Department of
Microbiology Quality Manual
Section: Equipment
Prepared by: QA Committee
Issued by: Laboratory Manager
Approved by: Laboratory Director
Policy QEQMI02002.11
Page 1 of 3
Subject Title: Equipment Validation Procedure
Original Date: December 22, 2003
Revision Date:
Annual Review Date: May 31, 2013
Purpose:
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.
Procedure:
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.
UNIVERSITY HEALTH NETWORK /MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This is a CONTROLLED document. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not
controlled and should be checked against the document (titled as above) on the server prior to use.
D:\533559884.doc
Department of Microbiology
Quality Manual
Section: Equipment
Policy QEQMI02002.11
Page 2 of 3
Subject Title: Equipment Validation
Procedure
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.
UNIVERSITY HEALTH NETWORK /MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This is a CONTROLLED document. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not
controlled and should be checked against the document (titled as above) on the server prior to use.
D:\533559884.doc
Department of Microbiology
Quality Manual
Section: Equipment
Policy QEQMI02002.11
Page 3 of 3
Subject Title: Equipment Validation
Procedure
Record of Edited Revisions
Manual Section Name: Equipment
Page Number / Item
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Date of Revision
March 1, 2004
March 1, 2005
July 23, 2006
April 26, 2007
June 16, 2008
June 16, 2009
June 11, 2010
May 31, 2011
May 31, 2012
May 31, 2013
Signature of
Approval
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
UNIVERSITY HEALTH NETWORK /MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This is a CONTROLLED document. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not
controlled and should be checked against the document (titled as above) on the server prior to use.
D:\533559884.doc