What is an ISO 9001 Gap Analysis?

One of the first steps in your Quality Management System (QMS) transition or implementation project is to compare your current QMS to the requirements of the ISO 9000:2000 standard. This is most commonly called a Gap Analysis. There are many consultants that can assist you with this, or you may choose to do it yourself. Either way, it is important to understand what the Gap Analysis involves, and what information it will provide.

The most important tool for the Gap Analysis is the Gap Analysis Checklist. This is a list of the requirements in the standard, written in question format. The auditor will use this list to compare the QMS that is in place with the standard requirements. A well-designed checklist will provide 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 should also give the auditor a specific place to document what they saw that did or did not meet the standard.

When you design or purchase a checklist, keep in mind that you will want to use the completed checklist to make task lists for the implementation plan. For each section of the standard you will want to prepare a list of items that need to be implemented, redesigned or documented. Make sure your auditor is aware of what information you need documented on the checklist in order to prepare the checklists. You will need:
  • Every question on the checklist answered with comments on what is in place or what is not in place
  • Notes explaining what practices do not meet the standard
  • Notes on where additional documentation is required
  • Other observations relating to compliance with the standard
  • Auditors must be familiar with the standard in order to perform an effective audit. If your auditors have not been trained on the ISO 9000:2000 requirements be sure to provide training before performing the audit.

Schedule and perform the audit. Allow enough time to do an in-depth audit. The more information you can provide for your task lists and project plan, the more efficient and effective your project will be.