ISO9001质量管理体系现场审核记录参考要点

1、ISO9001-2008质量管理体系现场审核记录参考General Checklist TSO 9001:2008 for Document Assessment and Site Audit通用检查表一一ISO 9001:2008文件审核及现场审核Company 公司: Current Address 现地址: PostCode 邮区编号:Tel电话:Fax传真:CurrentContacts 现联络人:Current Employees 现员工总数： Assessment Scope 审核范围:Washing and cleaning the Anti-static clothes and cleaned clothes Exclusions 删减:7。3DocumentsSubmitted 已提交之文件：质量手册 程序文 件 Doc Assess Date文件审核日期：2007-08-28 Prog Date 计划日期：Sep,12-13,2007SiteAssess Date现场审核日期Sep,12-13,2007 Lead Auditor 主任审核员 :Team Member

2、s(s)小组成员:Comments备 Thisdocument or attached notesshall be completed in sufficient detail to provide evidence of the depth and content of the audit.文件及所附记录应充分且详尽地提供审核深度和内容的证据(E) = enhancement/clarification 澄# Compared to ISO 9001:1994(N) = new requirement 新要求These notes are for guidance only and reference should be made to the specific terms of the ISO 9001:2000 standard. 本检查表仅提供 指南，应参考ISO9001:2008标准的条款4.0 Qualit) Management Systems 质量管理体系Docs.文件Site 现场References orcomments备注卅F语4.1 General Requir

3、ements 总要求(N) requires continual improvements from QMS (see paia 8.5) 要求持续改进质量管理体系(见8.5)(E) requires identification of processes and interaction 要求识别过程及相互作用(E) any out-sourced processes identified for control? 对任何识别的外包过程的控制Note: these are general requirements and may be addressed anywhere in the DQS备注:这些是总嬖求，川.在任何文件化的质贸体系中描述a. identify the processes needed for the quality management system and their appKcat ion throughout the organisation (see 1.2) 识别质量管理体系所需的过程及其在组织中的应用(见1.2) b, determine the s

4、equence and interaction of these processes. 确定这些过程的顺序和相互作用c. determine criteria and methods needed to ensure that both the operation and control of these processes are effective.确定为确保这些过程的行效运行和控制所需的准则和方法d. ensure the availability of resources and information necessary to support the operation and monitoring of these processes.确保川.以狭石必要的资源和，以ji”匕过程的运作和对这 些过程的监视e. monitor, measure and analyse these processes, and 监视，测量和分析这些过程f. imp lenient actions necessary to achieve planned results andcontinual

5、improvements of these processes.实施必要的措施，实现对这些过程规划的结果和对这些过程的持 续改进OKOK质用手册：QEM01 版本：AA)生效日期：2007-05-30 批准人，鲍琪公司介绍：第覃 组织架构：第章： .门职责：第五号 计、目标，手册A通过所有项目的审核证实QMSH：康上目标、质配方小内审、 管理浮市以及质量方.B经誉公司已建立质量手曷 一套，程序文件27套,机器 操作说明书.作业指导书、 管理觇定36 c .质量记#93 个,可 一:C该公司是专业从事:无尘 服及防静电JR清洗、清洁 服务D：删减7.3E特殊过程:外包过程：仪器外校4.2 Documentation Requirements 文件要求4.2.1 General 总则(N) documented statement of quality “objectives” 质量目标文件化陈述Note: on ly six clauses have mandatory requirement for documented procedures.注：只有六个条款强制要求文件化的程序a.

6、documented statements of a quality policy and quality objectives. 形成文件的质量方针和质量目标b. a quality manual.质量手册c. documented procedures required by this International Standard. 标准要求的形成文件的程序d. documents needed by the organisation to ensure the effective planning, operation and control of its processes and 组织为确保其过程的仃效策划、运作和控制所需的文件e. records required by this Internal Standard (see 4.2.4)本标准要求的记录(见4.2.4)OKOK质量目标分解: 质量手册文件化的程序：共27个 程序丈件：文件和资料管理程序 质量记录管理程序 内部审核管理程序 不合格品管理程序 纠正预防措施管理程序 质量记录: 93个文件现场comments备注

7、将语4.2.2Quallty Manual 质量手册(E) must inc lude scope of QMS必需包括质量管理体系的范围(N) must include details and Justification for any exclusions必需包括任何删减的细V及其合理性(N) must include description of interaction between processes?必需包括过程之间相互作用的表述a. the cope of the QMS. including details of and justification for any exclusions (see 1.2).质量管理体系的范忖，包括任何删减的细行及其合理性b. the documented procedures established for the QMS. or reference to them, and为质量管理体系编制的形成文件的程序或时其引用c. a description of the interaction between the processes of

8、 the QMS 质量管理体系过程之间相互作用的表述质量 手册QEM0 1OK删减：7.3对各程之间的相互关系 及作用进行/描述，对 程序文件进行了用用 现场确认删减合理4.2.3Control of Documents 文件控制Note: there must be a dociunented procedure for dociunent controf 注：“文件控制必须有文件化的程序Note: only six clauses have mandatory requirement for documented procedures.注：只有六个条款强制要求文件化的程序a. to approve documents for adequacy prior to issue.文件发布前得到批准，以确保文件是充分和适宜的b. to review and update as necessary and re-approve documents.必要时对文件进停审与更新;并再次批准c. to ensure that changes and the current revision stat

9、us of documents are identified.确保文件的更改和现行修订状态得到识别d. to ensure that relevant versions of applicable documents are available at points of use.确保在使用处可获得文件的有关版本e. to ensure that documents remain legible and readily identifiable. 确保文件保持清晰,易卜识别f. to ensure that documents of external origin are identified and their distribution controlled and确保外来文件得到识别，并控制其分发g. to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.防止作废文件的非预期使用,若因任何原因而保留作废文件,对 这些文件进行适当的标识文件 和资 料管 理程 序 QEP0I文件修订/废止申请单文件借阅申请表文件分发、回收控制表文件控制总表外来文件清单4.2.4Control of Quality Records 质量记录的控制Note: there must be a documented procedure for control of records, unless they have retained a full se

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