13485:2016 Flow Charts

»Flowcharts, Software & Training to help you understand your business


Includes SmartDraw, Visio, and PDF formatting

Flow Chart to address every requirement

Customizable for your organization

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.

If you do not own a copy of MS Visio©, Standards Stores will provide FREE 6 month access to LucidChart, where you can upload the Visio© templates and edit or Share. LucidChart also allows you to collaborate online with others, easily make changes, and more.

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 flow charts 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.
  • Includes 6 month free subscription to LucidChart Flowchart Software
  • 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: $75.00

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