Thread View: sci.med.laboratory
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Started by biol-dk
Wed, 27 Aug 1997 00:00
ISO accreditation
Author: biol-dk
Date: Wed, 27 Aug 1997 00:00
Date: Wed, 27 Aug 1997 00:00
32 lines
2038 bytes
2038 bytes
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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Re: ISO accreditation
Author: Vitor Cruz
Date: Wed, 03 Sep 1997 00:00
Date: Wed, 03 Sep 1997 00:00
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2210 bytes
In Europe, ISO 9000 was transposed as EN ISO 9000 with exactly the same text. 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 ... Best success VC biol-dk@post4.tele.dk escreveu no artigo <872580590.16704@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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