⑴ 您好！请问ISO验厂品保需要哪些文件谢谢了！
Section 1: General Organization Structure
ItemQuestionResultRemark
YesNoN/A
1.1Does the factory have the up to date organizational chart? If yes, please attach a of organization chart.
是否有最新的组织结构图？如有，请提供一份组织结构图。
1.2Are there appropriate arrangements in case of absence of key staffs? Are there any supporting document or record?
主要人员不在时是否有替代安排?有何种支持性的文件或记录？
1.3Does the factory have the definition of responsibility & accountability for key staffs involved with activities impacting proct safety, legality and quality?
对于负责产品安全性、合法性和质量的主要人员，是否有规定的职责和权限？
Section 2: General Facility Management
ItemQuestionResultRemark
YesNoN/A
2.1Is the factory site being maintained to minimize potential for proct contamination and damage?
厂房是否维护良好，避免产品被污染或损害？
2.2Does the factory free of any process running outside/outdoors or only with a sunshade?
是否没有工序或操作在室外或只在有顶棚的外部区域进行？
2.3Does the factory have the process flow diagram? If yes, please attach a of flow diagram.
是否有工序流程图？如是，请提供流程图复印件。
2.4Does the factory site allow sufficient working space and storage capacity to enable all operations to be concted under safe and necessary hygienic conditions?
是否有足够的作业及储存空间，使生产处于安全和卫生的条件下进行？
2.5Does the factory effectively segregate raw material, work in progress, rework, packaging and finished procts to minimize the risk of cross-contamination?
是否对原材料、半成品、返工产品、包装材料及成品等进行有效隔离，防止交叉污染？
2.6Are all machine and equipment adequately maintained and operated to proct safety, quality and legality? Are there maintenance plan and records available?
所有的设备是否维护良好，以满足产品安全，合法性及质量的要求？是否有设备保养计划和记录？
2.7Are cleaning and pest control chemicals suitably identified, labelled, controlled and adequately stored to prevent risk of proct safety, quality and legality?
用于清洁和灭虫的化学品是否适当标识，控制和储存，以免影响到产品的安全，质量和合法性？
2.8Are documented cleaning proceres available (both in-house and outsourced) and maintained for the factory site, utilities, plants and all equipment? Following information should be included
??responsible person for cleaning
??item/area to be cleaned
??frequency of cleaning
??method of cleaning
??cleaning materials to be used
??cleaning records and responsible person for verification
??revalidation procere
对于厂区（内外部），公共设施及设备是否有书面的清洁程序，内容包括：负责人；清洁区域，范围；清洁频次；清洁方式；使用的清洁工具；清洁记录和验证人；消毒和清洁程序的再确认。
2.9Are cleaning, sanitation and housekeeping carried out by trained personnel in accordance with proceres, effectiveness, corrective actions verified and documented and records maintained?
清洁消毒等是否由经过培训的人员实施，是否有相应的清洁记录和必要的验证及纠正措施记录？
2.10Is there any license or registry required from the appropriate government agency? If yes, please attach a of license or registry.
是否有获得适当政府机构所发出的营业执照？如是，请提供营业执照的复印件。
Section 3: Quality Management Systems
ItemQuestionResultRemark
YesNoN/A
3.1Is this an ISO9000 accredited factory? If so, please attach a of certification.
是否获得ISO9000质量体系认证？如是，请提供质量体系认证证书复印件。
3.2Does the quality management system include quality policy, measurable quality objectives , quality manual, proct safety, procere and work instructions and reviewed at least annually?
质量管理体系是否包括质量方针，可测量的质量目标，质量手册，产品安全性，程序文件，作业指导书及年度评审？
3.3Is there an adequate system for controlling customer requirement?
是否有足够的系统来控制顾客的要求？
3.4Does the factory establish specifications for raw materials, components, and bought-in parts including packaging, intermediate/semi-processed and any proct or service which could impact the integrity of the finish proct?
对于所有影响最终产品的原材料，零部件，包材，半成品等，是否建立相关的规格要求？
3.5Does the factory have clearly proct specifications？
是否有成品规范？
*3.6Are specifications accurate and complying to relevant safety, legislative and customer requirements?
规范是否正确并符合相关安全标准、法规及顾客要求？
3.7Is there an up-to-date suppliers & sub-contractors list and suppliers / sub-contractor control procere available?
是否有最新的合格供方（供应商，分包商）清单，及供应商/分包商的控制程序？
3.8Are there internal audit procere and records available?
是否有内审程序和记录？
3.9Does the factory have document control procere?
是否有文件控制程序？
3.10Does the factory have record control procere?
是否有记录控制程序？
3.11Does the factory document all process and proct changes?
过程和产品的变更，是否都保留记录？
3.12Does the factory have CAPA procere?
是否有纠正预防措施程序？
3.13Are the management review concted at least annually, documented and include the evaluation of below?
??Internal, customer and external audits
??Previous management review documents, corrective action plans and time frames
??Customer performance indicators, complaints and feedback
??Incidents, non conforming materials and corrective actions
??An assessment of process performance
??Review of the proct risk assessment system
??Review of the results of monitoring and testing
??Developments in legal requirements or scientific information associated with the procts in scope
??Resource requirements
?Improvement for the validity of quality management system
是否进行年度管理评审，记录包括：
1.内部的，第2或第3方的审核报告
2.以往的管理评审记录，纠正措施计划和时间表
3.客户业绩指标，投诉和反馈
4.事故，不合格品及纠正措施
5.过程业绩的评估
6.产品风险评估系统的评审
7.监控和测试结果的评审
8.与产品相关的法规要求或科技信息的开发和改进
9.资源需求
10.质量管理体系及其过程有效性的改进
3.14Do finished procts (including re-work) have a full traceability to raw material source and vice versa?
是否能从成品追溯到原材料，或反之亦然?
3.15Does the factory test the traceability system to ensure the effectiveness of the system? Is the frequency of test conct at least annually? Results being retained? Time taken to complete the test being measured and recorded?
对该追踪系统有效性的测试，是否至少每年做一次，是否保留结果？是否测算并记录测试所需要的时间?
Section 4: Hazard & Risk Management Systems
ItemQuestionResultRemark
YesNoN/A
4.1Is there a documented procere in place for changing in proct design?
是否有订立文件程序来处理产品设计的更改？
4.2Does the factory define and list the legal statutes and mandatory standards applicable to each proct and to the materials from which it is made, relevant in the regions of intended sale?
是否列明所有与产品相关的符合销售国的法律法规和强制指令？
4.3Does the factory establish a Proct Risk Assessment procere for each proct or a group of similar procts?
是否对单个产品或产品组建立产品风险评估程序？
4.4Does the Proct Risk Assessment ensure the following?
??Hazard/risk identification
??Risk level for each hazard/risk
??Whether the risk is acceptable considering the probability or the severity and potential consequences of the effects on consumer safety
??The person responsible for the assessment
??The date performed and the evidence
??New Proct Risk Assessment for proct with modified design (The risk assessment may be provided by internal or external resources)
产品风险评估记录是否包括：风险识别；风险评级；是否考虑到对消费者安全影响的可能性，严重性和潜在性；评估负责人；评估日期，证据；对于设计更改的产品的重新评估？
4.5Is risk assessment concted and verified by competent personnel prior to proction?
是否在生产前由有资质的人员进行风险评估和验证？
4.6Is the risk assessment regularly and at least annually reviewed (while the procts are still in proction) taking account of complaints or incidents with the proct or similar group of procts and reflects any changes in legislation.
考虑到投诉或生产事故或法规的更改，是否进行至少每年一次的风险评估的评审？
*4.7Does the factory have testing results of a representative proct from a qualified and accredited laboratory (internal or external) as a supporting in risk assessment?
是否有有资质的实验室（内部或第3方）提供的测试结果作为风险评估的依据？
*4.8Does the factory document and verify the identity, qualification and/or license of the person procing the safety review or risk assessment?
是否记录及验证实施安全评审或风险评估的人员的身份、资格和执照?
Section 5: Compliance to Laws and Regulations
ItemQuestionResultRemark
YesNoN/A
*5.1Has the factory a system to ensure it is kept informed of changes to relevant legislation, proct standard, safety, instry/customer codes of practices relevant to the proct in scope and regions of intended sale? If yes, by which way?
是否建立获取最新法规，产品标准，安全性，行业标准的体系？如果有，通过什么方式获取？
5.2Is a documented process exist for incorporating changes in legislation, standards, safety etc, into the factory's proceres?
是否有将相应的变更融入公司程序的书面程序？
5.3Are the copies of legislation, proct standard, proct safety, instry norm and customer code of practices available to the staff?
员工是否能随时查阅相关的法规，产品安全，行业规范及标准？
Section 6: Training & Competency
ItemQuestionResultRemark
YesNoN/A
6.1Does the factory ensure that all employees are able to demonstrate competence with regards to their activity?
??identify the need for training
??document training proceres and records to demonstrate that training is effective and regularly reviewed
??ensure that training included both general information on the factory and specific job training
是否确保员工能力的胜任？培训需求的识别；书面的培训程序和培训记录；培训有效性评价及评审记录；工厂基本信息和特定的岗位培训。
6.2Are employees performing work that direct affects proct safety, legality and quality (including temporary employee and contractors) appropriately trained and instructed prior to commencing work？Are there training records available?
直接影响产品安全，合法性和质量的员工是否在上岗前接受培训？是否保留培训记录？
6.3Are employees concting or participating in risk assessment adequately trained in risk assessment methods? Are there training records available?
进行或参与风险评估的人员是否就风险评估的方法接受足够的培训？是否保留培训记录？
Section 7: Complain & Incidents Management
ItemQuestionResultRemark
YesNoN/A
7.1Is there a documented procere for handling of complains, including clearly defined steps and responsibility?
是否有书面的客诉处理程序，包括步骤及职责？
7.2Is there a documented procere for handling of incidents, which do or potentially can negatively affect proct quality, safety or legality?
针对影响到产品质量，安全或合法性的事故，是否有书面的事故处理程序？
7.3Are there proceres to ensure that customers are notified immediately if an incident arises that could result in or has resulted in customers receiving non-confirming procts?
如有意外事故会导致顾客收到不合格产品，是否有事故通报程序？
7.4Are the complaints / incidents and the actions taken to resolve them being recorded?
投诉/事故及采取的措施是否保留记录？
Section 8: Raw Material Control / Inventory
ItemQuestionResultRemark
YesNoN/A
8.1Does the factory have inspection instructions for incoming materials?
是否建立进料检验规范？
*8.2Does the factory conct incoming inspection in accordance with documented specifications and instructions? Are there inspection records available?
是否按照规格和检验规范要求实施进料检验？是否保留检验记录？
8.3Are raw materials and components stored under suitable conditions and special storage conditions (i.e. required temperature and humidity) are defined and according to established proceres?
原材料存放是否适宜，如有特别的存放条件（温湿度），是否建立相应的程序并遵照执行？
Section 9: Environmental Protection
ItemQuestionResultRemark
YesNoN/A
9.1Has the factory defined an environmental policy, objectives and targets?
是否建立环境方针和目标？
9.2Does the factory have any documents that in compliance with the local environment law and regulation? Such as environmental impact assessment report or pollutant ejection permit.
是否有符合当地环保要求的证明文件，如环评报告或排污许可证？
9.3Are the major environmental aspects defined?
是否定义重要的环境因素？
9.4Does the factory retain records of any hazardous waste disposal?
是否有危险废弃物的处理记录？
Section 10: Inspection / Training
ItemQuestionResultRemark
YesNoN/A
10.1Does the factory have in-process and final inspection instructions, which include the following?
??sample size to be taken
??inspection items
??acceptance / rejection criteria
??defined AQL
??defect classification
??actions to be taken in the case of rejection
是否建立过程和成品检验规范？检验规范是否包括：抽样量；检验项目；接收标准；AQL；疵点分类；拒收后的后续措施？
10.2Does the factory conct in-process inspection in accordance with documented specifications and instructions? Are there inspection records available?
是否按照规格和检验规范要求实施过程检验？是否保留检验记录？
*10.3Does the factory conct final inspection in accordance with documented specifications and instructions? Are there inspection records available?
是否按照规格和检验规范要求实施成品检验？是否保留检验记录？
10.4Are the inspection procere/ instruction approved and reviewed when changes in proction methods or materials occurred?
如果生产方式或材料变更，对即定的检验规范是否进行再确认和评估？
10.5Does the factory have procere to handle the inspected goods, which include the following?
??Policy/rule on returning inspected goods to proction
??Repacking requirements
??Disposal
是否对检验过的产品有处理程序？内容包括：返工；重新包装；处置。
10.6When inspection results are outside the defined acceptance level, does the factory evaluate and review non-conforming procts by a competent person? Where necessary, are corrective action taken and documented?
是否有适当的人员进行不合格品的评审，并保留相关记录？包括纠正措施记录。
10.7Does the factory have assessment/review records of proct test need and proct test plan?
是否有测试需求评审记录和测试计划？
10.8Is there a documented testing procere / programme established for each proct or a group of similar procts? If yes, does the testing procere / programme include the following?
??different stages (e.g., pre-proction, proction) at which testing is to be performed
??test sampling plan
??test specification
??pass or fail criteria
是否有单个产品或产品组的书面的测试程序？如果有，内容是否包括：不同阶段的测试；测试样本量；测试规范；接收标准？
10.9Is the testing of critical parameters undertaken by accredited laboratory (in-house or third party) or the customer's designated testing laboratories as agreed? Are there test reports available?
对于关键参数，是否由有资质的实验室（内部或第3方）或客人指定的实验室进行测试，是否保留测试报告？
10.10Where testing is carried out by third parties, does the factory clearly defined the testing requirements including the reference to number, date and version of the test standard or method to be used?
如果由第3方进行测试，是否在测试申请单里清楚说明测试的要求，包括测试标准或测试方法的编号，日期和版本号？
10.11When test results are outside the defined specification, are they evaluated and reviewed by a nominated person responsible for safety, legality and quality? Where necessary, are corrective action taken and documented?
是否对测试失败进行评审，并保留相关记录？包括纠正措施记录。
Section 11: Non-conforming Proct Capabilities
ItemQuestionResultRemark
YesNoN/A
*11.1Does the factory have non-conforming materials control procere?
是否建立不合格品的控制程序？
11.2Does the factory have re-inspection records for re-worked procts?
是否有返工重验的记录？
11.3Does the factory have recall procere?
是否建立召回程序？
11.4Are recall operations recorded?
是否保留召回记录？
Section 12: Manufacturing Operations / Capabilities
ItemQuestionResultRemark
YesNoN/A
12.1Are working instructions available for operator as a guideline at an accessible place or work station to ensure legality, quality & safety of proct?
是否有作业指导书作为确保产品符合法规，质量和安全的指引？
*12.2Is there any traceability and confirm information on the approved sample? Are the samples well stored and controlled?
确认样上是否有可追溯的信息和确认的信息？确认样是否良好地存放和控制？
12.3Are there pre-proction meetings concted prior to proction of new or substantially changed procts, and to evaluate and approve the processes? Are the meeting records available?
当生产新产品或产品本质变更时，是否召开产前会议来评估和确认相关的生产过程?是否保留会议记录？
12.4Does the factory have first sample checking record?
是否有首件样确认记录？
12.5Does the factory adjust or calibrate the identified measuring and monitoring devices to ensure accuracy? Verification and maintenance at defined period and recorded?
是否对计量设备/工具进行校准或检定？是否保留相关的记录及证书？
12.6Does the factory have a well organized maintenance team to give immediate response to a machinery breakdown or emergency that affects proction? Or have maintenance cover sub-contracted with a guaranteed response time? What is guaranteed time?
是否有机修组对故障设备立即响应？或机修业务外包的话，是否保证响应时间？响应时间是多少小时？
12.7Are there proceres in place for action to be taken if equipment if found not to be
如需更多内容，请留下邮箱，方便发送
⑵ iso验厂学到了什么
年审来而已，既然证书都拿自到了，说明体系文件齐全，提前通读一下质量手册及程序文件。现场管理及表单记录比较重要，请老板向各部门宣导一下，按文件来，该做的事项及记录都做到位就可以了。另外，接待的部分也要做好，接送，吃饭，住宿之类的
⑶ ISO验厂到底验什么东西
年审而已，既然证书都拿到了，说明体系文件齐全，提前通读一下质量手册及程序文专件。现场管理属及表单记录比较重要，请老板向各部门宣导一下，按文件来，该做的事项及记录都做到位就可以了。另外，接待的部分也要做好，接送，吃饭，住宿之类的
⑷ 考ISO认证咨询师，是不是必须要先培训后考试，可以直接参加考试吗在线等急，谢谢大家！
咨询师是不需要参加培训的，具体可以参看《质量管理体系认证咨询师注册准则》
可以直接参加考试，考试安排可去CCAA官方网站查询
⑸ 为什么企业要做ISO认证，9001验厂辅导费用
ISO9001认证是ISO9000族标准所包括的一组质量管理体系核心标准之一.ISO9001标准帮助您建立质量管理体系以符合您客户的质量要求.同时持续改进运作流程.由于ISO9001并非基于特定行业和特定产品.因此可以为任何提供产品或服务的组织所使用.
ISO9001认证用于证实组织具有提供满足顾客要求和适用法规要求的ISO9001认证证书产品的能力.目的在于增进顾客满意.随着商品经济的不断扩大和日益国际化.为提高产品的信誉.减少重复检验.削弱和消除贸易技术壁垒.维护生产者.经销者.用户和消费者各方权益,这个认证方不受产销双方经济利益支配.公证.科学.
⑹ ISO9000验厂需要准备哪些资料
自行检查一下以下文件和记录，审核中会审到的:
1、文件部分:文件台帐；受控专文件的发属放和签收记录；作废文件回收记录；文件更改审批记录；外来文件目录；文件标识等；
2、生产部分:生产流程图；生产现场作业指导票；各种检查规定；各种检查记录（按文件要求所作成的记录）；人员培训记录；特殊岗位培训、考核、上岗证；
3、采购部分:供应商资料，包括供应商分级、年度监查记录、各类执照及资质证明；采购清单；采购检查要求及记录（IQC）等；
4、人力资源部分:招聘需求；招聘计划；招聘实绩；人员入职要求；人员培训记录、考核记录；
5、设备部分:设备入库检查记录；设备日常检查记录；设备定期检查记录；设备维修记录；操作人员培训记录；操作人员上岗证；
6、生产计划及销售部分:生产计划记录；出入库记录；顾客满意度调查的各类记录，包括对不满意项的纠正和预防记录；订单管理等；
7、审核部分:内审计划；内审检查表；内审首（末）次会议记录；内审报告；不符合项报告及纠正措施；管理评审记录、报告；
8、目标管理部分:公司质量方针目标；各部门分解并实施情况等。
⑺ iso9001验厂学到了什么
年审复而已，既然证书制都拿到了，说明体系文件齐全，提前通读一下质量手册及程序文件。现场管理及表单记录比较重要，请老板向各部门宣导一下，按文件来，该做的事项及记录都做到位就可以了。另外，接待的部分也要做好，接送，吃饭，住宿之类的
⑻ ISO客户验厂需哪些资料，要如何回答客户提出的问题
1.客户审核前会发给你一份check list, 你可以根据list内容项目提前准备体系文件，表单记录等资料，做到心中先有底，就是所谓的自评。2.客户提出疑问时，有资料的就把资料拿出来，实际的东西比任何回答都重要，因为客户最看重的是你公司的执行力3.如确实没有资料能拿出来，那就告诉今后改善的方向，不管客户说的是对还是错，千万不要和客户争论4.客户需要的资料，一般是贵司ISO系统文件及各部门运行的资料,主要有以下几部分： a.管理体系手册 方针、目标、组织架构图、品质保证体系流程图(文控） b.培训资料 培训计划、签到表、考试卷、上岗证（行政） c.内审及管审资料 内部审核及管理评审计划、实施记录（文控） d.订单评审资料（业务） e.QC工程图、工程变更记录、新产品开发评审记录、SOP（工程） f.供应商管理资料，供应商稽查计划、评价记录、月考核记录（品保、采购） g.进料、制程、出货检验标准、检验记录、仪校记录 （品保） h.仓库及生产现场5S，标识、区域划分（仓库，生产） I.不合格处理流程图、异常改善资料（品保） 这是我多次接待客户稽查的经验，预祝贵司能顺利通过客户稽查。顺便BS下LS不懂的。
⑼ ISO9001是哪个机构在负责有什么要求验厂流程与CCC有啥不同请详细些，谢谢
ISO9001是国际标准化组织（ISO）提出的概念，由ISO/TC176（国际标准化组织质量管理和质量保证技术委员会）制定的国际标准。
验厂一般是根据客户要求来进行，CCC认证是国家强制性认证。
⑽ 如何三合一认证，为什么要做ISO认证，需要验厂吗
一、三合一认证就是ISO9000、ISO14000和OHSAS18000三个体系认证合在一起进行，出具一份证书回。
二、
1. 提升企业形象答；
2. 强化品质管理，提高企业效益；增强客户信心，扩大市场份额；
3. 获得了国际贸易“通行证”，消除了国际贸易壁垒；
4. 节省了第二方审核的精力和费用；
5. 在产品品质竞争中永远立于不败之地。
三、需要验厂