GMPQualityManual质量基础手册.doc

GMP Quality Manual This quality manual for Good Manufacturing Practices is based on the ISO 9001 standard, and addresses the requirements of FDAs medical device regulations. 此GMP质量手册是基于ISO 9001标准，叙述FAD医用仪器法规要求。 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 质量确定 QUALITY IMPROVEMENT 质量改善 ADMINISTRATIVE CONTROLS 行政控制 Comparison Matrix 比对矩阵 Organizational Matrix for Quality System Functional Responsibilities 质量系统功效图 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. 我们致力于让用户满意，承诺对质量永不妥协。 （确保产品质量，让用户满意） These high standards are realized through the following practices:经过下列实践达成高标准 An open door policy that enables all personnel to bring to managements attention any concerns regarding quality achievement and customer satisfaction. 确保产品质量，让用户满意应成为每一职员工作关注点。 Personnel performing their work in a manner that ensures products and services meet all quality requirements. 职员操作方法、行为规范要以满足全部质量要求为基础准则。 Enabling personnel to carry out their responsibilities by providing the necessary training, resources, and work environment. 为职员提供必需培训、资源及工作环境以确保职员推行其职责。 The development of a multi-disciplinary collaborative team structure throughout all activities of the company. 构建多个学科协作专业团体和组织架构。 The application of high standards to business conduct, including contacts with customers, co-workers, and collaborators. 建立和实施较高企业营运（包含和和用户、合作商及合作人联络和合作）操作标准。 References: \o Order this standard from Doxpubs Online Store ISO 9001, 4.1.1, Quality Policy Manual Objectives 质量目标 We have established a quality system that is designed to meet domestic and worldwide regulatory standards for its products in the market place. The key applicable regulatory standards include: \o Read this regulation at F