ISO9001内部审核程序(中英文)

ISO9001内部审核程序

Internal Quality System Audit

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, to ensure that the quality management system is in compliance with requirements and is implemented and maintained effectively.

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。 FP internal audit and all departments and persons related to quality management system 3.0定义Definitions: N/A

3.1IQAR:内部质量审核报告Internal Quality Audit Report

3.2NC: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 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.

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 is

the trend to become findings, or there is no evidence can show it is not

consist with requirements.

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 management

representative should review “annual internal quality audit plan”, and

“Internal audit implementing plan”.

4.2ISO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. ISO

system engineer should make “annual internal quality plan” and “internal

audit implementing p lan”, and summary audit data, ensure it can carried

out, follow up and verify the nonconforming items of the quality management

system, and submit the annual internal audit report to management review.

4.3公司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。FP’s

internal auditors perform internal audit and make audit conclusion, and

follow up the corrective and preventive actions.

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,

相关纠正和预防措施的实施。The audited departments shall arrange persons to

accompany audit team to accomplish the audit task， confirm nonconformance

reports, carry out the related corrective and preventive actions.

5.0程序 Procedure:

5.1年度审核计划制定 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，顾客投诉或重大不合格等特殊情况时，由ISO系统工