【正文】 d) 組織自訂的 任何額外需求。 桃園市中 正路 1249 號 172TEL： 88633179966 FAX： 88633173366 Email： 東莞稽核聯(lián)絡(luò)處：東管長安錦廈村小康街 2 號 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。 管理審查的輸出 管理審查的輸出應(yīng)包括下列各項(xiàng)的決議與行動 a) 品質(zhì)管理系統(tǒng)及其過程有效性 的改善， b) 與客戶需求有關(guān)的產(chǎn)品改善， c) 資源的需求。 桃園市中 正路 1249 號 172TEL： 88633179966 FAX： 88633173366 Email： 東莞稽核聯(lián)絡(luò)處：東管長安錦廈村小康街 2 號 2F TEL： 07695325815 FAX： 07695325817 Email： c) and implemented. Responsibility, authority and munication Responsibility and authority Top management shall ensure that the responsibilities, authorities are defined and municated within the anization. Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout the anization. NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. Internal munication Top management shall ensure that appropriate munication processes are established within the anization and that munication takes place regarding the effectiveness of the quality management system. Management review General Top management shall review the anization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to 責(zé)任、授權(quán)與溝通 責(zé)任與授權(quán) 高階管理者應(yīng)確保組織內(nèi)之責(zé)任、授權(quán)已被定義及溝通。品質(zhì)紀(jì)錄應(yīng)易於閱讀、識別及取用。 備註：上述品質(zhì)管理系統(tǒng)所須之過程包括管理活動、資源提供、產(chǎn)品實(shí)現(xiàn)與量測等過程。 ISO 9000:20xx 品質(zhì)管理系統(tǒng) – 基礎(chǔ)與詞彙 3 名詞與定義 ISO 9000:20xx 中之名詞與定義均適用於本國際標(biāo)準(zhǔn)。 應(yīng)用 此國際標(biāo)準(zhǔn)的所有要求乃通用性要求且期望能適用於所有組織，無論其行業(yè)、規(guī)模及所提供的產(chǎn)品。 2 引用標(biāo)準(zhǔn) 本國際標(biāo)準(zhǔn)引用下列標(biāo)準(zhǔn)的內(nèi)容以構(gòu)成本國際標(biāo)準(zhǔn)的條款。 本國際標(biāo)準(zhǔn)全文之中， ”產(chǎn)品 ”一詞亦等同於 ”服務(wù) ”。 備註 3 文件可能為任何形式或種類的媒體。 桃園市中 正路 1249 號 172TEL： 88633179966 FAX： 88633173366 Email： 東莞稽核聯(lián)絡(luò)處：東管長安錦廈村小康街 2 號 2F TEL： 07695325815 FAX： 07695325817 Email： e) ensuring the availability of resources. Customer focus Top management shall ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction (see and ). Quality policy Top management shall ensure that the quality policy a) is appropriate to the purpose of the anization, b) includes a mitment to ply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is municated and understood within the anization, and e) is reviewed for continuing suitability. Planning Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product [see a)], are established at relevant functions and levels within the anization. The quality objectives shall be measurable and consistent with the quality policy. Quality management system planning Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in , as well as the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned 顧客為重 高階管理者應(yīng)確保顧客之需求已被決定且滿足，以達(dá)到增進(jìn)客戶滿意為目的 (見 及)。 內(nèi)部溝通 高階管理者應(yīng)確保組織內(nèi)之溝通過程已被建立，並且對於品質(zhì)管理系統(tǒng)的有效性進(jìn)行溝通。 資格、認(rèn)知與訓(xùn)練 組織應(yīng)： a) 界定從事足以影響產(chǎn)品品質(zhì)工 作者之資格需求， 桃園市中 正路 1249 號 172TEL： 88633179966 FAX： 88633173366 Email： 東莞稽核聯(lián)絡(luò)處：東管長安錦廈村小康街 2 號 2F TEL： 07695325815 FAX： 07695325817 Email： b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience (see ). Infrastructure The anization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a) building, workspace and associated utilities。 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)劃與展開針對產(chǎn)品實(shí)現(xiàn)所需要的各