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
  • ISO 9001
  • ISO 13485
  • 93/42/EEC
  • ISO 8317
  • DMF
  • GMP QM-System

ISO 15378

This standard describes the special requirements for a producer of primary packaging items for the pharmaceutical industries, based on ISO 9001 and GMP rules.

ISO 9001

This is state-of-the-art standard for high quality in organisation and production with a commitment to continuous improvement of quality standards.

We have been certified 1994 by official Austrian ÖQS and are holding a international approved certificate (IQ-Net).

ISO 13485

KWK is certified according to 93/42/EEC. This allows production of medical devices for the use within the EU, wearing a "CE"-marking.

In addition the standard 13585 describes the requirements of a quality system for development, design and manufacturing of medical devices.


Manufacture of medical devices

This certificate entitles KWK to produce medical devices such as dosing devices (spoons and cups) to be sold within the EU.

ISO8317 / US 16 CFR § 1700.20

For childproof packaging


For specified packaging (USA)

GMP QM-System

For Pharmaceutical Industries


For Food Industries


Russia, Ukraine