In today’s highly regulated industries, especially in the medical device sector, an effective and compliant Quality Management System (QMS) is no longer optional, it is essential. At QMLogic we help organizations navigate the complex requirements of ISO 13485, FDA, EU MDR and other regulations and standards. We support companies in digitally transforming their quality systems by implementing a QMS with SharePoint and Power Platform, offering secure, scalable, and future-proof solutions. 

SharePoint: A Central Hub for Quality Management 

Microsoft SharePoint is an ideal platform for building a modern digital QMS. It offers a secure and flexible environment for managing controlled documents, structured records, and quality workflows, all integrated with Microsoft 365. 

Key SharePoint Capabilities That Support QMS Processes: 

Document Control 

Manage SOPs, work instructions, quality manuals, and forms using SharePoint libraries with full version control, automated approvals, and metadata tagging. Employees always access the latest approved versions, with draft and published stages clearly separated. 

Structured Records with SharePoint Lists 

Use Lists to track CAPAs, non-conformities, audits and training. Customize views, attach files, track statuses, and trigger automation for consistent process execution. 

Granular Permissions and Access Control 

Control who can view, edit, or approve each document. Permissions can be set at the site, library, folder, or document level, meeting ISO 13485 and FDA 21 CFR requirements for secure documentation. 

Smart Navigation with Metadata Views 

Replace deep folder hierarchies with metadata-driven filters. Users can quickly find what they need by department, process, or document type using custom views or SharePoint "masks." 

Microsoft 365 Integration  

Because SharePoint is part of the Microsoft 365 ecosystem, it connects natively with tools like Teams, Word, Excel, Outlook and OneDrive. This enables real-time collaboration, co-authoring, and even electronic signatures, all traceable for audit readiness. 

“Explore how SharePoint QMS can serve as the foundation of a comprehensive and compliant quality system.” 

Extending SharePoint QMS with Power Platform 

Microsoft Power Platform consisting of Power Automate, Power Apps and Power BI, adds automation, customization, and insight to your SharePoint-based QMS. Together, they transform a static document library into a dynamic electronic quality system built for regulated environments. 

Power Automate: Automating Compliance Workflows 

Power Automate enhances your SharePoint-based QMS by automating repetitive and compliance-critical processes, reducing human error and improving oversight. It allows you to build intelligent, logic-driven workflows that can be used for:  

• Approval workflows for SOPs, CAPAs, and change control. 

• Automated reminders for document reviews, audit actions, and renewals. 

• PDF record generation and storage. 

• Compliance tracking logs for audit readiness. 

Power Apps: Tailored Quality Management Applications 

Power Apps enables organizations to digitize manual or spreadsheet-based quality processes by building intuitive low code applications. 

At QMLogic we developed a Software Tool Validation App that aligns with ISO 13485 requirements for validating software tools used in a QMS. Built on SharePoint Lists and Document Libraries, the app mirrors the company’s internal validation process, guides employees step by step and automatically generates PDF records for compliance using Power Automate. It is a great example of how Power Apps and SharePoint can simplify quality processes, reduce errors, and improve business processes without heavy development costs. 

Other use cases that can be enabled using Power Apps include: 

• Complaint handling 

• Supplier evaluations 

• Audit checklists 

• Employee training tracking 

Power BI: Dashboards for Medical Device QMS 

Power BI integrates with SharePoint and Microsoft Dataverse to turn your QMS data into visual dashboards. With it, your quality team can monitor KPIs and identify trends in real time, supporting continuous improvement and regulatory readiness. 

Visualize your QMS data in real-time dashboards: 

• CAPA durations and bottlenecks 

• Overdue training items 

• Open audit findings and risk levels 

• Supplier performance and quality trends 

By transforming raw records into insights, Power BI helps leadership make informed decisions, support management reviews and demonstrate compliance more effectively. 

Microsoft Security for Regulated Industries 

Microsoft’s enterprise grade security infrastructure supports global compliance needs. SharePoint and Power Platform are backed by features such as: 

• Microsoft Entra ID for access control 

• Multi-factor authentication 

• Data loss prevention audit logging and eDiscovery 

• Compliance with ISO IEC 27001, GDPR, HIPAA and more 

SharePoint also allows documents to be declared as records, locking them from edits and triggering retention policies. Combined with Microsoft Purview and Power Platform governance tools, your QMS remains secure, traceable, and scalable. 

Partner with QMLogic: Digital QMS Expertise 

SharePoint and Power Platform are powerful, but not compliant out of the box. QMLogic brings deep medical device regulatory expertise and platform knowledge to design, implement, and validate your QMS in a way that meets both compliance and business needs. 

Whether you are preparing for ISO certification, regulatory audits, improving quality workflows, or advancing digital transformation, we bring together compliance expertise and technical innovation to support your goals. 

We can help you with: 

• Implementing SharePoint as a full featured QMS 

• Designing custom Power Platform solutions 

• Validating electronic systems for compliance 

• Modernize and automate your quality workflows 

“Contact QMLogic to start your digital transformation with SharePoint and Power Platform.”