I'd say both are probably right. I've never done medical. But, I
have
run into this type of thing when I was doing ISO-9001 as a lead
auditor.
Critical words for interpretation are
" This indication may be included ... "
It specifically says *may* which means either *you can* or
*you don't have to* depending upon some circumstances.
In this instance, I do not know what those circumstances are.
It does not say "shall" which means *must do*. The use of the
word *may* leaves it wide open to interpretation. The use
of the word *shall* leaves no room for interpretation. Thus,
the reason why I said both interpretations are probably right.
Now, an attempt to appeal their interpretation could be made.
But, if they are requiring others to do this, I doubt they'll back
down.
In any event, the requirement is to be able to trace from the label
of the device to the date of mfr for that device.
I suppose one could appeal in the case of:
1) a date was embedded in the serial number and
2) that date code was not of some obvious construction
(i.e. encoded/encrypted somehow),
then you'd have to look up the serial anyway.
Therefore, what's the need of a date code embedded in the serial
number when you have to look it up?
Also, the word "indication" may be interpreted any number of ways
also.
If you want to disect the wording, I'm sure it'll just get worse.
Regards, Doug McKean
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