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ISO 9001 and 13485 certificates issued to Medikro |
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Wednesday, 17 January 2007 |
VTT has certified Medikro's Quality Management System as complying with the ISO 9001:2000 and ISO 13485:2003 standards
ISO 13485:2003 quality standard is particularly issued to the manufacturers of medical devices and equipment. ISO 9001:2000 is universal quality management standard which impresses also customer satisfaction and continuous improvements.
Medikro Quality Management System assures high quality from the early developing phase to the final product quality assurance and customer feedback system. Besides ISO certificates, Medikro's Quality Management System is already certified according to Medical Device Directive (MDD 93/42/EEC).
The certificate is given by independent certification body. The certificate gives evidence that Medikro is committed to the principles and goals required by the standards. Besides the audit before certification, the certification body regularly follows up Medikro's operations development.
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