Quality requirements

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ESOP ® HA is a registered trademark

CE 0459 FDA ESOP N° K 02 11 08 - K 02 11 09

 

AFAQ

ESOP HA production quality

Fournitures Hospitalières Industrie

Has been ISO 9001 and EN 46001 certified by AFAQ and GMED

- full production traceability with 30 year data records

- regular inspection instrument calibration by specialised firms

- personnel trained for special processes, such as cleaning (approval issued by APAVE) and anodising

FHI

Dimensional test in an air conditioned metrology lab.

Class 100 (ASTM) clean room packaging at blister pack station.

Cleaning and rinsing using demineralised water, filtered at .1 microns, treated with an ultra violet gun.

For further information on systematic, statistical and parameter inspections,

Click here