ISO 15189 Gap Analysis & Readiness

ISO 15189 is detail-heavy. Most labs fail on documentation, not technical competence.

What I do:

• Gap analysis against ISO 15189:2022 requirements

• QMS document restructuring and SOP alignment

• Risk management and quality indicators setup

• Internal auditor training so your team can self-check

• Pre-assessment mock audit

Outcome: Clear action plan with priorities. No more guessing what SANAS expects.  

Best for: Labs in pre-assessment phase or re-accreditation cycle.

Timeline: 3-6 weeks for full gap analysis.

[See if your lab is ready for SANAS, book a "Lab Walkthrough Assessment"]