If you have started to become interested in ISO 9001:2015, the standard that deals with the Quality Management System, you have probably already heard of gap analysis. But what exactly is it and how can it be useful to you in implementing the system?
With regard to ISO 9001, a gap analysis is a simple comparison between what the company that wants to implement a quality system and certify it already does and what it does not yet do but is required by the requirements of the standard. Even if there is not yet a formal system for quality management, in fact, a company almost certainly has in place some processes used to interact with customers, to process orders, to plan and produce goods or to provide services and deliver them to customers. It is this set of processes that is evaluated against the requirements of ISO 9001 during a gap analysis.
Doing a gap analysis is not difficult: just take the standard, read the contents of each paragraph, identify the requirements, and check whether the company meets that requirement, or not. In the second case, it will be necessary to understand how to implement the changes necessary to satisfy it.
At the end of this work there will be a list of gaps between the work that is already being done by your company and what needs to be done to get ISO 9001 certified. Remember that gap analysis focuses on the present, so only consider the processes you have in place, not the ones you intend to add in the future.
Having clarified what a gap analysis is, let's see if it is necessary to do it to get certified. No, it is not necessary and no one will ask you to take a look at yours, but we highly recommend it because it is extremely useful as it immediately highlights the gaps on which it is necessary to work.
Another advantage of gap analysis is the possibility of better planning the time, money, resources needed, and energy to implement your quality system according to the requirements of ISO 9001:2015. If, for example, you have time constraints imposed by a customer who wants you to get certified as soon as possible, a gap analysis will allow you to respect a very strict deadline because you will have in hand exactly the list of things to do.
A gap analysis with respect to ISO 9001 should be done by a professional who has a certain mastery of the regulatory requirements, but, with a little effort, it can be prepared by anyone who has the patience to train adequately on the contents of the standard. If you do not have a person in your company who is an expert in ISO 9001 and you do not have time to train one, you can contact an external consultant who will simply do this work for you.
Operationally it is divided into three phases:
- planning the analysis;
- conducting the gap analysis;
- using the results deriving from the gap analysis
Using the output of the gap analysis, it is possible to develop an action plan to fill the "gaps" found. If you decide to use a consultant, you can ask them for suggestions on how, in their opinion, it would be good to fill the "gaps" with respect to the standard, but it is important that the company does not in any way distort its way of working to meet the requirements of ISO 9001, unless this way of proceeding is actually deficient.
From how we have described it, some of you may think that a gap analysis and an internal audit are the same thing, but this is not the case at all. The main difference between a gap analysis and an audit is that during a gap analysis your organization will compare its activity with what is required in the ISO 9001 standard, while in an internal audit the objective is to look for evidence that the requirements of ISO 9001 have been declined in the quality system and that the management system works exactly as described in the system documentation prepared by the company.