Push rules can be used to set requirements for commit messages.
#ISO 13485 SOFTWARE SOFTWARE#
Beyond enforcing software requirements, this can be a powerful tool for document control change management for files stored in a project repository. Merge request approvals can be used to enforce requirements and require review by specific persons or teams before merging the change. GitLab offers several tools to enforce process, standards, review, and approvals for both documentation and code: Project exports include everything in the project, including issues and files, making it a powerful tool for sophisticated workflows.Īs part of your QMS you may have process enforcement requirements. Project import and export can be used to effectively create project-level templates, making it easy to create and replicate more complex workflows. GitLab offers several integrations, including Jira, making it easy to extend GitLab's PPM features. A complete history of all wiki pages is maintained so a comprehensive record can be kept. Wiki pages can be created and managed through an easy-to-use web interface or Git for more advanced users. The Wiki is a documentation system that's built into each GitLab project.
GitLab has several built-in tools to help your organization manage the creation, modification, tracking, and distribution of documentation:
#ISO 13485 SOFTWARE ISO#
Creating and managing documentationĭocumentation management is a key aspect of an ISO 13485:2016 QMS.
By merging PPM under the same roof as development and deployment, you can better centralize and simplify your QMS while increasing collaboration between teams and reducing silos. GitLab can be used as both an application within the QMS and as a functional tool to enable faster development and deployment. Because GitLab isn’t a compliance tool and makes no guarantees about compliance, every application used as part of your QMS must be evaluated based on your unique requirements and needs. GitLab offers many features and controls that may be useful as part of an ISO 13485:2016 QMS. Can GitLab be used as part of an ISO 13485:2016 QMS? Using GitLab's portfolio and project management (PPM) tools, you may be able to drive compliance with requirements across ISO 13485:2016. ISO 13485:2016 is an international standard specifying requirements for a quality management system (QMS) for organizations involved in one or more stages of the medical device lifecycle - from design to disposal - including the suppliers and vendors to those organizations. Using GitLab as a Quality Management System for ISO 13485:2016 Meeting ISO 13485:2016 Requirements with GitLab.