质量 管理体系架构Quality Management System Architecture

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质量管理体系（Quality Management System, QMS）架构是组织为了确保产品或服务满足客户需求和法规要求而建立的一套管理框架。其核心目标是持续改进、客户满意和过程优化

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The Quality Management System (QMS) architecture is a management framework established by an organization to ensure that products or services meet customer needs and regulatory requirements. Its core goals are continuous improvement, customer satisfaction, and process optimization

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质量方针与目标

• 明确组织的质量承诺和追求的目标。
• 设定可衡量的质量指标
  

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Quality Policy and Objectives
Clearly define the quality commitment and goals pursued by the organization.
Set measurable quality indicators

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管理责任

• 高层管理的领导与承诺。
• 设定职责、权限和沟通渠道
  

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Management responsibility
Leadership and commitment of senior management.
Set responsibilities, authorities, and communication channels

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资源管理

• 人力资源：培训与能力建设。
• 基础设施：设备、环境等。
• 信息资源：文件控制和信息管理
  

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resource management
Human Resources: Training and Capacity Building.
Infrastructure: equipment, environment, etc.
Information Resources: File Control and Information Management

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• 产品实现过程
  • 需求管理：客户需求和法规要求。
  • 设计与开发：产品设计、验证和确认。
  • 采购管理：供应商选择和评估。
  • 生产与服务提供：制造过程控制、检验和测试。
  • 交付与售后：交付、安装、售后服务。
    
  
  

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product realization process
Requirement management: Customer requirements and regulatory demands.
Design and Development: Product design, validation, and confirmation.
Procurement management: supplier selection and evaluation.
Production and service provision: manufacturing process control, inspection, and testing.
Delivery and after-sales service: delivery, installation, and after-sales service.