Hohe Manufakturkosten für ISO 15189 QMS-Wartung
Definition
Ongoing maintenance involves detailed QMS revisions, risk assessments per ISO 22367, and DAkkS re-accreditations, driving excessive personnel and consultant costs.
Key Findings
- Financial Impact: 20-40 Stunden/Monat à €80/Stunde = €1.600-€3.200 monatlich; €20.000+ jährlich pro Labor
- Frequency: Monthly internal audits; annual DAkkS re-assessments
- Root Cause: Paper-based documentation, fragmented DATEV-QMS integration, manual Rili-BÄK reporting
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Medical and Diagnostic Laboratories.
Affected Stakeholders
QMS Coordinator, Lab Technicians, External Auditors
Deep Analysis (Premium)
Financial Impact
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Current Workarounds
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Methodology & Sources
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Related Business Risks
Akkreditationsverlust durch Fristüberschreitung ISO 15189
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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