What is a 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
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.
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