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ORA Quality Manual, January 2007
Updated: 2007-03-07

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


FOREWORD – (PDF PDF Icon, 503 kb)

Ch. 1 – INTRODUCTION – The purpose of the Manual, an overview of FDA and ORA, and definitions. (PDF PDF Icon, 503 kb)

Ch. 2 – QUALITY MANAGEMENT SYSTEM – The scope of the QMS, applicable requirements, and system documentation. (PDF PDF Icon, 503 kb)

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 PDF Icon, 503 kb)

Ch. 4 – RESOURCE MANAGEMENT – Resources provided by ORA to ensure work may be accomplished appropriately. (PDF PDF Icon, 503 kb)

Ch. 5 – WORK PROCESSES, CONTROLS, AND EXECUTION – How ORA plans, assigns, and completes work activities. (PDF PDF Icon, 503 kb)

Ch. 6 – QUALITY MEASUREMENT, ACCEPTANCE, AND IMPROVEMENT – Analyses and measurements undertaken by ORA including risk, trends, audits, corrective action, and continual improvement. (PDF PDF Icon, 503 kb)



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