供应商审核表中英文模板

汽车类供应商准入审核报告中英文双语版

Supplier Approval Audit Report 供应商准入审核报告Table instructions:表格使用说明：SUPPLIER SELF ASSESSMENT 供应商自评• The supplier shall use this tool to complete a Self Assessment in advance of the CATL on-site audit.• 供应商需要在CATL现场审核以前，用此评审标准进行自审。

• By completing the Self Assessment, the supplier will be able to prepare for the audit and seek advance help and guidance from CATL SQE to be best positioned for success. The supplier should use this opportunity to ask questions to clarify or better• 在进行自审时，供应商可向SQE就审核具体内容进一步澄清并准备现场审核，以达到审核的最佳效果。

• The Self Assessment should be submitted to the responsible CATL SQE one week in advance of the on-site audit which will signal the Supplier's readiness for the formal audit.• 供应商在CATL SQE发出正式审核要求一个星期以前，将自审结果报给CATL SQE。

CATL ON-SITE AUDIT & AUDIT SUMMARY CATL现场审核• The CATL auditor usually includes the SRC, design , SQE. The SRC staff audit business ; design staff audit technical; SQE audit quality.• CATL审核员通常包括采购人员、设计人员、供应商质量管理人员。

供应商资质调查表中英文

QMP7-4-1-01-00002SUPPLIER FACILITY SURVEY供应商(Supplier):地址(Address):评价日期Date of assessment:电话Phone:传真Fax:调查期间供应商联系人员名单/职务List of personnel contacted during audit / position title.联系人（Contact）：职务(Title)：蓝托考核小组(姓名及公司名称)Ranto Audit Team (Name & Ranto Facility)姓名（Name）：单位/部门（Facility/Department）步骤Process:（1）不是所有问题都需填写. 因观察项（次要的不合格项）与风险项（主要的不合格项）之间有差异，因此考核人员要将考核要素归类并记下其状态。

All questions do not have to be completed. For those discrepancies found that are a "finding" (minorunacceptable condition) or a "risk" (major not acceptable condition); the auditor will rank the element and describe the condition. （2）所有将要被审核的供应商都应被通知（在审核前必须将该调查表传真或发邮件给供应商）In all cases the supplier being audited will be notified.（3）对于加“★”的项目必须要审核到，并且就审核发现做出具体的描述。

To“★”items must be audited and make the detail description of findings。

供应商审核检查表中英文版

产品和原料检查、加工、储存，设备和器具的清洁区域需提供足够的照明
Light bulbs, fixtures, skylights or other glass suspended over any ingredient or packaging material exposed in any step of the operation are protected to prevent contamination.
Fixtures, ducts and pipes that drip or form condensation are not suspended over working areas where a potential of contamination may occur.
生产区域上方，设备、管路上的冷凝水、滴漏将是ห้องสมุดไป่ตู้在的污染
无不符合要求的储存：垃圾、废品、未切割的种子或者草，适合昆虫繁殖和鼠类藏匿的场所
There is adequate drainage in all areas to prevent the contamination of components through seepage or foot-borne filth.
在原料和包装材料上方的灯具、天窗以及其他悬挂的玻璃制品，必须有防护
Adequate ventilation or control equipment is provided to minimize odors and noxious fumes or vapors in areas where they may contaminate components
Separation by partition, location or other effective means is provided for those operations that may cause contamination of food products with undesirable microorganisms, chemicals, filth or other materials.

AO史密斯供应商质量体系审核表(中英文)

Points 分值Criteria or Function评分标准Score实分1There is no evidence of top management regularly review the quality system and product quality control. 高级管理层几乎没有定期对公司质量体系和产品质量控制情况进行评估2Senior management evaluate quality system and product quality regularly.高级管理层定期对公司质量体系和产品质量进行评估.3Management review is recorded and output the corrective action plan.管理层的评估记录在案并制定出修正方案和行动计划4Continious Improvement is implemented and close up.持续有效的增进措施得到了实施和完成2There is written corporation target and quality target.有成文的企业目标和质量目标.3Be posted and well known by employee.公之于众并且被员工所熟知.4There is continuous improvement and action.有持续改进计划和行动.1There is basical quality manual ,but needs improvement.有非常基本的质量手册，但内容仍需很多改进.2The quality manual is complete.质量手册比较完善.3Each department has quality manual.Be well known by emloyee.每一个部门都有质量手册，并且为员工所熟知4Detailed quality manual exists with a policy statement signifying top management's support.Quality manual to be enclorsed (in writing) by site's top manager.. 质量手册有细化的条款和反映高级管理层支持的政策规则.并且手册还附有部门最高负责人的签字1Be implemented sometimes and there is document evidence .偶尔有实施，并有一些文件记录.2Have audit interior plan.有内审计划.3Audits are performed on schedule. A corrective action verification process exists end.审核按照计划执行，有改进的行动措施和过程管理4Continuous improvemen and evaluate validity 持续的改善并且评估有效可行.52There is a clear organization chat and responsibilities and authority of all organizational functions are clearly defined有清晰的企业组织结构图和明确职能,权责分工的界定和描述3Also,be well known by employee.同时，为员工所熟知.4Also,especially separate quality department and the quality manage have veto.另外，独立的质量管控部门mangement fuction 管理职责4 4 4Quality manual 质量手册434interior managementsyetem 内部管理体系4Remark备注Management review管理层评估1Audit Item评审条款Quality policy and objective.质量目方针和目标2Points 分值Criteria or Function评分标准Total Points 实得分2There are written procedures for development system with responsibilities assigned.有明确责任的产品开发体系规则.4Including design review and validate.包括了设计评估和验证6There is evidence for implement.有显示表明对以上内容进行了实施.8Including feasibility,apqp and validate.同时还包括了可行性评审、先期评审和设计验证等1New product has been inspected for each item(appearance,size,performance etc.) .Haveinspecting record. 对新产品进行了各项检测（外观、尺寸、性能等），有检测报告.2New product has been inspected for each item(life,material,reliability etc.)Have completerecord. 对新产品进行各项性能测试（寿命、材料、可靠性等等），有完整的记录3Providing complete quality guarantee report.there is identical inspecting result .能提供完整的质量保证报告，并与检测结果一致4There is feasible production flow and quality control plan.制定了可行的产品流程和质量控制计划2Have experiential empoyee for similar product.具有类似产品开发经验的人员配置.3有关于人员任职资格的文件和人员认聘资料记录4Leading design sample and employee.具有行业领先的设计样本和设计人员2Adopt cad,ca and caq.采用了计算机辅助设计（CAD ）、制造（CAM ）和质量管理（CAQ ）4Software and hardware satisfy our product requirement.软件和硬件能够满足我们的产品需求.2Can provide sample in short time.能在短期内提供样品3have reliability and life test ability for sample.对样品有可靠性和使用寿命等性能等方面的测试能力4Satisfactory delivery.理想的交付Software &hardware 软件和硬件providing sample 样品提供Audit Item 评分条款product development 产品开发product approvement 产品许可design employee 设计人员资格Remark 备注12345Audit Item 评分条款Points 分值Criteria or Function评分标准Total Points 实得分2developed设计了工艺流程图4catched by employees 员工能够掌握6been accurately reflect process flow 准确地反映了制造流程8even there are proceduresfor notification of customer for process material changes,changes in manufacturing locations,quality problems. 不仅如此，还制定了诸如在材料,生产地点变更后以及出现质量问题时的客户通知程序和制度2developed制定了作业指导书3showed on the manufacture-line and catched by employees 作业指导书展示在生产线上，并被作业人员所掌握4all documents show evidence of Control and are latest revisions.employee act according these totally. 所有的文件都能起到有效的控制作用并保持最新的校订版本，员工完全能够按照指导进行操作1have factory management system ,such as 5S.有诸如5S 的管理体系3gauges and inspection equipment are available on changeless place and accessible to operatiors and inspectors.量具和检测设备都放置在易于操作人员和检测人员接触到的固定的位置4preventive actions system to deal with gusty matter,such as machine undoing,toolvanishing,compo. 制定了预防诸如机器失效，工具vanish，compo等紧急情况的行动指南1there are different sign on the qualified product,unqualified product,and container.有区别地对合格品、不合格品及其容器具进行了标识2there are written procedures for dealing with unqualified product,such as rework, accept in particular, scrap, and acting actually.订立了对不合格品的处理规则(如返工、另作他用、直接报废等), 并在现实中执行3statistical methods are used for improvement activities, i.e. Pareto Analysis, Control Charts,Bar Charts, Line Graphs.对不合格品进行统计分析4corrective actions are taken to reduce scrap and rework. evidence is shown.有根据表明企业采取了有效的改进措施来降低报废率和返工率84343123Process Flow Charts 工艺流程图Work instruction 作业指导书Factory Management 工厂管理Control of non-conforming 不合格品控制Remark 备注Audit Item 评分条款Points 分值Criteria or Function评分标准Total Points 实得分1client's property are properly remarked and putted orderly.对顾客的资产进行了正确的标注并摆放有序2storehouse's circumstance is adopt to client property's characteristic.仓储环境符合客户资产的存放要求3maintain client's property termly.定期对客户资产进行保养4there are written procedures for storage, including all action above.制定了包含上述所有行动内容的库存规章制度1documented inspection procedures are available for inspectors that include identification of critical characteristics.供检验员参考的检验程序有案可查,并且文档对重要特性进行了特别的定义2these written procedures are easily get and understanded by employee.检验程序和标准容易被员工获取和掌握3inspection circumstance,such as light, temperature,noise, humidity are proper.检验环境符合条件（如光线、温度、噪音、湿度等）4documented inspection procedures should include identification of criticalcharacteristics,tolerance,mark and packing.检验程序和标准必须包含重要特性、tolerance 、标识、包装等内容2documented equipment maintain record 有设备维护记录档案4there are written procedures for equipment maintain.all action shall be done.制定了设备维护保养规程并有效地执行了2there are procedures for checking for process changing in manufacture, such as processmaterial changes, changes in manufacturing locations, quality problems. 制定了生产过程变更的检查规程,比如生产原料变更,制造地点变更以及质量问题等等3documented register of testing and aproving for the process changes shall be done before the process update. 在生产过程更新前已经对生产变更的测试和许可进行了记录和存档4there are procedure for notification and approbation of customers before the process update.制定了在生产过程更新前的客户通知和客户许可规程2written employee manual, post responsibility, employee training record.有成文的员工手册、岗位职责和岗位培训记录3personel configure chart and fill-in were confirm.已确认了人员配置和上岗计划4effective assessing and encouragement procedures for employee's action 制定了有效的员工考核和奖励制度4445employee 作业人员Remark 备注44Protection of client's property 顾客资产的保护Inspecte process 检验过程equipment maintain 设备维护process changes in manufacture 生产工艺变更6789。

XX科技有限公司供应商调查表-中英文版(2024年)

3）卡具/Fixtures___________采购/Purchase ___________设计/Des品制造的最大误差是多少？
What manufacturing tolerance are most achievable for your manufacturing operation?
________________________________________________________________________________
2）贵公司的年销售额是多少/Howmuch is the company’s annual sales?
________________________________________________________________________________
贵公司是如何处理以下工装要求/How does your facility handle the following tool requirements?
1）胎具/Dies___________采购/Purchase ___________设计/Design __________制造/Build
2）仪器/Gauges___________采购/Purchase ___________设计/Design__________制造/Build
_________________________________________________________________________________________
8.材料/MATERIALS:
以下哪种材料为贵公司的常规产品？
Which of following material does your facility routinely work with?

供应商申请表英汉对照版

*
VMD application form
Creat a new vendor
Vendor information
供应商英文名 * Name（benificiary name) 供应商英文地址-街区 * Address 1 - Street 供应商英文地址-辖区 * Address 2 - District 供应商英文地址-城市 * Address 3 - City 供应商中文名/银行账户收款名称 * Name (Chinese)/Bank Account Holder Name 供应商中文地址-街区 * Address 1 - Street (Chinese) 供应商中文地址-辖区 * Address 2 - District (Chinese) 供应商中文地址-城市 * Address 3 - City (Chinese) 国家 * Country 邮编 Postal Code 电话 Tel. no. 传真 Fax no. Bank details (in case of telegraphic transfer) 国家 *$ Country 银行英文名 *$ Name 银行中文名 * Name (Chinese) 支行英文名 Branch 银行地址-街区 Address 1 (Street) 银行地址-城市 * Address 2 (City) Swift code $ IBAN or BLZ(if exist) $ 币种 Currency Type $ 银行账号 *$ (Either IBAN or Bank account no.) Bank account no. 银行编号 Bank code 支行编号 Brato avoid affecting the process of your payment, please kindly make sure the correctness and authenticity of the information in the table. And also please put your company or finance chop on the form,Thanks a lot for your kindly cooperation! *The Items with “ “ Must be Supplied. 带有*信息为所有供应商必备信息 *Province & City of the bank are always required.银行名称必须具体到其所在的省、市 * The Items with "$" Must be supplied for any foreign currency bank account.外币账户必须提供对应币种 * Pls attach tax registration certificate. 请附上税务登记证作为附件

供应商评估表(中英文对照)模板

供应商评估表（中英文对照）模板Supplier Evaluation Form (Chinese-English Comparative Template)Introduction 简介：本供应商评估表旨在帮助企业对供应商进行全面评估，以确保供应链的可靠性和效率。

本评估表将提供一份供应商的综合分析，包括质量管理、交货能力、价格竞争力、服务水平和合规性等方面的评估。

为了方便使用，本文提供了中英文对照的模板，供使用者参考和使用。

This Supplier Evaluation Form aims to assist businesses in conducting thorough assessments of their suppliers to ensure reliability and efficiency within the supply chain. The evaluation form will provide a comprehensive analysis of suppliers, including assessments of quality management, delivery capabilities, price competitiveness, service levels, and compliance. For easeof use, this article provides a template with both Chinese and English sections as a reference for users.供应商信息 Supplier Information：供应商名称：______________________________Supplier Name: _______________________________供应商地址：______________________________Supplier Address: _______________________________联系人：______________________________Contact Person: _______________________________联系电话：______________________________Contact Number: _______________________________评估日期：______________________________Evaluation Date: _______________________________评估人员：______________________________Evaluator: _______________________________供应商综合评估 Comprehensive Supplier Evaluation：1.质量管理 Quality Management：1.1 产品质量 Product Quality请根据以下指标对供应商的产品质量进行评估，请在右侧打"√"表示评估结果。

供应商QPA审核表单中英

6 7 8 9 10 11
是否有内校人员？ Are there people within the school? 此人是否有资格从事内部测量仪器或设备的校验活动？ Whether the person is qualified to undertake verification activities inside the measuring instrument or device? 是否有内校作业指导书？ Whether the school operating instructions? 外校机构是否有资质或是国家认可的机构？ Are there agencies outside the school nationally recognized qualification or institution? 是否按校验计划准时或提前对量具及测试/检验设备进行校验，并保存校验证书或记录？ Whether the check on time or ahead of plan for measuring and testing / inspection equipment calibration, and save the calibration certificate or 对校验后的仪器如何进行区分与标识？ After calibration of the instrument and how to distinguish identity? 对校验失效或损坏的仪器设备如何管理？ Checksum failure or damage to the equipment how to manage? 是否有适当的管控以确保针对校验失效采取相应的措施? Are there adequate controls to ensure that the failure to take appropriate measures for the verification? 对所用的测量仪器或设备是否都做测量系统分析（重复性与再现性分析GR&R），并保存有记录？ Of the measuring instrument or device used to measure whether the system analysis done (repeatability and reproducibility analysis GR & R), and the preservation of records?

供应商审核表 SUPPLIER COMPANY AUDIT

1
1
1 1
1
1 1 1 1
DOCUMENT ID SQA_2010_DATE 2010/3/15
SECTION DESIGN
In the Control Plan critical features are clearly identified
and the control frequency and tools are adequate.
Control Plan is present
B3.1 (Audit: get copy of CP for RCP)有控制计划 (审核: 取一份控制计划的复印件)
FORM
F0401
FORM REVISION
1.0
PLANT::
0
FORM REVISED
2010/2/1
1
2
3 EVIDENCES AND REMARKS
B4.1 统计过程控制方法(Cpk)
1
B4
CAPABILITY STUDIES
(审核: 3=经常; 2=只对新零件; 1=新设备)
SPC records and measurements are continuously collected.
B4.2 (Audit: 3=often, 2=on new parts, 1=new equip.)经常收
Brevini Power Transmission SpA
SUPPLIER COMPANY AUDIT
Page 1 of 1
AUDIT CHECKLIST
DESIGN SECTION
SUPPLIER ID:
-
SUPPLIER NAME:
-
SEC TITLE

供应商考察评估表(中英文版本)

Receiving inspection personnel have QA C-6 controlled
10 0 3 4 5 6 7 8 9 10 20 0 6 8 10 12 14 16 18 20
instructio ns defining characteri stics, equipmen and methods used during inspection . 检验员有受控的作业指导书指导，指导书内容包括了检验的项目、设备和方法。
TOTAL RATIN
10 0 3 4 5 6 7 8 9 10 105 20 0 6 8 10 12 14 16 18 20
verified, analyzed and improvem ent actions are generated on a continuou s basis. 在生产中发现的不合格物料经过确认、分析并在持续的基础上推进改善活动。 Nonconformin g materials are properly D-3 identified and segregate d from good material. 不合格物料能明确区分并与合格物料隔离。
Com plian ce Ratin g
Degre e of Imple menta Full tion
Pag e2 of ___ _
Weighted
Score None
NI
Yes No NA (FS)
AD
ER
Score
15 0 4 6 8 9 11 13 14 15
meeting acceptabl e quality standards 品质保证组织的职责以书面形式明确定义，并反映在品质手册中；品质保证组织有权停止不符合质量标准的项目。 There is QA Manual and revision history A-2 reveals continuou s update and review within the 品质保证手册和历史版本能体现出一年内的持续更新和评审。 The QA organizati on operates a defect A-3 preventio program that includes defect analysis and the generatio n of improvem ent actions 品质保证组织推行包括了缺陷分析和改善行动的缺陷预防计划 The QA organizati on prepares and issues A-4 periodic reports and maintains records relative to process

供应商审核报告表中英文对照版

表格编号form code:A-PQEO-15/1-5/03Page页: 2Supplier/供应商: Date日期: QM audit/体系审核a = Requirements are fully satisfied/完全满意*) Please enclose copy附上复印件b = Requirements are satisfied with deviations/基本满意，但稍有偏差c = Requirements are not satisfied/不满意n.a. = Not applicable/不适用a = Requirements are fully satisfied/完全满意*) Please enclose copy附上复印件b = Requirements are satisfied with deviations/基本满意, 但稍有偏差c = Requirements are not satisfied/不满意n. a. = Not applicable/不适用a = Requirements are fully satisfied/完全满意*) Please enclose copy附上复印件b = Requirements are satisfied with deviations/基本满意，但稍有偏差c = Requirements are not satisfied/不满意n. a. = Not applicable/不适用Page页: 3Supplier供应商: Date日期:表格编号form code:A-PQEO-15/1-5/03a = Requirements are fully satisfied完全满意b = Requirements are satisfied with deviations/基本满意，但稍有偏差c = Requirements are not satisfied/不满意n.a. = Not applicable/不适用b = Requirements are satisfied with deviations/基本满意, 但稍有偏差c = Requirements are not satisfied/不满意n. a. = Not applicable/不适用b = Requirements are satisfied with deviations/基本满意，但稍有偏差c = Requirements are not satisfied/不满意n. a. = Not applicable/不适用Page页: 5Supplier/供应商: Date日期:EHS audit/环境健康安全审核表格编号form code:A-PQEO-15/1-5/03a = Requirements are fully satisfied/完全满意*) Please enclose copy附上复印件b = Requirements are satisfied with deviations/基本满意, 但稍有偏差c = Requirements are not satisfied/不满意n.a. = Not applicable/不适用Action plan Enclosure for audit conducted on:Signature Supplier (corrective actions started): ___________________表格编号form code:A-PQEO-15/1-5/03。

供应商评审中英文对照

GCLSolar Energy保利协鑫太阳能SUPPLIER :供应商Assessment Team :供应物名称ASSESSMENT DATE: 供应时间SARSupplier AuditReport供应商审核报告SUPPLIER ASSESSMENTGUIDELINE供应商评估指南2010SUPPLIER ASSESSEMENTMANUFACTURING制造类供应商评估INTRODUCTION引言GCL Solar Energy is committed to product excellence in the markets we serve. We intend to continuously demonstrate this commitment by providing defect-free products on time and at competitive prices.协鑫光伏能源致力于对产品精益求精，在我们服务的市场,我们将不断证明这一承诺，并提供有竞争力的价格，无缺陷的产品。

This requires that we exercise every possible means to assure quality and consistent on-time delivery of purchased goods, which in-turn, contributes to continuous Quality improvement. Through the application of Statistical Process Control (SPC) combined with the cooperation and commitment of our Suppliers and Supply Chain Teams, GCL Solar Energy will drive continuous improvement both in Technical and Commercial aspects of business.这就要求我们千方百计保证质量和购进一致好的部件，不断提高服务质量。

X公司供应商资格评审表(中英文)

XX（XX）有限公司供应商资格评审表批准：审核：评审人：XX Ltd.XXCompany Name:Functionary /Contact person:Address: Postcode:Telephone Number: Fax:Set Up In :Major Product:Work Force: (Senior Technician Quantity); (Commonly Technician Quantity); (Workers)Output Per Year/Production Value Per Year (10 thousand):Related Certificates:Passed Product Or System Attestation：□ Yes (Details) □ NoCapacity: Delivery、Shipment Ability：Business Mode: □ Produce and Sell □ wholesale and retail □AgentProduction Mode: □ Batches □ Mass □ SingleEquipment Status: □All Ready □ Basic Equipment □Lack of EquipmentProduct、Quanlity Standard:A、International Standard Name/Code：B、National/Trade Standard Name/Code：C、Supplier Standard Name/Code：D、Others：Process Document：□ All Ready □ Segment □NoneInspect Department and Inspect Equipment ：Equipment□ All Ready □Part-Time Inspector, Commonly □ None, Need AssistanceInspect Equipment Calibrate Status：□ Have Rooms for Calibrate □ CommissionedMajor Customer (Company/Trade)：Major Material Source：New Product Develop Ability：□ New Product Design And Develop Ability □ Single Product Design And Develop Ability □No AbilityWorkers' Training Status：□Always, Normally □ Not AlwaysOccupational Health and Safety Management Systems 18001：20071、Have Been Punished Due To Illegal Acts On Safety Or Healthy □ yes □ No2、Have Never Put Protect Equipment Or Provided Effective Self-Protect Tools On The Workplace With Big Risks□Yes □ No3、Have Risks In Workplace And Equipments, Or Use Harmful、Poison Chemical □ Yes □ No4、Have Comunnication Mode Of The Law、Safety And Healthy □ Yes □ No5、Had Not Acted At Safety Or Sanitation Accident □Yes □NoEnvironmental Management Systems 14001：20041、Have Been Punished Due To Illegal Acts On Environment □ Yes □ No2、Below Standard Of Contamination □ Yes □No3、Use Resouce Reasonable□ Yes □No4、Have Comunnication Mode Of The Environment Protection □Yes □ No5、Had Not Acted At Environment Accident □ Yes □NoRemark:Result after Appraise：Approved by: Checked by : Judge：。

供应商审核单表(中英文)

检查表——供应商质量审核
Checklist——supplier audit
产品型号/part no: 供应商名称/supplier name ：审核日期/audit date：
1、平面布置图和过程流程图/Plant Layout and Process Flow Diagram
NO.
文
件
要
求/document questions
1.3 流程图是否是最新版本的并标注有日期？
1.4 生产过程中，材料和产品流动是否与过程流程图一致？ does the actual material and production flow follow the process flowchart?
2、设计和过程FMEA/design and process FMEA
评价 evaluate
记录/comments
1.1 是否有最新版平面布置图？ is there a dated copy of the current floor plan readily available? 1.2 平面布置图上是否有所有装配、生产和检测岗位、原材料、半成品、成品的区域划分？ does the floor plan identify the following :all required assembly, process and inspection stations? locations for all raw material, work in process(WIP) and finished product? are process flowcharts dated and current? 操作要求/implementation/process questions

供应商现场审核表-中英文对照表

现场审核表 Onsite Audit FormSupplier 供应商: Address 地址:Supplier Rep. 陪审人员: City/State 省/县: Title/Position 职位:Zip 邮编:Date of Completion 日期:/ /Quality Systems Third Party or Customer Approval第三方或客户批准的质量体系Personnel Contacted相关人员Number of Personnel 人员数量ProductionQualityInspectionEngineeringOtherTotal Plant AreaLead Auditor 审核组长 Department 部门 Auditor 审核员 Department 部门 Auditor 审核员 Department 部门Survey/ Audit Disposition 调查/审核描述: Re-surveyed and Approved : Yes Date:____________ Auditor Name:__________________ Reason for Conditional Approval:______________________________________________________________________________________ Reason for Disapproval:______________________________________________________________________________________ Approved to Manufacture or Service Only:______________________________________________________________________________________ISO 9001 ISO 13485 cGMP (QSR)Other(s)YesNoYes No Yes No YesNoApproved 批准 Conditional Approved Disapproved Yes 是 No 否 Yes NoDate Expires____________Date Expires____________Audit CategoriesCATEGORY I QUALITY ASSURANCE ORGANIZATION AND PLANNING (2)CATEGORY II INITIAL QUALITY PLANNING (3)CATEGORY III INSPECTION AND TEST DOCUMENTATION (3)CATEGORY IV RECORD RETENTION (3)CATEGORY V CORRECTIVE AND PREVENTIVE ACTION (4)CATEGORY VI DRAWING, DOCUMENTATION AND CHANGES (4)CATEGORY VII MEASURING AND TEST EQUIPMENT (4)CATEGORY VIII PURCHASE RESPONSIBILITY (5)CATEGORY IX MATERIALS CONTROL (5)CATEGORY X PRODUCTION PROCESS CONTROL (6)CATEGORY XI FINAL INSPECTION (6)CATEGORY XII STOCKROOM CONTROL (6)CATEGORY XIII PACKAGING, MARKING AND SHIPPING (6)CATEGORY XIV NONCONFORMING MATERIAL (7)CATEGORY XV STATISTICAL SAMPLING (7)CATEGORY XVI FACILITIES/HOUSEKEEPING (8)CATEGORY XVII STERILIZATION/LABORATORY CONTROL (6)Audit Notes:a)Items noted in the “P” column, on the following pages, indicates a deficient area identified during theperformance of the audit.b) A certificate showing third party approval / compliance to either ISO 9001 or ISO 13485 or CMDCAS willsatisfy the quality systems portion of the survey/ audit.c)Self-Declare compliance to cGMP (QSR), at a minimum document control, material control,manufacturing control, and quality control shall be verified.d)Sterilization subcontractor should have ISO 11137 (Radiation) or ISO 11135 (EtO) certified.Category I Quality Assurance Organization and PlanningYes No P OtherA Is the supplier’s system of the Quality Assurance adequately described in approved writtenprocedures/instructions/policies?供應商的質量认证系統是否在經核准的程序/手册/方针里面说明？B Are procedures/instructions/policies maintained current and made available to all concernedpersonnel?是否所有相关人员使用的是最新的程序/手册/方针。