Software Acceptance Testing - ISO 13485

ISO 13485:2016 QMS Template - Software Acceptance Testing Plan and Record (QMS.4.1.6.2 - QT)

Enhance your Quality Management System with our ISO 13485:2016 compliant Software Acceptance Testing Plan and Record 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 software acceptance testing plan, demonstrating robust quality management as required by ISO 13485:2016.

When Do We Need to Perform Software Acceptance Testing?

• If you modify a software application to add new functions not originally intended.
• If you use the software to perform critical calculations for product validation, quality control checks, equipment calibration, etc.

Which Clause Within the ISO 13485 Standard Will This Template Help Our Company Comply To?

The Software Acceptance Testing Plan and Record template aids your compliance with Clause 4.1.6, which requires companies to document procedures and records for the validation of computer software used within the QMS. Software must be validated before its initial use and revalidated if any changes are made.

Do You Require Any Supporting Documents?

Additional templates that may be of interest include:

• QMS.4.1.6 - QP - Software Validation and Revalidation Procedure
• QMS.4.1.6.1 - QR - Master Software List

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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