ISO9001程序文件-中英文

1.0目的：为确保质量管理体系持续有效运行，使其充分符合ISO9001：2000标准的要求，特制定本程序，以规定开展相应的审核活动，来评价本厂质量管理体系是否有效，是否需要采取纠正及预防措施。

Purpose: In order to ensure the effective and continuous implementation of the quality management, fully meet the requirements of ISO9001:2000 standard, specially make the procedure so as to implement audit action and verify the effectiveness of the quality management system and to take corrective or preventive action if needed.

2.0 范围：本厂所开展的内部质量审核的全部活动均适用本程序。 Scope: applies to all the actions relating to internal quality audit. 3.0 职责 Responsibility

3.1 管理者代表：负责年度内审计划的拟定并计划组织实施。

Management Representative: responsible for the annual internal audit plan and its implementation.

3.2 内审组长：负责制定审核日程并具体组织、指导内审作业。

Internal audit leader: responsible for making audi agenda and instructing audit. 3.3 内审员：负责按审核计划要求对相关单位实施审核。

Internal auditor: responsible for performance the audit according to audit plan. 3.4 受审部门：组织有关人员配合审核。

Auditee Dept.: ensure full cooperation be given to audit. 4.0 参考文件 Reference Document

4.1 《管理评审程序》（QP-总-002) Management Review Procedure

4.2 《纠正及预防措施程序》（QP-品-005） Corrective and Preventive Action Procedure

5.0 定义 （无） Definition (None) 6.0 程序内容 Procedure Content

6.1 年度内审计划 Annual internal audit plan

6.1.1 本厂每半年实施内部质量评审一次，但受管理者代表指定时，可追加审核。 Carry out internal quality audit half a year, can add audit times when management representative has special requirements.

6.1.2 根据质量体系关于内部审核的时间和内容的要求，在每年12月份由管理者代表编制下一年度的《年度内审计划表》。

Management representative shall make out Annual Internal Plan of next year in December, according to the requirements of internal audit of quality system. 6.1.3 各部门及要素的审核频次，应取决于本厂相关阶段的作业现状及相关活动对质量管理体系的影响程度。 但所开展的审核活动在一年内，必须覆盖ISO9001:2000标准所要求的所有要素及相关部门。

The audit times of each Dept. or element shall depend on the current operation status or the affections given to quality management by the relative action. The carried audit action shall refer to all the elements and departments in ISO9001:2000 within the one year.

6.2 内审员资格认定 Appointment of internal auditor

6.2.1 本厂为有效地开展内审工作，应在实施内审前的适当时间，由管理者代表根据内审计划的性质成立内内审小组，并制定组长。

For the better implementation of internal audit, management representative shall set up an internal audit group and assign the leader sometime before the internal audit.

6.2.2 内审小组的内审员必须同时具备如下条件： Internal auditor shall meet following requirements: 6.2.2.1 熟悉认证的质量管理标准和有关法律、法规。

Be familiar with the law or regulation of quality management standard.

6.2.2.2 接受相关机构的培训，并持有内审员资格证书。

Has ever been trained by some training organization and owns the internal audit qualification certificate.

6.2.2.3 能确保与被审核部门无直接关系。 Independent of the areas being audited. 6.2.2.4 经管理者代表批准。

Approved by the management representative. 6.3 内审准备 Internal audit perparation

6.3.1 具体审核计划的核定 Internal audit plan preparation6.

3.1.1 具体审核计划由审核组长负责拟定；Audit leader shall make out the detail audit plan.

6.3.1.2 内审计划应遵守“确保内审人员与被审核的部门无关”的原则；

Audit plan shall stick to the principle of \auditor is independent of the areas being audited\

6.3.1.3 审核计划应包括所有与本次审核目标、范围有关的相关部门和要素。

Audit Plan shall include all the departments and elements relative to the goal and scope of the audit.

6.3.1.4 审核小组应与被审核部门负责人商定适当的审核日期，并根据审核的重点与要求拟定好审核路线。

Audit group shall negotiate the appropriate audit date with audit department, and determine the audit route according to the audit focus.

6.3.1.5 审核计划经管理者代表核准后，应提前通知被审核单位，以便其作相应的准备工作。 After the approval of the management representative, notify the auditee department in advance for its better preparation work.

6.3.2 审核前，审核员必须事先准备与审核程序相关的《内审检查表》，经组长审核后报管理者代表批准。为顺利开展审核工作，审核员应准备适当的空白《纠正措施单》，以便审核时使用。