Quality
KWK Kremsmünster is certified according to ISO 15378, ISO 9001 and further CE certified for medical devices according to regulation (EU) 2017/745. Other quality standards are GMP and HACCP.
ISO 15378
Pharmaceutical primary packaging items
Since 2009 - Quality Austria
ISO 9001
Quality Management Systems
Since 1994 - Quality Austria
ISO 13485
QM system for medical devices
Since 2010 - mdc GmbH
(EU) 2017/745
Manufacturer of medical devices for the EU
Since 2023 - mdc GmbH93/42/EEC
Manufacture of medical devices
Since 1998 - mdc GmbH
ISO8317 / US 16 CFR § 1700.20
For childproof packaging
ivm GmbHDMF
For specified packaging (USA)
Food and Drug AdministrationGMP QM-System
For Pharmaceutical Industries
HACCP QM-System
For Food Industries
International
Different international certificates