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U.S. Department of Health and Human Services

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ORA Quality Manual

Updated: March 2012


The ORA Quality Manual, version 2.0, 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


Chapter 1  – INTRODUCTION – The purpose of the Manual, an overview of FDA and ORA, and definitions. 

Chapter  2 – QUALITY MANAGEMENT SYSTEM – The scope of the QMS, applicable requirements, and system documentation. 

Chapter 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. 

Chapter 4 – RESOURCE MANAGEMENT – Resources provided by ORA to ensure work may be accomplished appropriately. 

Chapter 5 – WORK PROCESSES, CONTROLS, AND EXECUTION – How ORA plans, assigns, and completes work activities. 

Chapter 6 – QUALITY MEASUREMENT, ACCEPTANCE, AND IMPROVEMENT – Analyses and measurements undertaken by ORA including risk, trends, audits, corrective action, and continual improvement.