FDA医疗器械质量体系手册框架介绍

FDA医疗器械质量体系手册框架介绍

  Medical Device Quality Systems Manual

  医疗器械质量体系手册

  A Small Entity Compliance Guide First Edition (Supersedes the Medical  Device Good Manufacturing Practices [GMP] Manual)

  小实体企业认证指南第一版(用于取代原医疗器械GMP手册)

  Chapters

  章节

  Cover page, Preface, Foreword

  首页，前言

  Table of Contents

  目录

  1. The Quality System Regulation

  1. 质量体系法规

  2. Quality Systems

  2. 质量体系

  3. Design Controls

  3. 设计控制

  4. Process Validation

  4. 流程验证

  5. Personnel and Training

  5. 人员和培训

  6. Buildings and Environment

  6. 建筑和环境

  7. Equipment and Calibration

  7. 设备和校准

  8. Device Master Record

  8. 器械主记录

  9. Document and Change Control

  9. 文档和变更控制

  10. Purchasing and Acceptance Activities

  10. 采购和接收活动

  11. Labeling

  11. 标签

  12. Product Evaluation

  12. 产品评价

  13. Packaging

  13. 包装

  14. Storage, Distribution and Installation

  14. 存储，分发和安装

  15. Complaints

  15. 投诉

  16. Servicing

  16. 售后服务

  17. Quality Systems Audits

  17. 质量体系审计

  18. Factory Inspections

  18. 工厂检查

  19. Appendices

  19. 附件

  Cover page, Preface, Foreword

  HHS Publication FDA 97-4179

  首页，前言

  MEDICAL DEVICE QUALITY SYSTEMS MANUAL:

  A SMALL ENTITY COMPLIANCE GUIDE

  First Edition

  (Supersedes the Medical Device Good Manufacturing Practices Manual)

  Andrew Lowery, Judy Strojny, and Joseph Puleo

  Division of Small Manufacturers Assistance

  Office of Health and Industry Programs

  CENTER FOR

  DEVICES AND

  RADIOLOGICAL HEALTH

  CDRH

  December 1996

  (This publication supersedes FDA 91-4179)

  U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

  Public Health Service

  Food and Drug Administration

  Center for Devices and Radiological Health

  Rockville, Maryland 20850