供应商质量审核检查表
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要求requirement评审人员的记录Records of audit客观证据Evidence组织是否按照ISO9001:2000的要求建立、执行并维护一个书面化的品质管理系统?Does the organization established, implemented and maintained adocumental quality management system according to the requirement ofISO9001:2000?组织是否对影响产品符合要求的外包过程实施控制?Does the organization perform necessary control when outsource will affect the quality of producf?品质管理系统文件是否包括以下方面:Does the quality management system documentation including thefollowing?a)文件化叙述的品质方针和品质目标?Documented statiments of a quality policy and quality objectives?b)品质手册?Quality Manual?c)ISO9001:2000所要求的文件化程序?Documented procedures required by ISO9001:2000?d)组织为确保其过程有效规则、运作和控制所需文件?Documents needed by organization to ensure the effective planningoperation and control of its processes?e)ISO9001:2000所需求的记录?Records required by ISO9001:2000?组织是否对品质管理系统所要求的文件进行控制?Does the organization control the documents required by qualitymanagement system?组织是否编制文件化的程序,以规定以下方面所需的控制:Does the organization establish documental procedure to prescribe thefollowing?a)文件发布前得到适宜的批准? To approve the documents for adequacy prior to issue?b)必要时,对文件进行审查与更新,并再次批准? To review and update as necessary and rd-approve documents?c)确保文件的更新和现行修订状态已得到识别? To ensure that changes and the current revision status of documents areidentified?d)确保在使用的处所可获得适用文件的有关版本? To ensure that relevant versions of applicable documents are available atpoints of use?e)确保文件保持清晰、易于识别? To ensure that documents remain legible and readily identifiable?f )确保外来原始文件得到识别、并控制其分发? To ensure that documents of external origin are identified and theirdistribution controlled?g)防止作废文件的非预期使用,若因任何原因而保留某作废文件时,对这些文件进行适当的标识?To prevent the unintended use of obsolets documents, and to applysuitable identification to them if they are retained for any purpose?组织是否建立一过程以确保能根据顾客要求的时程来及时审查、发放和实施所有顾客工程标准/规范及更改?Does the organization establish a process to assure the timely reviewdistribution and implementation of all customer engineering standards/specifications and changes based on customer-required schedule?组织是否保存每项更改在生产中实施的日期记录?Does the organization maintain a record of the date on which each674.2.3.1工程规范 Engineering specifications54.2.3 文件控制 Control of documents43供应商质量审核检查表Supplier quality audit checklist
4.2.1总则General2要素4.2文件要求Documentation requirements要素4-品质管理系统Quality management system4.1总要求General requirement1
change is implemented in production?组织是否建立并保持记录,以提供符合要求和品质管理系统有效运行的证据?Does the organization establish and maintain records to provide evidenceof conformity to requirements and of the effective operation of the qualitymanagement system?记录是否保持清晰、易于识别和存取?Does the records remain legible,readily identifiable and retrievable?组织是否编制文件化的程序,以规定记录的标识、储存、保护、存取、保存期限和处置所需的控制?Does the organization establish documental procedure to define thecontrols needed for the identification,storage,protection,retrieval,retentiontime and disposition of records?最高管理者是否以增进顾客为满意目标,确保顾客的要求以得到确定并予满足?Does the top management ensure that customer requirements aredetermined and fulfilled with the aim of enhancing customer satisfaction?最高管理者是否确保在组织中的相关职能和阶层上建立品质目标,品质目标包括满足产品要求所需要的内容?Does the top management establish quality objectives at relevantfunctions and levels within the organization?Quality objectives,includingthose needed to meet requirements for product.组织的品质目标是否是可测量的,并与品质政策维持一致?Does the quality objectives are measurable and consistent with thequality policy or not?组织的最高管理者是否确保:Top management shall ensure:a)品质管理系统规划的实现,以满足品质目标以及ISO9001:2000对品质管理系统的一般要求?Dose the planning of the quality management system is carried out inorder to meet the requirements of ISO9001:2000,as well as the qualityobjectives?b)当对品质管理系统的变更进行规划和实施时,维持品质管理系统的完整性?Does the integrity of the quality management system is maintained whenchanges to the quality management system are planned andimplemented?组织的最高管理者是否确保组织内的职责、授权得到规定和传达?Does the top management ensure that the responsibilities andauthorities are defined and communicated within the organization?负责产品品质的组织人员,为了矫正品质问题,是否有权停止生产?Do the personnel responsible for quality have the authority to stopproduction to correct quality problems?对横跨所有班次的组织生产作业是否指定了负责确保产品品质的人员?Do the production operations across all shifts have been staffed withpersonnel in charge of,or delegated responsibility for,ensuring productquality?组织的最高管理者是否任命一名管理阶层人员,无论该成员为何,必须具有心下方面的职责和授权:Has the top management appointed a member of management who,irrespective of other responsibilities, shall have responsibility andauthority that include?a) 确保品质管理系统所需的过程得到建立、实施和维持? Ensuring that proceses needed for the quality management system1516175.5.1.1品质职责Responsibility for quality
5.2.2管理者代表Management representative
185.4.2品质管理系统规划 Quality management system planning
5.5 职责,授权和沟通Responsibility,authority and communication5.5.1职责和授权Responsibility and authority7
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124.2.4记录控制Control of records
5.3品质政策5.4品质目标89105-管理职责Management responsibility5.2以顾客为关注焦点 Customer focus