【正文】 Where the organization or its customer intends to perform verification at the supplier39。變更在執(zhí)行前應(yīng)予以評審﹑檢驗(yàn)﹑確認(rèn)﹐必要時應(yīng)進(jìn)行批準(zhǔn)。d) specify the characteristics of the product that are essential for its safe and proper use. 定議對產(chǎn)品安全及適當(dāng)用途之必要的特性。b) applicable statutory and regulatory requirements, 適用法律法規(guī)的要求。 Customer munication 客戶溝通The organization shall determine and implement effective arrangements for municating with customers in relation to組織應(yīng)決定與實(shí)施與客戶進(jìn)行有效溝通的安排﹐包括如下內(nèi)容﹕a) product information, 產(chǎn)品信息b) enquiries, contracts or order handling, including amendments, and 詢問﹑合同和訂單處理﹐包括修訂。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組織 應(yīng)對與產(chǎn)品相關(guān)的要求進(jìn)行評審﹐該評審應(yīng)在產(chǎn)品決定或承諾交送客戶前(如接受合約或訂單﹐接受合同或訂單的變更)實(shí)施﹐以確保﹕a) product requirements are defined, 產(chǎn)品需求已確定。s method of operations.規(guī)劃結(jié)果應(yīng)以適合組織運(yùn)作方法的格式輸出。產(chǎn)品實(shí)現(xiàn)的計(jì)劃應(yīng)與質(zhì)量管理體系的其它流程的要求相一至。c) evaluate the effectiveness of the actions taken, 評估所遷擇的行動的效果。f) changes that could affect the quality management system, and 可能影響質(zhì)量管理體系的改進(jìn)。 Internal munication 內(nèi)部溝通Top management shall ensure that appropriate munication processes are established within the organization and that munication takes place regarding the effectiveness of the quality management system.最高管理層應(yīng)確保在組織間應(yīng)建立適當(dāng)?shù)臏贤鞒泰o確保品質(zhì)管理系統(tǒng)的有效。質(zhì)量目標(biāo)應(yīng)包含符合產(chǎn)品要求所需之內(nèi)容。a) municating to the organization the importance of meeting customer as well as statutory and regulatory requirements, 向組織偉達(dá)符合客戶及規(guī)章/法令的重要性。d) to ensure that relevant versions of applicable documents are available at points of use, 在需要使用文件的場合﹐確保得到相應(yīng)文件的有效版本。NOTE 3 The documentation can be in any form or type of medium.備注3﹕文件化的程序和文件可存在任何形式的媒體。b) a quality manual, 質(zhì)量手冊。c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, 確定所需標(biāo)準(zhǔn)及方法﹐以確保這些流程可達(dá)成有效作業(yè)及管制。IEC和ISO成員都持有現(xiàn)行有效的國際標(biāo)準(zhǔn)。NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.備注﹕在本國際標(biāo)準(zhǔn)中﹐述語’產(chǎn)品’指的是客戶訂購或客戶需求的產(chǎn)品。三﹑更方便地適用于各種產(chǎn)品類型和規(guī)模的組織。3. ISO9004﹕2000質(zhì)量管理體系業(yè)績改進(jìn)指南﹐取代現(xiàn)行的ISO9004—1,2,3,4標(biāo)準(zhǔn)。四﹑標(biāo)準(zhǔn)要求NOTE In addition, the methodology known as “PlanDoCheckAct” (PDCA) can be applied to all processes. PDCA can be briefly described as follows.Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization39。否則就不能聲稱符合本國際標(biāo)準(zhǔn)。4 Quality management system 質(zhì)量管理體系 General requirements 一般要求The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.組織應(yīng)建立﹑執(zhí)行并保持一個文件化的質(zhì)量管理體系﹐并持續(xù)改進(jìn)其有效性使其與本國標(biāo)標(biāo)準(zhǔn)要求相一至。Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.當(dāng)組織遷擇會影響到產(chǎn)品符合要求的外部流程時﹐組織應(yīng)確保這些外部流程得到控制﹐并在質(zhì)量管理體系中對這些流程進(jìn)行鑒別。NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to備注2﹕品質(zhì)管理體系文件的范圍可能因以下原因在組織間會有差異﹕a) the size of organization and type of activities, 組織的規(guī)模和類型。A documented procedure shall be established to define the controls needed建立一個文件化程序確定a) to approve documents for adequacy prior to issue, 發(fā)行前批準(zhǔn)其適當(dāng)性。質(zhì)量記錄應(yīng)保持清楚易讀并易于獲取。c) provides a framework for establishing and reviewing quality objectives, 為目標(biāo)的建立及評審提供框架。b) reporting to top management on the performance of the quality management system and any need for improvement, and 向最高管理層報(bào)告質(zhì)量管理體系的執(zhí)行成效及改善需求。() Review input 管理評審輸入The input to management review shall include information on管理評審輸入應(yīng)包括﹕a) results of audits, 審核的結(jié)果b) customer feedback, 客戶的反鑽c) process performance and product conformity, 過程的執(zhí)行及產(chǎn)品的符合性。 Human resources 人力資源 General 總則Personnel performing work affecting product quality shall be petent on the basis of appropriate education, training, skills and experience.執(zhí)行與產(chǎn)品質(zhì)量有關(guān)工作的人員﹐應(yīng)有適當(dāng)?shù)慕逃p訓(xùn)練﹑技朮和經(jīng)驗(yàn)。c) supporting services (such as transport or munication). 支援服務(wù)如運(yùn)輸﹑溝通。c) required verification, validation, monitoring, inspection and test activities specific to the product and the ] criteria for product acceptance。c) statutory and regulatory requirements related to the product, and 與產(chǎn)品相關(guān)的法律﹑法規(guī)的要求。當(dāng)顧客需求沒有提供書面陳述時﹐顧客要求應(yīng)在被接受前組織需予以確認(rèn)。The organization shall manage the interfaces between different groups involved in design and development to ensure effective munication and clear assignment of responsibility.組織應(yīng)對設(shè)計(jì)和開發(fā)各小組之間的接口進(jìn)行管理確保信息的有效傳達(dá)﹐并清楚的規(guī)定各部門職責(zé)。Design and development outputs shall設(shè)計(jì)和開發(fā)輸出應(yīng)﹕a) meet the input requirements for design and development, 符合設(shè)計(jì)和開發(fā)輸入的要求。 Design and development verification 設(shè)計(jì)和開發(fā)驗(yàn)証Verification shall be performed in accordance with planned arrangements (see ) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see ).應(yīng)實(shí)施設(shè)計(jì)和開發(fā)驗(yàn)証以確保輸出符合設(shè)計(jì)和開發(fā)輸入要求。選擇標(biāo)準(zhǔn)對供方進(jìn)行定期的評估﹐評估結(jié)果和隨后的躍進(jìn)措施應(yīng)予以記錄. Purchasing information 采購資料Purchasing information shall describe the product to be purchased, including where appropriate采購資料應(yīng)包含對所采購產(chǎn)品的適當(dāng)描述﹐包括﹕a) requirements for approval of product, procedures, processes and equipment, 產(chǎn)品﹑程序﹑流程﹑設(shè)備的認(rèn)可條件。b) the availability of work instructions, as necessary, 必要時編制工作指導(dǎo)文件﹔c) the use of suitable equipment, 使用相應(yīng)設(shè)備﹔d) t