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 , 503 kb) FOREWORD – (PDF , 503 kb) Ch. 1 – INTRODUCTION – The purpose of the Manual, an overview of FDA and ORA, and definitions. (PDF , 503 kb) Ch. 2 – QUALITY MANAGEMENT SYSTEM – The scope of the QMS, applicable requirements, and system documentation. (PDF , 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 , 503 kb) Ch. 4 – RESOURCE MANAGEMENT – Resources provided by ORA to ensure work may be accomplished appropriately. (PDF , 503 kb) Ch. 5 – WORK PROCESSES, CONTROLS, AND EXECUTION – How ORA plans, assigns, and completes work activities. (PDF , 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 , 503 kb) APPENDICES (PDF , 503 kb)
If you need assistance in accessing these files, please contact Patricia.Maroney-Benassi@fda.hhs.gov, (240) 632-6819. |