Templates ISO 13485 Templates

Updated May 31, 2023

Template: SOP Software Validation

Sven Piechottka

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SOP Software Validation


This SOP ensures that the organization only works with validated computer/software systems to avoid erroneous systems affecting the safety and performance of its medical devices. The process outlines requirements for validation before use.

Process Owner <enter role of process owner>
Key Performance Indicators <enter KPIs to be tracked for the Management Review>
Regulatory References ISO 13485:2016 Sec. 4.1.6 and 6.3 and 7.6
IEC 62304:2016 Sec. 9.8

Process Steps

1.1 Collecting Information and Preliminary Assessment

Employee intending to work with the new system
Input Output
Information about the system Preliminary Software Assessment
Software Validation Form  
List of Softwares  

1.2 Plan Validation

Input Output
Software Validation Form Updated Software Validation Form

1.3 Perform Validation

Employee working with the system
Input Output
Software Validation Form Updated Software Validation Form

1.4 Release

If validation was not successful:

If validation was successful:

Input Output
Software Validation Form Completed Software Validation Form
Software List Updated List of Software
  Notification sent

1.5 Monitoring of Softwares

QMO in collaboration with employee working with the system
Input Output
Error reports by users / developers Updated List of Software
  If required: new record of Softwares Validation Form created

1.6 Decommissioning of Software

Input Output
Software Validation Form Updated List of Software
Software List  

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