ISO9001-2015内部审核程序(中英文)

1、内部审核程序Internal Quality System Audit(ISO9001：2015)1.0目的 Purpose:本程序规定了开展内部质量审核的策划，准备，实施，审核，报告，跟踪验证各阶段的 控制要求和方法， 以确定本公司的质量管理体系是否符合标准要求并得到有效地实施和 保持。This procedure give the methods and control requirements of internal quality audit planning,preparing, implementing, auditing, reporting and following-up,

2、to ensure that the qualitymanagementsystem is in compliance with requirements and is implemented and maintainedeffectively.2.0范围 Scope: 适用于本公司内部质量管理体系审核及质量体系涉及的所有部门或个人。 DXCinternal audit and all departments and persons related to quality management system3.0定义 Definitions: N/A3.1IQAR: 内部质量审核报告 Inter

3、nal Quality Audit Report3.2NC: 不符项(不符合 ISO 要求的项目) Non-conformance (item against ISO requirement.)a)Major 严重不符合项 : there are systematic problem, territorial problem,and the findings will cause the major result during the system run;体系运行出现系统性失效，体系运行出现区域性失效，出现影响产品或体系运行 的严重后果的不合格现象 .b)Minor 一般不合格项 : aim

4、 at the systematic requirements, the finding is separate,occasional and isolated minor problem;对不满足质量体系过程或体系文件的要求而言，是个别的、偶然的、孤立的性质轻微的问题 .德信诚培训网UJUJUJtOp.COfT好好学另天天向上3.3OBS 观察项：未构成不合格，但有变成不合格的趋势，或是证据暂时不足。There isthe trend to become findings, or there is no evidenee can show it is not con sist withreq

5、uireme nts.3.4QMS:质量管理系统 Quality Management System.4.0职责 Responsibility:4.1质量管理者代表负责审核“年度内审计划”及“内审实施计划”。The ma nageme ntrepresentati ve should review “annual internal quality audit plan”，andInternal audit implementing plan4.2ISO 系统工程师负责制定“年度内审计划”和“内审实施计划”，组织内部审核，汇总审核资料并归档，不符合项的跟踪验证，及向管理评审提交年度内审报告.IS

6、Osystem engineer should make “annual internal quality plan ” and “ internal audit implementing plan ”，and summary audit data, ensure it can carriedout, follow up and verify the nonconforming items of the quality management system, andsubmit the annual internal audit report to management review.4.3公司

7、内部审核员参加内部质量审核、内审总结，负责纠正和预防措施的跟踪。FPsinternal auditors perform internal audit and make audit conclusion, and follow up thecorrective and preve ntive acti ons.4.4被审核单位安排陪同人员配合审查小组完成本部的审核工作，不符合项报告的确认，相关纟片正和预防措施的实施。 The audited departments shall arrange persons toaccompa ny audit team to accomplish the a

8、udit task , confirm noncon forma nee reports,carry out the related corrective and preve ntive acti ons.5.0程序 Procedure :5.1年度审核计戈 U 制定 Prepare the annual internal audit plan:5.1.1ISO 系统工程师负责进行年度审核方案的策划，根据上年度各部门质量体系运 行情况，结合本年度质量工作安排策划后确定本年度审核的范围、频次、时间、方法并形成“年度内审计划”（一年至少进行一次），报管理者代表审核，厂 长批准。若遇机构变化，顾客投

9、诉或重大不合格等特殊情况时，由ISO 系统工ISO9001-2015 内审员升级培训（100 元）ISO9001-2015 内审员培训（200 元）：http:/德信诚培训网ujiuu;，55top.cofr好好学习天天向上德信诚培训网程师核次数，报管理者代表审核，厂长批准。审核方式一般采用集中审核，需要时也可采用部门滚动审核。 ISO system engin eer shall plan the in ternal quality auditsfor the year. The scope, freque ncy, schedule and method of the annual aud

10、it shallbe decided accord ing to operati on status of quality system in each department lastyear, as well as the audit plan of this year. And this“Annual Internal AuditPlan ”（at least onceper year） shall be reviewed by the Management Representativeandapproved by Pla nt Man ager. Once there is specia

11、l things as cha nge inorga ni zatio n, customer complai n or serious non-con forma nee, ISO systemengineer shall put forward written application and verify the plan after it is approvedby the Man ageme nt Represe ntative or Pla nt Man ager.5.1.2“年度审核计划”必须覆盖公司质量管理体系所涉及的各个部门及所有的品质系统要素，当发生内部/外部不合格或客户抱怨

12、时，计划的审核频次应增加。The “Annual Internal Audit Plan ” shall cover all departments included in qualityman ageme nt system and all quality system eleme nts. When intern al/exter nalcon forma nces or customer complai ns occur, the pla nnedaudit freque ncy should be in creased.5.2成立审核小组： Establish the in terna

13、l audit team5.2.1由管理者代表担任审核组长，并成立审核小组。由审核组长分配审核小组成员任 务，在分配审核任务时应注意：审核人员不能审核他们直接负责的部门和区域。ManagementRepresentative acts as the audit team leader and establishes the auditteam and assigns the audited area to each auditor. Auditors shall not audit their ownwork.5.2.2内部质量管理体系审核员应经过内部或外部的权威机构培训，考核合格并持有相 应的资格证书方可具备内审员资格。All interna