Quality

KWK Kremsmünster is certified according to ISO 15378, ISO 9001 and further CE certified for medical devices according to ISO 13485 and MDR (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. MDR (CE)

Since 2023 - 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

Qualifyze

Platinum Pharma Supplier Award

Since 2024 - Qualifyze

EcoVadis

Supply chains, sustainability, ethics

Since 2024 - EcoVadis

Awards

Different Customer Awards

International

Different international certificates