Many organizations with as few as 2 people have found benefit from registration to ISO 9001.  Many of these organizations go through the ISO 9001 systems development and implementation because their customers make registration a requirement in order to do business with them.  Others feel there is a marketing need, particularly if their direct competitors are registered.  And still others get registered because of statutory or regulatory requirements attached to the products that they provide.  These reasons obviously legitimate reasons for achieving registration, but are they the best reasons.

Many many times over the years I have encountered the same difficulty in trying to help organizations.  The problem is the “Chinese House Problem”.  Let me first explain the ‘Chinese House Problem’.

8D, 7Step, Drill Wide and Deep, etc. etc. etc.  These are all excellent processes, if they are used effectively.  Critical analysis of hundreds of corrective action records has drawn me to conclude that any of these processes can work, but most don’t.

TS 16949 requires internal laboratories to have a Laboratory Scope. There are specific requirenents for this. They are defined in the standard as;