Hohe Kosten für Lieferantenaudits
Definition
Supplier audits are mandatory for critical suppliers under German ZLG guidelines and EU MDR, involving on-site inspections, documentation reviews, and Notified Body assessments, driving significant manual costs.
Key Findings
- Financial Impact: 20-40 Stunden/Audit + €5,000-€10,000 pro kritischer Lieferant (Reise, Auditoren, Vorbereitung)
- Frequency: Mindestens alle 5 Jahre pro kritischer Lieferant; öfter bei Risiken
- Root Cause: Manuelle On-Site-Audits und fehlende digitale Überwachung
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Medical Equipment Manufacturing.
Affected Stakeholders
Qualitätsmanager, Einkaufsleiter, Compliance Officer
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
Strafen bei Auditversagen der Lieferantenqualifikation
Kosten durch Lieferanten-bedingte Qualitätsmängel
Kapazitätsverluste durch HTA-Bewertungsengpässe
Bußgelder für verspätete Lieferketten-Meldungen
Kosten durch mangelhafte Eingangsinspektion und Materialzertifizierung
Bürokratische Mehrkosten durch MPBetreibV-Anpassungen
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