iso9001質量管理體系標準要素詳解-資料下載頁

　　

【正文】 in conflict with each other.應對這些輸入的適用性進行評審﹐所有的需求都應滿足﹐表述清楚且各部分間接口清楚。 Design and development outputs 設計和開發輸出The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.設計和開發過程的輸出應提供一種格式﹐以驗証設計和開發的輸入及實現的預先設計。Design and development outputs shall設計和開發輸出應﹕a) meet the input requirements for design and development, 符合設計和開發輸入的要求。b) provide appropriate information for purchasing, production and for service provision, 提供適當的采購﹑生產﹑和服務的資訊。c) contain or reference product acceptance criteria, and 包括或引用設計或開發產品接受的標準。d) specify the characteristics of the product that are essential for its safe and proper use. 定議對產品安全及適當用途之必要的特性。 Design and development review 設計和開發評審At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see )在適當階段﹐組織應對設計和開發進行系統的評審以確保與計劃安排的相一至。()a) to evaluate the ability of the results of design and development to meet requirements, and 評估設計和開發滿足需求的能力。b) to identify any problems and propose necessary actions. 識別問題并建議解決方案。Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see ).參與評審的人員包括各職能部門的參與設計和開發各階段評審的代表﹐評審的結果記錄及采取的相關行動應給予保存。 Design and development verification 設計和開發驗証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 ).應實施設計和開發驗証以確保輸出符合設計和開發輸入要求。驗証結果及隨后的跟進措施應予以記錄() Design and development validation 設計和開發確認Design and development validation shall be performed in accordance with planned arrangements (see ) to ensure that the resulting product is capable of meeting the requirements for the specified application 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 ).應實施設計和開發確認設計和開發出的產品能夠滿足特殊或預期的使用要求﹐無論如何﹐應在交付或實現產品前完成確認。確認驗証結果及隨后的跟進措施應予以記錄() Control of design and development changes 設計和開發變更的控制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 design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.應識別設計和開發變更并記錄其修訂。變更在執行前應予以評審﹑檢驗﹑確認﹐必要時應進行批準。Records of the results of the review of changes and any necessary actions shall be maintained (see ).變更評審結果的記錄及隨后的跟進措施應予以保存() Purchasing 采購 Purchasing process 采購流程The organization 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品符合采購需求。控制的類型和程度應取決于其對隨后的實現過程和輸出的作用。The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization39。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 ).組織應根據提供符合組織要求產品的能力來評估和選擇供方。選擇標準對供方進行定期的評估﹐評估結果和隨后的躍進措施應予以記錄. Purchasing information 采購資料Purchasing information shall describe the product to be purchased, including where appropriate采購資料應包含對所采購產品的適當描述﹐包括﹕a) requirements for approval of product, procedures, processes and equipment, 產品﹑程序﹑流程﹑設備的認可條件。c) requirements for qualification of personnel, and 人員資格要求﹔d) quality management system requirements. 質量管理體系要求﹔The organization shall ensure the adequacy of specified purchase requirements prior to their munication to the supplier.組織應確保采購資料所包含的規定要求適當后才發出。 Verification of purchased product 采購產品的驗証The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.組織應識別并實施對采購進行驗証或其他必須的活動﹐確保采購的產品符合采購需求。Where the organization or its customer intends to perform verification at the supplier39。s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.當組織或其客戶提出在供方貨源處進行驗証活動時﹐組織應在采購資料中規定驗証安排和產品放行方法。 Production and service provision 產品和服務的準備 Control of production and service provision 產品和服務的準備控制The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable組織應對生產和服務準備進行計劃和管制﹐包括﹕a) the availability of information that describes the characteristics of the product, 得到規定產品特性的有效信息。b) the availability of work instructions, as necessary, 必要時編制工作指導文件﹔c) the use of suitable equipment, 使用相應設備﹔d) the availability and use of monitoring and measuring devices, 提供并使用測量和監控設備﹔e) the implementation of monitoring and measurement, and 執行監控活動﹔f) the implementation of release, delivery and postdelivery activities. 實施規定的放行﹑交付和相應的音樂會活動。 Validation of processes for production and service provision 確認產品及服務準備流程The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or mea