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Volume I - 6.0 Document/Change History

DFS Pyramid Logo

ORA Laboratory Policies

Food and Drug Administration

DOCUMENT NO.:
ORA-LAB.QM

 VERSION NO.:1.9

ORA Laboratory Manual of Quality Policies

 EFFECTIVE DATE:
10-01-03		 REVISED:
01-22-13

 

Version
No.		 Status
(I, R, C)		 Date
Approved		 Location of Change History Name & Title
Author Approving Official

1.2

R

 01/19/05

 Table of Contents - added Document History, page 44.
Section 4.2.4, page 10, second bullet item - (technical management) added to Responsible Managers.		  LMEB  LMEB

1.3

R

04/29/05

Section 4.1, Organization, I. Principal Responsibilities, page 4 - added PHS Act.
Section 4.4.3, page 13 - Volume I Subsection 4.5. title changed from "Subtracting of Tests" to "Subcontracting of Tests".
Section 4.11.2, page 19, first bullet under Related Procedures - added the word "has".
Section 5.2.1, page 25, second paragraph - changed Office of Regional Management to Office of Resource Management.
Section 5.4.2, Selection of Methods, page 29, first paragraph - added after LIBS "that are included in compliance programs and special assignments.
Section 5.4.5.2., page 30 - corrected "amplifications" to "applications".

  LMEB  LMEB

1.4

R

11/10/05

Quality System and quality system references changed to Management System and management system throughout document.
Table of Contents – page column renumbered
Section 1.0, changed date to 2005.
Section 4.12, add “assignments” to fourth bullet.
Section 4.1.5 a., page 4, added second sentence.
Section 4.1.5 d., page 5, website updated.
Section 4.1.5 k., page 6, added.
Section 4.1.6, page 6, added.
Section 4.2.2 c., page 10, added last sentence.
Section 4.2.3, page 10, added new and moved former 4.2.3. to 4.2.5, page 10.
Section 4.2.4, page 10, added new and moved former 4.2.4 to 4.2.6, page 10.
Section 4.2.7, page 11, added.
Section 4.7, page 17, renumbered with 4.7.1 and added 4.7.2
Section 4.15, Improvement, added to Table of Contents and page 24.
Section 5.2.2.1, page 26, added last sentence to third paragraph.
Section 5.9, page 41, renumbered with 5.9.1 and added 5.9.2; added ORA laboratory procedure for handling control of non-conforming work to Related Procedures.
Section 5.10.9, page 44, revised.

  LMEB  LMEB
1.5
R
11/15/07
 Version 1.5 changes:
Table of Contents – Improvement moved to 4.10 & elements moved down; page column renumbered
Section 4.1.5 d., page 5, website updated.
Section 4.2.2, page 7, FDA mission statement deleted & ORA mission statement added; revised second sentence
Section 4.2.2 e., page 10, revised second sentence.
Section 4.3.2, page 12, corrected number to 4.3.3
Section 4.10, page 18, corrected to Improvement to align with ISO 17025:2005
Section 4.11-4.15, pages 19-23, moved elements down one to align with ISO 17025:2005
Section 4.7, page 17, renumbered with 4.7.1 and added 4.7.2		  LMEB  LMEB
1.6
R
06/06/08
 Version 1.6 changes:
Section 4.1.5 i. and j - Quality Management System Manager changed to QSM
Section 4.2.6, Quality Manager changed to Quality System Manager
Sections 4.1, 4.11, 4.12, 4.13, 4.14, 4.15 - Related Procedures, numbering corrected for procedures
Section 4.8, 4.9.2, 4.11.5 - numbering corrected for procedures
Section 5.9 Related Procedues, updated websites		  LMEB  LMEB
1.7 R 02/02/10

Section 4.15 a. and f. - updated Section 4.15 d. – web link updated 
Section 4.1, Related Procedures – deleted first bullet 
Section 4.2.2 b. – third bullet revised 
Section 4.2.5 – changed "Volume" to "Manual in last sentence 
Section 4.3.2.2 d. – revised 

Section 4.3.3.1 – revised 

Section 5.2.4 - revised 

Section 5.2.5 – changed "Director" to "Management" 

Section 5.4.2 – added last sentence to first paragraph 

Section 5.5.7.1 – revised 

Section 5.5.9 - revised 

Section 5.9 related Procedures – web links updated 

Section 5.10.4 - revised Footer – web link updated

  LMEB  LMEB
 1.8  R  02/06/12 Section 4.1 I. – changed Associate Commissioner for Regulatory Affairs to Office of Regulatory Affairs Associate Commissioner
Section 4.1.3 – changed “addresses” to “locations”; changed SMG 1300 to 1300.1 through 1316.4
Section 4.1.4 - changed SMG 1300 to 1300.1 through 1316.4; added “About FDA”
Section 4.1.5 d. – updated weblink
Section 4.1.5 e. - changed SMG 1300 to 1300.1 through 1316.4
Section 4.1.5 f. – added Rockville and changed (HHS) to (RHRC)
Section 4.1 – Related Procedures – added ORA-QMS.007
Section 4.3 – Related Procedures – added ORA-QMS.001
Section 4.4.1 – changed FMD17B with ORA-ORM.003 in last sentence of last paragraphy
Section 4.4 – Related Procedures – deleted FMD 17B; added ORA-ORM.003
Section 4.5.1 – changed FACTS Manual to LM Volume III, Section 2
Section 4.5 – Related Procedures - changed FACTS Manual to LM Volume III, Section 2
Sections 4.5, 4.8, 4.9, 4.11, 4.12 – Related Procedures – added applicable ORA-QMS procedure
Section 4.13.1.3 – changed “process” to “requirements” in third sentence
Sections 4.13, 4.14, 4.15 – Related Procedures – added applicable ORA-QMS procedure
Section 5.2.2.1 – changed “by” to “in accordance with”
Section 5.5.11 – reformatted number
Section 5.8 – Related Procedures - deleted FACTS Manual
Section 5.9 – Related Procedures – updataed weblinks
Section 5.10.3.1 c. - reworded		  LMEB  LMEB
1.9 R   Division of Field Science changed to Office of Regulatory Science throughout
DFS changed to ORS throughout
Office of Regional Operations changed to Office of Operations throughout
ORO changed to OO throughout
Section 5.9.2 – Related Procedures – SOP numbering series revised and websites deleted
 		  LMEB  LMEB
           

 

 

 

Approving Official's signature: _________________________________ Date: _____________

 

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