审厂要求 Audit Document List - Ver A _原创精品文档.pdfVIP

QMSAuditDocumentsList质量体系审核文件清单

1.1BusinessLicense营业执照

FactoryProfile1.2ISO9000certificateorotherQualityAssuranceSystemscertificate

工厂概况ISO9000证书或其他质量体系证书

1.3Organizationchart,responsibilitiesandauthoritydescription组织架构和职责权限描述

1.4Productionprocesschart生产工序流程图

2.1Qualitymanual质量手册

2.2QualityProcedure程序文件(文件.记录.不合格.内审.矫正措施和预防措施控制程序)

2.3QualityPolicy质量方针

2.4Qualityobjectivesandmonitoringrecords质量目标和监控记录

Management2.5QMSinternalauditplan/records质量体系内审计划/记录;

CommitmentOpeningmeetingandclosemeetingrecords首末次会议;

andContinualQMSinternalauditchecklist检查表

ImprovementQMSinternalauditNCreports不符合项报告;

管理承诺和持

QMSinternalauditreport内审报告

续改善

QMSmanagementreviewplan/records质量体系管理评审计划/记录:

2.6QMSmanagementreviewmeetingrecord管理评审会议记录;

QMSmanagementreviewreport管理评审报告;

QMSmanagementreviewdecisionsfollow-uprecords决议事项的跟进记录

2.7Documentcontrolrecords.文件更改收发记录

2.8Externaldocumentslistandcontrolrecords外来文件清单和管控记录

2.9Customersatisfactioninvestigationandactionrecords客户满意度调查和改善措施记录

3.1Productsriskassessmentprocedureandrecords产品风险评估程序和记录

Risk3.2Record/planforriskassessmentoftheentiremanufacturingprocesses

Management整个生产流程风险评估记录/计划

风险管理

4.1Newproductsdesignanddevelopment新产品设计开发:

Designcontrolprocedure设计控制程序

Designinputandreviewrecord设计输入和评审记录

Verificationandvalidationrecords(Pilotrunsrec