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