ISO 9001: 2015 (ISO 9001: 2015) as a quality management standard, requires organizations to produce and provide services under controlled conditions. The standard also includes measures to prevent human error.
What is human error?
Human error is inevitable due to the negligence, unpreparedness or mistake that a person commits, with unintended consequences. These mistakes can occur when planning and executing tasks and can be the result of several effects such as distraction and stress.
Some examples of human error are:
- Do not do or delete a task
- Doing the wrong thing
- Perform tasks out of order
- Failure to perform the task within the specified time
Human error may be identified as the cause. In fact, the main reason is something else. Some possible causes of human error include:
- Low attention
- Insufficient training
- Wrong communication
- Unknown instructions
- Workplace distraction
- Over-complacency or overconfidence
ISO 9001 Human error
Section 8.5.1 of ISO 9001, Production Control and Service Delivery, states that organizations must perform production and service delivery under controlled conditions, including measures to prevent human error.
According to ISO / TS 9002: 2016, measures to prevent human error may include the following:
- Creating a better work environment
- Provide appropriate training and instructions
- Automated processes
- Make devices available to prevent errors
- Avoid distractions (such as personal electronics)
- Need to complete information before sending
- Plan changes
In Section 6.3, change planning, the purpose of ISO 9001 is to determine the need for changes in an organization’s quality management system in order to adapt to changes in its business environment, as well as to ensure that any proposed changes are planned in a controlled manner.
Proper planning for change can help prevent negative consequences such as rework or cancellation or delay of a service. It can also lead to positive results, such as reduced inconsistent outputs or reduced human error incidents.
In Section 7.1.4, an environment for process operations, the purpose of ISO 9001 is to ensure that the necessary environment for the operation of its processes is determined and provided, and to facilitate the provision of compliant products and services by the organization.
In some cases, human factors can play a vital role in a process. Therefore, when determining the environment for the performance of processes, for example, to avoid excessive workload and stress for employees (to avoid possible errors) they should be considered.
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