ISO 20658 is officially titled:
"Medical laboratories — Requirements for collection, transport, receipt, and handling of samples"
It outlines clear requirements and guidelines for the pre-examination phase of laboratory testing. This includes procedures for:
ISO 20658 can be applied independently or in conjunction with ISO 15189, the core standard for medical laboratory quality and competence.
Errors in the pre-analytical phase account for up to 70% of all diagnostic mistakes in clinical laboratories. These include:
ISO 20658 addresses these challenges by ensuring that labs and collection centers:
Implementing ISO 20658 in your organization helps establish a reliable and quality-driven foundation for diagnostic accuracy:
Ensure consistent sample collection and handling across all branches or departments.
Reduce the risk of contamination, degradation, or mislabeling.
Maintain full traceability of each sample from collection to analysis.
Enable timely and correct interpretation of lab results.
High-quality test results lead to faster, more reliable clinical decisions.
With GMC’s expertise in ISO 20658 implementation, your lab or healthcare organization gains:
Better sample management leads to more reliable test outcomes.
Align with international health standards and support ISO 15189 accreditation.
Streamlined processes reduce delays, retests, and wasted resources.
Demonstrate to patients, partners, and inspectors your commitment to excellence.
Traceable documentation protects against disputes and medical errors.
Faster and more accurate results enhance the overall healthcare experience.
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