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1、0 1 General No additional requirements 0 2 Process approach Whenever this specification refers to a process this process should be documented and should be controlled by appropriate key performance indicators 0 3 Relationship with ISO 9004 No additional requirements 0 4 Compatibility with other mana
2、gement systems NOTE 1 Although ISO 9001 2000 standard only provides requirements for quality management systems these requirements are understood as requirements for a more general business management system All processes shall be integrated in the business management system and controlled through a
3、ppropriate key performance indicators KPIs and continuously improved NOTE 2 With regard to Environment Occupational Health b process equipment both hardware and software and c supporting services such as transport or communication 组织必须确定 提供及维护为满足产品要求符合性所必需的基础设施 基 础设施 在适用时 包括 a 建筑物 工作空间及附属的设施 b 过程用设备
4、 硬件和软件两方面 和 c 支持性的服务 例如运输或通讯 Additional IRIS requirements 附加的 IRIS 的要求 6 3 1 General 通则 In addition to the ISO9001 2000 requirements the infrastructure includes as applicable d planned maintenance activities E packaging and preservation of equipment tooling and measurement equipment F availability o
5、f replacement parts for key manufacturing equipment and G documenting evaluating and improving maintenance objectives The organization should utilize predictive maintenance methods to continually improve the effectiveness and the efficiency of production equipment 在 ISO9001 2000 要求之外 适用时 基础设施包括 D 预先
6、计划的维护维修活动 E 设备 工装和测量仪器的包装和保存 F 关键制造设备的备品备件的有效供给 G 文件化 评估和改进维护维修活动的目标 组织应当运用预测性维护维修方法来持续改进生产设备的有效性和效率 Additional IRIS requirements 附加的 IRIS 的要求 6 3 2 Contingency plan 应急计划 The organization shall prepare contingency plans to mitigate the event of an emergency such as utility interruptions interruption
7、s in the supply chain labour shortages key equipment failure and field returns taking into account the output of the resources analysis and including a succession plan 组织必须准备应急计划以减轻紧急事件的影响 如公用设施中断 供应链 中断 劳动力短缺 关键设备故障以及现场退货 在制定应急计划时 要 考虑到资源分析的输出 并要包括接替计划 6 4 Work environment 工作环境 ISO requirements ISO
8、 要求 要求 The organization shall determine and manage the work environment needed to achieve conformity to product requirements 组织必须确定和管理为满足产品要求符合性所必需的工作环境 Additional IRIS requirements 附加的附加的 IRIS 的要求 的要求 NOTE 1 Factors that might affect the conformity of the product include temperature humidity lighti
9、ng cleanliness protection from electrostatic discharge Product safety and means to minimize potential risks to employees shall be addressed by the organization especially in the design and development process and in the production process activities The organization shall maintain its premises in a
10、state of order cleanliness and repair consistent with the product and production process needs 注 1 对产品符合性产生影响的因素 包括温度 湿度 亮度 洁净度 静电防护 组织必须涉及产品的安全性和减少对员工潜在风险的方法措施 特别是在 设计开发过程中和在制造过程活动中 组织必须维持其厂房设施处于整洁干净完好的状态 以满足产品和生产过 程的需要 7 Product realization 7 1 Planning of product realization ISO requirements The
11、organization shall plan and develop the processes needed for product realization Planning of product realization shall be consistent with the requirements of the other processes of the quality management system see 4 1 In planning product realization the organization shall determine the following as
12、 appropriate a quality objectives and requirements for the product b the need to establish processes documents and provide resources specific to the product c required verification validation monitoring inspection and test activities specific to the product and the criteria for product acceptance d
13、records needed to provide evidence that the realization processes and resulting product meet requirements see 4 2 4 The output of this planning shall be in a form suitable for the organization s method of operations NOTE 1 A document specifying the processes of the quality management system includin
14、g the product realization processes and the resources to be applied to a specific product project or contract can be referred to as a quality plan NOTE 2 The organization may also apply the requirement given in 7 3 to the development of product realization processes 7 产品实现 7 1 产品实现的策划 ISO 要求 组织必须策划和
15、开发对产品实现所必需的各种过程 产品实现过程的策划 必须与质量管理体系其它过程的要求相协调 在策划产品实现过程时 组织必须 根据具体情况恰当地 确定下列事项 a 产品的各项质量目标和各项要求 b 针对产品必须建立的各种过程 文件 提供各种资源 c 针对产品必要的验证 确认 监控 检验与试验活动以及产品的合格 验收判别准则 d 用以证明产品实现过程以及最终产品符合要求所必需的各种记录 见 4 2 4 这项策划工作的输出应采用适合组织运作方式的格式 注 1 针对特定产品 专题或合同规定 质量管理体系要采用的各种过程 包括产品实现过程 以及要用的各种资源的书面文件 能称为质量计划 注 2 组织亦可把
16、条文 7 3 所规定的各项要求用于产品实现过程的开发工 作 7 2 Customer related processes 顾客相关的过程 7 2 1 Determination of requirements related to the product 确定产品相关的要 求 ISO requirements ISO 要求 The organization shall determine a requirements specified by the customer including the requirements for delivery and post delivery activities b requirements not stated by the customer but necessary for specified or intended use where known c statutory and regulatory requirements related to product and d any additional requirements det
