I could use some help understanding sections 7.2.1 (Determination of Requirements Related to the Product) and 7.2.2 (Review of Requirements Related to the Product). I tried several searches but came up empty.
My question is how do folks handle these sections in their Quality Systems? We are a small contract R&D company and generally get, at best, some high-level requirements (e.g., "we want a widget") when discussing new contracts. We perform enough due diligence to give a rough order of magnitude estimate. We generally elaborate a little (e.g., "the widget will have a graphical user interface and will meet UL EMI standards") but still keep things at a high level. As a contract shop, we can't invest too much in pre-award time.
Is this high-level 'review' sufficient to meet the standard (from 7.2.2 "...review the requirements... prior to commitment to supply a product...")? After contract award, we generally create a more traditional Requirements Specification in line with Design Inputs (7.3.2). Any feedback appreciated.
My question is how do folks handle these sections in their Quality Systems? We are a small contract R&D company and generally get, at best, some high-level requirements (e.g., "we want a widget") when discussing new contracts. We perform enough due diligence to give a rough order of magnitude estimate. We generally elaborate a little (e.g., "the widget will have a graphical user interface and will meet UL EMI standards") but still keep things at a high level. As a contract shop, we can't invest too much in pre-award time.
Is this high-level 'review' sufficient to meet the standard (from 7.2.2 "...review the requirements... prior to commitment to supply a product...")? After contract award, we generally create a more traditional Requirements Specification in line with Design Inputs (7.3.2). Any feedback appreciated.