Department of Microbiology
Quality Manual / Policy QEQMI02002.11 / Page 3 of 3
Section: Equipment / Subject Title: Equipment Validation Procedure


The objective is to ensure an optimal working instrument providing accurate qualitative and/or quantitative results prior to implementation.

·  Validate and calibrate all equipment used in the department.

·  This will be done on site prior to implementation of the item to ensure that it meets the manufacturer’s performance claims.

·  Where possible the department will use control material of known values for calibration and quality control of the instruments. Commercial control material will be used when available. If commercial control is not available, known positive and negative material will be used.


1.  All tests on the instrument should be validated on newly acquired instruments before they are placed into routine use.

2.  A validation study will be performed to compare results with the existing methodology where applicable.

3.  The number of samples used for validation depends on:

·  the manufacturer’s recommendation

·  regulatory guidelines such as NCCLS, QMPLS, CAP

·  the prevalence of the disease

·  the availability for an external validation panel

4.  All validation test runs will include external and internal controls.

5.  Samples with discrepant results will be sent to a Reference Laboratory for further investigation.

6.  The acceptance of the new method/equipment/instrument depends on the review of all comparison results.

7.  Instruments that have undergone repairs and preventive maintenances should be re-validated by running both external and internal controls. These controls must fall within the acceptable limits. Test LIS interface if applicable.

8.  Embedded software updates must be validated according to the manufacturer’s instructions. The LIS officers must be informed of all such updates so that they can validate results sent through all interfaces.

Record of Edited Revisions

Manual Section Name: Equipment

Page Number / Item / Date of Revision / Signature of Approval
Annual Review / March 1, 2004 / Dr. T. Mazzulli
Annual Review / March 1, 2005 / Dr. T. Mazzulli
Annual Review / July 23, 2006 / Dr. T. Mazzulli
Annual Review / April 26, 2007 / Dr. T. Mazzulli
Annual Review / June 16, 2008 / Dr. T. Mazzulli
Annual Review / June 16, 2009 / Dr. T. Mazzulli
Annual Review / June 11, 2010 / Dr. T. Mazzulli
Annual Review / May 31, 2011 / Dr. T. Mazzulli
Annual Review / May 31, 2012 / Dr. T. Mazzulli
Annual Review / May 31, 2013 / Dr. T. Mazzulli


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