ISO accreditation

Vitor Cruz vitorcruz at mail.telepac.pt
Wed Sep 3 17:38:51 EST 1997


In Europe ISO 9000 was transposed to a CEN standard - EN ISO 9000 with
exactly the same text. This is a standard for quality assurance in various
steps: conception, production, quality control, distribution,...
As you developed yourselves the kits, the standard EN ISO 9001 applies to
your company and you should ask for a Certification.

Accreditation is used often for laboratories conducting tests, and the
applicable standard is EN 45001 (similar to ISO Guide 25)

Nevertheless, you shall never forget that certifying a quality system in
your company is not the same as validating your kits. Each laboratory using
them must perform an internal validation to assure that they are working
accordingly with specifications.


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.




More information about the Microbio mailing list