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第4部分質(zhì)量管理系統(tǒng)(已修改)

2025-04-24 04:09 本頁面
 

【正文】 Section 4 Quality management system第四章 質(zhì)量管理體系 General requirements一般要求 Documentation requirements文件要求 General總則 Quality manual質(zhì)量手冊 Control of documents文件控制 Control of CustomerSupplied Documents and Data – The organization shall establish and maintain a documented procedure(s) to control all customersupplied documents and data (., network architecture, topology, capacity, installation termination assignments, and database) if these documents and data influence the design, verification, validation, inspection and testing, or servicing the product.客戶提供文件及數(shù)據(jù)控制- 組織將建立并且維護(hù)文件化程序以控制所有客戶提供的文件和數(shù)據(jù)(例如,網(wǎng)絡(luò)體系結(jié)構(gòu),布局,容量,安裝結(jié)束任務(wù)及數(shù)據(jù)庫)如果這些文件和數(shù)據(jù)影響設(shè)計(jì),驗(yàn)證,確認(rèn),檢查及測試,或服務(wù)于產(chǎn)品。 Control of records記錄控制Section 5 Management responsibility第五章-管理職責(zé) Management mitment管理承諾 Customer focus 以顧客為關(guān)注焦點(diǎn) Customer Relationship Development – Top management shall demonstrate active involvementin establishing and maintaining mutuallybeneficial relationships between the organization and itscustomers. [4]發(fā)展顧客關(guān)系-最高管理者應(yīng)積極參與建立并維護(hù)組織與顧客之間的相互受益的關(guān)系。 Customer Communication Procedures – The organization shall establish and maintain adocumented procedure(s) for municating with selected customers. The documented procedure(s) shall include:顧客溝通程序-組織應(yīng)建立并維護(hù)文件化的程序以確保與特定顧客之間的溝通。該程序文件應(yīng)包括:a) a strategy and criteria for customer selection,選擇顧客的策略及標(biāo)準(zhǔn)b) a method for the organization and its customers to share joint expectations and improve the quality of products, and組織和顧客共同參與策劃及提高產(chǎn)品質(zhì)量的方法,和c) a joint review with the customer at defined intervals covering the status of shared expectations and including a method to track the resolution of issues. [4]會(huì)同顧客安既定的時(shí)間間隔評審期望目標(biāo)的狀況,并且應(yīng)有可以追蹤決定流轉(zhuǎn)的方法。 1: It is recognized that it is not possible for an organization to provide the same level of munication with all its customers. The level provided may depend on the amount of business with the customer, the history of problems, customer expectations, and other factors (see Appendix F, “Guidance for Communication with Customers”).注解1:眾所周知,組織不可能對所有顧客提供同樣級別的溝通。所提供的級別應(yīng)依據(jù)與顧客的生意數(shù)量、歷史問題、顧客期望值,以及其它因素(參見附錄F,“顧客溝通指導(dǎo)”) Quality policy質(zhì)量方針 Planning策劃 Quality objectives質(zhì)量目標(biāo) Quality Objectives – Objectives for quality shall include targets for the TL 9000 measurements defined in the TL 9000 Quality Management System Measurements Handbook.質(zhì)量目標(biāo)-質(zhì)量目標(biāo)應(yīng)包括在TL9000 質(zhì)量管理體系計(jì)算手冊中為TL9000定義的對象。 Quality management system planning質(zhì)量管理體系策劃 Long and ShortTerm Quality Planning – The organization’s quality planning activities shall include long and shortterm plans with goals for improving quality and customer satisfaction.長期和短期質(zhì)量策劃-組織的質(zhì)量策劃行為應(yīng)包括以提高質(zhì)量和顧客滿意度為目標(biāo)的長期策劃和短期策劃。Performance to these goals shall be monitored and reported. These plans shall address:實(shí)現(xiàn)這些目標(biāo)需要監(jiān)控和匯報(bào)。這些策劃應(yīng)注明:a) cycle time, 循環(huán)時(shí)間b) customer service, 顧客服務(wù)c) training, 培訓(xùn)d) cost, 成本e) delivery mitments, and 交貨承諾,等f) product reliability. 產(chǎn)品可靠性 1: Top Management should demonstrate their active involvement in long and shortterm quality planning.注解1:最高管理者應(yīng)積極參與到長期和短期質(zhì)量策劃中。 Customer Input – The organization shall implement methods for soliciting and considering customer input for quality planning activities. The organization should establish joint quality improvement programs with customers. [4]顧客輸入- 組織應(yīng)將顧客輸入納入質(zhì)量策劃中。組織應(yīng)會(huì)同顧客建立質(zhì)量改進(jìn)程序。 Supplier Input – The organization shall implement methods for soliciting and using supplier input for quality planning activities. [4]供應(yīng)商輸入-組織應(yīng)將供應(yīng)商輸入納入質(zhì)量策劃中。 Responsibility, authority and munication職責(zé)、權(quán)限與溝通 Responsibility and authority職責(zé)和權(quán)限 Management representative管理者代表 Internal munication內(nèi)部溝通 Organization Performance Feedback – The organization shall inform employees of its quality performance and the level of customer satisfaction. [4]組織成績反饋-組織應(yīng)通知其員工關(guān)于質(zhì)量成績以及顧客滿意程度。 Management review管理評審 General總則 Review input評審輸入 Review output評審輸出Section 6 Resource management第六章 資源管理 Provision of resources資源提供 Human resources人力資源 General 總則 Competence, awareness and training能力、意識和培訓(xùn) Internal Course Development – When the organization develops internal training courses, it shall establish and maintain a process for planning, developing, and implementing these courses. [4]內(nèi)部課程開展-當(dāng)組織開展內(nèi)部培訓(xùn)課程時(shí)應(yīng)當(dāng)建立并維護(hù)一個(gè)程序以確保課程的計(jì)劃、開展及實(shí)現(xiàn)。[4] Quality Improvement Concepts – Those employees that have a direct impact on the quality of the product, including top management, shall be trained in the fundamental concepts of continual improvement, problem solving, and customer satisfaction. [4]質(zhì)量改進(jìn)觀念-包括最高管理者在內(nèi)的所有對產(chǎn)品質(zhì)量有直接影響的員工應(yīng)當(dāng)接受持續(xù)改進(jìn)、解決問題及顧客滿意等基本觀念的培訓(xùn)。[4] Training Requirements and Awareness – Training requirements shall be defined for all positions that have a direct impact on the quality of products. Employees shall be made aware of training opportunities. [4]培訓(xùn)需求和意識-培訓(xùn)需求應(yīng)針對所有對產(chǎn)品質(zhì)量有直接影響的職位。員工應(yīng)該知曉培訓(xùn)的機(jī)會(huì)。 ESD Training – All employees with functions that involve any handling, storage, packaging,preservation, or delivery of ESDsensitive products shall receive training in electrostatic discharge (ESD) protection prior to performing their jobs.ESD 培訓(xùn)-所有包括操作、倉儲(chǔ)、包裝、保存及運(yùn)輸ESD敏感產(chǎn)品的員工都應(yīng)接受靜電放電培訓(xùn),以確保他們開展工作。 Advanced Quality Training – The organization shall offer appropriate levels of advanced quality training. Examples of advanced quality training may include statistical techniques, process capability, statistical sampling, data collection and analysis, problem identification, problem analysis, and corrective and preventive action. [5]高級質(zhì)量培訓(xùn)-組織應(yīng)體統(tǒng)適當(dāng)更高層次的質(zhì)量培訓(xùn)。高級質(zhì)量培訓(xùn)可以包括統(tǒng)計(jì)技術(shù)、過程能力、統(tǒng)計(jì)取樣、數(shù)據(jù)收集及分析、問題判斷、問題分析積極糾正預(yù)防措施等。[5] Training Content – Where the potential for hazardous conditions exists, training content shouldinclude the following:培訓(xùn)內(nèi)容-有潛在危險(xiǎn)的地方,培訓(xùn)
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