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Step 2: Perform a Gap Analysis

What is an ISO 9001 Gap Analysis?

An ISO 9001 gap analysis is an objective evaluation of your organization’s current arrangements against the ISO 9001 requirements of the standard. An ISO Gap Analysis can be an ideal place to start when implementing a new standard in your organization.

Starting with a gap analysis can be very beneficial as it often saves time and money. The gap analysis will identify the ‘gaps’, allowing you to produce a more accurate project plan for filling those gaps and achieve ISO 9001 certification.

Recommended steps to be completed before conducting the Gap Analysis:

  • Appoint one or more people within your organization to conduct the Gap Analysis; it is helpful if they have some quality system experience or audit experience.
  • You may also want to consider having assistance from a consultant. They have the experience to conduct a successful gap analysis and to ensure areas will not be overlooked.
  • Create or purchase a Gap Checklist.

How does a gap analysis differ from an Audit?

The main difference between a gap analysis and an audit is that during a gap analysis your organization will compare your business to the standard. During an audit, the goal is to compare an organization’s policies and procedures to the requirements of the standard, and then look for evidence that they are being followed within the business.  

ISO 9001 Gap Checklist

  • The most important tool for the Gap Analysis is the Gap Checklist. This is a list of the requirements in the standard, written in question format.
  • The auditor (person conducting the Gap Analysis) will use this list to compare the QMS that is in place with the requirements of the ISO 9001 Standard. Where there is a shortfall, it is called a “gap”.
  • The checklist provides the auditor with recommendations of what documents to look for, examples of what will meet the requirements and other guidance on auditing to the standard. The checklist also gives the auditor a specific place to document what they saw that did or did not meet the standard.

There are three main components to completing an ISO 9001 Gap Analysis:

Product: Gap AnalysisA consultant can save you time by performing the gap analysis for you.  They are well versed in all of the ISO 9001:2015 requirements, and will help you focus in on the areas of your organization that need improvement to achieve certification.  (Virtual Analysis available.)

Product: Gap Checklist. This toolkit includes a detailed, 40 page checklist with guidance on what to look for to evaluate your current processes and their compliance to the ISO 9001 Requirements, as well as a 2 page PDF document explaining a gap analysis.


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