How to devise Gap Analysis for implementation of ISO 9001 QMS

Any organization that has become certified against ISO 9001 can testify that it's a significant undertaking, with a major investment of your time, resources, and information required. Meeting legislative necessities, defining Quality aspects that have an effect on your organization, and process programs to influence and improve your QMS (Quality Management System) will all seem intimidating, However, it's entirely attainable that once you begin on the journey of ISO 9001 implementation that your organization is really undertaking a number of the actions required to satisfy various components of the ISO 9001 QMS standard already. If that's the case, The gap between wherever your company QMS is currently and meeting the terms of this ISO certification standard in readiness for a certification audit might not be as good as you imagine. But, how are you able to determine precisely what's done and what must be done? This can be where a gap analysis becomes helpful.

What is Gap Analysis?

Gap analysis isn't mentioned in the ISO 9001 QMS certification standard nor in its implementation process, and clearly isn't a demand of the standard itself; but, most organizations who are certified in line with the ISO 9001 QMS standard can testify that a gap analysis is that the correct place to begin if your organization needs to obviously determine what areas of its QMS would like reinforced, and additionally to stop extra work in the case of functioning on a method or initiative that has already been established. So, what should a gap analysis bring back your organization? Let’s examine the most benefits:

• Establish the processes and documentation that exist at intervals your organization.
• Identify the necessities of the quality so the gap between what you have got and what's needed is accurately perceived.

It can typically occur that a gap analysis will leave the organization in an exceedingly stronger position than before, even before the ISO 9001 implementation begins. Along with the characteristic gaps, your information of the necessities of this ISO standard itself can greatly increase during the gap analysis itself, thereby increasing your organization’s ability to fulfill the necessities of the ISO certification standard and challenges that lie ahead. So, given that, how precisely should the gap analysis be carried out? Let us delve into this in detail:

• Use a gap analysis tool and a range of workers who are very experienced with the inner processes among your organization. Examine ISO 9001 QMS certification itself and use the gap analysis tool to measure the distinction between the standard’s necessities and your processes and documents.
• Measure what your organization does versus the necessities of the ISO certification standard: do you have the mandatory resources and information to prepare your QMS in a perfect approach that ensures that the requirements of the ISO 9001 standard are often met? It should be that you just have to be compelled to additionally train your workers, hire additional workers, or have interaction with an external consultant to fill that gap.
• Create a project plan from your findings and plan how these gaps will be self-addressed in terms of responsibilities, methods, and timescales. This could offer an accurate guide of how and when your QMS and its performance will be aligned with the ISO 9001 QMS standard, sometimes signifying that your QMS could also be prepared for certification

Is Gap analysis for my organization apt?

The answer to this question depends on several other things and factors. It should be that you just have some processes that existed before ISO 9001 implementation was thought of, however nevertheless, it will still pay to audit these processes and their outputs against the necessities of the ISO 9001 standard. Throughout a recent gap analysis at a medium-sized technology company it had been expressed that the organization believed it met the necessities regarding documented data. However, on close study of clause 7.5 of the standard it quickly became clear that the necessities for review and approval of documents was not absolutely met, and actions were taken to deal with this, illustrating the tangible advantage of a gap analysis during this state of affairs. i might counsel that unless you have got associate degree QMS with nearly no processes in the least – that looks extremely unlikely – then a niche analysis are often an honest plan. At best, you will discover that you just have a method that meets one in all the obligatory necessities and permits you to get that off your project plan; at worst, you may at least have the right data at hand to live the gap between what your organization has and what it has to follow. In other words, it looks obvious that a gap analysis will bring real advantages to the majority organizations that have an QMS and have aspirations to be ISO 9001:2015 certificatied

The gap analysis can enable your organization to better manage its prices, wastage, and resources in a a lot of economical manner, and may be particularly useful in the instance your organization is struggling to deliver 9001 certification because of external influences, corresponding to stakeholder, investor, or client expectations. No matter your reasons, a gap analysis will give a sound foundation for your ISO 9001:2015 implementation.