ISO 13485:2016 Forms Package

A complete set of forms & tables to complete your ISO 13485 Quality Management System


Created in MS Word and Excel for ease of use

Forms for EVERY required record in the standard

Includes templates to create your own Work Instruction, Form and Procedure

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.

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

The forms record the data to measure the effectiveness of a procedure. So every requirement will need to have a form.

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

Complete set of ISO 13485:2016 Forms

13485:2016 Forms
  1. A-500-001 Quality Policy
  2. A-550-001Organization Chart
  3. A-710-001 Flow chart for ISO QM
  4. F-424-001 Master Document Lists
  5. F-424-002 Software Inventory
  6. F-424-003 Document Change Request
  7. F-424-004 Document Revision Checklist
  8. F-425-001 Quality Records Table
  9. F-500-001 QMS Measuring Monitoring and Analysis Table
  10. F-500-002 Key Process Master List
  11. F-560-001 Management review agenda
  12. F-560-002 Management review checklist
  13. F-620-001 Action Plan for Training-Form
  14. F-620-002 Group Training Sign-In
  15. F-620-003 Job description form
  16. F-630-001 Equipment problem report
  17. F-630-002 Equipment maintenance record
  18. F-700-005 Clause-Inclusion/Exclusion worksheet
  19. F-710-001 Quality Planning Table-Form
  20. F-720-001 Client assessment memo
  21. F-722-001 Risk Management Plan
  22. F-722-002 Risk List
  23. F-730-001 Design Plan
  24. F-730-002 Design Review
  25. F-730-003 Design Change form
  26. F-740-001 Supplier Quality Report
  27. F-740-002 Supplier Corrective Action Request
  28. F-740-003 Approved Subcontractor List
  29. F-750-001 Process routing summary sheet
  30. F-750-002 Process routing detail sheet
  31. F-7510-005 Customer property control log
  32. F-7511-001 Storage inspection report
  33. F-756-001 Process validation worksheet
  34. F-759-001 Traceability serial number log
  35. F-760-001 Equipment List
  36. F-821-001 Customer satisfaction survey
  37. F-824-001 Audit Plan
  38. F-824-002 Internal Audit Report
  39. F-824-003 Procedure by Work Area
  40. F-824-004 Audit Checklist
  41. F-826-001 Product Realization Measuring Monitoring and Analysis Table
  42. F-830-001 Rejected Material-Disposition report-NCR
  43. F-841-001 Root Cause Analysis Action Plan
  44. F-852-001 Corrective Preventive Action Form
  45. T-001 Procedure Template
  46. T-002 Work Instruction Template
  47. T-003 Form Template

Product Details

Product Type: Digital

Price: $100.00

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