Medical Device Quality Systems Manual

醫療器械質量體系手冊

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

小實體企業認證指南第一版（用于取代原醫療器械GMP手冊）

Chapters

章節

Cover page, Preface, Foreword

首頁，前言

Table of Contents

目錄

1. The Quality System Regulation

1. 質量體系法規

2. Quality Systems

2. 質量體系

3. Design Controls

3. 設計控制

4. Process Validation

4. 流程驗證

5. Personnel and Training

5. 人員和培訓

6. Buildings and Environment

6. 建筑和環境

7. Equipment and Calibration

7. 設備和校準

8. Device Master Record

8. 器械主記錄

9. Document and Change Control

9. 文檔和變更控制

10. Purchasing and Acceptance Activities

10. 采購和接收活動

11. Labeling

11. 標簽

12. Product Evaluation

12. 產品評價

13. Packaging

13. 包裝

14. Storage, Distribution and Installation

14. 存儲，分發和安裝

15. Complaints

15. 投訴

16. Servicing

16. 售后服務

17. Quality Systems Audits

17. 質量體系審計

18. Factory Inspections

18. 工廠檢查

19. Appendices

19. 附件

Cover page, Preface, Foreword
HHS Publication FDA 97-4179
首頁，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