| 
   
  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. 
  
  
  
 When the audit has been completed, meet with the auditors to summarize 
 the results. These results can be transferred to task lists for the 
 implementation. This meeting should be held shortly after the audit, 
 so that information is fresh in the auditors' memory. 
 Next: 
 Scheduling and Conducting a Gap Analysis 
 Useful tools: 
  
 
 
 |