⑴ 您好！請問ISO驗廠品保需要哪些文件謝謝了！
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.
是否有最新的組織結構圖？如有，請提供一份組織結構圖。
1.2Are there appropriate arrangements in case of absence of key staffs? Are there any supporting document or record?
主要人員不在時是否有替代安排?有何種支持性的文件或記錄？
1.3Does the factory have the definition of responsibility & accountability for key staffs involved with activities impacting proct safety, legality and quality?
對於負責產品安全性、合法性和質量的主要人員，是否有規定的職責和許可權？
Section 2: General Facility Management
ItemQuestionResultRemark
YesNoN/A
2.1Is the factory site being maintained to minimize potential for proct contamination and damage?
廠房是否維護良好，避免產品被污染或損害？
2.2Does the factory free of any process running outside/outdoors or only with a sunshade?
是否沒有工序或操作在室外或只在有頂棚的外部區域進行？
2.3Does the factory have the process flow diagram? If yes, please attach a of flow diagram.
是否有工序流程圖？如是，請提供流程圖復印件。
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?
是否有足夠的作業及儲存空間，使生產處於安全和衛生的條件下進行？
2.5Does the factory effectively segregate raw material, work in progress, rework, packaging and finished procts to minimize the risk of cross-contamination?
是否對原材料、半成品、返工產品、包裝材料及成品等進行有效隔離，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?
所有的設備是否維護良好，以滿足產品安全，合法性及質量的要求？是否有設備保養計劃和記錄？
2.7Are cleaning and pest control chemicals suitably identified, labelled, controlled and adequately stored to prevent risk of proct safety, quality and legality?
用於清潔和滅蟲的化學品是否適當標識，控制和儲存，以免影響到產品的安全，質量和合法性？
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
對於廠區（內外部），公共設施及設備是否有書面的清潔程序，內容包括：負責人；清潔區域，范圍；清潔頻次；清潔方式；使用的清潔工具；清潔記錄和驗證人；消毒和清潔程序的再確認。
2.9Are cleaning, sanitation and housekeeping carried out by trained personnel in accordance with proceres, effectiveness, corrective actions verified and documented and records maintained?
清潔消毒等是否由經過培訓的人員實施，是否有相應的清潔記錄和必要的驗證及糾正措施記錄？
2.10Is there any license or registry required from the appropriate government agency? If yes, please attach a of license or registry.
是否有獲得適當政府機構所發出的營業執照？如是，請提供營業執照的復印件。
Section 3: Quality Management Systems
ItemQuestionResultRemark
YesNoN/A
3.1Is this an ISO9000 accredited factory? If so, please attach a of certification.
是否獲得ISO9000質量體系認證？如是，請提供質量體系認證證書復印件。
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?
質量管理體系是否包括質量方針，可測量的質量目標，質量手冊，產品安全性，程序文件，作業指導書及年度評審？
3.3Is there an adequate system for controlling customer requirement?
是否有足夠的系統來控制顧客的要求？
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?
對於所有影響最終產品的原材料，零部件，包材，半成品等，是否建立相關的規格要求？
3.5Does the factory have clearly proct specifications？
是否有成品規范？
*3.6Are specifications accurate and complying to relevant safety, legislative and customer requirements?
規范是否正確並符合相關安全標准、法規及顧客要求？
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（供應商，分包商）清單，及供應商/分包商的控製程序？
3.8Are there internal audit procere and records available?
是否有內審程序和記錄？
3.9Does the factory have document control procere?
是否有文件控製程序？
3.10Does the factory have record control procere?
是否有記錄控製程序？
3.11Does the factory document all process and proct changes?
過程和產品的變更，是否都保留記錄？
3.12Does the factory have CAPA procere?
是否有糾正預防措施程序？
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
是否進行年度管理評審，記錄包括：
1.內部的，第2或第3方的審核報告
2.以往的管理評審記錄，糾正措施計劃和時間表
3.客戶業績指標，投訴和反饋
4.事故，不合格品及糾正措施
5.過程業績的評估
6.產品風險評估系統的評審
7.監控和測試結果的評審
8.與產品相關的法規要求或科技信息的開發和改進
9.資源需求
10.質量管理體系及其過程有效性的改進
3.14Do finished procts (including re-work) have a full traceability to raw material source and vice versa?
是否能從成品追溯到原材料，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?
對該追蹤系統有效性的測試，是否至少每年做一次，是否保留結果？是否測算並記錄測試所需要的時間?
Section 4: Hazard & Risk Management Systems
ItemQuestionResultRemark
YesNoN/A
4.1Is there a documented procere in place for changing in proct design?
是否有訂立文件程序來處理產品設計的更改？
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?
是否列明所有與產品相關的符合銷售國的法律法規和強制指令？
4.3Does the factory establish a Proct Risk Assessment procere for each proct or a group of similar procts?
是否對單個產品或產品組建立產品風險評估程序？
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)
產品風險評估記錄是否包括：風險識別；風險評級；是否考慮到對消費者安全影響的可能性，嚴重性和潛在性；評估負責人；評估日期，證據；對於設計更改的產品的重新評估？
4.5Is risk assessment concted and verified by competent personnel prior to proction?
是否在生產前由有資質的人員進行風險評估和驗證？
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.
考慮到投訴或生產事故或法規的更改，是否進行至少每年一次的風險評估的評審？
*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?
是否有有資質的實驗室（內部或第3方）提供的測試結果作為風險評估的依據？
*4.8Does the factory document and verify the identity, qualification and/or license of the person procing the safety review or risk assessment?
是否記錄及驗證實施安全評審或風險評估的人員的身份、資格和執照?
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?
是否建立獲取最新法規，產品標准，安全性，行業標準的體系？如果有，通過什麼方式獲取？
5.2Is a documented process exist for incorporating changes in legislation, standards, safety etc, into the factory's proceres?
是否有將相應的變更融入公司程序的書面程序？
5.3Are the copies of legislation, proct standard, proct safety, instry norm and customer code of practices available to the staff?
員工是否能隨時查閱相關的法規，產品安全，行業規范及標准？
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
是否確保員工能力的勝任？培訓需求的識別；書面的培訓程序和培訓記錄；培訓有效性評價及評審記錄；工廠基本信息和特定的崗位培訓。
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?
直接影響產品安全，合法性和質量的員工是否在上崗前接受培訓？是否保留培訓記錄？
6.3Are employees concting or participating in risk assessment adequately trained in risk assessment methods? Are there training records available?
進行或參與風險評估的人員是否就風險評估的方法接受足夠的培訓？是否保留培訓記錄？
Section 7: Complain & Incidents Management
ItemQuestionResultRemark
YesNoN/A
7.1Is there a documented procere for handling of complains, including clearly defined steps and responsibility?
是否有書面的客訴處理程序，包括步驟及職責？
7.2Is there a documented procere for handling of incidents, which do or potentially can negatively affect proct quality, safety or legality?
針對影響到產品質量，安全或合法性的事故，是否有書面的事故處理程序？
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?
如有意外事故會導致顧客收到不合格產品，是否有事故通報程序？
7.4Are the complaints / incidents and the actions taken to resolve them being recorded?
投訴/事故及採取的措施是否保留記錄？
Section 8: Raw Material Control / Inventory
ItemQuestionResultRemark
YesNoN/A
8.1Does the factory have inspection instructions for incoming materials?
是否建立進料檢驗規范？
*8.2Does the factory conct incoming inspection in accordance with documented specifications and instructions? Are there inspection records available?
是否按照規格和檢驗規范要求實施進料檢驗？是否保留檢驗記錄？
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?
原材料存放是否適宜，如有特別的存放條件（溫濕度），是否建立相應的程序並遵照執行？
Section 9: Environmental Protection
ItemQuestionResultRemark
YesNoN/A
9.1Has the factory defined an environmental policy, objectives and targets?
是否建立環境方針和目標？
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.
是否有符合當地環保要求的證明文件，如環評報告或排污許可證？
9.3Are the major environmental aspects defined?
是否定義重要的環境因素？
9.4Does the factory retain records of any hazardous waste disposal?
是否有危險廢棄物的處理記錄？
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
是否建立過程和成品檢驗規范？檢驗規范是否包括：抽樣量；檢驗項目；接收標准；AQL；疵點分類；拒收後的後續措施？
10.2Does the factory conct in-process inspection in accordance with documented specifications and instructions? Are there inspection records available?
是否按照規格和檢驗規范要求實施過程檢驗？是否保留檢驗記錄？
*10.3Does the factory conct final inspection in accordance with documented specifications and instructions? Are there inspection records available?
是否按照規格和檢驗規范要求實施成品檢驗？是否保留檢驗記錄？
10.4Are the inspection procere/ instruction approved and reviewed when changes in proction methods or materials occurred?
如果生產方式或材料變更，對即定的檢驗規范是否進行再確認和評估？
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
是否對檢驗過的產品有處理程序？內容包括：返工；重新包裝；處置。
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?
是否有適當的人員進行不合格品的評審，並保留相關記錄？包括糾正措施記錄。
10.7Does the factory have assessment/review records of proct test need and proct test plan?
是否有測試需求評審記錄和測試計劃？
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
是否有單個產品或產品組的書面的測試程序？如果有，內容是否包括：不同階段的測試；測試樣本量；測試規范；接收標准？
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?
對於關鍵參數，是否由有資質的實驗室（內部或第3方）或客人指定的實驗室進行測試，是否保留測試報告？
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方進行測試，是否在測試申請單里清楚說明測試的要求，包括測試標准或測試方法的編號，日期和版本號？
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?
是否對測試失敗進行評審，並保留相關記錄？包括糾正措施記錄。
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製程序？
11.2Does the factory have re-inspection records for re-worked procts?
是否有返工重驗的記錄？
11.3Does the factory have recall procere?
是否建立召回程序？
11.4Are recall operations recorded?
是否保留召回記錄？
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?
是否有作業指導書作為確保產品符合法規，質量和安全的指引？
*12.2Is there any traceability and confirm information on the approved sample? Are the samples well stored and controlled?
確認樣上是否有可追溯的信息和確認的信息？確認樣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?
當生產新產品或產品本質變更時，是否召開產前會議來評估和確認相關的生產過程?是否保留會議記錄？
12.4Does the factory have first sample checking record?
是否有首件樣確認記錄？
12.5Does the factory adjust or calibrate the identified measuring and monitoring devices to ensure accuracy? Verification and maintenance at defined period and recorded?
是否對計量設備/工具進行校準或檢定？是否保留相關的記錄及證書？
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?
是否有機修組對故障設備立即響應？或機修業務外包的話，是否保證響應時間？響應時間是多少小時？
12.7Are there proceres in place for action to be taken if equipment if found not to be
如需更多內容，請留下郵箱，方便發送
⑵ iso驗廠學到了什麼
年審來而已，既然證書都拿自到了，說明體系文件齊全，提前通讀一下質量手冊及程序文件。現場管理及表單記錄比較重要，請老闆向各部門宣導一下，按文件來，該做的事項及記錄都做到位就可以了。另外，接待的部分也要做好，接送，吃飯，住宿之類的
⑶ ISO驗廠到底驗什麼東西
年審而已，既然證書都拿到了，說明體系文件齊全，提前通讀一下質量手冊及程序文專件。現場管理屬及表單記錄比較重要，請老闆向各部門宣導一下，按文件來，該做的事項及記錄都做到位就可以了。另外，接待的部分也要做好，接送，吃飯，住宿之類的
⑷ 考ISO認證咨詢師，是不是必須要先培訓後考試，可以直接參加考試嗎在線等急，謝謝大家！
咨詢師是不需要參加培訓的，具體可以參看《質量管理體系認證咨詢師注冊准則》
可以直接參加考試，考試安排可去CCAA官方網站查詢
⑸ 為什麼企業要做ISO認證，9001驗廠輔導費用
ISO9001認證是ISO9000族標准所包括的一組質量管理體系核心標准之一.ISO9001標准幫助您建立質量管理體系以符合您客戶的質量要求.同時持續改進運作流程.由於ISO9001並非基於特定行業和特定產品.因此可以為任何提供產品或服務的組織所使用.
ISO9001認證用於證實組織具有提供滿足顧客要求和適用法規要求的ISO9001認證證書產品的能力.目的在於增進顧客滿意.隨著商品經濟的不斷擴大和日益國際化.為提高產品的信譽.減少重復檢驗.削弱和消除貿易技術壁壘.維護生產者.經銷者.用戶和消費者各方權益,這個認證方不受產銷雙方經濟利益支配.公證.科學.
⑹ ISO9000驗廠需要准備哪些資料
自行檢查一下以下文件和記錄，審核中會審到的:
1、文件部分:文件台帳；受控專文件的發屬放和簽收記錄；作廢文件回收記錄；文件更改審批記錄；外來文件目錄；文件標識等；
2、生產部分:生產流程圖；生產現場作業指導票；各種檢查規定；各種檢查記錄（按文件要求所作成的記錄）；人員培訓記錄；特殊崗位培訓、考核、上崗證；
3、采購部分:供應商資料，包括供應商分級、年度監查記錄、各類執照及資質證明；采購清單；采購檢查要求及記錄（IQC）等；
4、人力資源部分:招聘需求；招聘計劃；招聘實績；人員入職要求；人員培訓記錄、考核記錄；
5、設備部分:設備入庫檢查記錄；設備日常檢查記錄；設備定期檢查記錄；設備維修記錄；操作人員培訓記錄；操作人員上崗證；
6、生產計劃及銷售部分:生產計劃記錄；出入庫記錄；顧客滿意度調查的各類記錄，包括對不滿意項的糾正和預防記錄；訂單管理等；
7、審核部分:內審計劃；內審檢查表；內審首（末）次會議記錄；內審報告；不符合項報告及糾正措施；管理評審記錄、報告；
8、目標管理部分:公司質量方針目標；各部門分解並實施情況等。
⑺ iso9001驗廠學到了什麼
年審復而已，既然證書制都拿到了，說明體系文件齊全，提前通讀一下質量手冊及程序文件。現場管理及表單記錄比較重要，請老闆向各部門宣導一下，按文件來，該做的事項及記錄都做到位就可以了。另外，接待的部分也要做好，接送，吃飯，住宿之類的
⑻ ISO客戶驗廠需哪些資料，要如何回答客戶提出的問題
1.客戶審核前會發給你一份check list, 你可以根據list內容項目提前准備體系文件，表單記錄等資料，做到心中先有底，就是所謂的自評。2.客戶提出疑問時，有資料的就把資料拿出來，實際的東西比任何回答都重要，因為客戶最看重的是你公司的執行力3.如確實沒有資料能拿出來，那就告訴今後改善的方向，不管客戶說的是對還是錯，千萬不要和客戶爭論4.客戶需要的資料，一般是貴司ISO系統文件及各部門運行的資料,主要有以下幾部分： a.管理體系手冊 方針、目標、組織架構圖、品質保證體系流程圖(文控） b.培訓資料 培訓計劃、簽到表、考試卷、上崗證（行政） c.內審及管審資料 內部審核及管理評審計劃、實施記錄（文控） d.訂單評審資料（業務） e.QC工程圖、工程變更記錄、新產品開發評審記錄、SOP（工程） f.供應商管理資料，供應商稽查計劃、評價記錄、月考核記錄（品保、采購） g.進料、製程、出貨檢驗標准、檢驗記錄、儀校記錄 （品保） h.倉庫及生產現場5S，標識、區域劃分（倉庫，生產） I.不合格處理流程圖、異常改善資料（品保） 這是我多次接待客戶稽查的經驗，預祝貴司能順利通過客戶稽查。順便BS下LS不懂的。
⑼ ISO9001是哪個機構在負責有什麼要求驗廠流程與CCC有啥不同請詳細些，謝謝
ISO9001是國際標准化組織（ISO）提出的概念，由ISO/TC176（國際標准化組織質量管理和質量保證技術委員會）制定的國際標准。
驗廠一般是根據客戶要求來進行，CCC認證是國家強制性認證。
⑽ 如何三合一認證，為什麼要做ISO認證，需要驗廠嗎
一、三合一認證就是ISO9000、ISO14000和OHSAS18000三個體系認證合在一起進行，出具一份證書回。
二、
1. 提升企業形象答；
2. 強化品質管理，提高企業效益；增強客戶信心，擴大市場份額；
3. 獲得了國際貿易「通行證」，消除了國際貿易壁壘；
4. 節省了第二方審核的精力和費用；
5. 在產品品質競爭中永遠立於不敗之地。
三、需要驗廠