ABSTRACT

There are some issues that cross cultural boundaries. I once asked another consultant who did a lot of work in the Middle-East and Indian Ocean rim, what was the biggest weakness in ISO 9000 quality systems? Without hesitation he replied, “training!” I too have found that same weakness. Although my auditing has been limited to North America, I seldom found an organization where I did not have a finding in the area of training. It is just a weak link around the globe. Another area of confusion that crosses cultural boundaries is preventive action. I’m glad this requirement has been removed from ISO 9001:2015. I wrote more major findings on preventive action, or actually the lack thereof, than any other requirement. This covers audits in general industry, aerospace, medical device, and automotive industries. Statistical process control (SPC) can be used in a problem solving situation.