Non-compliance with AS ISO 15189 and ISO/IEC 17025
Definition
Failure to log calibrations traceably results in non-compliance with accreditation standards, leading to potential suspension by NATA and regulatory penalties.
Key Findings
- Financial Impact: AUD 10,000+ per audit failure; 20-40 hours/month manual logging; 2-5% revenue loss from accreditation suspension
- Frequency: Annual audits; quarterly checks
- Root Cause: Manual logging errors and incomplete records violating traceability requirements
Why This Matters
The Pitch: Medical and Diagnostic Laboratories in Australia 🇦🇺 risk AUD 10,000+ penalties and lost revenue from accreditation suspension. Automation of calibration logging eliminates this risk.
Affected Stakeholders
Laboratory Managers, Calibration Technicians, Compliance Officers
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
Cost of Poor Quality from Calibration Failures
Idle Equipment from Calibration Logging Delays
Claim Denials from Coding Errors
Proficiency Testing Rework Costs
Delayed Reimbursements from Denied Claims
Revenue Leakage from Unappealed Denials
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