J
In an initial meeting with the registerars, it was commented that section 7.3 of 9001 would have to be complied with as there would be "design and development" of the reports produced.
Jeff is completely correct:
you need to change the way you are viewing the standard. When reviewing the standard replace the word “product” with “service” and yes you must apply 7.3 to the design and development of the product, which in this case is the report. If this company designs and develops a report that does not meet the needs of the client then they are non-conforming to clause 7.3 of the standard.
It's typical of such analytical types of businesses (eg, consulting) where the end product IS the report supplied. No, it isn't 'just a report' - what the customer has paid for is the information - the content - of that report. Similar thing, perhaps, to a market research report. Again, it isn't 'just a report', it's the findings, the data and the conclusions in it.
The report is just the format in which the output of the process is presented to the customer. The content of the report is the result of the service provided.
Perhaps if they're doing exactly the same kind of assessment and producing exactly the same kind of report (albeit with different data) for every customer, then you can argue design isn't applicable.
But a more intelligent approach would be to look at the requirements and say, how and where do we do this? (And it'll be very different from manufacturing widgets). A comptent auditor will interpret & apply the requirements in a way that is appropriate for the nature of the organisation, its activities and of course the registration scope.
