Milestone | We Have Just Received our ISO 9001:2015 Certificate

Cyntegrity is now ISO 9001:2015 certified. Learn how this strengthens quality governance, continuous improvement, and trust in AI-augmented RBQM solutions.

Milestone | We Have Just Received our ISO 9001:2015 Certificate

Cyntegrity is now ISO 9001:2015 certified. Learn how this strengthens quality governance, continuous improvement, and trust in AI-augmented RBQM solutions.

ISO 9001:2015 Certified — Strengthening Trust in Quality-by-Design

Quality is not something that is inspected at the end of a process — it is shaped by how we work every day. We are proud to share that Cyntegrity has achieved ISO 9001:2015 certification, validating that our quality management system is structured, consistent, and aligned with internationally recognized standards. 

 

This certification reinforces what has guided our work since the beginning: clinical research benefits most when quality is intentional, measured, and continuously improved. 

What ISO 9001:2015 Means in Practice

The standard emphasizes three principles that are already foundational to modern Risk-Based Quality Management (RBQM):

ISO 9001:2015 Principle

How It Strengthens Clinical Trial Oversight

Risk-based thinking

Anticipate issues earlier and prevent avoidable study burden.

Continuous improvement (Plan-Do-Study-Act)

Learn from each study decision to improve the next.

Cost of poor quality awareness

Quality is designed into processes — not corrected afterward.

This is closely aligned with ICH E6(R3) expectations, which also emphasize proactive oversight, clarity in decision logic, and built-in quality by design. 

Why This Matters for Our Partners

Clinical trial environments evolve rapidly — study designs, data sources, hybrid execution models, AI-assisted analytics. A certified quality system means you can rely on how we operate, how we validate our tools, and how we support you throughout your study lifecycle. 

 

It ensures that our teams and our technology consistently deliver: 

  • Transparency in processes and decision-making 
  • Documented and auditable quality controls 
  • An environment where improvement is systematic, not situational

A Shared Achievement 

This certification reflects the effort and professionalism of every team member who contributes to our culture of learning, accountability, and meaningful innovation. 

We grow with quality in mind — because responsible innovation requires structure, clarity, and discipline.

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We grow with quality in mind — because responsible innovation requires structure, clarity, and discipline.

Next Step

If you would like to see how our quality management practices are embedded into the MyRBQM® Portal and our service model: 

Stay Informed with Us

MyRBQM® Portal Onboarding Plan

Download the MyRBQM® Portal Onboarding Plan — a realistic 3–6-month roll-out blueprint covering pilots, integrations, governance, validation, and hypercare. Adaptable to in-house, hybrid, and outsourced delivery models....

AI-Driven Predictive Analytics in Risk-Based Monitoring

Discover how AI-driven predictive analytics is reshaping risk-based monitoring under ICH E6(R3), enabling earlier intervention and stronger oversight. ...

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ISO 9001:2015 Certification

ISO 9001:2015 Certification