that both the operation and control of these processes are effectived. 確?？梢垣@得必要的資源和信息, 以支持這些過程的運(yùn)作和監(jiān)視;Ensure the availability of resources and information necessary to support the operation of these processese. 監(jiān)視、測量和分析這些過程;Monitor,

13、measure and analyze these processes, and f. 實(shí)施必要的措施, 以實(shí)現(xiàn)對(duì)這些過程所策劃的結(jié)果和對(duì)這些過程的持續(xù)改進(jìn)Implement actions necessary to achieve planned results and continual improvement of these processes B. 本公司必須按照ISO9001: 2008質(zhì)量管理體系-要求管理上述的過程;These processes shall be managed by our company in accordance with ISO9001:2008 Qu

14、ality Management System C. 針對(duì)本公司所外包的任何影響產(chǎn)品符合性的過程, 本公司將確保對(duì)其予以識(shí)別和控制.Where we choose to outsource any process that affects product conformity with requirements, we shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. 本公

15、司的外包活動(dòng): 部分工序, 按照本公司生產(chǎn)管理程序進(jìn)行控制. Some processes will be outsourced sometimes, and shall be in control according to Production Management Procedure. 3.2 文件要求Documentation requirements 3.2.1 總則General 質(zhì)量體系文件包括:Documentation of the quality management system consists of A. 質(zhì)量方針和質(zhì)量目標(biāo);Quality policy and qua

16、lity objectivesB. 質(zhì)量手冊;Quality Manual C. ISO9001: 2008質(zhì)量管理體系-要求所要求的程序文件和本公司確定的其它程序文件, 見附件4:質(zhì)量手冊和程序清單;Documented procedures required by ISO9001:2008 Quality Management System and our company, see attachment 4: D. 本公司為確保過程有效策劃、運(yùn)作和控制所需的文件;Documents needed by our company to ensure the effective planning

17、, operation and control of its processes, and QMS Manual and Procedure ListE. ISO9001: 2008質(zhì)量管理體系-要求所要求的記錄(見本手冊第4.2.4條)Records required by ISO9001:2008 Quality Management System (see 4.2.4 in this Manual F. 文件的形式: 紙質(zhì)或電子文件.Media of documents: paper or electronic carrier 3.2.2 質(zhì)量手冊Quality Manual A. 本公

18、司編制和保持本質(zhì)量手冊, 且包括:We shall establish and maintain this Quality Manual that includes a) 質(zhì)量管理體系的范圍,包括任何刪節(jié)的細(xì)節(jié)和合理性,見本手冊第1章節(jié): “范圍”; The scope of the quality management system, including details of and justification for any exclusion (see chapter 1: Scope) b) 為質(zhì)量管理體系編制的形成文件的程序或?qū)ζ湟?The documented procedure

19、s established for the quality management system, or reference to them, and c) 質(zhì)量管理體系過程的相互作用的表述.A description of the interaction between the processes of the quality management system B. 本質(zhì)量手冊由管理者代表編制、總經(jīng)理審核;This Quality Manual shall be drafted by Management Representative, and shall be approved by Ge

20、neral Manager C. 本質(zhì)量手冊按照文控程序進(jìn)行控制.This Quality Manual shall be controlled based on Document Control Procedure3.2.3 文件控制Control of document A. 質(zhì)量管理體系所要求的文件必須予以控制. 質(zhì)量記錄是一種特殊類型的文件, 應(yīng)按照第4.2.4條款的要求進(jìn)行控制;Documents required by the quality management system shall be controlled. Records are a special type of d

21、ocument and shall be controlled according to the requirements given in 4.2.4 B. 建立文控程序, 以規(guī)定以下方面所需的控制:Document Control Procedure shall be established to define the controls needed a. 文件發(fā)布前得到批準(zhǔn), 以確保文件是充分與適宜的; to approve documents for adequacy prior to issue b. 必要時(shí), 對(duì)文件進(jìn)行評(píng)審與更新, 并再次批準(zhǔn); to review and upd

22、ate as necessary and re-approve documents c. 確保文件的更改和現(xiàn)行修訂狀態(tài)得到識(shí)別; to ensure that changes and the current version status of documents are identifiedd. 確保在使用處可獲得有關(guān)版本的適用文件; to ensure that relevant versions of applicable documents are available at points of usee. 確保文件保持清晰、易于識(shí)別; to ensure that documents r

23、emain legible and readily identifiablef. 確保外來文件得到識(shí)別, 并控制其分發(fā); to ensure that documents of external origin are identified and their distribution controlled, andg. 防止作廢文件的非預(yù)期使用, 若因任何原因而保留作廢文件時(shí), 對(duì)這些文件進(jìn)行適當(dāng)?shù)臉?biāo)識(shí). to prevent the unintended use of obsolete documents, and to apply suitable identification to th

24、em if they are retained for any purpose3.2.4 質(zhì)量記錄的控制Control of quality records 建立記錄管理程序, 以便:Record Control Procedure shall be established to A. 建立并保持質(zhì)量記錄, 以提供符合要求和質(zhì)量管理體系有效運(yùn)行的證據(jù);establish and maintain quality records in order to provide evidence of conformity to requirements and of the effective oper

25、ation of the quality management systemB. 確保質(zhì)量記錄保持清晰、易于識(shí)別和檢索;ensure records can remain legible, readily identifiable and retrievable C. 規(guī)定質(zhì)量記錄的標(biāo)識(shí)、貯存、檢索、保存期限和處置所需的控制. to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records4. 管理職責(zé)M

26、anagement responsibility 4.1 管理承諾Management commitment 總經(jīng)理將通過以下活動(dòng), 對(duì)建立、實(shí)施質(zhì)量管理體系并持續(xù)改進(jìn)有效性的承諾提供證據(jù):General Manager shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness byA. 向公司全體成員傳達(dá)滿足顧客和法律法規(guī)要求的重要性; co

27、mmunicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,B. 制定質(zhì)量方針; establishing the quality policyC. 制定質(zhì)量目標(biāo), 并定期進(jìn)行統(tǒng)計(jì)和檢討; ensuring that quality objectives are establishedD. 進(jìn)行管理評(píng)審; conducting management reviews, andE. 提供適當(dāng)?shù)馁Y源; ensuring the a

28、vailability of resources4.2 以顧客為中心Customer focus A. 總經(jīng)理以增強(qiáng)顧客滿意為目的, 確保顧客的要求得到確定并予以滿足;General Manager shall ensure that customer requirements are determined and met with the aim of enhancing customer satisfactionB. 建立和實(shí)施客戶服務(wù)程序,包括對(duì)顧客訂單進(jìn)行有效評(píng)審及顧客滿意度的調(diào)查.Customer Service Procedure shall be established and

29、implemented, including the customer Order Review and Customer Satisfaction Survey. 4.3 質(zhì)量方針Quality policy A. 總經(jīng)理應(yīng)確保質(zhì)量方針:General Manager shall ensure that the quality policy a. 與公司的宗旨想適應(yīng);is appropriate to the purpose of our company b. 包括對(duì)滿足要求和持續(xù)改進(jìn)質(zhì)量管理體系有效性的承諾;includes a commitment to comply with requ

30、irements and continually improve the effectiveness of the quality management systemc. 提供制定和評(píng)審質(zhì)量目標(biāo)的框架;provides a frame work for establishing and reviewing quality objectivesd. 在組織內(nèi)得到溝通和理解;is communicated and understood within the organization, and e. 在持續(xù)適宜性方面得到評(píng)審.Is reviewed for continuing suitabilit

31、y B. 本公司的質(zhì)量方針, 見“前言”章節(jié).About quality policy of our company, see the Foreword to this Manual 4.4 策劃Planning 4.4.1 質(zhì)量目標(biāo)Quality objectives A. 總經(jīng)理應(yīng)確保在公司的相關(guān)職能和層次上建立質(zhì)量目標(biāo), 質(zhì)量目標(biāo)包括滿足產(chǎn)品要求所需的內(nèi)容;General Manager shall ensure that quality objectives, including those needed to meet requirements for product, are es

32、tablished at relevant functions and levels within the organizationB. 質(zhì)量目標(biāo)應(yīng)是可測量的, 并與質(zhì)量方針保持一致;The quality objectives shall be measurable and consistent with the quality policyC. 本公司的質(zhì)量目標(biāo)見附件6: 質(zhì)量目標(biāo)分解表About the quality objectives of our company, see attachment 6, Quality Objectives4.4.2 質(zhì)量管理體系策劃Quality

33、management system planning 總經(jīng)理應(yīng)確保:General Manager shall ensure that A. 對(duì)質(zhì)量管理體系進(jìn)行策劃, 以滿足質(zhì)量目標(biāo)和本手冊第4.1條款的要求;the planning of the quality management system is carried out in order to meet the requirements given in 4.1 of this Manual, as well as the quality objectives, and B. 在對(duì)質(zhì)量管理體系的更改進(jìn)行策劃和實(shí)施時(shí), 保持質(zhì)量管理體系

34、的完整性. the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented4.5 職責(zé)、權(quán)限和溝通Responsibility, authority and communication 4.5.1 職責(zé)和權(quán)限Responsibility and authority A. 總經(jīng)理應(yīng)確保組織的職責(zé)、權(quán)限及其相互關(guān)系的得到規(guī)定和溝通; General Manager shall ensure th

35、e responsibilities and authorities are defined and communicated within our company B. 各部門的職責(zé)與權(quán)限, 見附件2: 組織架構(gòu)圖; 附件3: 部門職責(zé)對(duì)照表; 附件5: 部門職責(zé)一覽表About departmental responsibilities and authorities, see attachment 2: Organizational Structure; and attachment 3: Departmental Responsibility Deployment4.5.2 管理者代表

36、Management Representative 總經(jīng)理應(yīng)任命管理者代表 (見附件7: 管理者代表任命書), 以便履行下述職責(zé)與權(quán)限:General Manager shall appoint a member of management who (see attachment 7: Appointment of QMS Management Representative), irrespective of other responsibilities, shall have responsibility and authority that include A. 確保質(zhì)量管理體系所需的過程

37、得到建立、實(shí)施和保持; ensuring that processes needed for the quality management system are established, implemented and maintained B. 向總經(jīng)理報(bào)告質(zhì)量管理體系的業(yè)績和任何改進(jìn)的需求; reporting to General Manager on the performance of the quality management system and any need for improvement, and C. 確保在公司內(nèi)提高滿足顧客和法律法規(guī)要求的意識(shí); ensuring

38、the promotion of awareness of customer requirements throughout our company, and D. 與質(zhì)量管理體系有關(guān)事宜的外部聯(lián)絡(luò), 如: 認(rèn)證機(jī)構(gòu)、咨詢機(jī)構(gòu), 等. liaising with external parties on matters relating to the quality management system 4.5.3 內(nèi)部溝通Internal communication A. 總經(jīng)理應(yīng)該確保在組織內(nèi)建立適當(dāng)?shù)臏贤ㄟ^程, 并確保對(duì)質(zhì)量管理體系的有效性進(jìn)行溝通;General Manager shall

39、 ensure that appropriate communication processes are established within our company and that communication takes places regarding the effectiveness of the quality management system B. 本公司的溝通途徑: 電子郵件、信件、會(huì)議, 等Communication channels in our company include email, letter, meeting, etc 4.6 管理評(píng)審Management

40、review4.6.1 總則General 總經(jīng)理應(yīng)確保建立、實(shí)施和改進(jìn)管理評(píng)審程序, 以便 General Manager shall establish, implement and improve Management Review Procedure to A. 最少一年一次評(píng)審公司的質(zhì)量管理體系, 以確保其持續(xù)的適宜性、充分性和有效性;review the quality management system of our company at least yearly to ensure its continuing suitability, adequacy and effecti

41、veness, and B. 評(píng)審應(yīng)包括評(píng)價(jià)質(zhì)量管理體系改進(jìn)的機(jī)會(huì)和變更的需要, 包括質(zhì)量方針和質(zhì)量目標(biāo);assess opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives 保留管理評(píng)審記錄Records from management review shall be maintained4.6.2 評(píng)審輸入Review input 管理評(píng)審的輸入必須包括以下方面的信息

42、:The input to management review shall include information onA. 質(zhì)量方針的適宜性;suitability of the quality policy B. 質(zhì)量目標(biāo)的適宜性;suitability of quality objectivesC. 外/內(nèi)部審核的結(jié)果;results of both internal and external auditsD. 顧客反饋;customer feedbackE. 過程的業(yè)績和產(chǎn)品的符合性;process performance and product conformity F. 預(yù)防和糾正

43、措施的狀況;status of preventive and corrective actionsG. 以往管理評(píng)審的跟蹤措施;follow-up actions from previous management reviews H. 經(jīng)策劃的可能影響質(zhì)量管理體系的變更;changes that could affect the quality management system, and I. 改進(jìn)的建議recommendations for improvement 4.6.3 評(píng)審輸出Review output 管理評(píng)審的輸出應(yīng)該包括與以下方面有關(guān)的任何決定和措施:The output f

44、rom the management review shall include any decisions and actions related to A. 質(zhì)量管理體系及其過程有效性的改進(jìn);Improvement of the effectiveness of the quality management system and its processesB. 與顧客有關(guān)的產(chǎn)品的改進(jìn);improvement of product related to customer requirements, and C. 資源的需求.resource needs 5. 資源管理Resource mana

45、gement 5.1 資源提供Provision of resources 總經(jīng)理應(yīng)確定并提供所需要的資源, 以:General Manager shall determine and provide the resources needed A. 實(shí)施、保持質(zhì)量管理體系并持續(xù)改進(jìn)其有效性;to implement and maintain the quality management system and continually improve its effectiveness, and B. 通過滿足顧客要求, 增強(qiáng)顧客滿意.to enhance customer satisfactio

46、n by meeting customer requirements 5.2 人力資源Human resources 5.2.1 總則General 基于適當(dāng)?shù)慕逃⑴嘤?xùn)、技能和經(jīng)驗(yàn), 從事影響產(chǎn)品質(zhì)量工作的人員應(yīng)是能夠勝任的. Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience5.2.2 能力、意識(shí)和培訓(xùn)Competence, awareness and trai

47、ning 建立、實(shí)施和改進(jìn)培訓(xùn)程序, 以:Training Procedure shall be established, implemented and improved to A. 確定從事影響產(chǎn)品質(zhì)量工作的人員所必要的能力; determine the necessary competence for personnel performing work affecting product quality B. 提供培訓(xùn)或采取其它措施以滿足這些需求; provide training or take other actions to satisfy these needs C. 評(píng)價(jià)所采取

48、措施的有效性; evaluate the effectiveness of the actions taken D. 確保員工意識(shí)到所從事活動(dòng)的相關(guān)性和重要性, 和如何為實(shí)現(xiàn)質(zhì)量目標(biāo)作出貢獻(xiàn);ensure that the personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and E. 保持教育、培訓(xùn)、技能和經(jīng)驗(yàn)的適當(dāng)記錄. maintain appropriat

49、e records of education, training, skills and experience 5.3 基礎(chǔ)設(shè)施Infrastructure A. 公司應(yīng)確定、提供并維護(hù)為達(dá)到產(chǎn)品要求的符合性所需的基礎(chǔ)設(shè)施, 如:Our company shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicablea. 建筑物、工作場所和相關(guān)設(shè)施;buildin

50、gs, workspace and associated utilities b. 過程設(shè)備, 包括硬件和軟件;Process equipment (both hardware and software), and c. 支持性服務(wù), 如運(yùn)輸或通訊supporting services (such as transport or communication)B. 建立、實(shí)施和改進(jìn)生產(chǎn)設(shè)備管理程序, 以對(duì)生產(chǎn)設(shè)備進(jìn)行正確的操作、保養(yǎng)和維修;Production Equipment Management Procedure shall be established, implemented and

51、 improved to properly operate, maintain and repair production equipment C. 建立、實(shí)施和改進(jìn)監(jiān)控與測量設(shè)備控制程序, 以對(duì)測量和監(jiān)視裝置進(jìn)行正確的操作、保養(yǎng)和校正;Monitoring and Measuring Device Management Procedure shall be established, implemented and improved to properly operate, maintain and calibrate measuring and monitoring devices D. 建

52、立、實(shí)施和改進(jìn)模具管理程序, 以對(duì)模具裝進(jìn)行驗(yàn)證和保養(yǎng). Mold Management Procedure shall be established, implemented and improved to verify and maintain molds. 5.4 工作環(huán)境Work environment 公司應(yīng)確定和管理為實(shí)現(xiàn)產(chǎn)品要求符合性所需的工作環(huán)境。Our company shall determine and manage the work environment needed to achieve conformity to product requirements，6. 產(chǎn)

53、品實(shí)現(xiàn)Product realization 6.1 產(chǎn)品實(shí)現(xiàn)的策劃Planning of product realization A. 本公司將策劃和開發(fā)產(chǎn)品實(shí)現(xiàn)所需的過程. 產(chǎn)品實(shí)現(xiàn)的策劃應(yīng)與質(zhì)量管理體系其他過程的要求相一致. Our company shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the

54、 quality management system B. 在對(duì)產(chǎn)品實(shí)現(xiàn)進(jìn)行策劃時(shí), 應(yīng)確定以下方面的適當(dāng)內(nèi)容:In planning product realization, we shall determine the following, as appropriate a. 產(chǎn)品的質(zhì)量目標(biāo)和要求;quality objectives and requirements for the productb. 針對(duì)產(chǎn)品確定過程、文件和資源的需求;the need to establish processes, documents, and provide resources specific t

55、o the product c. 產(chǎn)品所需求的驗(yàn)證、確認(rèn)、監(jiān)視、檢驗(yàn)和試驗(yàn)活動(dòng), 和產(chǎn)品接收準(zhǔn)則;required verification, validation, monitoring, inspection and test activities specified to the product and the criteria for product acceptance d. 為實(shí)現(xiàn)過程及其產(chǎn)品滿足要求提供證據(jù)所需的記錄.records needed to provide evidence that the realization processes and resulting pr

56、oduct meet requirements C. 策劃的輸出形式應(yīng)適于本公司的運(yùn)作方式.The output of this planning shall be in a form suitable for our companys method of operations 注1: 對(duì)應(yīng)用于特定產(chǎn)品、項(xiàng)目或合同的質(zhì)量管理體系的過程(包括產(chǎn)品實(shí)現(xiàn)過程)和資源作出規(guī)定的文件可稱之為質(zhì)量計(jì)劃;Note 1: A document specifying the processes of the quality management system (including the product realizatio