Using the App

UKAS Audit Training

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A UKAS witnessed visit can be high-pressure. This simulator drills the assessor's likely questions and your evidence-on-demand responses against the ISO 15189:2022 framework.

What it does

• Generates a simulated UKAS visit covering one or more clauses of ISO 15189:2022
• Asks you assessor-style questions (e.g. "Show me how you verified this new method", "Where is the evidence that this CAPA was effective?")
• Tracks your response — did you produce the evidence within the expected time?
• Shows the finding category that would have applied — Major / Minor / Recommendation / Observation
• Produces a closure plan for any findings raised

Clauses covered

The simulator picks from the full ISO 15189:2022 structure:

• Clause 4 — General requirements
• Clause 5 — Structural and governance
• Clause 6 — Resource requirements (personnel, environment, equipment, reagents)
• Clause 7 — Process requirements (pre-examination, examination, post-examination, complaints, NCs)
• Clause 8 — Management system requirements

It also covers the flexible scope model for accredited laboratories.

ISO 15189:2022 vs 2012

Key differences the simulator highlights:

• Risk-based approach — formal risk assessment requirement
• Updated information-management requirements — covers LIS / LIMS, digital records
• Patient and clinician engagement — explicit clause
• POCT incorporated — ISO 22870:2016 retired, now in 15189:2022 Annex A
• Stronger continuity-of-service expectations

Finding categories

• Major non-conformance — a critical clause is not met or systemic failure
• Minor non-conformance — specific clause partially met or one-off failure
• Recommendation — improvement suggestion, not a finding
• Observation — assessor note for future visits

Each level has different closure timeframes — typically 30 days (Minor), shorter for Major.

Standards alignment

• ISO 15189:2022 — Medical laboratories (current standard, fully replaced 2012 by 6 December 2025)
• ISO 22870:2016 — retired; POCT now in 15189:2022 Annex A
• UKAS TPS 70 — UK-specific application of 15189
• MHRA for regulated device interactions
• EA-4/17 — European cooperation guidance on accreditation

Bands and competency mapping

• Band 5 — answer assessor questions in your area; produce evidence on demand
• Band 6 — lead your section through assessment; close non-conformances
• Band 7 / 8 — service-wide UKAS lead; chair pre-assessment readiness reviews

Completed sessions form strong IBMS Specialist Portfolio (Quality Management) evidence.

Common interview question themes

• "What changed between ISO 15189:2012 and 15189:2022?"
• "Walk me through how you prepared your section for the last UKAS visit"
• "How do you close a Major non-conformance?"
• "How does the risk-based approach in 15189:2022 work in practice?"
• "Where does flexible-scope accreditation help your service?"

Pair with EQA Investigation Training (article 42) and Method Validation Simulator (article 41) — UKAS assessors will probe both, and the simulator builds linked scenarios.