【正文】 n, training, skills and experience 能力、意識和培訓(xùn) Competence, awareness and training 建立、實施和改進 《 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 petence 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. 評價所采取措施的有效性 。 evaluate the effectiveness of the actions taken D. 確保員工意識到所從事活動的相關(guān)性和重要性 , 和如何為實現(xiàn)質(zhì)量目標(biāo)作出貢獻 。 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)驗的適當(dāng)記錄 . maintain appropriate records of education, training, skills and experience 基礎(chǔ)設(shè)施 Infrastructure A. 公司應(yīng)確定、提供并維護為達到產(chǎn)品要求的符合性所需的基礎(chǔ)設(shè)施 , 如 : Our pany shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a. 建筑物、工作場所和相關(guān)設(shè)施 。 buildings, 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) , 如運輸或通訊 supporting services (such as transport or munication) B. 建立、實施和改進 《 生產(chǎn) 設(shè)備管理程序 》 , 以對生產(chǎn)設(shè)備進行正確的操作、保養(yǎng)和維修 。 Production Equipment Management Procedure shall be established, implemented and 質(zhì)量手冊 QUALITY MANUAL 文件編號 : QM 01 Document No.: QM 01 版本 :02 Version:02 頁次 : 16 of 47 Page: 16 of 47 更多免費資料下載請進： 好好學(xué)習(xí)社區(qū) improved to properly operate, maintain and repair production equipment C. 建立、實施和改進 《 監(jiān)控與測 量 設(shè)備控制 程序 》 , 以對測量和監(jiān)視裝置進行正確的操作、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. 建立、實施和改進 《 模 具 管理程序》 , 以對模具裝進行驗證和保養(yǎng) . Mold Management Procedure shall be established, implemented and improved to verify and maintain molds. 工作環(huán)境 Work environment 公司應(yīng)確定和管理為實現(xiàn)產(chǎn)品要求符合性所需的工作環(huán)境 。 Our pany shall determine and manage the work environment needed to achieve conformity to product requirements， 7. 產(chǎn)品實現(xiàn) Product realization 產(chǎn)品實現(xiàn)的策劃 Planning of product realization A. 本公司將策劃和開發(fā)產(chǎn)品實現(xiàn)所需的過程 . 產(chǎn)品實現(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 pany 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 quality management system B. 在對產(chǎn)品實現(xiàn)進行策劃時 , 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 product b. 針對產(chǎn)品確定過程、文件和資源的需求 。 the need to establish processes, documents, and provide resources specific to the product c. 產(chǎn)品所需求的驗證、確認(rèn)、監(jiān)視、檢驗和試驗活動 , 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 product meet requirements C. 策劃的輸出形式應(yīng)適于本公司的運作方式 . The output of this planning shall be in a form suitable for our pany’s method of operations 注 1: 對應(yīng)用于特定產(chǎn)品、項目或合同的質(zhì)量管理體系的過程 (包括產(chǎn)品實現(xiàn)過程 )和資源作出規(guī)定的文件可稱之為質(zhì)量計劃 。 Note 1: A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan 注 2: 也可以將條款 的要求應(yīng)用于產(chǎn)品實現(xiàn)過程的開發(fā) . Note 2: The anization may also apply the requirements given in to the development of product realization processes 與顧客有關(guān)的過程 Customerrelated processes 與產(chǎn)品有關(guān)的要求的確定 質(zhì)量手冊 QUALITY MANUAL 文件編號 : QM 01 Document No.: QM 01 版本 :02 Version:02 頁次 : 17 of 47 Page: 17 of 47 更多免費資料下載請進： 好好學(xué)習(xí)社區(qū) Determination of requirements related to the product 公司必須確定 : Our pany shall determine A. 顧客規(guī)定的要求 , 包括對交付及交付后活動的要求 。 requirements specified by the customer, including the requirements for delivery and postdelivery activities B. 顧客雖然沒有明示 , 但規(guī)定的用途或已知和預(yù)期用途所必需的要求 。 requirements not stated by the customer but necessary for specified or intended use, where known C. 與產(chǎn)品有關(guān)的法律法規(guī)要求 。 statutory and regulatory requirements related to the product, and D. 本公司確定的任何附加要求 . any additional requirements determined by our pany 與產(chǎn)品有關(guān)的要求的評審 Review of requirements related to the product A. 公司建立、實施和改進 《 客戶服務(wù) 程序 》 , 以評審與產(chǎn)品有關(guān)的要求 。 Customer Service Procedure shall be established, carried out and improved to review the requirements related to the product B. 評審在向顧客作出提供產(chǎn)品的承諾之前進行 (如 : 提交標(biāo)書、接受合同或訂單、接受合同或訂單的更改 ), 并確保 : this review shall be conducted prior to our mitment to supply a product to the customer (. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that a. 產(chǎn)品要求得到規(guī)定 。 product requirements are defined b. 與以前表述不一致的合同或訂單的要求已予以解決 。 contract or order requirements differing from those previously expressed are resolved, and c. 有能力滿足規(guī)定的要求 . we have the ability to meet the defined requirements C. 評審結(jié)果及評審所引發(fā)的措施的記錄必須予以保持 。 Records of the results of the review and actions arising from the review shall be maintained D. 若顧客提供的要求沒有形成文件 , 業(yè)務(wù)人員在接收顧客要求前應(yīng) 要求 顧客 提供書面文件 ,本公司不接受口頭指示 。 Where the customer provides no documented statement of requirement, the sales personnel shall request the customer to provide the document. XXXXX does not accept any verbal instructions. E. 若產(chǎn)品要求發(fā)生變更 ,應(yīng)確保相關(guān)文件得到修改 ,并確保相關(guān)人員知道已變更的要求 . Where product requirements are changed, we shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements