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| ORA Laboratory Policies Food and Drug Administration |
| DOCUMENT NO.: ORA-LAB.QM | VERSION NO.:1.6 | ORA Laboratory Manual of Quality Policies | EFFECTIVE DATE: 10/01/2003 | REVISED: 06/06/2008 |
6.0 Document/Change History
6.0 Document History
Version
No. |
Status
(I, R, C) |
Date
Approved |
Location of Change History |
Name & Title |
| Author |
Approving Official |
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1.2
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R
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01/19/05
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Table of Contents - added Document History, page 44.
Section 4.2.4, page 10, second bullet item - (technical management) added to Responsible Managers.
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LMEB
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LMEB
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1.3
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R
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04/29/05
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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".
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LMEB
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LMEB
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1.4
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R
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11/16/05
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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.
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LMEB
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LMEB
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1.5
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R
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11/15/07
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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
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LMEB
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1.6
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R
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06/06/08
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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
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LMEB |
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Approving Official's signature: _________________________________ Date: _____________
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