Master Software List Template - ISO 13485

ISO 13485 2016 +A11 2021

QMS.4.1.6.1 - LQR - Master Software List 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.

Frequently asked questions

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

• The Master Software List will assist you in compliance with Clause 4.1.6 which states; the organisation shall have documents and records in place to outline the computer software used within the Quality Management System (QMS).

What are the main benefits of using this template?

• The ISO 13485 master software list is a useful tool for management review meetings and internal/ external audits. This allows you to have all your information centralised, making it easier to share, review, update and approve.

• The template also includes a table that will assist you in identifying whether or not software requires validation.

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.4.1.6.2 - QR - Software Acceptance Testing Template.

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.

Quality Management Support:

If you are looking for support with your QMS then Patient Guards consultancy services could be a cost effective solution for your organisation.