【導(dǎo)讀】桃園市中正路1249號(hào)17-2TEL：886-3-3179966FAX：886-3-3173366E-mail：。東莞稽核聯(lián)絡(luò)處：東管長(zhǎng)安廈村小康街2號(hào)2FTEL：0769-5325815FAX：0769-5325817E-mail：

　　

【正文】 的工 作環(huán)境。 桃園市中 正路 1249 號(hào) 172TEL： 88633179966 FAX： 88633173366 Email： 東莞稽核聯(lián)絡(luò)處：東管長(zhǎng)安錦廈村小康街 2 號(hào) 2F TEL： 07695325815 FAX： 07695325817 Email： 7 Product realization Planning of product realization The anization 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 (see ). In planning product realization, the anization shall determine the following, as appropriate: a) quality objectives and requirements for the product。 b) the need to establish processes, documents, and provide resources specific to the product。 c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance。 d) records needed to provide evidence that the realization processes and resulting product meet requirements (see ). The output of this planning shall be in a form suitable for the anization’s method of operations. NOTE 1 A document specifying the processes of the quality management system (including the product realization 7 產(chǎn)品實(shí)現(xiàn) 產(chǎn)品實(shí)現(xiàn)的規(guī)劃 組織應(yīng)規(guī)劃與展開(kāi)針對(duì)產(chǎn)品實(shí)現(xiàn)所需要的各項(xiàng)過(guò)程，產(chǎn)品實(shí)現(xiàn)過(guò)程的規(guī)劃必須與品質(zhì)管理系統(tǒng)其他過(guò)程的要求相一致。 在規(guī)劃產(chǎn)品實(shí)現(xiàn)過(guò)程時(shí)，組織必須適當(dāng)?shù)貨Q定下列要項(xiàng)： a) 品質(zhì)目標(biāo)及產(chǎn)品的需求； b) 針對(duì)產(chǎn)品所需過(guò)程、文件及資源的提供； c) 針對(duì)產(chǎn)品必要的驗(yàn)證、確認(rèn)、監(jiān)控、檢驗(yàn)與測(cè)試的活 動(dòng)及產(chǎn)品的允收標(biāo)準(zhǔn)； d) 必要的記錄以證明產(chǎn)品實(shí)現(xiàn)過(guò)程與最終產(chǎn)品符合要求 (見(jiàn) )。 此項(xiàng)規(guī)劃產(chǎn)出的結(jié)果，其格式應(yīng)適合其組織的作業(yè)方法。 備註 1 針對(duì)特定產(chǎn)品、專(zhuān)案或合約用以描述其品質(zhì)管理系統(tǒng)所有過(guò)程 (包括產(chǎn)品實(shí)現(xiàn)過(guò)程 )及所需資源的書(shū)面文件，可被稱(chēng)為品質(zhì)計(jì)劃。 桃園市中 正路 1249 號(hào) 172TEL： 88633179966 FAX： 88633173366 Email： 東莞稽核聯(lián)絡(luò)處：東管長(zhǎng)安錦廈村小康街 2 號(hào) 2F TEL： 07695325815 FAX： 07695325817 Email： processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. NOTE 2 The anization may also apply the requirement given in to the development of product realization processes. Customerrelated processes Determination of requirements related to the product The anization shall determine a) requirements specified by the customer, including the requirements for delivery and postdelivery activities, b) requirements not stated by the customer but necessary for specified or intended use, where known, c) statutory and regulatory requirements related to product, and d) any additional requirements determined by the anization. Review of requirements related to the product The anization shall review the requirements related to the product. This review shall be conducted prior to the anization’s 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) product requirements are defined, b) contract or order requirements differing from those previously expressed are resolved, and c) the anization has the ability to meet the defined requirements. 備註 2 組織亦可運(yùn)用條文 的要求於產(chǎn)品實(shí)現(xiàn)過(guò)程的展開(kāi)。 顧客相關(guān)的過(guò)程 決定產(chǎn)品相關(guān)的需求 組織應(yīng)決定 a) 顧客已指明的需求，包括對(duì)交貨與售後的需求， b) 非顧客所明確指定，但對(duì)於已知特定或使用目的是必要的需求， c) 與產(chǎn)品相關(guān)法令及法規(guī)的需求，和 d) 組織自訂的 任何額外需求。 產(chǎn)品相關(guān)需求的審查 組織應(yīng)審查產(chǎn)品相關(guān)的需求。此項(xiàng)審查應(yīng)該在向客戶(hù)承諾提供產(chǎn)品之前完成 (即：提出標(biāo)單、接受合約或訂單、接受合約或訂單的變更 )，並且確保 a) 產(chǎn)品的需求已被定義， b) 合約或其它需求與先前表達(dá)有所不同處已被解決，和 c) 組織有能力滿(mǎn)足各項(xiàng)已定義之需求。 審查結(jié)果及後續(xù)措施的紀(jì)錄必須加以維持 (見(jiàn) 桃園市中 正路 1249 號(hào) 172TEL： 88633179966 FAX： 88633173366 Email： 東莞稽核聯(lián)絡(luò)處：東管長(zhǎng)安錦廈村小康街 2 號(hào) 2F TEL： 07695325815 FAX： 07695325817 Email： Records of the results of the review and actions arising from the review shall be maintained (see ). Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the anization before acceptance. Where product requirements are changed, the anization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. NOTE: In some situations, such as in inter sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material. Customer munication The anization shall determine and implement effective arrangements for municating with customers in relation to: a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedback, including customer plaints. Design and development Design and development planning The anization shall plan and control design and development of product. During the design and development planning, the anization shall determine a) the design and development stages, b) the review, verification and validation that are appropriate to each design and development stage, and c) the responsibilities and authorities for design and development. The anization shall manage the interfaces )。 當(dāng)客戶(hù)提供非文件化的需求敘述時(shí)，組織在接受客戶(hù)需求前應(yīng)加以確認(rèn)。 當(dāng)產(chǎn)品需求被改變時(shí)，組織應(yīng)確保相關(guān)文件被修正，及相關(guān)人員都知道改 變後的需求。 備註： 在某些情況下，例如網(wǎng)路行銷(xiāo)，對(duì)每一張訂單進(jìn)行正式審查並不實(shí)際。取代的方式為對(duì)相關(guān)產(chǎn)品資訊，例如型錄、廣告素材等加以審查。 客戶(hù)溝通 組織應(yīng)決定及實(shí)施有效的安排，以進(jìn)行與客戶(hù)有關(guān)下列的溝通： a)產(chǎn)品資訊， b) 詢(xún)價(jià)，合約或訂單的處理及修改，和 c)客戶(hù)回饋，包括客戶(hù)的抱怨。 設(shè)計(jì)與開(kāi)發(fā) 設(shè)計(jì)與開(kāi)發(fā)的規(guī)劃 組織須規(guī)劃和管制產(chǎn)品的設(shè)計(jì)與開(kāi)發(fā)活動(dòng)。 在設(shè)計(jì)與開(kāi)發(fā)規(guī)劃時(shí)，組織必須決定 a) 設(shè)計(jì)與開(kāi)發(fā)過(guò)程的各階段， b) 適合於各設(shè)計(jì)開(kāi)發(fā)階 段的審查 ,驗(yàn)證和確認(rèn)活動(dòng)，和 c) 設(shè)計(jì)與開(kāi)發(fā)活動(dòng)的責(zé)任與授權(quán)。 組織需管理參與設(shè)計(jì)開(kāi)發(fā)不同群組間的界，確保有效的溝通和責(zé)任的分配。