ISO 13485 QMS Matrix

Referenced Included
Procedure # Procedure Name Form# Included Form Name Referenced Documents NOT included
AP-423 Document Control F-423-001 Master Document List
F-423-002 Software Inventory Spreadsheet
F-423-003 Document Change Request Form
F-423-004 Document Revision Checklist
AP-424 Control of Quality Records AP-424-001 Quality Records table
AP-500 Management Responnsibility F-500-001 QMS Measuring, Monitoring and Analysis Table Minutes of management review meetings
F-500-002 Key Process Master List
F-824-001 Product Realization Measuring, Monitoring and Analysis Table
A-500-001 Quality Policy
AP-622 Competence, Awareness and Training F-622-001 Action Plan For Training Form Employee resume or application with qualifications
F-622-002 Group Training Sign In
A-500-001 Quality Policy
AP-740 Purchasing F-740-001 Supplier Quality Report Purchasing documents required for traceability
F-740-002 Supplier Corrective Action Request Records of verification of purchased product
F-740-003 Approved Subcontractor List
F-824-001 Product Realization Measuring, Monitoring and Analysis Table
AP-821 Monitoring, Measuring and Analysis of Customer Satisfaction None Project records as identified by management
EP-630 Infrastructure None Preventive Maintenance Spreadsheet or database
Preventive maintenance summaries
EP-640 Work Environment None
EP-722 Risk Management F-722-001 Risk Management Plan
F-722-002 Risk List
EP-730 Design and Development F-730-001 Design Plan Records of design outputs: specifications, manufacturing procedures, etc.
F-730-002 Design Review Records of Validation
F-730-003 Design Change Form
MP-710 Planning of Product Realization Processes F-710-001 Quality Planning table Form
MP-750 Control of Production and service Provision None Batch Records
Installation and Verification Records
Sterilization Process Records
MP-752 Validation of Processes Product Realization None Records of validation
MP-753 Identification and Traceability None
MP-754 Customer Property None
MP-755 Preservation of Property None
MP-760 Control Of Monitoring and Measuring Devices F-760-001 Equipment List Equipment Logs
Calibration Certificates and Records
MP-824 Monitoring and Measuring of Product Realization Processes F-824-001 Product Realization Measuring, Monitoring and Analysis
RecordsTable
as identified on the Product Inspection and Process Monitoring Table
QP-821 Post Production Feedback None Customer Survey Records
Add records that must be maintained to the Quality Records Table
QP-822 Internal Audits F-822-001 Internal Audit Plan
F-822-002 Internal Audit Report
F- 822-003 Applicable Procedures by Work Area
F- 822-004 Audit Checklist
QP-830 Control of Non-Conforming Product None Department Scrap Reports
NCR forms
Corrective and Preventive Action Requests
QP - 840 Statistical Techniques None
QP-841 Root Cause Analysis F-841-001 F-841-001 Root Cause Analysis Action Plan 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
QP-852 Corrective Action F-852-001 Corrective/Preventive Action Request
QP-853 Preventive Action F-852-001 Corrective/Preventive Action Request
QP - 854 Product Recall and Advisory Notices None List the forms that you have referred to above
Records that must be maintained. Add these records to the Quality Records Table.
SP-720 Customer Related Processes None Order database
Customer feedback spreadsheet
Order forms
Customer Inquiry Form
T-001 Procedure Template
T-002 Work Instruction Template
T-003 Form Template

4/24/2010