GMPQualityManual质量手册

GMP Quality ManualThis quality manual for Good Manufacturing Practices is based on the ISO 9001 stan

GMP Quality Manual This quality manual for Good Manufacturing Practices is based on the ISO 9001 standard, and addresses the requirements of FDA's medical device regulations. GMP 此质量手册是基于 ISO 9001FAD 标准，叙述医用仪器的法规要求。 Table of Contents 目录 POLICY 方针 QUALITY SYSTEM DESCRIPTION 质量系统描述 QUALITY DEFINITIONS 质量定义 QUALITY ACHIEVEMENT 质量目标 QUALITY VERIFICATION 质量确认 QUALITY IMPROVEMENT 质量改进 ADMINISTRATIVE CONTROLS 行政控制 Comparison Matrix 比对矩阵 Organizational Matrix for Quality System Functional Responsibilities 质量系统功能图 Quality Systems Organizational Chart 质量系统组织机构图 Parent Category 上级分类 Quality Manuals 质量手册 POLICY 方针 Quality Policy 质量方针 We are dedicated to achieving customer satisfaction through an uncompromising commitment to quality. 我们致力于让客户满意，承诺对质量永不妥协。 （保证产品质量，让用户满意） These high standards are realized through the following practices: 通过下列实践达到高 标准 1. An open door policy that enables all personnel to bring to management's attention any concerns regarding quality achievement and customer satisfaction. 保证产品质量，让用户满意应成为每一员工的工作关注点。 2. Personnel performing their work in amanner that ensures products and services meet all quality requirements. 员工的操作方式、行为规范要以满足所有质量要求为基本准则。 3. Enabling personnel to carry out their responsibilities by providing the necessary training, resources, and work environment. 为员工提供必要的培训、资源及工作环境以保证员工履行其职责。 4. The development of amulti-disciplinary collaborative team structure throughout all activities of the company. 构建多种学科协作的专业团队和组织架构。 1/ 17