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.
此GMP质量手册是基于ISO 9001标准，叙述FAD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 a manner 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 a multi-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。
5.The application of high standards to business conduct, including contacts with customers, co-workers, and collaborators.
建立和实施较高的企业营运（包括与与客户、合作商及合作人的联系与合作）操作标准。References:
▪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:
▪21 CFR Part 820, Quality System Regulations for Medical Devices
▪93/42/EEC, European Medical Device Directive
▪ISO 9001, ISO Quality Management Systems Requirements
▪EN ISO 13485:2001, ISO Quality Systems for Medical Devices
The quality system addresses the elements necessary for implementing quality management including the organizational structure, responsibilities, procedures, processes and resources.
The Quality Manual describes our quality system. The central objective of the Quality Manual is to help employees meet all applicable regulatory requirements and to understand the quality commitments. In Appendix A, the requirements of 21 CFR 820, ISO 9001 and the Medical Device Directive 93/42/EEC have been cross-referenced to the sections of this Quality Manual.
The manual describes an overall process approach of planning for quality, application to activities, verification, and improvement (Deming's PDCA cycle). Where applicable, Standard Operating Procedures (SOPs) applicable to each section are cited. The Quality Manual is updated, reviewed and approved every 2 years. The current version of the Quality Manual is distributed to all personnel.
References:
▪12-0048-SOP, Controlled External Document File
▪ISO 9001, 4.2.1, Develop Quality System Documents
QUALITY SYSTEM DESCRIPTION
Scope
The quality system applies to all our products and services. We have a single, global quality system applicable to all worldwide locations.
Commitment
Our commitment to quality is demonstrated with a comprehensive system that satisfies all applicable regulatory requirements. Assurance of quality and its continuous improvement requires the support of the entire organization. Quality is assured by working in a
