ISO 9000 is usually something a company can choose to follow
or not (although there may be considerable pressure from clients),
but if you want to sell a radiology system in the US, isn't FDA
approval a necessity?
> -----Original Message-----
> From: Jeff Sutherland [mailto:jeff.sutherland@...]
> Sent: December 4, 2003 11:07 AM
> To: email@example.com
> Subject: Re: [scrumdevelopment] Heavy weight requirements
> When I had over 500 developers at IDX, the standard I laid
> down for agile development which worked was:
> 1. No heavy weight requirement would affect a Scrum directly
> 2. FDA approval, CRM, ISO, anything that layered more
> documentation would be wrapped around the SCRUM and cost
> justified as a separate project for purpose of meeting standards.
> This gave the CFO a real choice. He could see exactly what
> the cost was of extra work for the heavyweight process. He
> decided against ISO and for FDA approval for radiology systems.
> No Scrum was affected.
> Jeff Sutherland