Akkreditationsverlust durch Fristüberschreitung ISO 15189
Definition
Laboratories missing the ISO 15189:2022 transition by Dec 5, 2025 face DAkkS non-recognition, halting licensed operations and triggering state inspections under Rili-BÄK.
Key Findings
- Financial Impact: €50,000+ revenue loss per month from testing suspension; €10,000-€30,000 audit/re-certification costs
- Frequency: One-time high-risk deadline Dec 2025; ongoing annual audits
- Root Cause: Manual QMS updates, documentation silos, missed DAkkS transition notices
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Medical and Diagnostic Laboratories.
Affected Stakeholders
Lab Manager, Quality Assurance Officer, Compliance Director
Deep Analysis (Premium)
Financial Impact
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Current Workarounds
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Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
Hohe Manufakturkosten für ISO 15189 QMS-Wartung
Betriebsunterbrechungen durch Akkreditationsprüfungen
Verpasste Erstattungen bei Eligibility-Fehlern
IVDR-Verstöße in Diagnostiklabors
Verzögerte Abrechnung durch ePA-Integration
Kapazitätsverlust durch manuelle Prüfungen
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