【導讀】本國際標準各項規(guī)定系由下列標準之規(guī)定所組成，并于全文中引述參考。時而陸續(xù)修正或改版，造成引用的國際標準不再適用。然而，使用本國際標準之各方被鼓勵探討應用。下列各項標準最新版次的可能性。IEC和ISO會員則維持最新有效國際標準之登錄。為了本國際標準之目的，ISO9000：2020內(nèi)所賦予的用詞和定義適用。商」，即是以前的用詞「分包商」，這些改變是因為與組織所使用字匯相對應。

　　

【正文】 lication or intended use, where known. Wherever practicable, validation shall be pleted prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see ). 應依據(jù)規(guī)劃的安排 (見 )執(zhí)行設(shè)計和開發(fā)確認，以確保最終產(chǎn)品有能力滿足其原訂或特 定使用或應用上的要求。適當時，確認應在產(chǎn)品交貨前或?qū)嵤┣巴瓿?。確認的結(jié)果和任何所需的措施應予以記錄。 (見 ) Control of design and development changes 設(shè)計和開發(fā)變更的管制 Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of 企業(yè) ()大量管理資料下載 14 design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. 設(shè)計和開發(fā)變更應予以鑒別和記錄。適當時，變更應加以審查、查證和確認，并于實施前核準。設(shè)計和開發(fā)變更應包含評 估所構(gòu)成零組件和已交貨的產(chǎn)品因變更的影響。 Records of the results of the review of changes and any necessary actions shall be maintained (see ). 變更審查的結(jié)果和任何所需的措施應加以記錄。 (見 ) Purchasing 采購 Purchasing process 采購流程 The anization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. 組織應確保采購的產(chǎn)品能符合所訂要求。應用于供貨商和采購的產(chǎn)品之管制的的方式和程度應依采購的產(chǎn)品對后續(xù)的產(chǎn)品實現(xiàn)或最終產(chǎn)品的沖擊而定。 The anization shall evaluate and select suppliers based on their ability to supply product in accordance with the anization’s requirements. Criteria for selection, evaluation and reevaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see ). 組織應基于供應與組織要求一致之產(chǎn)品的能力來評估和選擇供貨商。應建立選擇供貨商、評估和再評估的準則。來自評估而提出的評估的結(jié)果和措施應予以記錄。 (見 ) Purchasing information 采購信息 Purchasing information shall describe the product to be purchased, including where appropriate 采購文件應描述所采購產(chǎn)品的信息，適當時包括： a) requirements for approval of product, procedures, processes and equipment, 為了產(chǎn)品、程序、流程、設(shè)施和設(shè)備核準的要求； b) requirements for qualification of personnel, and 為了人員資格之要求； c) quality management system requirements. 品質(zhì)管理系統(tǒng)要求。 The anization shall ensure the adequacy of specified purchase requirements prior to their munication to the supplier. 組織應確保在與供貨商溝通前對所訂要求之適切性。 Verification of purchased product 采購產(chǎn)品的查證 企業(yè) ()大量管理資料下載 15 The anization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. 組織應建立和實施為了確保采購的產(chǎn)品符合所訂要求所必須的檢驗或其它活動。 Where the anization or its customer intends to perform verification at the supplier’s premises, the anization shall state the intended verification arrangements and method of product release in the purchasing information. 當組織或其顧客擬在供貨商現(xiàn)場進行查證時，組織應在采購信息中規(guī)定所訂的查證安排和產(chǎn) 品放行的方法。 Production and service provision 生產(chǎn)和服務運作 Control of production and service provision 生產(chǎn)和服務運作管制 The anization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable 組織應在既定規(guī)劃和管制的條件下，執(zhí)行生產(chǎn)和服務的供應，適當時，包括： a) the availability of information that describes the characteristics of the product, 規(guī)定產(chǎn)品特性信息的可用性； b) the availability of work instructions, as necessary, 當需要時，工作指導書之可用性； c) the use of suitable equipment, 為 了生產(chǎn)和服務的供應而使用適當?shù)脑O(shè)備； d) the availability and use of monitoring and measuring devices, 監(jiān)督和量測裝置的可用性和使用； e) the implementation of monitoring and measurement, and 監(jiān)督和量測活動的實施； f) the implementation of release, delivery and postdelivery activities. 產(chǎn)品放行、交貨和售后活動的實施。 Validation of processes for production and service provision 生產(chǎn)和服務運作流程確認 The anization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This i ncludes any processes where deficiencies bee apparent only after the product is in use or the service has been delivered. 組織應確認其最終輸出不能由隨后的監(jiān)督和量測來查證的任何生產(chǎn)和服務供應流程。這包括可能因產(chǎn)品使用后或服務已經(jīng)提供后才顯現(xiàn)出失效的任何流程。 Validation shall demonstrate the ability of these processes to achieve planned results. 確認應展現(xiàn)流程達到規(guī)劃結(jié)果的能力。 The anization shall establish arrangements for these processes including, as applicable 企業(yè) ()大量管理資料下載 16 組織應對確認的安排加以界定，適當時應考慮以下要求： a) defined criteria for review and approval of the processes, 流程的資格； b) approval of equipment and qualification of personnel, 設(shè)備和人員的資格； c) use of specific methods and procedures, 已界定的方法和程序的使用； d) requirements for records (see ), and 記錄所要求； e) revalidation. 重新確認。 Identification and traceability 鑒別與追溯性 Where appropriate, the anization shall identify the product by suitable means throughout product realization. 適當時，組織應對產(chǎn)品藉由適當?shù)姆椒?，于產(chǎn)品實現(xiàn)各階段予以鑒別。 The anization shall identify the product status with respect to monitoring and measurement requirements. 組織應鑒別有關(guān)于監(jiān)督和量測要求的產(chǎn)品狀況。 Where traceability is requirement, the anization shall control and record the unique identification of the product (see ). 當有可追溯要求時，組織應管制和記錄產(chǎn)品的唯一的鑒別。 (見 ) NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained. 注：在某些行業(yè)中是以型態(tài)管理來維持鑒別與追溯性。 Customer property 顧客財產(chǎn) The anization shall exercise are with customer property while it is under the anization’s control or being used by the anization. The anization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see ). 當顧客財產(chǎn) 被組織控管或正被使用時，組織應給予妥善保管。組織應對提供作為使用或組合成為產(chǎn)品的顧客財產(chǎn)予以鑒別、查