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