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

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.

93/42/EEC

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

DMF

For specified packaging (USA)

GMP QM-System

For Pharmaceutical Industries

HACCP QM-System

For Food Industries

International

Russia, Ukraine