【正文】 當(dāng)產(chǎn)品需求被改變時，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。 基礎(chǔ)設(shè)施 組織應(yīng)決定、提供及維護(hù)為達(dá)成符合產(chǎn)品需求必要的基礎(chǔ)設(shè)施。 規(guī)劃 品質(zhì)目標(biāo) 高階管理者應(yīng)確保 組織內(nèi)各相關(guān)機(jī)能及各層級之品質(zhì)目標(biāo)被建立，品質(zhì)目標(biāo)包含符合產(chǎn)品要求之各項需求 (見 )。 組織應(yīng)： a) 鑑別品質(zhì)管理系統(tǒng)所需的過程及其在組織 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： a) identify the processes needed for the quality management system and their application throughout the anization (see ), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the anization in accordance with the requirements of this International Standard. Where an anization chooses to outsource any process that affects product conformity with requirements, the anization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. Documentation requirements General The quality management system documentation shall include a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this International Standard, 中之運(yùn)用 (見 )， b) 決定這些過程的順序及相互關(guān)係， c) 決定確保這些過程有效運(yùn)作及管制的必要的準(zhǔn)則及方法， d) 確保提供支援這些過程的運(yùn)作及監(jiān) 督必要的資源與資訊 ， e) 監(jiān)控、量測及分析這些過程，和 f) 採取必要行動以達(dá)成這些過程的預(yù)期結(jié)果及持續(xù)改善。 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： 立 仰 國 際 驗 證 機(jī) 構(gòu) 編 譯 Index: 1 Scope General 目 錄： 1 範(fàn)圍 通則 ISO9001/20xx IS REON International Certification 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： Application 2 Normative reference 3 Terms and definitions 4 Quality management system General requirements Documentation requirements General Quality manual Control of documents 5 Management responsibility Management mitment Customer focus Quality policy Planning Quality objectives Quality management system planning Responsibility, authority and munication Responsibility and authority Management representative Internal munication Management review General Review input Review output 6 Resource management Provision of resources Human resources General Competence, awareness and training Infrastructure Work environment 7 Product realization Planning of product realization Customerrelated processes of requirements related to the product Review of requirements related to the product Customer munication Design and development and development planning Design and development inputs Design and development 應(yīng)用 2 引用標(biāo)準(zhǔn) 3 名詞與定義 4 品質(zhì)管理系統(tǒng) 一般要求 文件化要求 通則 品質(zhì)手冊 文件管制 5. 管理責(zé)任 管理承諾 顧客為重 品質(zhì)政策 規(guī)劃 品質(zhì)目標(biāo) 品質(zhì)管理系統(tǒng)規(guī)劃 責(zé)任、授權(quán)戌溝通 責(zé)任與授權(quán) 管理代表 內(nèi)部溝通 管理審查 通則 管理審查的輸入 管理審查的輸出 6 資源管理 資源提供 人力資源 通則 資格、認(rèn)知與訓(xùn) 基礎(chǔ)設(shè)施 工作環(huán)境 7 產(chǎn)品實現(xiàn) 產(chǎn)品實現(xiàn)的規(guī)劃 顧客相關(guān)的過程 決定產(chǎn)品相關(guān)的需求 產(chǎn)品相關(guān)需求的審查 客戶溝通 設(shè)計與開發(fā) 設(shè)計與開發(fā)的規(guī)劃 設(shè)計與開發(fā)的 輸入 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： outputs Design and development review Design and development verification Design and development validation Control of design and development changes Purchasing Purchasing process Purchasing information Verification of purchased product Production and service provision Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring devices 8 Measurement, analysis and improvement General Monitoring and measurement Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product Control of nonconforming product Analysis of data Improvement Continual improvement Corrective action Preventive action Quality management systems – Requirements 1 Scope General This International Standard specifies requirements for a 設(shè)計與開發(fā)的輸出 設(shè)計與開發(fā)的審查 設(shè)計與開發(fā)的驗證 設(shè)計與開發(fā)的確認(rèn) 設(shè)計與開發(fā)變更的管制 採購 採購過程 採購資訊