Calibration Of Medical Equipment Policy

Accredited calibration lab the calibration laboratory must be iso 9001 2008 accredited or be the original equipment manufacturer.

Calibration of medical equipment policy.

Environment of care policy no. At present nabl has accredited about 5 000 laboratories in india relia said. Medical equipment management 6 ensure that qualified personnel inspect test and maintain all medical equipment diagnostic therapeutic life support and monitoring. Equipment calibration must be carried out routinely as per the company s written directions.

In a nutshell fda guidelines for calibration of a medical device require the following. Calibrationhouse is able to calibrate your medical test equipment with a 3 day turnaround or visit you on site to reduce the downtime of your critical equipment. The committee produced the first national medical equipment policy in 1991 which assisted both government and non government agencies to rationalize procurement and management of medical equipment. The procedure that is used to inspect measure and test equipment should be traceable to national or international standards.

A top priority for medical device manufacturers is the health and safety of patients and the accuracy and precision of the instruments used in production is of the utmost importance. Comprehensive equipment list to pass the iso audit the company must demonstrate that it has a comprehensive equipment list with controls in place for additions subtractions and custodianship of equipment. The medicines healthcare products regulatory agency mhra requirements state that healthcare organisations are responsible for ensuring their medical. Over the years the medical equipment policy and guidelines have been reviewed to update equipment specifications so as to conform to.

If errors are noticed adjustments and repairs need to be made followed by re calibration to verify the accuracy of calibrated equipment. Medical equipment management plan cross reference. The accuracy provided by such medical equipment was crucial to the overall output with respect to both quality and profitability. Calibration of medical devices and manufacturing equipment needs to be performed on a routine basis by trained and certified professionals.

Consider contracting the services of an approved biomedical engineering company to assist with equipment testing and maintenance. Regular calibration was required to receive necessary certifications and licenses from regulatory authorities he said. Medical equipment calibration calibration and asset management for medical device manufacturers. We have decades of experience managing calibration programs in.