ISO验厂文件清单.docx

1、ISO验厂文件清单Section 1: General Organization StructureItemQuestionResultRemarkYesNoN/A1.1Does the factory have the up to date organizational chart? If yes, please attach a copy 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 the

2、re 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 product 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 ManagementI

3、temQuestionResultRemarkYesNoN/A2.1Is the factory site being maintained to minimize potential for product 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 proces

4、s flow diagram? If yes, please attach a copy 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 conducted 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 ef

5、fectively segregate raw material, work in progress, rework, packaging and finished products 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 product safety, quality and legality? Are there mainten

6、ance 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 product 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 cl

7、eaning procedures 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

8、 cleaning records and responsible person for verification revalidation procedure 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 procedures, effectiveness, corrective

9、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 copy 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

10、SystemsItemQuestionResultRemarkYesNoN/A3.1Is this an ISO9000 accredited factory? If so, please attach a copy 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, product safety, procedure an

11、d 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 packag

12、ing, intermediate/semi-processed and any product or service which could impact the integrity of the finish product?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 product specifications？是否有成品规范？*3.6Are specifications accurate and complying to relevant safety, legislative and

13、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 procedure 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 procedure and records available?是否有内审程序和记录？3.9Does the factory have doc

14、ument control procedure? 是否有文件控制程序？3.10Does the factory have record control procedure? 是否有记录控制程序？3.11Does the factory document all process and product changes?过程和产品的变更，是否都保留记录？3.12Does the factory have CAPA procedure?是否有纠正预防措施程序？3.13Are the management review conducted at least annually, documented a

15、nd 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 Rev