Independent healthcare quality, accreditation readiness and laboratory excellence support.
A useful gap analysis should test whether requirements are actually implemented, evidenced and sustained—not simply whether a policy exists.
Use it as a structured readiness conversation with your team. Do not ask only whether a document exists—ask whether the process is current, consistently practiced, supported by evidence and actively reviewed.
Confirm responsibilities, quality objectives, document governance, performance oversight and evidence that leadership reviews the effectiveness of the laboratory quality system.
Review role requirements, authorization, initial training, competency assessment, continuing education and records that demonstrate ongoing staff capability.
Check whether policies and procedures are current, approved, accessible, controlled and consistently followed. Review retention and retrieval of quality and technical records.
Verify equipment qualification, maintenance, calibration, reagent management, lot acceptance and traceability appropriate to the examination process.
Assess patient/specimen identification, collection, transport, acceptance, method performance, QC, result review, reporting, critical results and turnaround-time controls.
Identify risks across the total testing process and verify that risk controls are documented, implemented, monitored and reviewed.
Check whether internal audits cover the QMS and technical activities and whether quality indicators generate meaningful improvement rather than just data collection.
Sample recent nonconformities. Look for clear root causes, proportionate corrective actions, owners, deadlines and evidence that effectiveness was checked.
Confirm that management review considers required inputs, identifies decisions/actions and follows through on improvement priorities.
Test whether staff can retrieve evidence, explain their processes and demonstrate implementation consistently during an assessment.
A useful ISO 15189 gap analysis looks beyond the existence of documents. It tests whether laboratory processes are controlled, technically valid, risk-aware, consistently implemented and supported by objective evidence.
Select only the statements your team can confidently demonstrate today with current practice and evidence.
Book a Free 20-Min Readiness ConsultationThis self-check is a planning aid, not an accreditation score and not a substitute for the official requirements applicable to your organization.AHQS can help convert a broad gap list into a risk-based implementation plan, clarify evidence expectations and test whether the QMS is functioning consistently in daily practice.
AHQS provides independent readiness, audit and quality-improvement support tailored to your organization’s scope, maturity, risk profile and accreditation goals. Use the options above to start with a focused consultation or explore the relevant service.
For a meaningful readiness program, begin early enough to identify, correct and verify gaps rather than waiting until immediately before the assessment.
No. A strong gap analysis also checks implementation, staff practice, records and objective evidence.
Yes. AHQS provides independent ISO 15189 readiness, QMS review, audit and improvement support.
Independent healthcare quality, accreditation readiness and laboratory excellence support.
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