What is an ISO 9000 Gap Analysis?

If you are thinking of preparing an ISO 9000 Quality Management System (QMS) then where do you start?  We start with a Gap Analysis to determine the gap between your current management system and an ISO 9000 conforming QMS.  A Gap Analysis is used to assess an organizations scope, readiness, and its resources for building the system.  It also provides us with the data to develop a project plan for ISO implementation.

The first question we need to answer is Scope?  Your QMS scope applies to what product lines, ISO 9000 clauses, and facilities that you are planning on registering to ISO 9001.  You do not have to register every product line.  At Bizmanualz, we are preparing for our own registration audit that will include our manual products, consulting and training services.  That means both our products and services will be included in the registration process. 

To define the scope within the Gap Analysis we look at what processes need to be included and described within the ISO QMS.  The output is a draft process map.  Next we examine each clause of the ISO 9000 standard.  There are 136 “shall” statements that we count to see which ones apply and how an organization may be conforming.  These shall statements include 21 required records, six required procedures, a Quality Manual, and many process requirements that must be fulfilled, but there is a lot of leeway on how you might fulfill those requirements.

For example, collecting customer feedback is a required process or that processes must be measured is a requirement, but how you do this is totally up to you.  You do not have to write a procedure for this or  keep a record of measurements.  As odd as this sounds you have to free your mind of paper solutions and think of visual or electronic methods that could accomplish this.

The output of the ISO Quality “shall” count is a histogram that shows you how your organization stacks up, clause by clause, and a list of possible exclusions of areas within clause seven that may not apply.  Each exclusion claimed will require a proper justification within the Quality manual.  In the Gap Analysis phase we should be able to give you an idea on possible exclusions.

With the Gap Analysis complete, we write up what we saw and deliver to you a draft process map, scope with exclusions, a histogram that lists your conformance by clause and a set of implementation milestones to meet your target date.  An ISO Gap Analysis is basically a full systems audit but instead of audit findings you get consulting advice on how ready your organization is for ISO 9000.  If you are thinking of preparing an ISO 9000 Quality Management System, then an ISO 9000 Gap Analysis will provide the answers to your scope, budget, and implementation questions that management will be asking.

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Bizmanualz has been at the forefront of deploying business best practices since 1995 delivering Policies, Procedures and Forms; quality systems implementation; and strategic business process improvement to help business owners achieve the growth and expansion they envision.

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Originally published in 2009 by Bizmanualz, Inc. under the title What is an ISO 9000 Gap Analysis?. All rights reserved. Reproduction permitted with attribution only. www.bizmanualz.com