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Templates ISO 13485 Templates

Updated November 1, 2023

Template: SOP Software Validation

Sven Piechottka

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Related Records

The following templates are records of this template. That means that this document mentions them somewhere and you need to fill them out to actually implement whatever this document proposes.

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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

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

1.2 Plan Validation

Responsible QMO
Input Software Validation Form
Output Updated Software Validation Form

1.3 Perform Validation

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

1.4 Release

If validation was not successful:

If validation was successful:

Responsible QMO
Input Software Validation Form
List of Software
Output Completed Software Validation Form
Updated List of Software
Notification Sent

1.5 Monitoring of Softwares

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

1.6 Decommissioning of Software

Responsible QMO
Input Software Validation Form
List of Software
Output Updated List of Software

Template Copyright See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

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