Quality System Standards
ISO 9001, ISO 13485 and EN 46003
In the area of
medical devices and in vitro diagnostic devices the application of quality systems is
meanwhile established. In former times quite a range of medical devices and in vitro
diagnostic devices was regulated under the pharmaceutical legislation, which asked
manufacturers for the fulfillment of GMP (Good Manufacturing Practice) regulations.
Further in countries like the United States of America and United Kingdom and quality
systems were a requirement for the market access in the medical device sector.
Meanwhile there are no doubts at all, that
a suitable quality system, which is implemented in all relevant stages, can be an
important factor for the safety and performance not only of products but also of services.
Because of our activity as Notified Body we
are concerned daily with the assessment of quality systems. So it is a consequence that we
do not offer only certifications according to legal requirements but also voluntary
certifications according to quality system standards in the field of medical devices and
health care. In this field we cover the following:
ISO 9001
Meanwhile the worldwide mostly used basis for quality systems is the Standard ISO 9001.
mdc offers these certifications in the field of medical devices, in vitro diagnostic
devices and health care in cooperation with accredited registrars.
ISO 13485
In November 2000 the Standards EN ISO 13485:1996 and EN ISO 13488:1996 have been accepted
as European Standards for replacing the EN 46001 and the EN 46002. (The Standards EN 46001
and EN 46002 were only valid until: 28.2.2004) These Standards are published as EN ISO
13485:2000 and EN ISO 13488:2000 and effective. These Standards are very similar to the EN
46001 and EN 46002 and they are based on the EN ISO 9001(1994) and the EN ISO 9002 (1994),
which were valid until 15.12.2003.
In November 2003 the Standard EN ISO 13485
"Medizinprodukte Qualitätsmanagementsysteme Anforderungen für regulatorische
Zwecke" has been publicated. The assembling and the structure are based on the EN ISO
9001:2000. The Standard EN ISO 13485:2003 has been harmonized by mid of 2004.
The Standards EN ISO 13485:2000 and EN ISO 13488:2000 have been
withdrawn and replaced by the Standard EN ISO 13485:2003 on July, 31
2006.
The Standard EN ISO 13485:2003 is an
independent Standard, but it refers to EN ISO 9001:2000. The terms of content are mainly
taken over from the EN ISO 9001:2000 and they are completed with the specified
requirements to medical devices. Therefore the EN ISO 13485:2003 is clearly more extensive
than the EN ISO 9001:2000. The intention of the EN ISO 13485:2003 is the fulfilment of the
legal requirements. The intention of the EN ISO 9001:2000 is the improvement of the
competitiveness.
The requirements of the new EN ISO
13485:2003 are mainly identical to the EN ISO 13485:2000 or rather EN ISO 13488:2000. The
law "Medizinprodukte-Gesetz" and the MDD 93/42/ECC are remaining the basis.
EN 46003
This European Standard specifies the quality system requirements for the final inspection
and test of medical devices, which are more specific than the general requirements
specified in EN ISO 9003:1994. The Standard EN 46003 is not a „stand alone"
standard and it can only be used in combination with EN ISO 9003:1994. The specific
requirements of the EN 46003 only apply to named groups of medical devices; in-vitro
diagnostics and active implantable medical devices are excluded. For sterile medical
devices this Standard is not sufficient.
We will be happy to answer your questions
regarding the certification of quality systems. Please ask us. For inquiries regarding
cost estimates please use the questionaire.
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