ISO 17025 Quality Management Simplified
Easily centralize ISO 17025 and FDA-compliant laboratory processes with QT9™ QMS and QT9 ERP. Eliminate time-consuming manual tasks by putting key workflows on autopilot in a secure, cloud-based platform.
Automate Workflows
QT9 QMS and QT9 ERP help reduce staff time by automating and eliminating manual processes.
Hassle-Free Compliance
Ensure ISO 17025 compliance with QT9 QMS or QT9 ERP or both!
Connect & Collaborate Online
QT9 QMS and QT9 ERP streamline document upload, publishing, and distribution through a connected platform.
Be More Accurate & Efficient
QT9 QMS and QT9 ERP help you anticipate and address changes and problems.
ISO 17025 modernization for today's laboratory
Keep track of laboratory compliance items and synchronize documentation with anyone, anywhere.
Explore how ISO 17025 software can benefit your organization
Enhance operating efficiency
Simplify ISO 17025 compliance
Streamline audits and inspections
Simplify internal and external audits by automating scheduling, tracking, and reporting compliance data in one central place.
Reduce waste and costs
Increase customer satisfaction
See how QT9 QMS stacks up against the ISO 17025 standard
QT9 is available in the cloud or on-premise
Flexible deployment to match your IT strategy without compromising security or speed.
Work smarter with intelligent automation in quality and compliance
QT9 Software’s built-in automation streamlines compliance workflows, quality checks, and alerts, reducing human errors, accelerating decision-making and freeing your team to focus on higher-value work.
Speed up implementation with pre-validated software
QT9 Software offers a fully pre-validated environment, with every module and feature tested and documented for compliance. Save time, avoid costly internal validation processes and go live faster with confidence.
Ensure audit-ready traceability across all processes
Track every action, change and event in real time with QT9 Software. Timeline-based traceability supports inspections, audits and product recalls by providing complete visibility into your processes and product history.
Empower teams with secure, self-service portals
QT9 Software provides dedicated web portals for employees, suppliers and customers, enabling secure self-service access to documentation and data while streamlining collaboration across your organization.
Catch and resolve issues instantly with real-time monitoring
Monitor operations live with real-time dashboards and automated alerts using QT9 Software. Enable proactive responses to nonconformances, minimize downtime and improve compliance outcomes across your organization.
Onboard faster with an intuitive, user-friendly platform
Whether you’re a startup or an enterprise, QT9 Software’s clean, intuitive interface minimizes the learning curve, empowering users to work confidently, complete tasks accurately and stay audit-ready from day one.
FAQ: ISO 17025 compliance
ISO 17025, also referred to as ISO/IEC 17025, is the international standard for testing and calibration laboratories. It sets out requirements for the competence, impartiality and consistent operation of laboratories, ensuring the accuracy and reliability of their testing and calibration results.
The standard is published by the International Organization for Standardization (ISO) in collaboration with the International Electrotechnical Commission (IEC). It is reviewed for relevancy every five years. The most current version is ISO/IEC 17025:2017.
ISO 17025 is applicable to any size laboratory or facility that performs testing, sampling or calibration – any measurable result – and seeks to assure stakeholders of the competence of their systems and reliability of their results. Examples of industries covered by the rule include chemicals, forensics, automotive and food production.
Note that ISO 17025 does not apply to medical labs. Instead, ISO 15189 is the standard that specifies requirements for quality and competence in medical laboratories.
Requirements for ISO/IEC 17025 fall into five main categories:
- General Requirements – Centered around impartiality and confidentiality
- Structural Requirements – Covering management and employee involvement, and lab organization
- Resource Requirements – Requirements for personnel, facilities, equipment, systems and support needed to optimally perform lab activities
- Process Requirements – Core processes to improve efficiency, including selection, verification and validation of methods
- Management Systems Requirements – Including documentation, document control, risk assessment, continuous improvement and corrective actions
For detailed information about ISO 17025 visit ISO/IEC 17025
Companies can be certified to ISO 17025 by an authorized, third-party accrediting body. Certification is not mandatory, however many organizations require this certification as a prerequisite to doing business.
Obtaining official certification shows customers and stakeholders that your lab resources and practices are competent and your results are trustworthy. Start by examining the standard and comparing it to your lab's current activities. Create a gap analysis and work on improving in necessary areas.
Both ISO 9001 and ISO 17025 are quality management systems. The biggest difference is that ISO 17025 is specific to testing and calibration laboratories. ISO 17025 and ISO 9001 have many similarities, including requirements for document control, risk management, resource management and corrective actions. Testing labs often use ISO 9001 alongside ISO 17025 to ensure that all aspects of quality management are addressed.
QT9 QMS offers 23-plus standard modules that help streamline and centralize ISO 17025 compliance, including document control, risk management, audit management and employee training. Our highly rated QMS is cost effective, easy to use and offers full customer support, an available ERP integration and Business Intelligence tool.
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