What does a visit to the doctor have to do with ISO 9001 processes?

I was horrified when I went to see my new doctor. My doctor of 15 years retired and his replacement had been on the job for the past six months. I went in to see him for some pain I was having in my side that would not go away.

After I told him about my symptoms, my doctor looked at me and said “well, I really don’t know human anatomy that well, but I’m sure we can figure this out”!

What?? As you can imagine, I just couldn’t believe what I was hearing!

Ok….Actually, that didn’t happen at all. I just made it up…

But you could understand how concerned I’d be if my doctor, who I depend on to help me keep my body running efficiently and effectively. didn’t have a working knowledge of the parts and characteristics of the human body, right?

After all, that’s the entire foundation of a doctor’s ability to help. They know what they expect to see when they examine the body. And if they don’t see something they should – or if they see something they shouldn’t – it provides a logic starting point.

That makes sense, right?

Well, let’s bring our focus back to business.

This same scenario plays out every day in the business world. Business leaders, supervisors, team leaders, and line level employees don’t know what an effective process actually looks like. So when something goes wrong, and symptoms start to show…. there’s no central understanding of what part of the process anatomy to use as a logical starting point.

So let’s get this sorted out right away.

Defining Your Processes (ISO 9001 Processes)

The first thing to understand about processes is that we actually have to define them. This simply means we have to identify and define the purpose of those key processes that are critical for meeting customer requirements. Again, if you read my previous post, “What is a Quality Management System Anyway?“., you saw an example of what key processes could look like. It’s important that we identify our processes because it’s the first part in breaking our business down into manageable parts.

ISO 9001:2015 Processes

The Anatomy of a Process – A close look at ISO 9001 Processes

There are specific characteristics of an effective process that makes up it’s anatomy. Examining each of these “parts” will provide a logical point at which to start improving or troubleshooting.

An Owner – Accountability in ISO 9001 Processes

In business, we often know who is in charge of “departments” (which I wish were never “invented”), but when it comes to processes, there is often a grey area. Remember, there are some processes that overlap “departments”. When this happens the point of responsibility gets a tad fuzzy.

Take for example, a Training process. In a business in which each “department” supervisor is responsible for managing the training of their people, it leaves the question as to who is responsible for the overall training process. This can be especially true in small businesses that may not have a dedicated HR department.

In any situation where there is no defined Process Owner, it exposes the business to ambiguity, the lack focus on improvement, and increased chances of risks becoming reality.

Competent People

Of course, people make a process work. But just having the right amount of people is not enough. Effective processes have competent people working within. This means that organizations with effective processes define the knowledge, skills, and abilities required to perform within a process – and review employee competency at planned intervals.

Linkages (inputs and outputs)

In my previous blog post, What is a Quality Management System Anyway?, we covered what a process-based business looks like. If you haven’t checked that out, you’ll want to make sure you do that.

But to recap, all process must have defined inputs and outputs.

When I cook a meal. That’s a process. The prepped ingredients are the input, the cooked meal is the output. This provides a defined start and stop for the process. The process doesn’t start at the store when I buy the ingredients, and it doesn’t end when the food is set at the table. Those may be part different processes, but not the cooking process. Makes sense?

In a addition, understanding inputs and outputs allows us to set criteria that must be met prior to beginning a process, as well as what is expected to be delivered to the next process(s)

This is key because it helps isolate problems, responsibilities and activities to provide focus to, and eliminates grey areas of responsibility.


The worst thing to see in a process is chaos. Now, chaos can take many forms and doesn’t always refer to lawless activity with catastrophic outcomes. Chaos simply means a lack of order.

When processes are not defined, either through documentation or visual tools like flowcharts for instance, it’s left up to the interpretation of those working within the process which creates a lack of order.

Documented processes provide consistency and let’s people know the required sequence of events and interactions within a given process. In a addition, records provide evidence the required activites actually took place.

The depth of documentation depends on the size of the company, the complexity of the process, and the competency of the people in the process. But the process must be documented to a level the ensures order and effectiveness.

Effectiveness Measures (Metrics)

If the activities are important enough to define as key process, they’re important enough to monitor how well they work.

A doctor’s understanding of anatomy allows them to take vital measurements and determine if the main components of the body are functioning properly. When a process is measured, it allows the process owner to determine if the main components of the process are functioning properly.

Every Process had defined resources.

The word resources gets thrown around quite a bit. But when analyzing a process it helps to get specific on what is meant by “resources” in order to allow focus for improvement. After all, everything is really a resource, am I right?

Let’s categorize these things so we can track them down when needed. In a quality management system (including ISO 9001 Quality Management System), all processes have the following types of resource:

  • People
  • Infrastructure
  • Work Environment
  • Monitoring and Measuring Tools/Equipment (where applicable)
  • Organized Knowledge

Below you can see a visual example of an ISO 90001 process.

ISO 9001 Processes Diagram

Understanding these components of a process can mean the difference between continuous improvement and confusion and chaos. When we use our knowledge of a process to analyze and troubleshoot, we can save countess hours and avoid unwanted expenses.

To learn more about your ISO 9001 processes or to learn how we may be able to help, please feel free to schedule a call at anytime.

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