Software Acceptance Testing Plan and Record - ISO 13485

ISO 13485 2016 +A11 2021 

QMS.4.1.6.2 - QT - Software Acceptance Testing Plan and Record Template

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which, then be modified to suit your company branding/marketing requirements.

When do we need to perform software acceptance testing?

• If you modify a software application in any way to complete additional functions not stated in its intended use

• If you use the software to perform calculations for product validation, QC checks, equipment calibration etc.

Which clause within the ISO 13485 standard will this template help our company comply to?

• The software acceptance testing template will aid your compliance with Clause 4.1.6 which states; the company should document procedures and records for the validation of computer software used within the QMS. Software should be validated before its first use, in addition, software revalidation is required if any further changes are made.

Do we require any supporting documents?

• Additional templates that may be of interest to you include the QMS.4.1.6 - QP - Software Validation and Revalidation Procedure and the QMS.4.1.6.1 - QR - Master Software List.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.