Product Realisation

Clause 7 of the standard is product realisation and it is the only clause in the standard that you can seek exclusions.  When seeking exclusions for a quality management system or a certification, you cannot just pick and choose to suit.  If your company designs, then you need to include design.  If they purchase, you need to include purchasing. 

Some say, that if it does not have a direct impact on the product or service then you can exclude it.  However, I venture to say that any aspect of your business will have an impact on your product or service do don’t seek exclusions unless it is absolutely necessary.  In fact, if you are implementing a quality management system for continuous improvement and customer focus, then include all of your business aspects so as there is not a ‘rule for some and not for others’ mentality. 

My thoughts is that the only real exclusions that should ever be sort is design control or test equipment and I will deal with each in forthcoming blogs.  Just remember, if you seek an exclusion you will need to provide evidence and a justification for seeking an exclusion.  To ensure transparency, such justifications should be clearly stated in prominent documentation such as the quality manual or even the quality policy, just make sure it is readily available when requested.