ISO 9001 on Human Error

The ISO 9001:2015 quality standard requires organizations to carry out production and service provision under controlled conditions, which may include taking actions to prevent human error.

What is a human error? It has been defined as when a person does something wrong; a mistake.

Some examples of human error are:

  • failing to perform or omitting a task
  • performing the task incorrectly
  • including an extra or non-required task
  • performing tasks out of sequence
  • failing to do the task within the time limit
  • not responding adequately to a contingency

Human error may be identified as the cause when the root cause is actually something else. Some reasons for human error might be:

  • limits of memory and attention
  • fatigue
  • inadequate training
  • miscommunications
  • unclear instructions or directions
  • workplace distractions
  •  complacency or overconfidence

ISO 9001 on Human Error

ISO 9001:2015, 8.5.1.g, Control of production and service provision, states that organizations must implement production and service provision under controlled conditions, including as applicable the implementation of actions to prevent human error.

According to ISO/TS 9002:2016, the actions to prevent human error may include:

  • limiting excessive working hours
  • putting in place a more suitable working environment
  • providing appropriate training and instructions
  • automating processes
  • requiring double electronic entry of critical information
  • making available devices to avoid incorrect tooling
  • avoiding distractions (such as personal electronic devices)
  • rotating jobs
  • requiring completion of information before submission

Planning of Changes

The intent of ISO 9001:2015, 6.3, Planning of changes, is to determine the need for changes to the 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, introduced, and implemented in a controlled manner.

Properly planning a change can help to avoid negative consequences such as rework or cancellation or postponement of a service. It can also result in positive outcomes, such as the reduction of nonconforming outputs or reduced incidents of human error.

Operational Environment

The intent of ISO 9001:2015, 7.1.4, Environment for the operation of processes, is to ensure the organization determines and provides the necessary environment for the operation of its processes and to facilitate provision of conforming products and services.

In some cases, human factors can be critical in a process; therefore, they should be considered when determining the environment for the operation of the processes, e.g., by avoiding high workloads and stress for employees (to prevent potential errors, burn-out, or bullying).