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Quality Assurance Systems

AFH Europe Quality Leader: Niall Wallace
Responsible To: Andy Wilson,
Director of European Strategy
Manufacturing Operation
The company is registered with the regulatory bodies: Barrow Mill:
BVQI ISO 9002
Certificate No. 17781/B

Flint Mill:
BSI ISO 9002 Certificate No. FM12999

Horwich Sewing:
SGS Yarsley ISO 9002
Certificate No. Q8729

The Kimberly-Clark Professional Sector Development Laboratory is accredited by the Kimberly-Clark Corporation and by UKAS.

CE Marks in Hospitals

There has been a lot of concern about the need for CE marks on products supplied to hospitals. This concern has come from the implementation of an EU directive on Medical Devices.

However our products are not covered by this directive and therefore do not require a CE mark for their use in the healthcare industry. If you examine the wording of the directive (93/42/EEC) of June 14, 1993, the reason becomes clear.

The directive defines medical devices as:

"The devices concerned by these directives are intended by their manufacturer to be used for the purposes of diagnosis, prevention, monitoring, treatment or alleviation of disease or injury, investigation, replacement or modification of the anatomy or of a physiological process, control of conception"

This in practice means that the item needs to be used in treating a disease or ailment. Our products are not designed for these types of uses, but are designed to be used either in the washroom for hand washing or for the cleaning and maintenance within the healthcare facility.

The impact of this is that our products are not sold as medical devices and therefore are not required to have a CE mark for their use in healthcare establishments.

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