ISO 22870:2016 is officially titled:
"Point-of-care testing (POCT) — Requirements for quality and competence"
These international standard outlines requirements specific to POCT, covering:
ISO 22870 is not a stand-alone standard. It must be used alongside ISO 15189, which governs the overall quality and competence of medical laboratories.
As healthcare delivery becomes faster and more decentralized, POCT plays a critical role in:
However, without standardization, POCT can result in:
ISO 22870 ensures that POCT systems deliver accurate, traceable, and safe results, meeting the same standards as central labs.
Implementing ISO 22870 provides critical quality, safety, and operational advantages for healthcare providers:
Harmonize methods across departments, locations, and devices.
Assign accountability for POCT performance, oversight, and review.
Improve clinical decision-making with reliable test outcomes.
Ensure tests meet internal QC and external quality assurance standards.
Identify, mitigate, and monitor risks related to POCT devices and use
Partnering with GMC to implement ISO 22870 offers measurable benefits to your institution or diagnostic business:
Be audit-ready for ISO, NABL, CAP, or country-specific requirements.
Implement standardized processes that reduce test errors.
Ensure accurate, real-time diagnostics at the point of care.
Train and assess non-laboratory staff involved in POCT.
Integrate POCT data, documentation, and processes into ISO 15189 systems.
Meet national and international healthcare quality mandates.
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