Building Quality. Achieving Compliance.

Comprehensive gap analyses and mock inspections that mirror the real accreditation experience. We identify deficiencies before inspectors do, giving your lab the time and roadmap to resolve every finding.

• Full-scope CAP, CLIA, and ISO gap analysis
• Simulated mock inspections with trained inspectors
• Prioritized deficiency response planning
• Pre-inspection staff training and readiness drills

We design and implement QMS frameworks that go beyond checkbox compliance — building the quality culture that sustains accreditation year after year. From document control to CAPA, we cover every pillar.

• ISO 15189 and CAP-aligned QMS design
• Document control and record management systems
• Corrective and preventive action (CAPA) programs
• Quality indicator monitoring and reporting

Expertly written standard operating procedures and validation protocols that meet regulatory requirements and reflect your lab's actual workflows. We write, review, and validate — so your team can focus on testing.

• Custom SOP authoring for all laboratory disciplines
• Method validation and verification protocols
• Proficiency testing program management
• Procedure gap identification and remediation

Launching a new clinical laboratory is complex. We guide you from facility design through first accreditation — helping you build the right infrastructure, hire the right team, and achieve compliance from day one.

• Regulatory pathway and licensure planning
• Facility and workflow design consultation
• Personnel qualification and competency programs
• First-accreditation project management