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Never before have reliability and accuracy been so important for medical laboratories. Robust risk management processes are the best defence against errors and false results. One of the world’s most trusted guidance documents for risk management in medical laboratories has just been updated to help.

The reliability of laboratory results in medical settings is essential for correct diagnoses and positive clinical outcomes, so implementing measures to reduce the risk of errors is an essential part of business.  

ISO 22367, Medical laboratories – Application of risk management to medical laboratories, specifies a process for a medical laboratory to identify and manage the risk to patients and service providers that are associated with medical laboratory examinations. It has just been updated to align with other International Standards in the industry, such as ISO 14971 for risk management in medical devices, and to provide more effective guidance for the sector.

The standard replaces ISO/TS 22367, Medical laboratories – Reduction of error through risk management and continual improvement, a technical specification used by governments and laboratories around the world to help reduce and manage risks associated with medical laboratory services.

Dr Jack J. Zakowski, Chair of the committee of experts that developed the standard, said risk management in medical settings is complex because it involves the cooperation of many stakeholders, and each stakeholder may have a different perspective on the risk of harm. Internationally agreed and adopted standards, therefore, ensure adequate safety levels.

“Activities in a medical laboratory can expose patients, workers or other stakeholders to a variety of hazards, which can lead directly or indirectly to varying degrees of harm,” he said.

“Effective risk management involves a planned, systematic process that addresses both the probability of harm occurring and the consequences of that harm.

“It works best when aligned with quality and safety management to cover all possible sources of risk, which is why ISO 22367 was updated to correspond with the latest version of ISO 14971 for risk management in medical devices and ISO 15190 that provides guidance on medical laboratory safety. It is also a key requirement of ISO 15189 for the quality and competence of medical laboratories.”

ISO 22367 was developed by ISO technical committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, the secretariat of which is held by ANSI, ISO’s member for the USA. It can be purchased from your national ISO member or through the ISO Store.

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Clare Naden
Clare Naden

+41 22 749 0474

Стандарт/ы

Комитет/ы

  • ISO/TC 212
    Clinical laboratory testing and in vitro diagnostic test systems

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