ORA Quality Manual. January 2007

Foreword......Page 2
Table of Contents......Page 3
1.2  The Food and Drug Administration......Page 5
1.3  The Office of Regulatory Affairs......Page 7
1.4  Definitions and abbreviations......Page 9
2.2  Applicable requirements......Page 11
2.3   Documentation......Page 12
2.3.2   Directive control......Page 13
2.3.3   Record control......Page 14
3.2  Customer focus......Page 15
3.3  Quality policy......Page 16
3.5  Responsibility and authority......Page 17
3.6  Internal communication......Page 19
3.7  Management review......Page 20
4.3  Competency and training......Page 21
4.6  Facilities and work environment......Page 22
4.8  Purchase of supplies and services......Page 23
4.9  Support services......Page 24
5.2  Work plans and assignments......Page 25
5.5.1   Work and method controls......Page 26
5.5  Operations......Page 27
5.6  Reporting results......Page 28
6.1.2   Process/product measures and monitoring......Page 31
6.3  Data analysis......Page 32
6.5  Audits......Page 33
6.8 Continual improvement......Page 34
A2.  ORA organizational charts......Page 35
B.  Priority work processes......Page 37