【正文】 立并保持 形成文件的程序 ,識別培訓(xùn)需求和達到所有從事影響產(chǎn)品質(zhì) 量工作的人員能力。 Training 培訓(xùn) 43 The anization shall provide onthejob training for personnel in any new or modified job affecting product quality including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements. 組織 應(yīng) 為包括合同工或代理在內(nèi)的從事新的或更改的影響產(chǎn)品質(zhì)量的工作的人 員提供 崗位培訓(xùn) 。 組織 應(yīng) 有一個過程以 測量 員工 認識 到所從事活動的 相關(guān)性和重要性的程度 ， 以 及如何 為實現(xiàn)質(zhì)量目標(biāo)做出貢獻 （ 見 d） 。 注：這些要求應(yīng)以“ 精益生產(chǎn) ”原則和 質(zhì)量管理體系 的有效性的聯(lián)系為關(guān)注焦點。 Cleanliness Of Premises 生產(chǎn)現(xiàn)場的清潔 49 7 Product Realization 50 注 : 有些顧客將項目管理或產(chǎn)品先期質(zhì)量策劃作為一種完成產(chǎn)品實現(xiàn)的方法。 對于 計數(shù)型 數(shù)據(jù)的抽樣 ， 接受準(zhǔn)則應(yīng)是 零缺陷 （ 見 ). Acceptance Criteria 接受準(zhǔn)則 53 The anization shall ensure the confidentiality of customercontracted products and projects under development, and related product information. 組織 應(yīng) 確保 顧客合同 中在開發(fā)的產(chǎn)品和項目以及相關(guān)產(chǎn)品信息的保密性 . Confidentiality 保密 54 Change Control 更改控制 The anization shall have a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure pliance with customer requirements. Changes shall be validated before implementation. For proprietary designs, impact on form, fit and function (including performance and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated. When required by the customer, additional verification/identification requirements, such as those required for new product introduction, shall be met. 組織 應(yīng) 有一個過程對影響產(chǎn)品實現(xiàn)的更改進行控制和反應(yīng) 。 對有專利權(quán)的設(shè)計 ， 影響形狀 、 配合和功能 （ 包括性能和 /或耐久性 ） 應(yīng)會同顧 客進行評審 ， 以便所有影響能被正確地評估 。 55 Determination Of Requirements Related To The Product 與產(chǎn)品有關(guān)的要求的確定 NOTE 1: Postdelivery activities include any aftersales product service provided as part of the customer contract or purchase order. NOTE 2: This requirement includes recycling, environmental impact and characteristics identified as a result of the anization’s knowledge of the product and manufacturing processes (see ). NOTE 3: Compliance to item c) includes all applicable government, safety and environmental regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials. 注 1：交付后的活動包括顧客合同或采購定單中要求提供的任何售后產(chǎn)品服務(wù) 。 57 Review Of Requirements Related To The Product — Supplemental 相關(guān)產(chǎn)品要求的評審 － 補充 Waiving the requirement stated in for a formal review (see note) shall require customer authorization. （ 見注 ） 的免除 應(yīng) 經(jīng) 顧客授權(quán) 。 61 Multidisciplinary Approach 多方論證方式 The anization shall use a multidisciplinary approach to prepare for product realization, including . development/finalization and monitoring of special characteristics, . development and review of FMEAs, including actions to reduce potential risks, . development and review of control plans. NOTE: A multidisciplinary approach typically includes the anization39。 注 :一個典型的多方論證的方法包括組織的設(shè)計 、 制造 、 工程 、 質(zhì)量 、 生產(chǎn)和其他 適當(dāng)人員 。 符合顧客規(guī)定的定義和符號； 把顧客特殊特性符號或組織等效符號或記號標(biāo)注在過程控制文件 （ 包括圖紙 、 FMEAs、 控制計劃和操作者指導(dǎo)書 ） 上 ， 包括那些影響特殊特性的過程步驟 。 65 Design And Development Review 設(shè)計和開發(fā)評審 NOTE: These reviews are normally coordinated with the design phases and include manufacturing process design and development. 注 ： 這些評審?fù)ǔ＝Y(jié)合設(shè)計階段并包括 制造過程設(shè)計和開發(fā) 。 68 Prototype Programme 樣件項目 When required by the customer, the anization shall have a prototype programme and control plan. The anization shall use, wherever possible, the same suppliers, tooling and manufacturing processes as will be used in production. All performancetesting activities shall be monitored for timely pletion and conformity to requirements. While services may be outsourced, the anization shall be responsible for the outsourced services, including technical leadership. 當(dāng)顧客要求時 ， 組織 應(yīng) 有一個 原型樣件計劃和控制計劃 。 69 Product Approval Process 產(chǎn)品批準(zhǔn)過程 The anization shall conform to a product and manufacturing process approval procedure recognized by the customer. NOTE: Product approval should be subsequent to the verification of the manufacturing process. This product and manufacturing process approval procedure shall also be applied to suppliers. 組織 應(yīng) 符合顧客認可的產(chǎn)品和制造過程批準(zhǔn)程序 。 71 Purchasing Process 采購過程 NOTE 1: Purchased products above include all products and services that affect customer requirements such as subassembly, sequencing, sorting, rework and calibration services. NOTE 2: When there are mergers, acquisitions or affiliations associated with suppliers, the anization should verify the continuity of the supplier’s quality management system and its effectiveness. 注 1：上述采購產(chǎn)品包括 影響顧客要求 的所有產(chǎn)品和服務(wù) ， 包括分組裝 、 排序 、 挑選 、 返工和校準(zhǔn)服務(wù) 。 符合 ISO9001： 2023是達到此目標(biāo)的第一步 。 采用 顧客指定的貨源 不能免除組織確保采購產(chǎn)品的質(zhì)量的責(zé)任 。 . part evaluation by a designated laboratory。 . special status customer notifications related to quality or delivery issues. The anization shall promote supplier monitoring of the performance of their manufacturing processes. 應(yīng) 通過以下指標(biāo) 監(jiān)視供方業(yè)績 ： 交付產(chǎn)品質(zhì)量 包括現(xiàn)場退貨的對顧客的困擾 交付日程業(yè)績 （ 包括超額運費指標(biāo) ） 與質(zhì)量或交付問題有關(guān)的特殊狀況的顧客通知 組織應(yīng)促進供方對他們制造過程業(yè)績監(jiān)視 。 78 Work Instructions 作業(yè)指導(dǎo)書 The anization shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product quality. These instructions shall be accessible for use at the work instructions shall be derived from sources such as the quality plan, the control plan and the product realization process. 組織 應(yīng) 為所有負責(zé)影響產(chǎn)品質(zhì)量的過程操作的所有員工準(zhǔn)備 文件化的作業(yè)指導(dǎo) 書 ， 這些指導(dǎo)書在工作崗位應(yīng)易于得到使用 。 適用時 ， 組織應(yīng)使用 統(tǒng)計方 法 進行驗證 。 . availability of replacement parts for key manufacturing equipme