Hello everybody,
At the moment I have really "nice" discussions with colleagues from the R&D department regarding the formal documenting of requirements.
I mentioned, that during documenting design input requirements it is always necessary to define acceptance criteria too - otherwise a developer would not know how he should design the product, respectivly it's components.
Perhaps you know the working-philiosophy in R&D areas - document as less as possible to get a maximum flexibility... My colleagues are asking me now - where in the quality standards (QSR, ISO 13485,...) is the requirement to document an design input requirement with acceptance criteria?
They are asking me - why isn't enough to document acceptance criteria directly before verification or validation acitivities start?
Do you have any suggestions - how can I demonstrate that I am right?
Thank you very much in advance for your support!
Best regards,
Aphel
At the moment I have really "nice" discussions with colleagues from the R&D department regarding the formal documenting of requirements.
I mentioned, that during documenting design input requirements it is always necessary to define acceptance criteria too - otherwise a developer would not know how he should design the product, respectivly it's components.
Perhaps you know the working-philiosophy in R&D areas - document as less as possible to get a maximum flexibility... My colleagues are asking me now - where in the quality standards (QSR, ISO 13485,...) is the requirement to document an design input requirement with acceptance criteria?
They are asking me - why isn't enough to document acceptance criteria directly before verification or validation acitivities start?
Do you have any suggestions - how can I demonstrate that I am right?
Thank you very much in advance for your support!
Best regards,
Aphel