An ISO 9001 certification is a certification that an organisations Quality Management System (QMS) comply with the ISO 9001 standard. If your organisation is planning to develop and implement a quality management system in line with ISO 9001, the first step in the process is to conduct an ISO 9001 gap analysis. An ISO 9001 compliant QMS keeps the customer in focus, drive continual improvement and ensures consistency in your processes. An ISO 9001 certification is a useful for your organisation as it adds credibility and ensures your potential customers you have robust systems in place to manage quality. With the development of the modern world, there is a need for a comprehensive quality management and assurance system.

The ISO 9001 Gap Analysis

To do a gap analysis for an ISO 9001 certification is an assessment process to compares a current and up to date quality system with the ISO 9001 requirements. It identifies any gaps between the requirement of ISO 9001 and the management system you have in place. The standard outlines a range of requirements an organisation must meet in order to get certified and the ISO 9001 gap analysis identifies if some of these requirements are not met.

The Reason for Conducting a Gap Analysis

An ISO 9001 gap analysis can be used to outline the scope of work required to get certified. Following are some of the most common questions people ask prior to initiating an ISO 9001 gap analysis:

  • How difficult is it to conduct a gap analysis?
  • What’s involved?
  • How long time will it take?
  • How much does a gap analysis for an ISO 9001 certification cost?

The answer to these questions can vary quite a bit from organisation to organisation. However, if you have a qualified employee or ISO 9001 consultant to conduct the gap analysis, for most companies it can be completed within 2 days on site in addition to the preparation time and report writing. The cost of the gap analysis depends on if you use internal or external resources and it can vary a great deal from consultant to consultant as well.

Step by Step on How to do a Gap Analysis

The first step on how to do a gap analysis is to assign a capable person to conduct the ISO 9001 gap analysis. This person should be a certified lead auditor for the standard and have experience with implementing an ISO 9001 compliant Quality Management System (QMS).

Once the qualified person has been assigned, there are some straightforward steps to take as outlined below:

  • Create a checklist to do a gap analysis.
  • Schedule your gap analysis at a convenient time for everyone who will be involved.
  • Conduct that gap analysis using your checklist as guidance.
  • Review the outcome of the ISO 9001 gap analysis.
  • After all these steps, set up a project plan to develop and implement your QMS.

Finding the right person for the job is often not that easy and there are several roads that can be taken. If you have a qualified internal person this could the way to go. However, if they haven’t had much experience with the standard or developing a QMS, it can often end up being a costly option over an experienced consultant.