As you are implementing your Quality Management System (QMS), utilising the recommendations of the ISO 9001 standard, people may have advised you to use a gap analysis. In fact, if you have hired an ISO 9001 consultant, they may have talked about how they have helped their clients in the past by conducting an in-depth gap analysis that improved the compliance and the efficiency of the QMS. Obviously, you must be thinking, what is a gap analysis, and what is it actually used for? In this article, we will clarify some confusion and discuss the gap analysis ISO 9001.

What is a Gap Analysis ISO 9001:2015? 

The concept behind gap analysis is quite simple. It is an assessment that compares what your company has done with the requirements outlined in ISO 9001 to identify which requirements have not been met. So, in the simplest of words, it is an assessment that identifies "gaps" in your compliance. Unlike an internal audit, it does not entail interviewing process owners and observing processes to see if they are operating as planned. However, a gap analysis entails a paperwork exercise done by someone with comprehensive knowledge of your company's standards and management to make an accurate and unbiased comparison. 

The process involves a competent, experienced and knowledgeable person assessing your operations for each requirement outlined in every standard clause. For every requirement of the standard, this individual will write down what you have already done to address the requirement, and if nothing has been done, it is highlighted and categorised as a gap. Taking the example of clause 7.1.2 of ISO 9001, which requires the organisation to determine competent people for QMS and process control, the gap analyst will write down the name, designation, role and responsibilities of the person or the team that is incharge of the highlighted process. It will also be specified how these individuals were hired, what steps were taken to measure their competency and how their work is monitored.

After completing this list of comparisons, the gap analyst/ISO 9001 consultancy will be able to generate a list of requirements that your company has not yet addressed. This list contains all the deficiencies, allowing you to make a customised action plan. You can implement new processes and procedures to address these requirements currently missing from your QMS or start afresh by creating new workflows.

Is Gap Analysis Really Required to Implement ISO 9001?

The short answer is no. There is no mandatory requirement to perform or conduct a gap analysis when implementing ISO 9001:2015. However, this analysis just improves the efficiency of the certification and compliance process. As you approach a certification body auditor, the first thing they will ask to see is your gap analysis list. If you fail to produce a list of all the deficiencies and, more importantly, the actions you took to mitigate them, you will fail your ISO 9001 audit. Like many other elements of implementing ISO 9001:2015, the gap analysis tool is available for usage and easy implementation. However, it is up to us to utilise or refute it. 

Why Should You Use an ISO 9001 Gap Analysis?

Many organisations find the gap analysis tool extremely beneficial, mainly if they have already implemented some elements of the QMS. This is because the gap analysis tool serves as a magnifying glass, helping to accentuate the inefficiencies and areas that could be improved. By gap analysis ISO 9001 you will be able to find a better understanding of ISO 9001 meaning and its requirements.


The Real Benefit of a Gap Analysis

The biggest and the most impactful benefit of a gap analysis is that it helps to allocate better time, money and resources required to implement your QMS as per ISO 9001:2015 requirements. It is beneficial if your organisation has specific time constraints that are imposed due to customer requirements. As you get a customised report of the areas where you are lacking, you can make a tailor-made plan and clearly understand how you must plan your resources, time and energy.

How to Plan Gap Analysis ISO 9001

Hiring an ISO 9001 consultant is extremely helpful as they are proficiently trained in this analytical tool. However, the analysis includes various documents, including a business summary, target engagement objectives, organisational charts, job descriptions, employee handbook, support contacts, organisational surveys, management manual, software review, and financial statements. The data gathering involves interviews, performance, data analysis, and observations with a cross-section of the organisation's personnel. This leads to creating the gap analysis report, where each finding becomes an action item within the implementation plan. During the gap analysis concluding meeting, the ISO 9001 consultant will sit with the top management and lead a presentation, discussing the report findings and recommendations. The consultant will answer any questions about the findings and discuss the implementation issues, including agreements and finalisation of the project plan, while simultaneously discussing resource allocation and estimated timeline.

Get ISO 9001 Certified With Edara Systems

Gap analysis is a highly effective tool that highlights exactly what you need to do to achieve compliance with the ISO 9001 standard. If you need help with the gap analysis ISO 9001 concept or achieving this beneficial certification, Edara Systems is here. Professional consultants in Edara Systems will guide the organisation step by step through the obtaining process. To contact Edara Systems, visit their website or call them.