Master Software List Template - ISO 13485

ISO 13485:2016 QMS Template - Master Software List (QMS.4.1.6.1 - LQR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Master Software List template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

• Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
• Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
• Compliance Assurance: Utilizing our template helps you maintain an effective Master Software List, demonstrating robust quality management as required by ISO 13485:2016.

Frequently Asked Questions

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

The Master Software List template assists in compliance with Clause 4.1.6, which requires organizations to document and record the computer software used within the Quality Management System (QMS).

What are the main benefits of using this template?

• Centralized Information: Ideal for management review meetings and internal/external audits, centralizing all your software information for easy sharing, review, update, and approval.
• Validation Table: Includes a table to help identify whether software requires validation.

Do we require any supporting documents?

Additional templates that may be of interest include:

• QMS.4.1.6 - QP - Software Validation and Revalidation Procedure
• QMS.4.1.6.2 - QR - Software Acceptance Testing Template

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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