Does ISO 9001 require controlled processes for improvement? By now, I think most users would agree that it does. The requirements for that controlled process are simple to describe. They start with planning. To meet the minimal requirements of ISO 9001, an organization must have thought through, planned, and implemented its processes for improvement. However, ISO 9001, even when we refer ... [Read More]

ISO 9001’s subclause 8.3 is intended to prevent inadvertent use or installation of nonconforming product. A primary requirement of this subclause is to ensure effective implementation of processes that prevent unintended use or delivery of product that doesn’t conform to requirements. This simple requirement makes business sense because one of the worst things an organization can do is ... [Read More]

Perhaps no concepts have been more abused than those related to controlling measurements. For decades it was common in many industries to calibrate measuring and test equipment to ensure it met its own specifications for accuracy and precision. Complex and expensive systems were developed to do the calibrations as scheduled. There was little emphasis on controlling the relationship between the ... [Read More]

Although other aspects of controls required by ISO 9001 may be critical, none receives as much attention as subclause 7.5.1--”Control of production and service provision.” Almost every organization must develop processes for delivering services or producing products. Subclause 7.5.1 focuses on the key concept that processes must be carried out under controlled conditions. Considerations for ... [Read More]

If any clause in ISO 9001 has increased in importance since the release of the standard’s 2000 edition, it must be subclause 7.4 on purchasing. Not that the relative importance of the words has changed, but rather purchasing and outsourcing have become much more common and important in our day-to-day business. So the relatively small subclause on controlling purchasing may be much more ... [Read More]