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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 (for pharmaceutical packaging) and HACCP (for food and beverage packaging). A certificate according ISO 13485 will follow in 2010.

Target is Zero defect quality.

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.

Certified according to this standard KWK fulfills a requirement of the demanding pharmaceutical customers.

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).

GMP - Good Manufacturing Practice / ISO 15378

These are standards for clean and high quality production under specified conditions and a requirement of pharmaceutical customers, who audit our facilities. We have already been pre-audited and plan to be certified according to ISO 15378 (requirements to produce primary packaging items for pharmaceutical use) within 2009.

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.

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.

This certificate describes the requirements for producers of medical devices. This certificate goes beyond the requirements of EU-directive 93/42/EEC for producers of medical devices with a measuring function. A certificate according 93/42/EEC is a precondition for the production and the sale of dosage spoons and dosage cups for medical devices in the EU requirements. Users of dosage spoons and dosage cups have the additional benefit to rely on specialized supplier.

Certificates

ISO 15378:
special requirements for producers of primary packaging for medicinal products
ISO 9001:
QM-System
ISO 13485:
special requirement for producers of medical devices
93/42/EEC:
medical devices for EU usage
ISO 8317:
for childproof packaging
DMF:
for specified packaging (USA)
Russia:
Producer of Pharmapackaging
Ukraine:
Producer of Pharmapackaging

further quality Standards

GMP QM-System:
for Pharmaceutical Industries
HACCP QM-System:
for Food Industries