BS EN ISO 22367:2020

What is ISO 22367 about?  

ISO 22367 discusses risk management for medical laboratories. ISO 22367 outlines a process for a medical laboratory to identify and manage the risks to patients, laboratory workers, and service providers associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling, and monitoring the risks.  

The requirements in ISO 22367 apply to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record, and other technical and management processes described in ISO 15189. 

Note 1: ISO 22367 does not specify acceptable levels of risk. 

Note 2: ISO 22367 does not apply to risks from post-examination clinical decisions made by healthcare providers. 

Note 3: ISO 22367 does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks. 

Who is ISO 22367 for? 

ISO 22367 on risk management for medical laboratories is useful for: 

• Medical laboratories 
• Hospitals and medical colleges 
• Research facilities 
• Regulatory authorities 

Why should you use ISO 22367? 

Medical laboratories often rely on the use of in-vitro medical devices to achieve their quality objectives. Thus, risk management must be a shared responsibility. The risk management process spans the complete range of medical laboratory services: pre-examination, examination, and post-examination processes, including the design and development of laboratory examinations. 

ISO 22367 guideline helps you with risk management, risk analysis, risk evaluation, risk control, benefit-risk-analysis, risk monitoring, and control activities for risk management to medical laboratories. This helps in the process of managing safety risks, primarily to the patient, but also to the operator, other persons, equipment and other property, and the environment. 

What’s changed since the last update? 

BS EN ISO 22367:2020 supersedes ISO 22367:2008, which has been withdrawn. BS EN ISO 22367:2020 has some technical changes with respect to ISO 22367:2008. These include: 

• Change in title to indicate this document focuses on the complete risk management cycle for all processes in the medical laboratory. The part on continual improvement is left out 
• The content is as far as possible in agreement with the approach used in ISO 14971 Medical devices -Application of risk management to medical devices 
• The relation with ISO 15189:2012 is indicated in Annex A in which Figure A.1 provides a flow chart which indicates how to apply risk management in the laboratory 
• Addition of 10 new annexes, all informative, providing valuable information about the different processes in the risk management cycle without demanding more than justified for the specific purpose 
• Annex F. provides an extensive list of aspects that could be considered as a source for risks in the different types of medical laboratories