Leap Compliance
For life sciences quality leaders

How mature is your quality culture?

A 39-question diagnostic that scores your organization across five research-backed dimensions and highlights where to focus next. Takes about 8 to 10 minutes.

Before you start
We collect your name so the Leap Compliance team can identify your submission. Company is optional. Data is stored securely, kept for 6 months, and never shared with third parties.
See the framework

What we measure

Leadership & Vision
ISO 10010 · Hofstede (long-term orientation)
Leaders establish and model the quality vision, set the tone, align quality with strategy, and allocate resources — including role modeling, communication, and visible leadership presence (Gemba).
Values, Attitudes & Behaviors
Edgar Schein · Edmondson (Psychological Safety) · Hofstede (power distance, uncertainty avoidance) · ISO 10010
Employees take ownership, feel accountable, act with patient focus, and maintain quality under pressure. Covers psychological safety, accountability, and 'doing the right thing'.
Engagement & Participation
Lean / Gemba · Hofstede (individualism vs collectivism) · ISO 9001 & ISO 13485 (customer/patient focus)
Employees are empowered, collaborate across functions, and actively contribute to improvements. Covers Gemba walks, coaching, cross-functional teamwork, and staff involvement in problem-solving.
Measurement & Review
ISO 10010 · ISO 9001 cl. 9 · ISO 13485 cl. 8 (risk-based monitoring)
Quality metrics and review processes drive learning and improvement. Covers leading/lagging indicators, clarity of goals, management review, lessons learned, and data-driven action.
Cultural Enablers
ISO 10010 · ISO 13485 (cl. 4.2, 6, 7.4) · ISO 9001 (cl. 7)
The infrastructure that sustains quality: training, resources, systems, problem-solving tools, communication channels, and career development that let people succeed.