ISO9001文件审核及现场审核通用检查表.docx

1、ISO9001文件审核及现场审核通用检查表General Checklist ISO 9001:2008 for Document Assessment and Site Audit通用检查表 ISO 9001:2008文件审核及现场审核Company公司: Current Address现地址: Post Code邮区编号: Tel电话: Fax传真: Current Contacts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 clea

2、ned clothes. Exclusions删减: 7。3 Documents Submitted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,12-13,2007 Site Assess Date现场审核日期: Sep,12-13,2007 Lead Auditor主任审核员: Team Members(s)小组成员: Comments备注: This document or attached notes shall be completed in sufficient detail to pro

3、vide 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澄清 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ISO9001:20

4、08标准的条款4.0 Quality Management Systems质量管理体系Docs.文件Site现场References or comments备注/评语4.1 General Requirements总要求(N) requires continual improvements from QMS (see para 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 c

5、ontrol?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:这些是总要求，可在任何文件化的质量体系中描述a. identify the processes needed for the quality management system and their application 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 sequenc

6、e 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有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 monitorin

7、g of these processes.确保可以获得必要的资源和信息，以支持这些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. implement actions necessary to achieve planned results and continual 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质量手册：QEM01版本：A/0生效日期：2007-05-30批准人：鲍琪公司介绍：

8、第-章组织架构：第-章部门职责 ：第五章方针、目标：手册A通过所有项目的审核证实该公司建立QMS时策划了质量目标、质量方针、内审、管理评审以及质量方案。B经查公司已建立质量手册一套，程序文件27套，机器操作说明书，作业指导书、管理规定36套，质量记录93个，可满足要求。C该公司是专业从事：无尘服及防静电服清洗、清洁服务D： 删减7.3E特殊过程：无外包过程：仪器外校4.2 Documentation Requirements 文件要求4.2.1General 总则(N) documented statement of quality “objectives”质量目标文件化陈述Note: onl

9、y 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. 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 organ

10、isation to ensure the effective planning, operation and control of its processes, and组织为确保其过程的有效策划、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个程序文件：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4.0 Quality Management Systems质量管理体系

11、Docs.文件Site现场References or comments备注/评语4.2.2 Quality Manual质量手册(E) must include 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节及其合理性(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 detai

12、ls of and justification for any exclusions (see 1.2),质量管理体系的范围，包括任何删减的细节及其合理性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对其引用c. a description of the interaction between the processes of the QMS质量管理体系过程之间相互作用的表述质量手册QEM01OK删减：7.3对各程之间的相互关系及作用进行了描述，对

13、程序文件进行了引用现场确认删减合理4.2.3Control of Documents文件控制Note: there must be a documented procedure for document control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. t

14、o review and update as necessary and re-approve documents,必要时对文件进行评审与更新，并再次批准c. to ensure that changes and the current revision status 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

15、 that documents remain legible and readily identifiable,确保文件保持清晰，易于识别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 r

16、etained 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QEP01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4.2.4 Control 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 set of procedures as previously required in

17、9001:1994 with records in each procedure.注：“记录的控制”必须有文件化的程序，除非已经保留了以前9001：1994中要求的已整套程序Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and

18、 retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and deposition of records应建立并保持记录，以提供符合要求和质量管理体系有效运行的证据。记录应保持清晰，易于识别和检索。应编制形成文件的程序，以规定记录的标识、贮存、保护，检索、保存期限和处置所需的控制QEP02记录管理程序OK文件中规定了各种记录的保存期限

19、记录一览表5. Management Responsibility管理职责Docs.文件Site现场References or comments备注/评语5.1 Management Commitment管理承诺(N)top management to communicate importance of meeting customer & statutory requirements最高管理层传达满足客户和法律法规要求的重要性(N)top management to ensure Policy and Quality Objectives are established最高管理层确保建立质量

20、方针和“质量目标”a. communicating to the organisation the importance of meeting customer as well as statutory and regulatory requirements,向组织传达满足客户和法律法规要求的重要性b. establishing the quality policy/建立质量方针c. ensuring that quality objectives are established 确保质量目标的制定d. conducting management reviews, and / 进行管理评审，及

21、e. ensuring the availability of resources.确保资源的获得质量手册QEM01OK询问总经理：公司于2007年5月制定了质量目标和质量方针及相关的质量方案，每年至少进行一次内部审核和管理评审，针对内审中发生的不符合项目进行纠正和预防措施，达到不断持续改进为目的。顾客要求和产品执行标准定期由部门管理在例会中宣导5.2 Customer Focus以顾客为焦点(N) must determine customer requirements with aim of enhanced customer satisfaction必须以增强顾客满意程度为目，确定顾客的

22、要求质量手册QEM01OK满足顾客要求详见7.2.1和8.2.15.3 Quality Policy质量方针(N)to include commitment to Continually Improve包括对持续改进的承诺(E)to provide framework for establishing quality objectives?提供建立质量目标的框架(E) is reviewed for continuing suitability (covered at Man. Review? Clause 5.6.2)在持续适当性方面得到评审a. is appropriate to the

23、purpose of the organisation,与组织的宗旨相适应b. includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,包括对满足要求和持续改进质量管理体系有效性的承诺c. provides a framework for establishing and reviewing quality objectives,提供制定和评审质量目标框架d. is communicated and u

24、nderstood within the organisation, and在组织内得到沟通和理解e. is reviewed for continuing suitability.在持续适当性方面得到评审质量手册QEM01OK质量方针：诚心、耐心、精心、放心、贴心为您的企业提供“五星级”管家服务满足ac要求 为确保方针的贯彻开展了方针宣传活动并用大的横幅进行宣传。对质量方针适宜性进行评审，评审结果：方针是适宜的。5.4 Planning 策划5.4.1Quality Objectives质量目标(N) must establish measurable Quality Objectives必

25、须建立可测量的质量目标质量手册QEM01OK2007年质量目标：洗衣合格率98%客户投诉每月2次5.4.2 QMS PlanningQMS质量管理体系策划(N) must plan to meet requirements including quality objectives必须策划满足包括质量目标的要求a. the planning of the quality management system is carried out in order to meet the requirements giving in 4.1, as well as the quality objective

26、s, and对质量管理系统进行有策划，以满足4.1以及质量目标的要求b. the integrity of the quality management system in maintained when changes to the quality management system are planned and implemented.在对质量管理体系的变更进行策划和实施时，保持体系的完整性质量手册QEM01OK质量手册1质量管理体系策划可满足4.1的要求；2未对质量方针和质量目标进行变更，现有体系完整5. Management Responsibility管理职责Docs.文件Site

27、现场References or comments备注/评语5.5 Responsibility & Authority职责与权限5.5.1Responsibility & Authority职责与权限(E) must be defined and communicated必须规定和沟通质量手册QEM01OK质量手册组织架构图各部门职责通过手册的发放进行沟通5.5.2Management Representative管理代表(N) to report on need for improvement?报告改进的需求(E) promote awareness of customer requirem

28、ents throughout organisation提高整个组织内满足顾客要求的意识a. ensuring that processes needed for the quality management system are established, implemented and maintained,确保质量管理体系所需的过程得到建立、实施和保持b. reporting to top management on the performance of the quality management system and any need for improvement, and向最高管理

29、层报告质量管理系统的业绩和任何改进的需求c. ensuring the promotion of awareness of customer requirements throughout the organisation.确保在整个组织内提高满足顾客要求的意识质量手册QEM01OK质量手册管理者代表任命书：2007年5月由任命：总经理为管理者代表。其权责范围符合标准要求5.5.3Internal Communication内部沟通(N) must establish process for internal communication?必须建立内部沟通过程QEP04信息交流控制程序质量手册沟

30、通的形式：会议/电话/公告/邮件5.6 Management Review管理评审5.6.1Management Review General (& Records)管理评审总则（和记录）(E) minimum agenda met?满足议程的最低要求(N) includes recommendations for improvement?包括改进的建议QEP13管理评审程序OK会议记录管理评审报告5.6.2 Review Inputs评审输入a. results of audits,审核结果b. customer feedback,客户反馈c. process performance and

31、 product conformity,过程的业绩和产品的符合性d. status of preventive and corrective actions,预防和纠正措施的状况e. follow-up actions from previous management reviews,以往管理评审的跟踪措施f. changes that could affect the quality management system, and可能影响质量管理系统的变更，及g. recommendations for improvement.改进的建议QEP13管理评审程序OK1目标、指标的达成状况检讨2为达成目标，各单位质量提升计划检讨及改善3系统文件的适用性与有效性检讨4教育训练需求5客诉及相关方投诉检讨6内部质量审核结果检讨