| 3.1 |
Quality Policy 质量方针 |
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| 3.1.1 |
Does the management demonstrate commitment to following an appropriate quality process? 管理层是否能证明他们严格执行了相应的质量管理体系？ |
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| 3.1.2 |
Does the factory have ISO 9000 accreditation? 工厂是否经过ISO9000的认可？ |
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| 3.1.3 |
Does the factory have an appropriate documented quality policy which has been communicated, understood and is used by the factory? 工厂是否制定了恰当的质量方针手册，该手册经过与员工的沟通并且得到员工的理解和使用？ |
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| 3.2 |
Implementation of Quality System 质量管理体系的实行 |
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| 3.2.1 |
Is the quality management system documented, used and monitored? 该质量管理体系是否有书面记录、执行并得到有效监督？ |
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| 3.2.2 |
Is there an effective quality manual in place and used? 是否制定并使用了质量管理手册？ |
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| 3.2.3 |
Does the factory have appropriate quality procedures in place and used? 工厂是否制定并使用了恰当的质量管理程序？ |
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| 3.2.4 |
Are there suitable document control processes in operation? 在操作中是否有恰当的文件控制程序？ |
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| 3.3 |
Competency, Training and Responsibility 能力、培训和责任 |
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| 3.3.1 |
Are responsibilities in the factory defined and known by the necessary people? 是否在工厂内部进行了清楚的职责划分并将其告知有关人员？ |
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| 3.3.2 |
Is there an effective, empowered manager with QA authority? 工厂内是否有一个有效的、有力的质保负责人？ |
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| 3.3.3 |
Are the workforce suitably educated, trained, capable and experienced for the jobs they are required to do? 工人是否经过合适的教育、培训，并能胜任他们所要做的工作？ |
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| 3.3.4 |
Do the workforce understand their part of the manufacturing process, are they trained, is training recorded and updated? 工人们是否理解他们所操作部分的制造工艺，他们受过相关培训吗？培训是否得到记录并时常更新？ |
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| 3.4 |
Measurement and Improvement 衡量和改进 |
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| 3.4.1 |
Are the procedures used assessed and reviewed, so that they are consistent with the quality policy of the factory? 工厂目前使用的程序是否经过评估和审查，这样它可以和工厂的质量管理方针保持一致性？ |
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| 3.4.2 |
Are effective internal audits and necessary corrective actions implemented in appropriate timescales? 是否进行定期的企业内审并采取了相应的整改措施？ |
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| 3.4.3 |
Is an appropriate calibration process in place which is traceable and documented? 是否制定了一个恰当的校准程序，该程序可被查询并可被书面记录？ |
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| 3.4.4 |
Does the factory have a customer feedback/complaint process which identifies problems and non-conformances? If so, are suitable corrective and preventative actions taken? 工厂是否制定了客户意见反馈/投诉程序来识别问题和违规？如果有的话，有没有制定合适的改正、预防方案？ |
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| 3.5 |
Customer Focus 客户 |
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| 3.5.1 |
Do processes exist which ensure customer needs, specifications and requirements are understood and met? 是否制定了相应的程序来确保客户的需求和要求被正确的理解并能得到满足？ |
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| 3.5.2 |
Is customer feedback monitored, reviewed and action taken? 客户的反馈是否得到关注、时常回顾并采取相应措施？ |
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| 3.6 |
Design & Development 设计和发展 |
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| 3.6.1 |
Are product requirements and technical details reviewed to ensure they meet customers safety, suitability, standards and specification requirements, before and during production? 是否在生产前及生产的过程中，对产品的要求及工艺过程进行审核，以确保达到客户在产品安全性、恰当性以及产品标准和规格方面的要求？ |
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| 3.6.2 |
Do appropriate 'Technical Files' exist? 是否制定了相应的技术文件？ |
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| 3.6.3 |
Is pack wording reviewed for suitability before production? 生产前是否对包装上的文字正确性进行了检查？ |
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| 3.6.4 |
Are instructions reviewed for suitability before production? 生产前是否对说明书的正确性进行了检查？ |
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| 3.6.5 |
Is there appropriate safety certification available for products being manufactured? 产品制造前是否获得相关的安全证书？ |
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| 3.6.6 |
Is there an effective design validation process in place for products being manufactured? 正在生产的产品是否有一个见效的设计确认程序？ |
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| 3.6.7 |
Are processes suitable to prevent design changes without appropriate checks and authorisation? 程序中是否可以有效阻止未经检查和授权的设计变更？ |
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