U.S. Food and Drug Administration - CDRH Mobile
Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule

FDA > CDRH > Good Manufacturing Practice / Quality Systems > Medical Device Quality Systems Manual: A Small Entity Compliance Guide

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

This page provides information and access to this CDRH manual in its entirety or as individual chapters as shown below:
Instructions for downloading the PDF reader.
Top of page
  1. The entire manual as originally created in Word Perfect 6.1 has been archived using ZIP format into a single file [qsrman.zip size = 1,929 KB].
  2. As individual chapters listed below. The reconstructed file consists of approximately 7 Megabytes.

Cover page, Preface, Foreword [Text Format]
Table of Contents [Text Format]

  1. The Quality System Regulation [Text Format]
  2. Quality Systems [Text Format]
  3. Design Controls [Text Format]
  4. Process Validation [Text Format]
  5. Personnel [Text Format]
  6. Buildings and Environment [Text Format]
  7. Equipment and Calibration [Text Format]
  8. Device Master Record [Text Format]
  9. Document and Change Control[Text Format]
  10. Purchasing and Acceptance Activities [Text Format]
  11. Labeling [Text Format]
  12. Product Evaluation [Text Format]
  13. Packaging [Text Format]
  14. Storage, Distribution, and Installation [Text Format]
  15. Complaints [Text Format]
  16. Servicing [Text Format]
  17. Quality Systems Audits[Text Format]
  18. Factory Inspections[Text Format]
  19. Appendix (Index of appendices)
    1. Appendix 1: The Quality Systems regulation; [Text Format], [PDF] [PDF].
    2. Appendix 2: Application of the Medical Device GMPs to Computerized Devices and Manufacturing Processes; [Text Format], [PDF] [PDF].


Information is available on Portable Document Format [PDF].

If you have questions or comments concerning this page, please contact the Division of Small Manufacturers, International and Consumer Assistance at dsmica@cdrh.fda.gov.

Back to Device Advice

Updated April 14, 1999

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH