The ISO 9001:2015 “Preventing Human Error” Requirement. Read Before Panicking

By Matt Leiphart

ISO 9001:2015 contains a requirement regarding the human error that at first glance may cause consternation.

8.5.1 Control of production and service provision

The organization shall implement production and service provision under controlled conditions. Controlled conditions shall include, as applicable: … g) the implementation of actions to prevent human error;

The concern is appropriate here because human error has been the cause of many quality problems, dating back to the day the wheel was invented. Despite all that has been done to eliminate human error, everyone knows if humans are involved in a process, there will be mistakes. (This includes errors introduced by humans programming robots when other humans are removed from a process.) The thought of a third-party auditor citing nonconformances when such errors persist will just add insult to injury.

Before going off the deep end, let’s look at the requirement in detail. There are many ways the rest of the ISO 9001:2015 standard comes to our aid, proving we already do a lot to prevent human error. All we need to do is connect the dots.

The Nature of Human Error

We have all heard the phrase, “To err is human.” Now it seems we are required to find a way to remove that most human of traits. In a management system environment, our objective is to achieve intended results using processes that are defined, communicated, implemented, monitored, evaluated, and improved. From that point of view, if human error is a cause of not achieving the intended results, then we must do something about it.

For decades quality management professionals have been attempting to reduce variation introduced by error including human error, to improve consistency and control outputs. This includes reducing variation in process inputs, operations, and process controls. Implementing actions to prevent human error does not mean taking action upon humans. It means continuing our quest for reducing variation and improving processes to give people a fighting chance to achieve intended results, every time, through the process.

Nothing promotes esteem like success. Humans will always be more valuable than machines because humans can learn and adapt better (for the moment). Approached from this angle, preventing human error is about expanding the knowledge, skills, practices, and tools used by our people to reduce variation and improve processes so the outcomes are consistent, perfect, and operated by people who feel good about being part of a job well done.

Defining the Path

If reducing human error is really about reducing variation that leads to mistakes, then the basic process approach will serve us well. Defined outcomes start with defined requirements and defined processes. ISO 9001:2015 is full of requirements that address human error through defined process controls.

Failing to plan is planning to fail, which is why the requirements of section 8.1 Operational planning and control is one key to preventing human error. Determining requirements for products and services, including criteria for the processes, provides the people operating the processes the information they need to understand the end in mind while operating the process.

One important focus of the new standard is risk-based thinking, and this extends to operational planning and control, an important aspect of preventing human error. In section 8.1, the standard requires an organization, “…implement the actions determined in clause 6,” where risks and opportunities associated with the QMS are identified. These risks would include risks introduced by the potential for human error. While budgeting, costs, and return on investment will never be ignored, this planning process must address actions required to cause outputs to meet requirements. Proper controls established at this stage can reduce the possibility of human error remaining in the process.

For example, due to the risk of losing several hundred lives every time an airline puts a plane in the air (which happens several times a day for each airplane), commercial airplane manufacturers have loaded their planes with expensive technology to improve the reliability of the machine and reduce the likelihood of human error. Despite that dedication of expensive technology, human error remains the top reason for commercial airplane crashes.1 Even in this circumstance, actions are required to train and equip pilots with tools to help them prevent errors the technology could not effectively eliminate.

When planning operational controls, targeted thinking about how those controls can prevent human error will support the effort to prevent human error. Section 8.1 requires, “…establishing criteria for:…1) the processes.” Human error may be prevented through, “..establishing criteria for the processes to prevent human error.” Section 8.1 also requires, “..determining the resources needed to achieve conformity to the product and service requirements.” The quest for preventing human error can be supported by, “…determining the resources needed to prevent human error to achieve conformity to the product and service requirements.”

Successful outcomes begin with robust plans. In section 8.1, the standard provides the outline for planning a successful outcome by preventing human error. When people understand the expected outcomes of a process and are provided resources and process controls, the likelihood of human error is reduced.

Variation – The Constant Adversary

Specifying working practices for humans should focus on the variation that matters. Determine the important elements of the work steps (the ones that can lead to mistakes) and find ways to eliminate variation with those steps. If using the left or right-hand does not matter, and may not lead to mistakes, then don’t specify it.

Machine variation can lead to human error too. When people exhaust their energy trying to get consistent outputs from an inconsistent machine, they are more prone to an error within the rest of the process. And while reducing machine variation is often a question of economics, the benefits of freeing humans from struggling with machine variation are many. Less time tending a high-variation machine frees time for innovation and higher levels of awareness and attention to the rest of the process, reducing the likelihood of error caused by a human too focused on a misbehaving machine.

For purposes of preventing human error, it is important to focus on the variation that can lead to mistakes. Variation outside the human element (for example, machine and/or materials variation) should be eliminated to prevent humans from having to focus their time and energy on dealing with variation. We need our full attention on what we are doing if we are going to avoid making mistakes. When our attention is anywhere else, we lose awareness of what we are doing, drastically increasing the opportunity for error. In these circumstances, we want to make it as easy as possible for humans so they don’t have to focus on process variation or variation in process output.

Showing the Way

After the plans and controls for operations are defined, it’s time to make sure everyone understands the path so they can do their part to keep the process on the path. This is where the support requirements of 7.1.6 Knowledge, 7.2 Competence, 7.3 Awareness, and 7.4 Communication assist with the reduction of human error.

This begins with understanding the process and how to operate it correctly (7.1.6 Knowledge), and making sure those who work within the process demonstrate they have the ability to apply knowledge and skills to achieve intended results (7.2 Competence). From there people are provided the awareness of how improved performance benefits them, the process, and the organization (7.3 Awareness), and implementing practices to communicate relevant information about the quality management system (7.4 Communication) to promote learning and continual improvement.

Great plans left in files do not prevent human error. A process comes to life by communicating knowledge to competent people and making them aware of the value of their role. Back that up with frequent and detailed communication, and the stage is set for actions that will reduce the likelihood of error, long before the chain of events leading to an error gets completed.

Making Sure It’s Right

Learning is dependent on feedback, comparing actions and their associated results to established targets. CEOs, military commanders, major league pitchers, and golf professionals all establish targets, execute, compare results, and make adjustments. Planning, doing, checking, acting are human processes, designed to optimize human learning, and is key to reducing human error. Checking performance is already built into the ISO 9001:2015 – making sure what was done was done right, with feedback to prevent human error.

Section 9 of ISO 9001:2015 is focused on making sure the results meet expectations, and by providing feedback to the humans operating the processes, it simultaneously provides information to help people reduce the occurrence of human error.

Feedback on performance can be difficult to deliver. We often project arguments and high stress accompanied with unchecked emotion when we have to deliver bad news on performance to another person. This is especially true when the final result was acceptable, but the process steps leading to the result varied from the plan. “What’s the big deal, it all worked out?” is the conversation we expect.

Going back to basic principles, if human error is caused by variation, and all humans want to feel good about being part of a successful process, then reducing process variation (even when the process gives the intended results), is the path to giving people the feedback they need to feel good about being part of a successful process. Despite all our projections about difficult conversations regarding performance, how often do we find the people we give feedback to are grateful for the information? By checking work and providing feedback on process variation, we show we care about the people who operate the process. We want them to succeed. We want the process to work every time. We get into the details of the leading measurements which eventually result in lag measures. Checking performance is an important aspect of what we do to prevent human error.

Learning and Development

The real fun for humans begins after planning processes, training, and implementing process monitoring. Section 10 of the standard addresses improvement, which includes addressing nonconformity and corrective action. It is in these sections where the learning and development are hardcoded into the organization, and where actions to further eliminate human error are discovered.

Section 10.1 of the ISO 9001:2015 states, “The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. These shall include:…b) correcting, preventing, or reducing undesired effects;” One such, “Undesired effect,” is human error.

Continual improvement is a journey, not a destination. Preventing human error parallels the journey of continual improvement. Will we ever be done with either? No. Will we ever stop trying even though life seems to knock us backward? No.

Continual improvement is a process just like any other. Do not wait for human error events to occur. Prevent them by examining the process. Seek out potential causes of error. Find the path of least resistance which may lead to error, then design an easier path that will lead to success. Discover the decisions people make every day that increase the risk of error, understand why those decisions get made, then take whatever actions are necessary to mitigate the risk. If the inputs to continual improvement are the current process and its results, then make sure the outputs include practices to help people do a more consistent job easier with fewer opportunities for error.

By reducing the opportunity for human error, we are also improving the processes and the entire system supporting the process.

People Will Still Fall Into Traps

Despite all the work to eliminate process variation, training on proper technique, communicating to ensure everyone knows what’s important, and improving processes to enhance learning, people still fall into traps that lead to error. It is, after all, in our nature.

Traps come in many varieties, including:2

  • Interpersonal Management – How we interact with others. A typical interpersonal management trap is, “Copilot Syndrome,” where one assumes they are “along for the ride” because someone else has the situation under control. In this situation, a potential error may be observed, but no action is taken to avoid the error.
  • Attitude Management – Our mental approach to life and our jobs. Attitude management traps include the, “We can always…” trap, which occurs when people delay dealing with a problem or making a difficult decision. This trap is one that can be heard, as someone says, “We can always do that later.” As a result, something is indeed done later – usually dealing with the consequences of the error that occurred after falling into the trap.
  • Stress Management – Our response to differing workloads. Stress can lead to distractions caused by both heavy and light workloads. In heavy workload situations, people can have problems determining which issues are important, and which are distractions. In low workload situations, distractions can be a relief from boredom, causing people to miss the important signals that indicate an error is about to occur.
  • Risk Management – Our awareness of and response to risks. “Accommodation to Risk” is a common trap in this category, and often occurs among people who perform high-risk jobs on a regular basis. When the risks are clear and present every day, it is easy to discount them and think they won’t affect us – they never have before. This trap is the one that causes an experienced construction worker to make a rookie mistake, leading to disability or death.
  • Attention Management – Our level of concentration and awareness. Attention management traps are encountered when people lose situational awareness. This can happen for many reasons, including the, “Strength of an Idea,” trap, where we unconsciously attempt to make available evidence fit a preconceived idea. When not detected, these attempts to have the data say something other than what is true are easy to see after the fact – hindsight is 20/20, after all.
  • Task Management – Our response to unanticipated challenges. The “Error/Accident Chain,” is the most common task management trap. When tasks are not defined and managed tightly, one small error or poor decision can lead to another, and decisions and actions to mitigate the errors from the previous poor decision can lead to additional poor decisions. In this case, one small problem can build into a major disaster.

The goal of controls, training, communication, monitoring and improvement is to prevent traps such as these from happening, and keep everyone engaged and involved so situational awareness is always high, thus preventing human error. First and foremost, the controls introduced into the process eliminate the opportunity for humans to make errors. Error-proofing the process is also error-proofing the humans who operate the process.

Noble Goal, Structure Already Established

I have spoken with many people about this new requirement, and with very few exceptions there is a lot of concern. “Are you saying we must now figure out a way to stop people from making mistakes? That’s impossible!” Yes, eliminating human error once and for all is impossible. Depending on your industry, mistakes may be a major contributor to defects, inefficiencies, and process breakdowns. Taking steps to make processes more robust, providing team members with the knowledge they need to perform well, implementing effective process monitoring, and actively finding ways to improve our noble goals. The structure for eliminating mistakes is already present in other areas of the standard – no magic new processes that defy reality are required.

People are prone to error. We all know that. None of us particularly enjoy that aspect of being human, especially when we are the ones committing the errors. From this regard, the ISO 9001:2015 is leading us to one of the most important things we can do for the people who work with us – set up processes to help them perform better, get better results, and learn how to avoid mistakes and stress that comes from correcting mistakes and then playing catch-up due to lost productivity. When the day is mistake-free and filled with success, everyone can’t wait to come back to work tomorrow and feel good again.

Cavendish Scott, Inc. has been implementing ISO management systems for over 30 years and that includes practical solutions to reduce variability, increase practical control and reduce error.  For more information visit

1 “Human error has been documented as a primary contributor to more than 70 percent of commercial airplane hull-loss accidents.” CURT GRAEBER, CHIEF ENGINEER, HUMAN FACTORS ENGINEERING, BOEING COMMERCIAL AIRPLANES GROUP.

2 “Preventing Human Error Study Guide,” Error Prevention Institute, Inc., 2000.

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