ISO9001-2015内部审核程序(中英文)

2020-04-14 05:42

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, 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。 DXC internal audit and all departments and persons related to quality management system

3.0

定义Definitions: N/A

3.1 3.2

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

NC: 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.

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3.3

OBS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.

3.4 4.0

QMS: 质量管理系统Quality Management System.

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”.

4.2 ISO

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 plan”, 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:

5.1.1

ISO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

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程师提出书面申请并经管理者代表批准后可对年度计划进行修改,可以增加审核次数,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 engineer shall plan the internal quality audits for the year. The scope, frequency, schedule and method of the annual audit shall be decided according to operation status of quality system in each department last year, as well as the audit plan of this year. And this “Annual Internal Audit Plan” (at least once per year) shall be reviewed by the Management Representative and approved by Plant Manager. Once there is special things as change in organization, customer complain or serious non-conformance, ISO system engineer shall put forward written application and verify the plan after it is approved by the Management Representative or Plant Manager.

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时,计划的审核频次应增加。The “Annual Internal Audit Plan” shall cover all departments included in quality management system and all quality system elements. When internal/external conformances or customer complains occur, the planned audit frequency should be increased.

5.2

成立审核小组:Establish the internal audit team

5.2.1 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。Management Representative acts as the audit team leader and establishes the audit team and assigns the audited area to each auditor. Auditors shall not audit their own work.

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 internal auditors must be trained by our company or external qualified training organization and pass their test and gets the certification of auditor.

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