Achieve ISO 20658 Compliance Across Your Pre-Analytical Processes
Standardize sample collection, reduce errors, and
gain full traceability across your pre-analytical processes.
Download the ISO 20658 guide
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What is ISO 20658?
Audit-Ready Data
- ISO 20658 is the international standard for the pre-examination phase of laboratory testing. It defines requirements and best practices for:
- Patient identification
- Sample collection
- Labeling and handling
- Transport and traceability
- It complements ISO 15189 by ensuring quality starts before analysis begins.
Most Lab Errors Happen Before Analysis
Up to 70% of laboratory errors occur during the pre-analytical phase — before the sample even reaches the lab.
Pre-analytical errors are one of the biggest hidden cost drivers in diagnostics.
Without standardized processes, organizations face:
- Patient misidentification
- Labeling and handling errors
- Sample loss or degradation
- Lack of traceability across sites
And the impact is not just clinical — it’s financial:
- Costly recollection and retesting
- Delays in diagnosis and treatment
- Operational inefficiencies
- Increased risk during audits and compliance checks
Why ISO 20658 Matters
Implementing ISO 20658 helps you:
- Reduce pre-analytical errors
- Protect patient safety
- Ensure sample integrity
- Standardize processes across sites
- Improve audit readiness and compliance
Because reliable results start with reliable samples.
Why Compliance is Difficult to Achieve
Most organizations struggle with:
- Fragmented workflows across collection sites
- Manual or paper-based processes
- Limited visibility on sample status
- Multiple stakeholders and handovers
Without digital support, consistency and traceability are difficult to maintain.
Get Ready for ISO 20658
Preparing for ISO 20658 requires structured workflows, full traceability, and control over every step of the pre-analytical phase.
S4DX supports laboratories in organizing and optimizing these processes in line with international standards.
Access the ISO 20658 guide and discover how to align your operations.
Who Is This Relevant For?
Laboratories with multiple collection sites
Diagnostic networks
Home collection services
Mobile or temporary collection units
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