AS9100C:2009_中英文对照(4)
g) 改进的建议。
5.6.3 Review output
5.6.3 管理评审输出
The output from the management review shall include any decisions
管理评审的输出应包括与以下方面有关的任何决and actions related to
定和措施:
a) improvement of the effectiveness of the quality management a)质量管理体系及其过程有效性的改进; system and its processes, b)与顾客要求有关的产品的改进; b) improvement of product related to customer requirements, and
c)资源需求。 c) resource needs.
6.资源管理 6 Resource management
6.1 资源提供
6.1 Provision of resources
组织应确定并提供以下方面所需的资源: The organization shall determine and provide the resources
needed
a) 实施、保持质量管理体系并持续改进其有效
a) to implement and maintain the quality management system
性;
and continually improve its effectiveness, and
b) 通过满足顾客要求,增强顾客满意。
b) to enhance customer satisfaction by meeting customer requirements. 6.2 人力资源
6.2 Human resources
6.2.1 总则 6.2.1 General 基于适当的教育、培训、技能和经验,从事影响Personnel performing work affecting conformity to product 产品与要求符合性工作的人员应是能够胜任的。 requirements shall be competent on the basis of appropriate education, training, skills and experience. NOTE Conformity to product requirements can be affected 注 :在质量管理体系中承担任何任务的人员都
可能直接或间接地影响产品与要求的符合性。 directly or indirectly by personnel performing any task within the
quality management system.
6.2.2 能力、意识和培训
6.2.2 Competence, training and awareness
组织应: The organization shall
a) determine the necessary competence for personnel performing a) 确定从事影响产品与要求的符合性工作的人
员所必要的能力;
a) results of audits,
b) customer feedback,
c) process performance and product conformity, d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.
AS9100C
work affecting conformity to product requirements,
b) where applicable, provide training or take other actions to achieve the necessary competence,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).
6.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport, communication or information systems).
6.4 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
NOTE The term "work environment" relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting, or weather).
7 Product realization
7.1 Planning of product realization
The 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 appropriate:
a) quality objectives and requirements for the product;
NOTE Quality objectives and requirements for the product
注: 产品的质量目标和要求包括考虑下述方面,
include consideration of aspects such as
如:
- product and personal safety,
b) 适用时,提供培训或采取其他措施以获得所
需的能力;
c) 评价所采取措施的有效性;
d) 确保员工认识到所从事活动的相互性和重要
性,以及如何为实现质量目标作出贡献;
e) 保持教育、培训、技能和经验的适当记录(见
4.2.4)。
6.3 基础设施
组织应确定、提供并维护为达到产品符合要求所需的基础设施。适用时,基础设施包括:
a) 建筑物、工作场所和相干的设施;
b) 过程设备(硬件和软件);
c) 支持性服务( 例如运输,通讯或信息系统)。
6.4 工作环境
组织应确定并管理为达到产品符合要求所需的工作环境。
注:术语“工作环境”是指工作时所处的条件,包括物理的、环境的和其他因素(如噪音、温度、湿度、照明或天气)。
7 产品实现
7.1 产品实现的策划
组织应策划和开发产品实现所需的过程。产品实现的策划应与质量管理体系其他过程的要求相一致(见4.1)。
在对产品实现进行策划时,组织应确定以下方面的适当内容:
a) 产品的质量目标和要求;
-产品和人员安全;
AS9100C
- - - - -
b) the need to establish processes and documents, and to provide b) 针对产品确定过程、文件和资源的需求; resources specific to the product; c) required verification, validation, monitoring, measurement, c) 产品所要求的验证、确认、监视、测量、检
验和试验活动,以及产品接收准则; inspection and test activities specific to the product and the criteria
for product acceptance;
d) records needed to provide evidence that the realization d) 为实现过程及其产品满足要求提供证据所processes and resulting product meet requirements (see 4.2.4); 需的记录(见 4.2.4)。 e) configuration management appropriate to the product; e) 适合于产品的技术状态管理;
f) resources to support the use and maintenance of the f) 支持产品使用及维护的资源。 product.
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