品质FC Major
　　6.2 Are personnel qualified based upon appropriate education, training requirements, and/or experience? 基于适当的教育,培训,技能和经验,从事产品要求符合性工作的人员是否能够胜任?.sampling
　　6.7 Does the vendor formally indicate inspection status of finished goods?（成品的检验标识状态）
　　6.12 Does the factory have bar code scanners and perform sampling scans of barcodes on all sizes of packaging?（条码扫描仪） 对各种型号的包装箱扫描
　　10.3 Is the calibration date of a gage or a test / inspection equipment documented?对测量仪器校验并文件化
　　10.4 Is the expire date of a gage or a test / inspection equipment documented?测量设备的文件上注明有效期
　　10.6 Are gages and test / inspection equipment controlled by a documented system and are calibration records maintained?对测量仪器文件化和点检记录要有文件系统控制
　　10.7 Does calibration frequency for equipment and reference standards meet PRC National Standard or other National Standard?按照国家或当地法规进行定期校验
　　10.8 Are controls in place to ensure that all appropriate equipment is calibrated?保证适用的设备已经校验是受控的
　　11.1 Does vendor have provisions for safety / reliability testing?有安全和可靠性测试
　　11.2 Does the vendor evaluate warranty failure data and modify the reliability test program accordingly?评估失败数据和可靠性测试程序
　　11.4 Are samples from current production used in the reliability test program?样品
　　11.5 Is there a recording system for failures?对失败数据有记录
　　11.6 Is there a formal system for investigating and correcting failures?有纠正预防措施执行吗

　　品质QMS Major
　　5.1
　　Is the question "Is the QMS system effective?" asked... and the answer reacted upon if needed? 是否对质量体系的有效性询问…必要性得到答复?

　　5.6
　　Are the above items discussed/documented/addressed (annually, at a minimum) at a Management Review?管理评审至少每年进行并且是否对以上问题进行讨论/形成文件/得到解决?

　　L7.1.3
　　Is there evidence of an implemented Advanced Product Quality Planning process? 是否有先期质量计划过程实施的证据?control plan, process?

　　L7.1.6
　　Do Failure Mode Effects Analysis (FMEA) consider all Key Product/Process/Safety Characteristics? 对于所有关键的产品/过程/安全性能是否进行失效模式分析(FMEA)? 1~10

　　L7.1.8
　　Do Control Plans (CP) follow the same process flow as the related FMEA? 控制计划是否与FMEA 一致?

　　L7.1.8
　　Are FMEAs, CPs and related documentation reviewed/updated regularly (or when corrective actions have been implemented)? 失效模式分析, 控制计划以及相关的文件是否定期审核及更新（纠正措施何时得到实施）？

　　7.6
　　Does the factory have documented policies, systems, programs, procedures, instructions and findings to assure the quality of calibration and tests performed? 工厂是否有文件化的方针,系统, 程序,指导书和发现以保证校验和测试的质量?procedure？

　　7.6
　　Does the factory use test and/or calibration equipment that meets the needs of the customer and are appropriate for the intended use? 工厂是否使用能满足客户要求并很好的满足使用目的的测试和校验设备？Do or not?

　　7.6
　　Is there an established record of calibration at prescribed intervals, against certified equipment having a known valid relationship to an internationally recognized standard in the correct environment? 是否建立合法的定期校验记录以保证校验设备与国际认可标准之间在正确的环境下具备有效的关系?

　　L8.2.2.1
　　Are internal audits carried out as planned? 内部审核是否按照计划进行?

　　L8.2.2.2
　　Are the audits recorded and brought to the attention of the responsible personnel? 审核是否记录并发放至相关责任人员?

　　L8.2.2.2
　　Are corrective actions carried out on a timely basis? 纠正行动是否即时执行?

　　L8.2.4.3
　　Are there documented procedures established and maintained to implement and control the application of statistical techniques (where a capability index CpK ≥ 1.33 is required and CpK ≥ 1.67 is desired)? 是否建立及维持文件化的程序以推行及控制统计技术(工序能力指数CpK 高于1.33, CpK期望值高于1.67)?

　　8.3
　　Does the control of non-conforming material process provide for identification, documentation, evaluation, segregation, disposition and for notification of all appropriate functions? 是否对不合格品进行识别, 形成文件, 评估, 隔离, 处置以及通知相关部门及人员?

　　8.3
　　Is the non-conforming product reviewed in accordance with the documented procedure? 不合格品是否按照相关程序进行评审?

　　8.5.1
　　Is there evidence of continuous improvement throughout the quality system that benefit internal,and external customers?是否有持续改进证据贯穿整个质量体系以惠及内外部客户? Internal audit? 内部审核Process audit?过程审核

　　8.5.2
　　Do procedures for corrective action include effective handling of customer complaints and demonstrate that the corrective action is effective? 处理客户投诉等纠正活动并且证明纠正有效性的程序是否有效?

　　8.5.3
　　Do procedures for preventative action include the use of appropriate sources of information to eliminate the causes of potential nonconformities (product quality, deviations, audit results, quality records etc…)? 预防措施的程序是否包括合适的信息资源的使用以消除潜在的不合格(产品质量,变异,审核结果,质量记录等...)？