Quality

KWK Kremsmünster has been certified according ISO 15378, ISO 9001 and further CE certified for medical devices according to directive 93/42/EEC. Other quality standards are GMP and HACCP Target is Zero defect quality.

ISO 15378

Pharmaceutical primary packaging items


Since 2009 - Quality Austria

ISO 9001

Quality Management Systems


Since 1994 - Quality Austria

ISO 13485

CE, medical devices within the EU


Since 2010 - mdc GmBH

93/42/EEC

Manufacture of medical devices


Since 1998 - mdc GmBH

ISO8317 / US 16 CFR § 1700.20

For childproof packaging

ivm GmbH

DMF

For specified packaging (USA)

Food and Drug Administration

GMP QM-System

For Pharmaceutical Industries

HACCP QM-System

For Food Industries

International

Different international certificates