ISO 22367:2020
Medical laboratories — Application of risk management to medical laboratories
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable 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.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document 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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management
4.1 Risk management process
4.2 Management responsibilities
4.3 Qualification of personnel
4.4 Risk management plan
4.4.1 General
4.4.2 Scope of the plan
4.4.3 Contents of the plan
4.4.4 Revisions to the plan
4.4.5 Risk management documentation
5 Risk analysis
5.1 General
5.2 Risk analysis process and documentation
5.3 Intended medical laboratory use and reasonably foreseeable misuses
5.4 Identification of characteristics related to safety
5.5 Identification of hazards
5.6 Identification of potentially hazardous situations
5.7 Identification of foreseeable patient harms
5.8 Estimation of the risk(s) for each hazardous situation
6 Risk evaluation
6.1 Risk acceptability criteria
6.2 Risk evaluation process
7 Risk control
7.1 Risk control options
7.2 Risk control verification
7.3 Role of standards in risk control
7.4 Role of IVD medical devices in risk control
7.5 Risks arising from risk control measures
7.6 Residual risk evaluation
8 Benefit-risk analysis
9 Risk management review
9.1 Completeness of risk control
9.2 Evaluation of overall residual risk
9.3 Risk management report
10 Risk monitoring, analysis and control activities
10.1 Surveillance procedure
10.2 Internal sources of risk information
10.3 External sources of risk information
10.4 Immediate actions to reduce risk
Annex A (informative) Implementation of risk management within the quality management system
Annex B (informative) Developing a risk management plan
Annex C (informative) Risk acceptability considerations
Annex D (informative) Identification of characteristics related to safety
Annex E (informative) Examples of hazards, foreseeable sequences of events and hazardous situations
Annex F (informative) Nonconformities potentially leading to significant risks
Annex G (informative) Risk analysis tools and techniques
Annex H (informative) Risk analysis of foreseeable user actions
Annex I (informative) Methods of risk assessment, including estimation of probability and severity of harm
Annex J (informative) Overall residual risk evaluation and risk management review
Annex K (informative) Conducting a benefit-risk analysis
Annex L (informative) Residual risk(s)
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk management
4.1 Risk management process
4.2 Management responsibilities
4.3 Qualification of personnel
4.4 Risk management plan
4.4.1 General
4.4.2 Scope of the plan
4.4.3 Contents of the plan
4.4.4 Revisions to the plan
4.4.5 Risk management documentation
5 Risk analysis
5.1 General
5.2 Risk analysis process and documentation
5.3 Intended medical laboratory use and reasonably foreseeable misuses
5.4 Identification of characteristics related to safety
5.5 Identification of hazards
5.6 Identification of potentially hazardous situations
5.7 Identification of foreseeable patient harms
5.8 Estimation of the risk(s) for each hazardous situation
6 Risk evaluation
6.1 Risk acceptability criteria
6.2 Risk evaluation process
7 Risk control
7.1 Risk control options
7.2 Risk control verification
7.3 Role of standards in risk control
7.4 Role of IVD medical devices in risk control
7.5 Risks arising from risk control measures
7.6 Residual risk evaluation
8 Benefit-risk analysis
9 Risk management review
9.1 Completeness of risk control
9.2 Evaluation of overall residual risk
9.3 Risk management report
10 Risk monitoring, analysis and control activities
10.1 Surveillance procedure
10.2 Internal sources of risk information
10.3 External sources of risk information
10.4 Immediate actions to reduce risk
Annex A (informative) Implementation of risk management within the quality management system
Annex B (informative) Developing a risk management plan
Annex C (informative) Risk acceptability considerations
Annex D (informative) Identification of characteristics related to safety
Annex E (informative) Examples of hazards, foreseeable sequences of events and hazardous situations
Annex F (informative) Nonconformities potentially leading to significant risks
Annex G (informative) Risk analysis tools and techniques
Annex H (informative) Risk analysis of foreseeable user actions
Annex I (informative) Methods of risk assessment, including estimation of probability and severity of harm
Annex J (informative) Overall residual risk evaluation and risk management review
Annex K (informative) Conducting a benefit-risk analysis
Annex L (informative) Residual risk(s)
Bibliography