Firstly I enjoyed the article on ISO 9001, I thought it balanced, thought and debate provoking. Some input from those contributing to its content deserves critical review, however.
John Hele’s view that the 9001 / 2 / 3 series was ‘hopeless’ looks like an attempt to rewrite history from a perspective of 20:20 hindsight. 9001 followed the lead of BS 5750 and its AQAP predecessors in offering tailored standards based on scope of activity this was probably only through habit but the series wasn’t the dog’s dinner portrayed. You only have to search the many fora and bulletin boards out there to see people debate the ‘brave new world’ of a single standard allowing an organization to determine and claim exclusions to standard requirements. There is no consensus as to what is a justifiable exclusion and what is not.
I also don’t accept Mr. Hele’s view that the structure of earlier editions of 9001 made quality management systems difficult to implement. My experience of those times is that there were those who could effectively apply the standard and those that struggled. I also believe that, for those with the right attitude to preventive and corrective action, the continual improvement aim of 9001 / 2 / 3 was used to deliver an effective management system.
The move through 87, 94 and 00 editions of 9001 is a reflection of users’ changing approaches to quality over time. It is true the year 2000 edition ‘revolution’ now provides more flexibility for users but recent experience with dealing with quality professionals and working in a certification environment is that few organizations have taken advantage of the changes or have really grasped those eight quality management principles, in particular the process approach. This 2008 amendment provides another opportunity to look again at our quality management systems without pressures of certification transition deadlines to embrace those ‘new’ requirements from 2000.
John Seddon’s comments were entirely predictable but still deserve a response. His assertion of market coercion ignores the initial demand from industry for a standard as a means of demonstrating capability and quality assurance (as described in the article) and also the flexibility the standard offers to users in how to satisfy requirements. The comment that really tickled me, however, was: ‘if people didn’t buy it, it wouldn’t have taken off’. Is this in the same way that the Model T Ford and the iPod wouldn’t have been successes if they hadn’t sold well?
In Mr Stanger’s piece I didn’t agree that 9001 is at fault for not being the chosen vehicle for accreditation of laboratories, test houses or indeed certification bodies. I do believe, however, he has a valid point. Conformity assessment bodies have chosen to plough their own furrow and develop separate standards (the ISO IEC 17000 series) rather than take a sector scheme approach based on the core standard for management of quality – ISO 9001. I also agree with Mr Stanger that it has created confusion in the market place and that there are few that understand what exactly accreditation is.