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Quality system vs SDLC (Software Development Life Cycle) (or ALM)?

A

ariannas

#1
Not sure if this is the right place to post this...:cfingers:


This is a bit of philosophical question --

I've been asked if a software development life cycle (SDLC) and/or application lifestyle management (ALM) are equivalent to a quality system. My gut feeling is that SDLC or ALM processes can support a quality system (such as FDA 820) but aren't a quality system on their own.

But I'm finding hit hard to defend this stance, both in my own head and to those who have asked, who are software developers (I'm not).


What do you all think? I'd welcome any points that either support or undermine my assertion.

Like they say in Mythbusters, even a negative result is a result.

Thanks all!
 
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yodon

Staff member
Super Moderator
#2
I guess it depends on your definition of a "quality system." If you define that as compliant to a standard such as ISO 9001 then an SDLC will fall short.

A Quality System (compliant to, say, 9001) will address aspects beyond "engineering" work (i.e., an SDLC). It would include those fun things like quality policies, quality objectives, management reviews, CAPA, etc. The SDLC would pretty much be limited to the 'product realization' aspects. So your thought that the SDLC or ALM would support the quality system would be correct in this sense.
 
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