ISO9001程序文件-中英文对照
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
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内审小组，并指定内审组长。 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 preparation
6.3.1.1 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 "the 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。
Auditor shall prepare Internal Audit Checklist before audit, after the check by the audit leader, shall send Internal Audit Checklist to the management representative for approval. In order to carry out audit smoothly, auditor shall prepare some blank "Corrective Action Sheet" for the use in the audit.
6.4 内审的实施 Audit Execution
6.4.1 首次会议，审核前由管理者代表召开首次会议，阐明此次审核的有关事项，包括审核目的、范围、时 间、路线安排、审核流程以及审核的人员配合要求。首次会议的参加者应包括内审小组成员、被审部 门负责人以及由管理者代表指定的相关人员。
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The first meeting: management representative carry out the first meeting before audit, state the actions including audit scope, purpose, time, route arrangement, audit flow chart and auditor cooperation requirement. The attendance shall include member of internal auditor group, responsible person of auditee department and staff designated by the management representative.
6.4.2 审核人员到达现场，在被审核部门指定人员配合下，开展评审工作，审核员应以内审检查表为指引， 通过观察、面谈、抽查有关文件记录及相关规定，以获得客观证据，并详细记录在《内审检查表》中。 The auditor will carry out audit action with the cooperation of the designated staff of auditee department. The auditor shall use the audit checklist as the guidance, obtain the evidence by observation, interview, spot check of the document records and relative regulation, and make detailed record in Internal Audit Checklist.
6.4.3 在判定质量管理体系的符合性时，审核员应视时机与被审核部门的相关人员进行讨论，并得到确认。 作出审核结果前，审核员必须获得相关的客观证据，以证明质量管理体系是否被切实执行。
The auditor shall make discussion with auditee department if necessary when decide the coincidence of the quality management system and then get approval. The auditor must obtain the objective evidence to prove the fully implementation of quality system when make the audit result.
6.4.4 审核员应完成《内审检查表》的内容，当发现不符合项时，应予以记载。
Auditor shall finish Internal Audit Checklist, and make record when nonconforming item is found.
6.4.5 针对审核情况，内审小组在每日结束时应进行小组会议，讨论当日审核遇到的各种疑难问题，并根据 查核记录，决定不符合事项，开出《纠正措施单》。
After audit of each day, internal group shall have the meeting and discuss the various problem during the audit, and check the record to determine the non-conforming item, and issue the "Corrective Action Sheet".
6.4.6 现场审核完成后，审核员应总结内审结果，由审核组长汇总后编制内审报告交管理者代表审批。 The auditor shall make conclusion after audit, and the audit leader shall make internal audit report and send to management representative for approval.
6.4.7 末次会议：由管理者代表主持，参加人员与首次会议相同，由审核组长作评审结果报告，要求有关部 门在规定的时间内提出纠正措施并按计划完成。
The final meeting: be presided by management representative, the attendance are same as the first meeting, the audit leader shall give audit report and require the relative department to take corrective action and finish within the specified time.
6.4.8 所有的纠正措施单都应记录于《纠正措施跟进检查记录表》中。
All corrective action shall be recorded in "Corrective Action Follow-up Checklist".
6.4.9 被审核部门的负责人接到《纠正措施单》后，应根据审核中所发现的客观事实对《纠正措施单》上的 改善内容和改善要求予以确认。
After the responsible person of departments audited receives "Corrective Action Sheet", he shall confirm the improvement items andrequirements indicated on the "Corrective Action Sheet" according to the objective facts found during the audit.
6.5 内审跟进 Follow-up Audit
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6.5.1 当受审部门纠正措施的完成时间已到，或接到提前完成的通知时，审核组长应派与该部门无直接责任 关系的内审员验证完成情况，并在《纠正措施单》上注明。
When the time for audited department to complete the corrective actions is up or notice of completing such actions in advance is received, the head of audit group shall appoint internal auditor who has not direct responsibility relation with this department to verify the completion of corrective actions and state such verification on the "Corrective Action Sheet".
6.5.2 对未能按期完成的纠正措施，应重新向责任部门发出《纠正措施单》，同时将此情上报管理者代表， 由其向责任部门采取限期改进的措施。
For corrective actions that are not completed in specified time, "Corrective Action Sheet" shall be re-issued to the responsible department, and meanwhile this condition shall be reported to the management representative, who shall take measures to order such responsible department to correct in specified time.
6.5.3 在改进中遇到难以解决的问题时，管理者代表应与责任部门共同商议修改方案，并在管理评审会议上， 对依然不能解决的问题向总经理做出汇报，以采取必要的措施和获得必要的资源。
When running across problems those are difficult to settle, the management representative should confer with responsible departments on amend project, and report problems those still can't be settled to general manager on the management audit meeting, so that take necessary measure and obtain necessary resources.
6.5.4 在下次内审时，应重新检查对上次发现的有关不符合项采取的纠正措施是否仍然有效。
In next internal audit, re-check shall be performed to see whether the corrective actions taken for related non-conformances discovered last time are still effective.
6.5.5 呈报管理评审：管理者代表须根据审核结果报告及其跟进结果呈报管理评审会议进行评审。
Submission of management review: the management representative shall submit the management audit meeting for review according to the audit result report and its follow-up result.
6.6 《纠正措施》编号方法：Numbering Method of Corrective Action Sheet
受审部门代码---年度码---审核次数码---流水码---跟进号
Code of audited department---Year Code---Review Number Code---Flow Code---Follow-up Number
例：在2002年第一次内审过程中对品质部共开出4张《纠正措施单》。其中第1张单的编号为：
品-02-1-01，第2张单号应为：品-02-1-02，以此类推，若受审单位未按要求执行第1张单要求的内容，审 审核组则须针对第1张《纠正措施单》的内容再发1张新的《纠正措施单》，新的《纠正措施单》单号 应为：品-02-1-01-1。
For example, in first internal audit process in 2002, four Corrective Action Sheet were issued to the Quality Dept. of which, the first sheet shall be numbered as Quality-02-1-01, the second as Quality-02-1-02, and the like. If audited department fails to execute the first notification according to the requirements, the audit group shall re-issue a piece of new Corrective Action Sheet according to the contents of the first notification, and such new sheet shall be numbered as Quality-01-1-01-1.
7.0 流程图 （略） Flow chart (omitted)
8.0 质量记录 Quality Record
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8.1 《年度内审计划表》 （QR-总-001） Annual Internal Audit Plan
8.2 《内审检查表》 （QR-总-002） Internal Audit Checklist
8.3 《纠正措施单》 （QR-总-003） Corrective Action Sheet
8.4 《纠正措施跟进检查记录表》 （QR-总-004） Corrective Action Follow-up Checklist
编号 (No.) QP-总-003发行日期 (Issuing date) 2002/0/26版本 (Edition) A 版生效日期 (Effective date) 2002/09/28内部质量审核程序
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