Quality Management Systems Consulting

We help companies of all sizes establish and improve Quality Management Systems based on:

  • ISO 9001
  • CFR 21 Part 820 (FDA Medical Devices)
  • College of American Pathology (CAP) and COLA

We can teach your organization how to utilize the latest technologies to design dynamic, innovative solutions built to scale with your business, while limiting the need for additional resources. Our risk-based approach to quality management has a proven track record for success.

Continual Quality Consulting

We are committed to being your laboratory’s long-term partner for quality-related services.  Our staff is detail-oriented, and create high-quality and professional documentation.  Below is list of some of our long-term services.

  • Initial CLIA and CMS application paperwork
  • Change of ownership, change of Laboratory Director
  • CLIA/CAP/COLA/NY State inspection readiness audits
  • Process improvement analysis
  • SOP Creation and Revisions

Contact us to see how we can provide quality Insights to your lab.