Steve
ISO
requires that you follow your own procedures. What do your internal
procedures require? You will probably find that the ISO requirements are
less stringent than the restrictions from internal specifications that were
written to satisfy the ISO requirements.
ISO9001-1994 merely requires documented procedures defining the manner of
production, installation, and servicing, where the absence of such procedures
could adversely affect quality (4.9 (a))
ISO
9001-2000 requires the availability of work instructions, as necessary (7.5.1
(b))
This
leads to the obivous question of "What's a work instruction?" The answer
is that it is the instructions needed to perform the function properly.
Work instructions can take the form of formal step-by-step instructions, flow
charts, pictures, prints, or who knows what. In other words, it's up to
you to define and justify what is necessary to ensure quality to comply with ISO
requirements. Keep in mind that specific customer or regulatory agency
requirements may place additional restrictions on your freedom of
choice.
Just
my opinion. I'm sure others will offer variations or contradictory
advice. In the end it's up to each organization to define the processes
and procedures needed to achieve customer satisfaction. Documents like ISO
provide an outline of the elements of an effective quality system. For the
most part, they don't dictate the particulars of how the elements must be
implemented.
Don
Vischulis
just curious...how do you deal
with ISO and prototypes? Do you do full-blown work instructions? Try to
run things through normal production processes, so that you have traceability?
Or do you you treat it as it is, a prototype?
Going through some stuff
here...thinking that we put more stuff into prototypes than we need to...just
curious what everybody else does...I have my past experience, but that's not
good enough.
Like to hear from everybody else...
-Steve
Gregory- ---------------------------------------------------