ISO Compliance Services

Challenge

• ISO standards provide the globally recognised quality benchmarks for regulated companies.
• Businesses focus the entire energy of their quality systems towards compliance, leaving no time for real quality improvement and turning audits into stressful nightmares.
• And with quality contained in paper and spreadsheets, a fatal lapse in compliance remains a constant risk.

Solution

• Qualio`s fully integrated eQMS software makes ISO compliance natural, automatic and easy.
• Workflows, audit trails and fully controlled records help you embed - and show off - the compliant processes you need without hours of admin.
• Audits become routine, adherence becomes unshakeable - and you get the headspace you need to make quality your secret weapon.

ISO 9001

• Holistic eQMS provides all the functionality needed for modern quality management, from document control to CAPA close-out
• Single source of truth aligns your business around key ISO requirements, from proving management commitment to managing resources and instilling customer focus
• Audit trails and incorruptible records make you 100% audit-ready, 100% of the time

ISO 13485

• Assemble all the elements of a holistic medical device QMS, from design controls to training, in a single cloud-based system
• Control all aspects of your device`s lifecycle, from design to PMS
• Pinpoint risks and drive digital workflows for a connected, right-first-time and patient-centric approach

ISO 14971

• Build a configurable database of design control data, from risks and risk levels to test cases and results
• Apply an ISO 14971 and FMEA risk management structure with configurable matrices, mitigation logs, associated V&V system data, and more
• Pull device design and testing data straight from their source systems with instant API synchronization

ISO 15189

• Give yourself the connected, cloud-powered quality system you need for a continuously improving medical laboratory
• Align all laboratory staff with version-controlled SOPs, digital training records, standardized workflow-driven processes, and more
• Unlock full visibility of quality issues - and the traceable, end-to-end accountability you need to fix them

ISO 17025

• Make your testing lab a patient-centric operation by connecting your teams to a central quality repository of processes and documents
• Ensure staff are properly trained and following the latest and greatest procedures
• Demonstrate control and compliance to your auditors