asme翻译--核质量程序--审查程序1

发布时间:2011-05-02 13:14:07
 

金亚洲登录 www.nifams.com ASME翻译--核质量程序--审查程序1

       Table of Content    目录

 

1.0                   Scope                     范围

2.0                   Responsibilities            责任

3.0                   Audit scheduling           审查时间进度表

4.0                   Pre audit planning          预审计划

5.0                   Audit team members        审查组成员

6.0                   Preparation for audit         审查前的准备

7.0                   Conducting and reporting the audit

审查工作的实施和汇报

8.0                   Definition of non conformity     不合格的定义

9.0                   Recording of non conformity     不合格记录

10.0          Audit report                     审查报告

11.0          Corrective action programme    整改计划   

                                                                                                        12.0              Records                           记录

                                                                                                         13.0              Related proformas                  相关表格
1.0   Scope 范围

1.1  This procedure defines the procedure and assigns responsibilities for conducting quality audits to establish that the defined BPS NQA programme is implemented effectively.

为有效执行英伦管架有限公司(BPS)核质量保证(NQA)计划,特制订本程序,明确了质量审查程序,并划分了责任。

1.2  This procedure applies to auditing activities for both internal departments within BPS and vendor approval activities as defined by NQAP07/01.

本程序适用于英伦管架有限公司(BPS)内部部门的审查活动,以及供应商核准工作审查活动(如NQAP07/01所规定)。

2.0        Responsibilities  责任

2.1  The QAM is responsible for: 质量保证经理职责如下:

  • Ensuring that audits are performed on BPS departments and vendor activities covered by the scope of the NQA Programme.
  • 确保对英伦管架有限公司(BPS)内部部门进行审查,并对核质量保证计划(NQA)范围内的供应商活动进行审查。
  • Ensuring that auditing personnel are qualified in accordance with NQAP 16/01.
  • 确保审查人员资质符合核质量保证程序(NQAP)16/01的要求。
  • Approval of the annual internal audit schedule to enable NQA Programme audit activities to be monitored.
  • 对年度内部审查计划进行核准,确保对核质量保证计划(NQA)的审查活动进行监控。
  • Approval of the external audit schedule to cover vendor approval activities.
  • 对外部审查计划进行核准,保证审查范围包括了对供应商核准活动的审查。
  • Implementing the above audit schedules to ensure that planned audit activity is performed in a timely manner.
  • 实施上述审查计划中的审查安排,确保计划的审查活动按时执行。
  • Ensuring that any recorded audit non conformity and the agreed corrective action programme are implemented to the agreed timescale.
  • 确保任何审查不符合的记录以及规定的整改计划,能按照协定的时间要求得以执行。
  • Allocation of audit personnel 审查人员的安排
  •  

3.0         Audit schedules 审查计划

3.1         Internal audit schedule (IAS) 内部审查计划(IAS

3.1.1  The NQAE will generate the annual internal audit schedule (IAS) which is approved by the QAM.

核质量保证工程师负责编制年度内部审查计划(IAS),并由质量保证经理负责核准。

3.1.2      The IAS defines: 内部审查计划(IAS)明确以下内容:

  • Departments to be audited
  • 待审查的部门
  • Schedule for audit
  • 审查计划时间表
  • Enables completion of audit activities including implementation of any agreed corrective action programme to be recorded and monitored.
  • 完成审查活动,包括实施任何协定的整改计划,记录并监控该计划的执行。

3.1.3  All departments within BPS involved with implementation of the NQA Programme will be subject to audit at least once a year.

在英伦管架有限公司(BPS)内,所有与核质量保证计划实施相关的部门,至少每年应接受一次审查。

3.1.4  Additional audits may be scheduled if required based upon departmental performance as recorded during routine QA/QC activities, past compliance history or if specifically requested by senior management.

根据常规质量保证(QA)/质量控制(QC)活动期间,所记录的各部门绩效,以及各部门以前的符合性历史记录,在必要情况下,可以要求进行附加审查,或者,当高级管理层认为有必要时,可安排附加审查。

       3.1.5      Quality audits of the Accountancy function are not incorporated within the IAS as activities                                                  performed within this department are not included within the scope of this NQAP.

会计部门的质量审查,不包括在本内部审查计划(IAS)中,因为该部门的活动不在核质量保证程序范围(NQAP)内。

       3.1.6      The IAS will be communicated to all departmental managers and supervisors.

该内部审查计划(IAS)应发放给所有部门经理和主管人员。

3.1.7  The IAS will be reviewed on a monthly basis to establish that audit process is proceeding in   accordance with the agreed timescales. The NQAE and QAM decide if additional action is required and implement this action to ensure that planned audits are performed as stipulated.

该内部审查计划应每月进行评审,以确定审查过程符合协定的时间计划要求。由核质量保证工程师(NQAE)和质量保证经理(QAM)决定是否需要进行附加审查,并由其负责实施附加审查,以确保计划的审查工作能按照规定要求执行。

3.2                 External audit schedule (EAS) 外部审查计划(EAS

 3.2.1    The NQAE will generate the EAS when required as part of the vendor approval process. The                                        EAS will be subject to review and approval by the QAM.

如有必要,核质量保证工程师(NQAE)负责编制外部审查计划(EAS),将其作为供应商核准程序的一部分。外部审查计划(EAS)由质量保证经理(QAM)负责评审和核准。

3.2.2  The EAS is created to control vendor auditing activities when vendor approval is to be established by audit as per section 7 of this NQAM.

当按照本核质量保证计划(NQAM)第7节要求,通过审查确定供应商核准工作时,应编制外部审查计划(EAS),以便对供应商审查活动进行控制。

The EAS defines:

外部审查计划(EAS)明确了以下内容:

  • Vendor details
  • 供应商详情
  • Schedule for audit
  • 审查计划时间表
  • Enables completion of audit activities including implementation of any agreed corrective action programme to be recorded and monitored.
  • 完成审查活动,包括实施任何协定的整改计划,记录并监控该计划的执行。

 

3.3.3  Additional vendor audits may be performed during the execution of activities required by a BPS purchase order. Such audits will be co-coordinated by the QAM and will be performed in accordance with this procedure. 

英伦管架有限公司(BPS)采购单所要求的各项活动实施期间,可以进行对供应商的附加审查。该附加审查由质量保证经理(QAM)负责协调,并应遵照本程序要求执行。

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