Professional Documents
Culture Documents
Quality Manual
Quality Policy
Quality Objectives
Quality Records
Six Procedures
Control of Documents (4.2.3)
Control of Records (4.2.4)
Internal Audit (8.2.2)
Control of Nonconforming Product (8.3)
Corrective Action (8.5.2)
Preventive Action (8.5.3)
Document Control
AP-424
AP-424-001
AP-500
Management Responnsibility
F-500-001
F-500-002
F-824-001
A-500-001
QMS Measuring, Monitoring and Analysis Table Minutes of management review meetings
Key Process Master List
Product Realization Measuring, Monitoring and Analysis Table
Quality Policy
AP-622
F-622-001
F-622-002
Procedure Name
Included
Form#
F-423-001
F-423-002
F-423-003
F-423-004
A-500-001
Quality Policy
AP-740
Purchasing
F-740-001
F-740-002
F-740-003
F-824-001
AP-821
None
EP-630
Infrastructure
None
EP-640
Work Environment
None
EP-722
Risk Management
F-722-001
F-722-002
EP-730
F-730-001
F-730-002
F-730-003
Design Plan
Design Review
Design Change Form
MP-710
F-710-001
MP-750
None
Batch Records
Installation and Verification Records
Sterilization Process Records
MP-752
None
Records of validation
MP-753
None
MP-754
Customer Property
None
MP-755
Preservation of Property
None
MP-760
F-760-001
Equipment List
MP-824
F-824-001
QP-821
None
QP-822
Internal Audits
F-822-001
F-822-002
F- 822-003
F- 822-004
QP-830
None
QP - 840
Statistical Techniques
None
QP-841
F-841-001
QP-852
Corrective Action
F-852-001
QP-853
Preventive Action
F-852-001
QP - 854
None
SP-720
None
Order database
Customer feedback spreadsheet
Order forms
Customer Inquiry Form
T-001
T-002
T-003
Procedure Template
Work Instruction Template
Form Template
Equipment Logs
Calibration Certificates and Records
Customer Survey Records
Add records that must be maintained to the Quality Records Table
4/24/2010
Records that must be maintained. Add these records to the Quality Records Table.
All reports generated through Root Cause Analysis proceedings
All Associated Corrective Action / Preventive Action requests