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 important now than it was back in 2000. (I addressed outsourced processes in my May column, “Is a Controlled QMS Possible?” More about them later.)

The requirements described in ISO 9001’s subclause 7.4.1 on the purchasing process permit an organization to decide the “type and extent of control” to be used for purchasing. The organization’s selection of controls should be based on the effect of the purchased material or services on the product realization processes and on the finished products delivered by the organization to its customers. If purchased materials or services have little effect (e.g., a threaded fastener that’s used inside a noncritical subassembly), then minimal control is needed.

 …