Internal Audit procedure内部审核程序(中英文).docx

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1、LOGOQUALITY SYSTEMPROCEDURE质量体系程序Number文件编号：MC-M3-01Department 部门：QA质量部Subject文件名称：Internal Audit procedure 内部审核程序Revision 版本：3.0Effective Date 生效日期：2021-05-10Page 1 of 7批准：审核：作成：Change History变更记录,Revision 版本Effective Date生效日期Originator编写人Reasons for Change修改原因1.02017-01-01Origin Revision2.02018-03

2、-13Update 4.3.1&4.4.4, Add internal auditor evaluationand product audit explanation3.02020-05-10Update 43.1,Delete internal auditor evaluation4.02021-02-05增加过程/产品审核的频次定义1.0 Purpose 目的This procedure describes how internal audits of the Management System (including QualityManagement System and Environ

3、mental Management System) are conducted, how Non-conformancesare recorded and how corrective actions are agreed, implemented and verified.本程序描述了如何对公司管理体系(包括质量管理体系和环境管理体系)进行内部审核，如何记录不符合事项以及如何制定、实施和验证纠正措施2.0 Scope 范围This procedure applies to Management System (including Quality Management System andEn

4、vironmental Management System) internal audit, process audit and product audit in *.本程序适用于本公司与管理体系(包括质量管理体系和环境管理体系)有关的审核活动，包括质量管理体系审核、环境管理体系审核、过程审核、产品审核。3.0 Definitions 定义3.1 IMSA Jnternal Management System Audit/内部管理体系审核；3.2 Internal Auditor: Based on training, a person who is capable and qualified

5、 to audit the performanceof Management System.内审员：经过相应培训，具有能力和资格对公司管理体系状况进行审核的员工3.3 Audit Team Leader: A person who is recommended to take charge in the internal audit.内审组长：指定的负责全程内审的人员3.4 Audit Criteria: A series of policies, procedures and requirements, which are used as basis for audit.审核准则：所依据的一

6、系列的方针、程序或要求3.5 Audit Evidence: Any fact, record or other information that can be got during audit.审核证据：与审核有并能够证实的记录、事实陈述或其他信息3.6 Audit Finding: The result after evaluating the audit evidence based on the audit criteria.审核发现：所收集到的审核证据对照审核准则进行评价的结果3.7 System Audits: Systematic assessment for quality a

7、nd environmental management to verify theeffectiveness.体系审核：对质量和环境管理体系进行审核，以确认体系运行的有效性。3.8 Process Audits: audit each manufacturing process to determine its effectiveness.过程审核：对每个制造过程进行审核，以确定其有效性.3.9 Product Audits: Assessment of products at appropriate stages of production and delivery to verifycon

8、formity to all specified requirements, such as product dimensions, functionality, packaging andlabeling, at a defined frequency.产品审核：在生产和交付的适当阶段对产品进行审核，以验证符合所有要求，如产品尺寸、功能、包装和标签等.3.10 Critical Nonconformity: The nonconformity will affect the operation of whole management system;the same nonconformity

9、 happens in several departments and w川 affect the operation of wholesystem; the operation is severe nonconforming with manuafs requirements.严重不符合事项：影响整个管理体系运行的重大不符合；或同一类不符合事项发生在数个部门足以影响整个体系运行；或执行的事项与手册的规定严重不符合时。3.11 Common Nonconformity: Except the critical nonconformities, other operation or mistak

10、es that dontcomply with the procedure or not reach the requirements.一般不符合事项：除上述主要不符合事项外，其余没有遵守公司工作程序的某一项过失或没有达到规定要求时，称之为一般不符合事项。3.120bserved Item: The operation has not disobeyed the system requirements or has no evidence toshow that audit findings are conformity, but the operation result maybe will

11、 affect the system.观察事项：虽未违反体系要求或没有客观证据可证明所发现的事实足以构成不合格，但结果可能会影响体系的事项。4 Procedure and Flow chart 程序及流程图4.1 Responsibility and authority 职责与权限4.1.1 The QEMS Representative is responsible for approval of the audit plan and ensuring thatthe internal audits are conducted in accordance with audit schedul

12、e.管理者代表批准审核计划，确保按照内审计划实施内部审核；4.1.2 Quality Dept, is responsible for making audit plan, coordinating the implementation of internal audit,summarizing the audit result and following up the corrective action and effectiveness.质量部负责制订审核计划，协调内审实施，汇总审核结果，跟踪审核改善和效果。4.1.3 An internal audit team leader is re

13、sponsible for whole audit activity.内审组长负责整个的内审过程。4.1.4 The auditors are responsible for reporting the details of any findings, issue CAR, andsubsequently verifying the corrective actions taken.内部审核员负责实施审核，汇报审核发现，提出纠正和预防措施要求，并跟踪验证纠正预防措施的执行。4.1.5 Other dept assist audit and take corrective and prevent

14、ive action for Non-conformance.其他部门：配合审核，并对不符合采取纠正预防措施。4.2 Audit Plan审核计划4.2.1 Quality department make internal audit plan, including QMS & EMS audit, process audit and productaudit, then get approval from Management Representative.质量部制定年度内部审核计划，包括质量体系审核、环境体系审核、过程审核、产品审核，并由管理者代表批准。4.2.2 The QMS and

15、EMS audit, process audit and product audit will be conduct once per year. Processaudit and product audit should be performed according to customers9 frequency while they had thespecial audit frequency requirements. Management Representative can increase the frequencyconsidering the previous performance, the importance of process and product, intemal and externalnonconformance and critical customer complaint.审核频次：每年1次质量体系审核、环境体系审核、过程审核、产品审核，当客户有对过程审核及产品审核有特定要求时，频度按照客户要求实施，具体参见审核计划。管理者代表可根据以往的质量/环境绩效、过程/产品重要性、