【導(dǎo)讀】設(shè)計，驗證，確認，檢查及測試，或服務(wù)于產(chǎn)品。發(fā)展顧客關(guān)系－最高管理者應(yīng)積極參與建立并維護組織與顧客之間的相互受益的關(guān)系。會同顧客安既定的時間間隔評審期望目標的狀況，并且應(yīng)有可以追蹤決定流轉(zhuǎn)的方法。所提供的級別應(yīng)依據(jù)與顧客的。質(zhì)量目標－質(zhì)量目標應(yīng)包括在TL9000質(zhì)量管理體系計算手冊中為TL9000定義的對象。實現(xiàn)這些目標需要監(jiān)控和匯報。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。

　　

【正文】 re that customers are informed when design changes affect contractual mitments. [5] 通知客戶－ 組織應(yīng)建立和維持一個程序文件以確保當設(shè)計變更影響合同承諾時通知客戶?！?5〕 Problem Resolution Configuration Management – The anization shall establish an interface between problem resolution and configuration management to ensure that fixes to problems are incorporated in future revisions. [11] 問題解決配置管理－ 組織應(yīng)建立一個問題解決和配置管理之間的接口，以確保問題整理合并成將來的版本。 Component Changes – The anization shall have a documented procedure(s) in place to ensure that material or ponent substitutions or changes do not adversely affect product quality or performance. The documented procedure(s) should include: a) functional testing, b) qualification testing, c) stress testing, 15 d) approved parts listing, and/or e) critical parts listing. 組成變化－組織應(yīng)有一個適當?shù)某绦蛭募ゴ_保材料或成分替代或變化不反過來影響產(chǎn)品質(zhì)量或性能。這個程序文件包括： a) 功能試驗 b) 資格試驗 c) 壓力試驗 d) 所列被批準的部分，和 /或 e) 所列關(guān)鍵部分 Purchasing 購買 Purchasing process 購買過程 Purchasing Procedure(s) – The documented purchasing procedure(s) shall include: a) product requirements definition, b) risk analysis and management, c) qualification criteria, d) contract definition, e) proprietary, usage, ownership, warranty, and licensing rights are satisfied, f) future support for the product is planned, g) ongoing supplybase management and monitoring, h) supplier selection criteria, i) supplier reevaluation, and k) feedback to key suppliers based on data analysis of supplier performance. [10] 購買程序－ 購買程序文件包括： a) 產(chǎn)品需求定義 b) 風(fēng)險分析和管理 c) 資格標準 d) 合同定義 e) 所有權(quán)，使用權(quán)，保證，和許可權(quán)被滿足 f) 對產(chǎn)品未來的支持被計劃 g) 正在進行的基本供應(yīng)管理和監(jiān)控 h) 供應(yīng)商選擇標準 i) 供應(yīng)商再評估，和 j) 根據(jù)供應(yīng)商績效的數(shù)據(jù)分析反饋給關(guān)鍵供應(yīng)商 1: The documented procedure(s) should be applicable to offtheshelf product. This typically includes original equipment manufacturer (OEM) products used in manufacturing and mercial offtheshelf (COTS) products used in software systems. －注 1：程序文件應(yīng)適用于現(xiàn)有產(chǎn)品。這特別包括用于制造的原有設(shè)備制造商（ OEM）產(chǎn)品和用于軟件系統(tǒng)的商業(yè)性現(xiàn)有（ COTS）產(chǎn)品。 Purchasing information 購買信息 Verification of purchased products 所購產(chǎn)品的確認 16 Production and service provision 產(chǎn)品和服務(wù)提供 Control of production and service provision 產(chǎn)品和服務(wù)提供的控制 Organization’s Support Program – The anization shall ensure that customers are provided support to resolve product related problems. [5] 組織的支持計劃－ 組織應(yīng)確?？蛻舯惶峁┙鉀Q相關(guān)問題產(chǎn)品的支持?！?5〕 Service Resources – The anization shall provide customer contact employees with appropriate tools, training, and resources necessary to provide effective and timely customer service. [4] 服務(wù)資源－ 組織應(yīng)提供客戶聯(lián)系員工，這些員工具有對提供有效的和即時的客戶服務(wù)的必要的適當?shù)墓ぞ撸寄芎唾Y源。 Emergency Service – The anization shall ensure that services and resources are available to support recovery from emergency failures of product in the field throughout its expected life. [4] 緊急服務(wù)－ 組織應(yīng)確保服務(wù)和資源能支持產(chǎn)品從整個期望生命中緊急故障恢復(fù)?！?4〕 Installation Plan – The anization shall establish and maintain a documented installation plan. The installation plan shall identify the resources, the information required, and list the sequence of events. The results associated with the installation sequence shall be documented. [10] 安裝計劃－ 組織應(yīng)建立和維持一個文件性的安裝計劃。安裝計劃應(yīng)鑒別資源，所需信息和列出事情的次序。和安裝次序有關(guān)的結(jié)果寫在文件中。〔 10〕 Patching Procedure(s) – The anization shall establish and maintain a documented procedure(s) that guide the decision to solve problems by patching. a) The documented procedure(s) shall address patch development procedures, propagation (forward and backward), and resolution. b) The documented procedure(s) shall be consistent with customer needs or contractual requirements for maintenance support. c) The anization shall provide the customer with a statement of impact on the customer39。s operation for each patch. [11] 修補程序－ 組織應(yīng)建立和維持一個程序文件指導(dǎo)通過修補解決問題的決定 a) 程序文件應(yīng)寫出修補發(fā)展程序，發(fā)展（向前和向后），和解決方案 b) 程序文件應(yīng)和用于維護支持的客戶需求或合同需求一致。 c) 組織應(yīng)提供客戶每個修補對客戶的操作影響的闡述。 Patch Documentation – The anization shall establish and maintain methods to ensure that all documentation required to describe, test, install, and apply a patch has been verified and delivered with the patch. [11] 修補文件－ 組織應(yīng)建立和維持一些方法，這些方法確保需要描述、試驗、安裝和使用修補的文件已被修改并分發(fā)。 Replication – The anization shall establish and maintain a documented procedure(s) for replication, which should include the following: a) identification of master copy, b) identification of replicate copies for delivery, c) quantity of replicates to deliver, d) type of media, e) labeling, 17 f) identification of required documentation such as user guides, g) packaging of documentation, and h) control of environment to ensure repeatable replication. [9] 復(fù)制－ 組織將建立和維持一個用于復(fù)制的程序文件，應(yīng)包括如下： a) 原版的鑒定 b) 傳遞的副本的鑒定 c) 傳遞副本的數(shù)量 d) 媒體類型 e) 標簽 f) 被要求文件如用戶指南的鑒定 g) 文件包裝，和 h) 確?？芍貜?fù)的復(fù)制的環(huán)境控制 Software Used in Service Delivery – Organizations shall document and implement processes for the maintenance and control of software used in service delivery to ensure continued process capability and integrity. 用于服務(wù)傳遞的軟件－組織應(yīng)編制和實施用于軟件控制和維護的過程，這些軟件用在服務(wù)傳遞，以確保持續(xù)的制程容量和完整性。 Tool Changes – The anization shall have a documented procedure(s) in place to ensure that substitutions or changes to tools used in performing the service do not adversely affect the quality of the service. 工具變更－組織應(yīng)適當?shù)赜幸粋€程序文件去確保用在服務(wù)上的工具的替代或變更不反過來影響服務(wù)的質(zhì)量。 Validation of processes for production and service provision 產(chǎn)品和服務(wù)提供的制程的確認 Operational Changes – Each time a significant change is made in the established operation (., a new operator, new machine, or new technique), a critical examination shall be made of the first unit(s)/service(s) processed after the change. [5] 操作 變更－ 每次一個主要的變更發(fā)生在已建立的操作（如： 一個新的操作者，新設(shè)備，或新技術(shù)），變化之后的第一個元件 /服務(wù)需經(jīng)過嚴格的檢驗。 Identification and traceability 鑒定和可追溯性 Product Identification – The a