ISO accreditation

biol-dk at post4.tele.dk biol-dk at post4.tele.dk
Wed Aug 27 03:51:49 EST 1997


ISO accreditation

We are a small diagnostic company in Denmark manufacturing laboratory
ready to use test kits for salmonella. AS we now are considering (and
are forced to by our parnters) to consider to have our activities
approved accoring to regulatory standards.
We develop the kits ourselves. Do the manufacturing in an ISO
conformed manner. And in some countries we even sell the product but
we often use distributors for the sales.
As we have now obtained AOAC approval and are close to the french
AFNOR approval we would like to introduce one or more of the following
standards or maybe a combined standard. We have considered the
following:
1) Accreditation
2) ISO standard
3) CEN or european standard
4) FDA standard
5) Paul Ehrlich Institute Standard for diagnostic kit manufacturers.
If you have information of one or more of these standards and
especially
how to proceed in order to save work we would be most greatful. Also
we
are of course willing to purchase the
necessary software and other CD-rom modules for a fast and efficient
progress.


Best regards

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