【正文】 技術(shù)水準(zhǔn)者，應(yīng)有充裕的時間開發(fā)所需能力；f. 在產(chǎn)品實現(xiàn)的各適當(dāng)階段鑒定其適切的驗證；g. 厘清所有性能與要求的允收標(biāo)準(zhǔn)，包括那些具主觀因素者；h. the identification and preparation of quality records (see )NOTE 8:The quality plans referred to [see ] may be in the form of a reference to the appropriate documented procedures that form integral part of the supplier39。品質(zhì)系統(tǒng) 概述 供貨商應(yīng)建立與維持一個書面化的品質(zhì)系統(tǒng)做為確保產(chǎn)合規(guī)定要求的手段。顧客滿意的趨勢以及顧客不滿意的主要指針，應(yīng)書面記載且具客觀信息予以證實。追蹤，檢討，更新及修訂計劃的方法應(yīng)以明文規(guī)定，以確保該計劃在整體組織中被適當(dāng)?shù)呢瀼嘏c溝通。備注：管理審查需以跨功能的團隊方式來舉行(參閱詞匯)。資源─供貨商應(yīng)鑒定資源的需求，并提供適當(dāng)資源包括指派經(jīng)訓(xùn)練的人員()以從事管理、執(zhí)行工作與包含內(nèi)部品質(zhì)稽核在內(nèi)的各項驗證活動管理代表─供貨商負經(jīng)營責(zé)任之管理階層應(yīng)指派供貨商管理階層其中一員，明定其授權(quán)且不受其它職務(wù)責(zé)任影響以從事下列活動a) 確保品質(zhì)系統(tǒng)依本國際標(biāo)準(zhǔn)建立、實施與維持，及b) 將品質(zhì)系統(tǒng)的運作成效向供貨商管理階層報告以供其審查，并作為品質(zhì)系統(tǒng)改善之依據(jù)。Section I：ISO 9000─Bases RequirementsManagement Responsibility─Element Quality The supplier’s management with executive responsibility shall define and document its policy for quality, including objectives for quality and its mitment to quality. The quality policy shall be relevant to the supplier’s organizational goals and the expectations and needs of its customers. The supplier shall ensure that this policy is understood, implemented and maintained at all levels of the organization. Responsibility and The responsibility, authority and the interrelation of personnel who manage, perform and verify work affecting quality shall be defined and documented, particularly for personnel who need the organizational freedom and authority to：a) initiate action to prevent the occurrence of any nonconformities relating to product, process and quality system；NOTE：It is remended that the personnel responsible for quality have the authority to stop production, if necessary to correct quality problems. b ) identify and record any problems relating to the produce, process and quality system；c) initiate, remend or provide solutions though designated channels； d) verify the implementation of solutions； e) control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.f) represent the needs of the customer in internal functions in addressing QS9000 requirements( selection of special characteristics, setting quality objectives, training, corrective amp。NOTE 5：The responsibility of a management representative may also include liaison with external parties on matters relating to the supplier’s quality system.Organizational Interfaces – The supplier shall have systems in place to ensure management of appropriate activities during concept development through production to Advanced Product Quality Planning and Control Plan reference manual). The supplier shall use a multidisciplinary approach for decisionmaking and have the ability to municate necessary information and data in the customerprescribed format. NOTE：Typical functions to be included are: l Engineering/Technical l Manufacturing/Production l Industrial Engineering l Purchasing/Materials Management l Quality/Reliabilityl Cost Estimating l Product Service l Management Information Systems/Data Processing l Packaging Engineering l Tooling Engineering/Maintenancel Marketing and Salesl Subcontractors, as necessaryInformation to Management with responsibility and authority for corrective action shall be promptly informed of products or processes which bee nonpliant with specified requirements.Management Review – The supplier’s management with executive responsibility shall review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this international Standard and the supplier’s stated quality policy and objectives.(See ). Records of such reviews shall be maintained.(See ).Management Review – This Management Review requirement shall include all elements of the entire quality system, not only those specifically required in other elements (. ).NOTE：Management Review should be conducted with a multidisciplinary approach(see Glossary).Business Plan – The supplier shall utilize a formal, documented, prehensive business plan. this Business Plan shall be a controlled document. The content of the Business plan is not subject to third party audit. This plan may typically include as applicable： l Marketrelated issues l Financial Planning and cost l Growth projections l Plant/facilities plans l Cost objectives l Human resource development l R amp。經(jīng)營計劃 供貨商必須應(yīng)用一份正式明文規(guī)定且完整的經(jīng)營計劃。備注：數(shù)據(jù)和信息需促進流程的改善計劃。這些趨勢需與競爭廠商，或適當(dāng)?shù)钠髽I(yè)標(biāo)竿來比標(biāo)，并經(jīng)高層管理階層審查。供貨商應(yīng)準(zhǔn)備一份涵蓋本國際標(biāo)準(zhǔn)要求的品質(zhì)手冊。s quality system.Advanced Product Quality Planning – The supplier shall establish and implement an advanced product quality planning process. The supplier should convene internal multidisciplinary teams to prepare for production of new or changed products. These teams should use appropriate techniques identified in the Advanced Product Quality Planning and Control Plan reference manual. Similar techniques that acplish the intent are acceptable. Team actions should include： l Development/finalization of special characteristics (see Appendix C)l Development and review of FMEAsl Establishment of actions to reduce the potential failure modes with high risk priority numbers l Development or review of Control PlansSpecial Characteristics – The supplier’s process control guidelines and similar documents ( FMEA’s, Control Plans, Operation Instructions) shall be marked with the customer’s special characteristic symbol (or the supplier’s equivalent symbol or notation) to indicate those process steps that affect Special characteristics, when Special Characteristics are identified on the customer design record (see Glossary) (see Appendix C)NOTE：Initially, the customer may determine Special Characteristics and identify them. Special Characteristics may be identified from any product characteristics category, ( dimensional, material, appearance, perf