vitorcruz at mail.telepac.pt
Wed Sep 3 18:06:17 EST 1997
In Europe, ISO 9000 was transposed as EN ISO 9000 with exactly the same
ISO 9000 is a quality assurance standard for companies with product
conception, production, quality control, distribution, ...
As you developed yourselves the kits, standard EN ISO 9001 applies to your
companie, and you must ask for a certification.
Many countries across Europe are working in a mutual recognition
process.So, if you ask for the certification by the official body of one of
these countries, sooner or later the same certification will be recognized
by all the other countries in the agreement.
Accreditation applies usualy to laboratory conducting tests and the related
standard is EN 45001, similar to ISO Guide 25.
Keep in mind that certifying a quality sistem in your companie is not the
same as validating the kit and each laboratory using it must perform an
individual validation. This validation can be made in several ways:
- comparing results with traditional techniques
- analysis of certified materials
- interlaboratory testing ...
biol-dk at post4.tele.dk escreveu no artigo <872580590.16704 at dejanews.com>...
> 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.
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