Once being an ISO9002 auditor, I found it difficult to accept that you
can actually send defective product out the door as long as your polices
and procedures are in place to manage the issue.
Consequently once I understood the reason you could ship non-conforming
product, and be 100% within your ISO program it was a bit easier to push
everyone to use it.
ISO9002 is not meant to be a quality program, simple put ISO9002 makes
sure that you do what your polices and procedures say with no regard to
quality.
73,
George, K4GVT
On 3/9/2013 2:05 PM, Roger (K8RI) wrote:
On 3/9/2013 6:02 AM, peter chadwick wrote:
Jim wrote:
So -- since SPE amps are made in Italy, an EU country, there's a
good chance that they are compliant with EU regulations. Or maybe
not. :)<
The link posted to the site of Bob, G4UJS
(http://g4ujs.shacknet.nu/spe_2k-fa.pdf) suggests that they should
be, as they claim ISO9000 QA.
However, under the terms of the Radio & Telecommunications Terminals
Directive (R&TTED), a manufacturer or importer with a suitable QA
policy and organisation (ISO 9000) may self certify against a
Harmonised Standard. A couple of years back, an assessment by the EC
showed something like 70% of Short Range Devices (SRD) and about 30%
of professional stuff such as Private Mobile Radio failed to comply,
although the vast majority of cases were a failure to have correct
paperwork rather than a failure to meet technical requirements.
"
In general" ISO "only guarantees that they have properly documented
what they have done, or what they have done matches the documentation.
For instance ISO9002 has absolutely nothing to do with how well a
device or product does its job, or even if it works at all, just that
they have properly documented it.
Many companies fail their certification because the go into too much
detail in the documentation.
In my projects we had FDA validation under ISO guidelines.
Even going with minimal docs we started with about an inch high
packet. Every action and its results had to be printed our resulting
in a stack over 4 feet tall. That's about 5 reams of paper.
Thing is, this was all on the process. there was not one mention of
the produce in the whole operation.
Now other ISO regs may bedifferent, but the original idea behind ISO
certification was only about the proper recording of what the company
did, or the steps to build a product, not the parts in the product.
73
Roger (K8RI)
Now second hand equipment, modified equipment and kits, all intended
for radio amateurs, are exempt. So a manufacturer could in theory
provide an amplifier as a 'kit'. That would mean the buyer installing
the power transformer and soldering the wires to it, rather than
having them on plugs and sockets. Perhaps provide the SO239 output
socket not installed but with the hardware to do it. There is even an
argument that a non-compliant amplifier with an SO239 socket as
standard would become a modified and thus exempt device if the socket
was changed to an N type by the owner before importation......
Fortunately, the volume of business that amateur radio represents in
the EU is small enough that Brussels haven't got around to excess
regulation of it - yet!
73
Peter G3RZP
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