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QT9™ Quality Management Software ISO Compliance


ISO 9001

QT9™ QMS is a one stop ISO 9001 software solution. QT9™ QMS goes above and beyond the requirements for ISO 9001 while automating your entire quality management system making it electronic and paperless. All major ISO 9001 record requirements are present in QT9™ QMS, putting your ISO 9001 system in cruise control.

AS9100/NADCAP

QT9™ QMS is the ultimate tool in handling AS9100 compliance. Key features of AS9100 compliance include ECR/ECN design deviation controls, Inspections & FMEA risk analysis, and supplier quality (supplier web portal, supplier surveys, supplier evaluations, nonconforming product, and corrective actions).

ISO 13485/21 CFR Part 820

ISO 13485 is the quality standard designed for medical device manufacturers. ISO 13485 is also an international standard that is commonly used as the basis of regulatory compliance for the FDA. If you are a medical device manufacturer, bio med, pharmaceuticals, or perform work with medical device manufacturing or distribution, ISO 13485 is an essential quality standard for your organization.

QT9™ QMS Quality Management Software is a one stop ISO 13485/21 CFR Part 820 software solution. QT9™ QMS is completely 21 CFR Part 11 compliant with electronic signatures and is validated after every release. QT9™ QMS is in line with FDA 21 CFR Part 820 to not only keep you in compliance with ISO 13485, but also FDA quality system requirements. Let QT9™ QMS handle the burden of your ISO 13485/21 CFR Part 820 requirements and automate your management system making your organization more efficient and productive.

ISO 14001

QT9™ QMS handles the ISO 14001 standard core compliance requirements as easy as any other standard on this page. Keep everything paperless and electronic while maintain ISO 14001 requirements for corrective actions, training and awareness, document control, emergency preparedness and response, etc.

TS 16949

QT9 QMS handles the automotive standard easily through its core modules (training, calibration, document control, CAPA, management review, etc.). Key features of compliance to TS 16949 in QT9 are supplier quality (supplier web portal, supplier surveys, supplier evaluations, nonconforming product, and corrective actions) and control of production with risk analysis using our preventive maintenance, FMEA, and inspection software modules.

ISO 17025

QT9 QMS handles the testing and calibration laboratories standard easily keeping you paperless and automated. Key features of compliance to ISO 17025 in QT9™ QMS are Corrective actions, nonconforming product (to track nonconforming work), preventive maintenance, calibration, document control, management review, training, and audits.

For more information on how QT9™ Quality Management Software works with your quality standard, click on the links to your left for more detailed information.