Quality Mission Statement
The Company aims to sustain its position of being a profitable designer & manufacturer of medical devices and associated products.

The Company aims to achieve the industry best practice of customer care and satisfaction through its philosophy of continuous self-improvement. The Company wishes to remain a recognised name within the industry, its reputation becoming synonymous with excellence.

The above aims shall be achieved profitably in order to aid growth and development within the industry. The company will remain respectful and caring of the individuals who make the mission achievable, and sensitive to the surrounding environment.

Quality Assurance System - Standards
The Quality Assurance System is designed to be as practical and effective as possible and to conform to BS EN ISO 13485:2003 for the Design, development and manufacture of IV drip monitors and syringe drivers and the manufacture of tubing sets.

Applied Standard BS EN ISO 13485:2003
Medical Devices - Quailty Management Systems Requirements for regulatory purposes.

Notified Body
TÜV Product Service GmbH
TÜV SÜD Gruppe - Zertifizierstelle
Ridlerstrasse. 65 - 80339 München
Germany.

TÜV Product Service Ltd
Octagon House
Concorde Way
Segensworth North
Fareham
Hampshire
PO15 5RL
United Kingdom

Audit Dates
22nd August 2007
BS EN ISO 13485:2003
Medical Devices - Quality Management System
Design, development and manufacture of IV drip monitors and syringe drivers and the manufacture of tubing sets.

10th & 11th July 2006
BS EN ISO 13485:2003
Medical Devices - Quality Management System
Design, development and manufacture of IV drip monitors and syringe drivers and the manufacture of tubing sets.

8th Febuary 2005
BS EN ISO 13485:2003
Medical Devices - Quality Management System
Design, development and manufacture of IV drip monitors and syringe drivers and the manufacture of tubing sets.

21st October 2004
Production Quality Assurance System
Sterile tubing sets (class1) for transfusion, infusion, urology enteral and parenteral feeding

21st October 2004
Production Quality Assurance System
Tubing sets and relatted accessories (Class IIa) for transfusion, infusion, paracentesis and thorasentesis

30th September 2004
EN ISO 13485:2000 For the design and manufacture of IV drip monitors and the design of syringe drivers

18th/19th November 2003
BS EN ISO 13485 -1996 for the design and manufacture of medical devices. ISO 9001-1994. EC-Directive 93/42/EEC Annex V.3

20th May 2003
BS EN ISO 9001-1994 For the design and manufacturer of Drip Flow Monitors and the design of sringe drivers

7th November 2002
ISO 9002 - 1994 for the EN 46002 - 1996 ISO 13488-1996

10th October 2001
ISO 9002 - 1994 for the EN 46002 - 1996 ISO 13488-1996

3rd October 2000
ISO 9002 - 1994 for the EN 46002 - 1996 ISO 13488-1996

9th March 2000
ISO 9002 - 1994 for the EN 46002 - 1996 ISO 13488-1996


Customer Audits
Cardinal Health, Alaris Products
The Crescent
Jays Close
Basingstoke
Hampshire
RG22 4BS.
Cardinal Health
   

Baxter S.A.
Medication Delivery Division
Boulevard Rene Branquart, 80
B-7860 Lessines / Belgium

Audit Date
15th November 2006
Zimed Ltd. is a Cardinal Health, Alaris Products supplier for the Design and Manufacture of the Syringe Driver Pump Product.

5th/6th June 2003
Zi Medical plc is a Baxter Approved supplier for the manufacturing of Red-Eye intravenous drip monitor in the class A.

Baxter