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 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