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QUALITY ASSURANCE MANUAL

A/FATRONICS International LimitedQuality ASSURANCE MANUAL , Rev UQUALITY ASSURANCE MANUALUNCONTROLLED COPYThis MANUAL contains information proprietary to Theratronics International Limited. Any disclosure or use of this information or any reproduction of this MANUAL other than for the specific purpose for which it is intended is expressly prohibited except as THERATRONICS may otherwise agree in 19977 MRTRONICS International LimitedQuality ASSURANCE MANUAL , Rev UQUALITY POLICY We will respond to the needs and expectations of our customers by: ".

The Quality Assurance program provides procedures which meet the requirements of ISO 9001, CAN3-Z299.2-1985, Z299.3-1985, Z299.4-1985, USFDA GMP, Health Canada, European Medical Device Directive 93/42/EEC and EN 46001. The Management fully endorses the Quality Assurance program as detailed in this manual. E.S. Martell Date Vice-President

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