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:
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