ORA Quality Manual, January 2007
The ORA Quality Manual, ORA.1.1, contains the required policy elements to structure the Office of Regulatory Affairs (ORA) quality management system (QMS) for internal work activities. Please refer to the FDA Staff Manual Guide "FDA
Quality System Framework for Internal Activities" for the requirements
the Quality Manual fulfills. The ORA Quality Manual does not modify
ORA's operational policies and procedures as presented in the Investigations
Operations Manual, Regulatory
Procedures Manual, Laboratory
Manual, or other FDA
guidance documents.
Chapter Descriptions COMPLETE MANUAL – (PDF
FOREWORD – (PDF
Ch. 1 – INTRODUCTION – The purpose of the
Manual, an overview of FDA and ORA, and definitions. (PDF
Ch. 2 – QUALITY MANAGEMENT SYSTEM – The
scope of the QMS, applicable requirements, and system documentation.
(PDF Ch. 3 – MANAGEMENT RESPONSIBILITY – ORA
Management's commitment to the QMS; focus on the customer; policies
and planning; and responsibilities for authority, communication, and
system review. (PDF Ch. 4 – RESOURCE MANAGEMENT – Resources
provided by ORA to ensure work may be accomplished appropriately. (PDF
Ch. 5 – WORK PROCESSES, CONTROLS, AND EXECUTION
– How ORA plans, assigns, and completes work activities. (PDF
Ch. 6 – QUALITY MEASUREMENT, ACCEPTANCE, AND IMPROVEMENT
– Analyses and measurements undertaken by ORA including
risk, trends, audits, corrective action, and continual improvement.
(PDF APPENDICES (PDF
If you need assistance in accessing these files, please contact Patricia.Maroney-Benassi@fda.hhs.gov, (240) 632-6819. |