Should you use a gap analysis in your ISO 9001 implementation?

When starting to implement a Quality Management System (QMS) using the ISO 9001:2015 standard, you will probably have heard about using a gap analysis, but what does this mean? What is a gap analysis, and what is it used for? Should I use a gap analysis, and how do I do that? These and many other questions may be going through your head, so here is some information to try to clear up some confusion.

What is a gap analysis for ISO 9001:2015?

A gap analysis is actually quite a simple concept: compare what your company already does with the requirements of ISO 9001:2015 and see which requirements you do not meet yet. This does not entail going around and auditing to see if you actually do what you have planned, like an internal audit, but it entails a paperwork exercise where someone knowledgeable in the management of your company compares what the requirements ask you to do and determines if what you already do meets those requirements.

So, the process, put simply, would be like this:

  • Take a gap analysis tool for ISO 9001:2015, or the standard itself for a very thorough analysis, and have a person knowledgeable in your operations assess each requirement.
  • For each requirement of the standard, write down what you already do that addresses this requirement. (For example, requirement 7.1.2 is the requirement for determining the people necessary for the QMS and process control; so, how do you hire people to make sure that the work happens correctly?)
  • After this is completed, you will be able to generate a list of requirements that you do not yet address in your company. This is considered the gap between what you do and what is required for an ISO 9001:2015-compliant QMS.
  • You will then need to make a plan to implement new processes and procedures to address these requirements that are currently missing from your QMS.

For more on the difference between a gap analysis and an internal audit, see this article on Gap analysis vs. internal audit in ISO 9001.

Is a gap analysis required to implement ISO 9001?

In short: no.

There is not a requirement to perform a gap analysis when implementing ISO 9001:2015. During your certification, no certification body auditor will ask to see your gap analysis; and, you will not fail your audit if you do not have one. The gap analysis tool, like many elements of implementing ISO 9001:2015, are available for use, but up to you if you use them.

So, the real question is: “Is a gap analysis necessary to implement ISO 9001:2015?” The answer to this is up to you, and is greatly determined by your company, your employees, and the maturity of any QMS that you may already have in place.

Why would you want to use an ISO 9001 gap analysis?

Many companies find a gap analysis useful, especially if they already have some elements of a QMS in place for other reasons. Some industries, such as automotive and aerospace, have had some QMS processes required for many years before ISO 9001 was first written, and these processes will address many of the requirements of the ISO 9001:2015 standard. In fact, it may be that the more elements of a QMS that you already have in place, the more useful a gap analysis will be, since it will point out the few things you are missing.

However, if you do not have much in place for controlling your operations and processes, then a gap analysis, especially a thorough one, may not be very useful for you. If you know that you will need to create a very large number of the processes required by ISO 9001:2015, then you might want to just start on your implementation with the assumption that you are creating the required processes – and, on the rare occasion that you find a process you already do, you can have a pleasant surprise and be able to close that action right away.

The real benefit of a gap analysis

Of course, the real benefit of a gap analysis is being able to better budget the time, money, and resources required to implement your QMS according to the ISO 9001:2015 requirements. This is particularly useful if you have time constraints due to customer-imposed requirements to obtain certification and need to stay on a strict timeline. It can also be important to set a reasonable goal for implementation if your timeline is self-imposed.

It is important to remember, no matter what your timeline, that it is in your best interest to take the time necessary to properly implement the processes and procedures needed to meet your needs and the requirements. Taking shortcuts to be done quicker will only hurt you in the long run when you are not getting the results you need to properly run your business. Remember, the QMS is yours, for your benefit, and you want it to meet your needs so that you can improve.

To see how close you are to ISO 9001:2015 requirements, check out this simple and free online  ISO 9001:2015 Gap Analysis tool.

Advisera Mark Hammar
Mark Hammar
Mark Hammar is a Certified Manager of Quality / Organizational Excellence through the American Society for Quality and has been a Quality Professional since 1994. Mark has experience in auditing, improving processes, and writing procedures for Quality, Environmental, and Occupational Health & Safety Management Systems, and is certified as a Lead Auditor for ISO 9001, AS9100, and ISO 14001.