ISO 22367 is officially titled:
“Medical laboratories — Application of risk management to medical laboratories”
This standard outlines principles and procedures for risk management in medical labs, helping labs:
The standard complements ISO 15189 by adding detailed guidance on how to implement a proactive and preventive risk-based approach across all laboratory activities.
In clinical laboratories, even minor errors can lead to:
ISO 22367 helps medical labs reduce these risks through structured risk analysis and mitigation planning, thereby improving clinical reliability and patient safety.
Implementing ISO 22367 offers laboratories multiple operational and clinical advantages:
Reduce the chance of diagnostic errors through proactive risk identification.
Use severity, frequency, and detectability to assess and prioritize risks.
Shift from reactive corrections to preventive actions.
Strengthen alignment with ISO 15189 and national healthcare regulations.
Maintain complete records for audits, accreditation, and investigations.
When your laboratory partners with GMC to implement ISO 22367, you unlock significant value for operations and stakeholders:
Prevent sample handling errors, equipment failures, and data entry mistakes.
Demonstrate effective risk controls and meet assessor expectations.
Minimize repeat testing, sample rejections, and patient complaints.
Engage your team in systematic problem-solving and risk awareness.
Clinicians and patients rely on the lab’s integrity and reliability.
Meet requirements from WHO, NABL, FDA, and other authorities.
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