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NEWS
2008-04- 28
Information regarding the „new“ DIN EN ISO 13485:2007
In October 2007, the standard DIN EN ISO 13485:2007 has been
published. This is the German version of the European Standard EN ISO
13485:2003/AC:2007. The new issues of the German and the European
version do not contain any changes regarding the requirements compared
to DIN EN ISO 13485:2003 or EN ISO 13485:2003. At international level
(ISO) there have not been any changes in this context anyway and ISO
13485:2003 is still the current valid issue.
The standards DIN EN ISO 13485:2007 and EN ISO 13485:2003/AC:2007 are
simply adjustments (AC: 2007) and solely refer to the European foreword,
in which the application in combination with the European Directives on
medical devices and in vitro diagnostic devices is ruled in a new way.
For certifications, the hitherto existing regulations for exclusions and
non applicable requirements, already defined in the 2003 version, are
valid in an unchanged way.
Because of the continuance of the standard’s requirements regarding the
quality system, mdc does not intend to change certificates from version
2003 to 2007.
Furthermore, DIN EN ISO 13485:2007 and EN ISO 13485:2003/AC:2007
respectively substitute the previously harmonized standard DIN EN
46003:1999 which will be offtaken in July 2009.
For further information regarding this topic, our team will be at your
disposal.
2008-04-10
EN ISO 15378:2007 – The new standard for primary
packaging materials for medicinal products
In 2006, this international standard had been passed for the first time
as ISO standard. It specifies requirements for a quality management
system, valid for manufacturers of primary packaging materials for
medicinal products and has become more and more important since then.
The new standard is based on the most common standard for quality
management systems: ISO 9001. ISO 15378 contains all requirements of ISO
9001:2000 and complies with the principles of Good Manufacturing
Practice (GMP).
In 2007, the standard ISO 15378 had been included in the European
Regulations.
The application of EN ISO 15378:2007 provides manufacturers of primary
packaging materials the possibility of implementing an effective quality
management system under consideration of legal and normative
requirements.
Since December 2007 mdc offers certifications according to EN ISO
15378:2007 and therefore ranks among the few certification bodies in
Europe which are
accredited for this standard by TGA - Trägergemeinschaft für
Akkreditierung German Association for Accreditation GmbH.
For further information regarding certifications, please do not hesitate
to contact us:
49 (0)711 253597-0 or mdc@mdc-ce.de
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