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Audited to ISO 13485 standard although customer was aware we're not and have no plans to be

NikkiQSM

Quite Involved in Discussions
#21
I've been audited several times to a standard that we did not comply with at the time. But the customer never issued findings for what was found that did not comply. I don't agree with that, at all.
 
#23
@Ronen E Historical tendencies led to people going for the shortest way (usually leading to a lost of lost context and continued confusion), and thus not necessarily taking the time (or being able to take the time for) the just or correct way. To keep resulting processes pragmatic and capable my advice focuses on matching intent behind all of the minor differences in interpretation. For cases such as these it is usually optimal to avoid having seperate processes per kind of party when much of the process is the same for each.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#24
@Ronen E Historical tendencies led to people going for the shortest way (usually leading to a lost of lost context and continued confusion), and thus not necessarily taking the time (or being able to take the time for) the just or correct way. To keep resulting processes pragmatic and capable my advice focuses on matching intent behind all of the minor differences in interpretation. For cases such as these it is usually optimal to avoid having seperate processes per kind of party when much of the process is the same for each.
In general I think you may be right, but in these particular instances I see it as a potential source of regulatory creep. At some point somebody says something that is not correct and doesn't make a lot of sense, yet is met with (resentful) compliance for the sake of "efficiency". It's not real efficiency because the result is often a lot of added paperwork that adds zero, or close to zero, value to anyone, yet consumes resources (sometimes a lot). And, today's "special" or "detour" is tomorrow's norm, if no one speaks up.
 
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