Service
Laboratory establishment from the beginning
MQS supports laboratory establishment from the initial plan through quality systems, regulatory procedures, license applications, and readiness to begin testing. We coordinate the required documentation and application follow-up; regulators and accrediting organizations make licensing and approval decisions.
Who this is for
- New laboratory owners
- Healthcare organizations establishing a laboratory
- Laboratory directors and startup teams
Common challenges
- Unclear sequence of regulatory and operational requirements
- Applications, staffing, procedures, and equipment plans progressing separately
- Missing evidence before opening
How MQS can support you
The exact scope is agreed with you after an initial consultation.
- Assess the proposed laboratory model, test menu, and applicable requirements
- Plan establishment milestones and regulatory documentation
- Prepare and follow up CLIA and state licensing applications as applicable
- Implement QMS, SOPs, document control, and staff training
- Coordinate method validation, verification, and LIS/EMR checks
- Support inspection preparation and required approvals before testing begins
How the engagement works
- 1
Discovery
We learn about your organization, services, goals, and quality, regulatory, or expansion priorities.
- 2
Gap assessment
We review procedures, records, and practices against the standards that apply to you, and report findings plainly.
- 3
Action plan
We agree on priorities, responsibilities, and a realistic sequence of work.
- 4
Implementation support
We work with your team to implement quality systems, develop procedures, prepare applications where needed, and train staff.
- 5
Inspection support
We help you prepare for external inspections and can attend alongside your team.
- 6
Follow-up
We help you respond to citations and sustain improvements over time.
Frequently asked questions
Does MQS issue the laboratory license?
No. MQS manages preparation and application support; the relevant authorities issue licenses and approvals.
Can you support us before we have opened?
Yes. We can work with your team from the initial establishment stage.
Talk to us about laboratory establishment & startup
Tell us about your quality, compliance, licensing, or growth priorities. We will recommend practical next steps.