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ISO 13485 Forms Package

A proper QMS should have forms referenced in the procedures.
This package of ISO 13485 Forms is a complete set of forms & tables to complete your ISO 13485 Quality Management System.

Buy complete Quality Manual, Procedures and Forms Package

They are in Microsoft Word and Excel format and are ready to customize for your organization.

The package of 30 forms includes:

• A-500-001 Quality Policy
• F-423-001 Document Master List
• F-423-002 Software Inventory
• F-423-003 Document Change Request Form
• F-423-004 Document Revision Checklist
• F-424-001 Quality Records Table
• F-500-001 QMS Measuring, Monitoring and Analysis Table
• F-500-002 Key Process Master List
• F-622-001 Training Action Plan
• F-622-002 Group Training Record
• F-710-001 Planning Table
• F-722-001 Risk Management Plan (sample)
• F-722-002 Risk List
• F-730-001 Design Plan
• F-730-002 Design Review Record
• F-730-003 Design Change
• F-740-001 Supplier Quality Report
• F-740-002 SCAR (sample)
• F-740-003 Approved Supplier List
• F-760-001 Equipment List
• F-822-001 Internal Audit Plan
• F-822-002 Internal Audit Report
• F-822-003 Applicable Procedure by Work Area
• F-822-004 Audit Checklist
• F-824-001 Product Realization Monitoring, Measuring and Analysis Table
• F-841-001 Root Cause Analysis Action Plan
• F-852-001 Corrective/Preventive Action Request
• T-001 Procedure Template
• T-002 Work Instruction Template
• T-003 Form/Attachment Template

These forms have been designed to be integrated with our Quality Manual and Procedures. Save by purchasing the Quality Manual, Procedures and Forms package.