13485:2016 Flow Charts

Flowcharts to help you understand your business.


Created in the most popular Flow-charting Software:

  • ISO 13485:2016 flowcharts created in MS Visio*© and SmartDraw*©. These flowchart templates can be exported to MS Word©, PowerPoint©, Excel©.
  • ISO 13485:2016 flowcharts as pdf files so you can view them before deciding on which software you will use to edit the documents.

This complete package of 23 flow diagrams integrates with your QMS:

  • The 5 main flow charts (FC-xxx-xxx in bold) provide a summary of the QMS while dealing with the 5 clauses of ISO 13485:2016 and integrating information from the QMS Docs package.
  • The remaining 18 flowcharts expand on the 5 main ones and deal with understanding what can be done to meet the requirements by providing examples of typical activities and processes.

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

*Software not included

  • The 23 included Flowcharts created in Visio, SmartDraw, and pdf format:
    • FC-400-001 Quality Management System
    • FC-420-001 Documentation requirements
    • FC-500-001 Management responsibility
    • FC-510-001 Business process map
    • FC-512-001 Management customer focus
    • FC-530-001 Operating principles
    • FC-540-001 PDCA Objectives planning
    • FC-550-001 Organization chart
    • FC-600-001 Resource management
    • FC-610-001 Contributors – 5Ms
    • FC-700-001 Product realization
    • FC-710-001 Process flow
    • FC-710-002 Service / Quality plan
    • FC-720-001 Customer related processes
    • FC-730-001 Design and development
    • FC-730-002 Stage-Gate design process
    • FC-740-001 Purchasing
    • FC-750-001 Process control
    • FC-750-002 Process steps / control points
    • FC-758-001 Identification and traceability
    • FC-800-001 Measurement and improvement
    • FC-850-001 Continual improvement
    • FC-852-001 Corrective action

Additional Flow Diagram Descriptions



Flow Chart Sample

Product Details

Product Type: Digital

Price: $109.00

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Map Flows
ISO 13485:2016
Flow Charts
ISO 13485:2016 Quality
Manual & Procedures
Online Map Flows Training Course N
ISO 13485:2016 Quality Manual
(not sold separately)
ISO 13485:2016 Procedures 26
ISO 13485:2016 Forms & Attachments 48
ISO 13485:2016 Flow Charts* N 23
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*software not included