Accreditation to a Management System Standard, Run Without a Management System.
ISO 15189 asks for what CLIA assumes and CAP samples: a functioning management system — documents controlled, risks assessed, nonconformities trended, effectiveness evaluated. Labs pursuing international accreditation typically bolt that system onto the same spreadsheets that barely carry their national requirements, and the assessment finds the bolt.
The 2022 revision sharpened the point: risk-based thinking throughout, patient impact explicit, and continual improvement with evidence — not a quality manual reciting intentions.
What ISO 15189:2022 Requires From the Laboratory
The standard requires structured management: document and record control (clause 8.3–8.4), risk and opportunity management (8.5), personnel competence with ongoing assessment (6.2), equipment qualification, calibration, and maintenance (6.4), examination process control including QC and EQA (7.3), nonconformity management with root cause where warranted (7.5, 8.7), and evaluation — internal audit and management review — closing the loop (8.8–8.9).
Kintavo runs the clause set as connected workflows on one data model, so the management system the assessor evaluates is the one the lab actually operates — daily, with records to show it.
The 2022 Structure, Running.
The assessor opens with clause 8.7: show me your nonconformity trending. The quality manager runs the view — events by category and section across twelve months, one upward trend flagged, its root cause analysis open with a linked corrective action. The assessor follows the thread to effectiveness criteria and the scheduled check. "And who reviews this?" — the management review record, with that exact chart as an input, actions assigned and tracked. The loop closes on screen.
The Management System the Assessor Can Watch Running.
Every clause’s evidence exists because a workflow created it — current, signed, linked. The assessment stops being a document review and becomes a system demonstration.
