Declaration of Conformity
The Sterile Services Department re-manufactures procedure packs, single instruments and theatre sets using the items which are mutually compatible and used in accordance with manufacturer's instructions and users requirements – to conform to Annex V Section 3.2 and Article 12 of MDD 93/42/EEC Revision 2007/47/EC
Sterilisation has been carried out in accordance with manufacturer's instructions.
Users are supplied with relevant information, including manufacturer's instructions where necessary, and packs are labelled accordingly.
There are Quality Control inspections at all stages of the manufacture, and records are kept of any adverse incidents or recalled products.
Changes to the Quality System are documented to conform to BS EN ISO 13485:2003 requirements.
All documentation is kept for specified periods.
The Sterile Services Department conforms to BS EN ISO 13485:2003