ISO 13485:2016 Forms Package

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


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 and Procedures. 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-542-001 QMS-Planning-Worksheet
  12. F-560-001 Management review agenda
  13. F-560-002 Management review checklist
  14. F-620-001 Action Plan for Training-Form
  15. F-620-002 Group Training Sign-In
  16. F-620-003 Job description form
  17. F-630-001 Equipment problem report
  18. F-630-002 Equipment maintenance record
  19. F-700-005 Clause-Inclusion/Exclusion worksheet
  20. F-710-001 Quality Planning Table-Form
  21. F-720-001 Client assessment memo
  22. F-722-001 Risk Management Plan
  23. F-722-002 Risk List
  24. F-730-001 Design Plan
  25. F-730-002 Design Review
  26. F-730-003 Design Change form
  27. F-740-001 Supplier Quality Report
  28. F-740-002 Supplier Corrective Action Request
  29. F-740-003 Approved Subcontractor List
  30. F-750-001 Process routing summary sheet
  31. F-750-002 Process routing detail sheet
  32. F-7510-005 Customer property control log
  33. F-7511-001 Storage inspection report
  34. F-756-001 Process validation worksheet
  35. F-759-001 Traceability serial number log
  36. F-760-001 Equipment List
  37. F-821-001 Customer satisfaction survey
  38. F-824-001 Audit Plan
  39. F-824-002 Internal Audit Report
  40. F-824-003 Procedure by Work Area
  41. F-824-004 Audit Checklist
  42. F-826-001 Product Realization Measuring Monitoring and Analysis Table
  43. F-830-001 Rejected Material-Disposition report-NCR
  44. F-841-001 Root Cause Analysis Action Plan
  45. F-852-001 Corrective Preventive Action Form
  46. T-001 Procedure Template
  47. T-002 Work Instruction Template
  48. T-003 Form Template

Product Details

Product Type: Digital

Price: $109.00

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Which version is right for me?
  • Choose 13485:2016 to create a new 13485 Quality Management System
  • Choose 13485:2003 to 13485:2016 QMS instructions to modify your existing 13485 QMS to meet the 13485:2016 requirements
  • Choose 13485:2016 FDA QMS Upgrade to develop an integrated management system that is 13485 and FDA.QSR (21 CFR 820) compliant as of April 2016 (this is the reference date of the CFR)
  • Choose ISO 9001:2015 / 13485:2016 QMS to align ISO 13485:2016 (8 section format) with ISO 9001:2015 (10-Section Annex L Format).
    • This QMS is for organizations (like Contract Manufacturers) who want ONE QMS for both ISO 9001:2015 and ISO 13485:2016.
    • Quality Management System Templates covering both the ISO 9001:2015 (Annex L 10-section format) and ISO 13485:2016 (8-Section format) in ONE combined, Annex L manual.

If you plan to reconfigure your existing quality manual completely by yourself, you can use either of the Upgrade Instructions to create everything on your own. They will tell you where to make the changes but will NOT provide any procedure or form templates for the new requirements.

Forms Package
Quality Manual &
Procedures Package
ISO 13485:2016 Quality Manual
(not sold separately)
ISO 13485:2016 Procedures & Attachments   N
ISO 13485:2016 Forms N N
ISO 13485:2016 Flow Charts   N
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