P
Padams13
Hello,
I work for a company that is ISO 9001:2000 certified and am working on making our QMS compliant with ISO 13485 with the goal of certification. We are pursuing this as a result of pressure from our customer base. In doing a gap analysis one of the major differences between 9001 and 13485 is in the last paragraph of 7.5.2. that states that there shall be documented procedures for the application of computer software. My question/ request is whether anyone can give some guidance on what types of software would be applicable to this requirement? I know things like test software would apply but I want to make sure we don't go overboard with what we identify as needing validation.
Any help would be greatly appreciated...
I work for a company that is ISO 9001:2000 certified and am working on making our QMS compliant with ISO 13485 with the goal of certification. We are pursuing this as a result of pressure from our customer base. In doing a gap analysis one of the major differences between 9001 and 13485 is in the last paragraph of 7.5.2. that states that there shall be documented procedures for the application of computer software. My question/ request is whether anyone can give some guidance on what types of software would be applicable to this requirement? I know things like test software would apply but I want to make sure we don't go overboard with what we identify as needing validation.
Any help would be greatly appreciated...