Build Your

Quality Management System

By the end of this program, you will have a complete quality management system.

A well-designed QMS enables your company to:

Each week, you will receive the following guidance to ensure your success throughout the program.

You’ll receive pre-built templates, frameworks, and guidances to give you a solid starting point.

You’ll also receive an instructional video to walk you through how to complete the templates and apply them to your own QMS.

You’ll have dedicated time with a QMS mentor who will help troubleshoot challenges, refine your SOPs, and ensure you stay compliant.

Compliance Simplified

Complex regulatory requirements are translated into clear, scalable systems appropriate for early-stage companies.
Own Your Own Processes

You know your company better than anyone. You’ll have our templates to get you started, but then you’ll have total control in how your systems are designed.
Founder-Centered Mentorship

You’ll receive personalized, one-on-one mentorship from a regulatory and quality expert. You’ll never have to guess if something is compliant or not.
Take It At Your Own Pace

The program is designed to help keep you on track, but we understand that things change fast for startups. Timelines can be made flexible according to your schedule.

Week 1: Document and Record Control, Training and Qualification
Week 2: Work Environment, Information Security
Week 3: Product Development
Week 4: Risk Management
Week 5: Supplier Management
Week 6: Purchasing, Incoming Quality Control, Process Software Validation
Week 7: Production, Operations
Week 8: Validation, Change Management
Week 9: Marketing, Sales, Installation, and Support
Week 10: Shipping, Labeling
Week 11: Complaint Management
Week 12: Nonconformities and CAPAs
Week 13: Audits
Week 14: Regulatory, Legal, Adverse Events, and Recalls
Week 15: Analysis, Improvements, and Management Responsibility
Week 16: Quality Manual