The Basics of ISO 9001:2008 Gap Analysis
One of the first steps in implementing ISO 9000 is to perform a gap analysis. This is the technical name for an initial comparison of the Quality Management System to the ISO 9001:2008 Standard. The goal in find the gap between the standard and the QMS. The Gap Analysis will establish the scope of the implementation project and will therefore be important information for determining the amount of resources that will be required to complete the project in the given timeline.
Typically the gap analysis is based on a Gap Analysis checklist. These can be purchased from several different sources on the web ( like theISOstore.com). A second option is to use the internal audit checklist from this web site as a gap analysis checklist. Either way, the key to have a list of questions based on the standard that will uncover any weaknesses in the QMS before the project begins.
Gap Analysis Auditors
Performing gap analysis is best done by someone who is familiar with the ISO 9001 standard. If the company has no one with this experience, then consider outside training for the person who will be the lead internal auditor. Without grasping the goals behind the standard, you and your company can waste a lot of time improperly documenting flaws and over engineering solutions.
Performing a Gap Analysis
I recommend performing a basic ISO 9000 awareness training before the gap analysis. The awareness training will help reduce fear or resistance to the change that sometimes comes with a large company wide project. Once everyone understands the goals of the ISO project and is ready to be audited, start the gap analysis in sections. Covering sections 4,5,6,7 and 8 all in one audit is a mind melting experience. Start with section 4 to see how fast you can properly document the a section. Then schedule the remaining section based on your experience.
As you go through each section, you will either find that a system is already in place that meets the requirements of the ISO9001 standard or you will write a finding for that section. If you find that the system is in place, simply log the document numbers on the gap analysis sheet and move on. If you find that a large portions of the quality systems are missing, then you can write the equivalent of a major finding with a larger scope and not waste too much time listing every detail of what is missing.
How to use the result of the gap analysis
Once you have completed the gap analysis, you will have a list of missing or under-developed documents, records and systems. If you use the checklist from this web site, the result of the gap analysis will be a list of individual item that must be corrected. If the check sheet said "what document is used to the describe record retention?" and you found no document, then the document should be created. Once you feel that everything is in place, then you will want to repeat the audit to confirm that you can answer every question on the internal audit checklist with a positive response.
If the gap analysis show that your systems are in relatively good shape with some area for improvement, then I would make the gap analysis the first record in your internal audit notebook. This will help build a history of audits. If the gap analysis shows major flaws, you may want to fix them and then perform an internal audit as the first record to meet your internal auditing requirements. External auditor will frequently look at your internal auditing records to see if there are any blatant problems with the QMS, so don't make their job too easy.