This standard, developed by the medical device industry in
Europe was first issued in 1993 as a European Norm: EN 46001/2
Quality Systems Medical Devices, Particular Requirements for the
Application of EN ISO 9001/2. EN 46001/2 was never intended
as a "stand alone" standard, but is an additional scheme
emphasizing relevant requirements in ISO 9001/2 for the medical
device industry. Accredited certificates cannot be issued for
EN 46000 alone; they are always issued in connection with ISO
9001/2.
In 1996 ISO issued EN 46001/2 as the standard ISO
13485/13488:1996. These almost identical standards have
co-existed until EN46001/2 was withdrawn in June 2001.
A new version of ISO 13485 is published in July 2003, based on the
2000 version of ISO 9001. For companies converting to ISO
9001:2000 before this new issue of ISO 13485, the scope of the
certificate will cover ISO 9001:2000/ISO 13485:1996 (based on ISO
9001/2:1994).
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On this CE-marking homepage, we will help you understand
the what and why
of CE-marking what it is and why your product may need to be
CE-marked. CE-marking of your product(s) to the
requirements of various EU Directives. Applicable to a wide range of
products sold within or exported to countries in the European Union
and European Economic Area.
The road to certification will help you
prepare for an independent audit. Accredited certification will explain
what the international ISO 9001:2000 quality management standard
applicable to any manufacturing or service industry.
