I work for an injection moulding company that produces medical parts in accordance with clients’ drawings & specifications. Recently, we have received a drawing that is a number of years old & references an ISO standard (ISO 594-1, which was valid at the time of the drawing’s approval), that is now withdrawn & replaced with another standard (ISO-80369-7).
I do not know exactly what the new requirements are, however, I do know they are more stringent on mould tool tolerances (which affects the component) & testing requirements. The quality of the existing mould tool (made according to the old standard) & hence the quality of the component, might not be in accordance with the new standard – this one concern. The other concern is the new standard requires us to achieve testing criteria that can only be met upon using equipment that we will have to purchase.
My question is, as a manufacturer, who does not take responsibility for the design of the component; only the manufacture & inspection of it, do we inspect & test against criteria stated on the drawing or do we have a duty to understand the requirements in the new standard? And should we have the client update their documentation to reflect this?
I do not know exactly what the new requirements are, however, I do know they are more stringent on mould tool tolerances (which affects the component) & testing requirements. The quality of the existing mould tool (made according to the old standard) & hence the quality of the component, might not be in accordance with the new standard – this one concern. The other concern is the new standard requires us to achieve testing criteria that can only be met upon using equipment that we will have to purchase.
My question is, as a manufacturer, who does not take responsibility for the design of the component; only the manufacture & inspection of it, do we inspect & test against criteria stated on the drawing or do we have a duty to understand the requirements in the new standard? And should we have the client update their documentation to reflect this?
