Service
Vertical expansion: introduce new laboratory tests
MQS supports vertical laboratory expansion by helping you add tests to your menu, from validation and verification planning to documentation and applicable health authority approval applications. Where approval is required, testing must not begin until that approval is obtained.
Who this is for
- Laboratories adding new tests
- Laboratory directors and technical supervisors
- Healthcare organizations expanding diagnostic services
Common challenges
- Unclear validation or verification requirements
- Incomplete technical evidence for an application
- Pressure to launch before required approval
How MQS can support you
The exact scope is agreed with you after an initial consultation.
- Review proposed tests and applicable regulatory requirements
- Plan and support validation and verification studies
- Review performance data and compile technical documentation
- Develop SOPs, QC, PT plans, and personnel training as applicable
- Verify LIS and EMR reporting for the new tests
- Prepare and follow up submissions to the applicable health authority
- Support launch readiness after required approvals are obtained
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
Can the new test start before health authority approval?
Where approval is required, no. We help prepare the evidence and application, but the applicable authority must grant approval before testing begins.
Does every test need the same studies?
No. The method, intended use, jurisdiction, and applicable standards determine the validation, verification, and approval requirements.
Talk to us about test-menu expansion & approval support
Tell us about your quality, compliance, licensing, or growth priorities. We will recommend practical next steps.