Data Sheet: Services

Instrument Qualification Services
Qualify Illumina instruments with professional services direct from the manufacturer.

Highlights• Comprehensive Advantage Plan
Maximize productivity, turnaround time, and laboratorycompliance with an all inclusive service bundle• Convenient Add-ons
Add instrument qualifications to any major service event at
your convenience• Flexible A La Carte Options
Select any instrument qualification service in conjunction witha service event or as needed

Why Qualify?
As basic research extends into areas of clinical interest, manylaboratories require installation, operation, and performance
qualification of their instruments. Illumina qualification reports canbe used to satisfy the specific performance and reporting needs ofeach laboratory.

Figure 1: Qualification Services—Experienced Illumina Field Service staff
offer a range of services to help research laboratories comply with quality
requirements.

Operational Qualification (OQ)

For laboratories operating in a purely research environment, Illumina
instrument qualification services can provide peace of mind, reduce
reactive service calls, and minimize instrument down time.

OQ verifies that the overall functionality and usability of an instrument
meet the specifications of the original manufacturer. OQ can beperformed after a reactive service call, software upgrade, preventive
maintenance, or any other requested situation.

Instrument Qualification Services From theCompany You Trust

Performance Qualification (PQ)

Illumina instrument qualification services ensure that instruments
perform within specifications—maximizing productivity and turnaroundtime. Qualification services also help ensure laboratory compliance byproviding the necessary documentation to satisfy internal or externalreview. Qualification services are available in several convenient,flexible options; services can be added-on to existing service eventsor purchased a la carte on an as needed basis. With the all-inclusive
Advantage Plan, qualification services are included at the lowest
incremental cost.

Illumina Qualification Service Offerings
Illumina offers 3 types of qualification services, enabling laboratories tobalance the cost with available resources (Table 1).

Installation Qualification (IQ)
IQ provides documented evidence that equipment has been delivered
and installed correctly. Laboratories typically require IQ after initialinstallation, laboratory relocation, or major remodeling.

PQ ensures the accuracy and precision of an instrument by comparing
operating parameters against predetermined criteria. Illumina
recommends PQ after servicing or replacement of certain modules
that are critical for optimal instrument performance.

Flexible Quality Service Plans
Illumina instrument qualification services reduce service calls,instrument down time, and deliver audit-quality reports to provide
ongoing assurance of exceptional data qualify and instrumentperformance. Illumina qualification services can be obtained by any of
the following methods:•••Purchase the Illumina Advantage Plan
Add on to an existing warranty or service plan
Purchase a quality service a la carte as needed

For more information, please contact your Illumina Account Manageror Illumina Inside Sales at 1 (800) 809–4566 (toll-free), 1 (858) 202–
4566 (outside North America), or email servicecontract@illumina.com.

Data Sheet: Services

Table 1: Qualification Services

Qualification Service

Service Description

Recommended Intervals

Event-Specific Service

Installation Qualification (IQ)

Provides documented proof that
instruments have been delivered andinstalled in accordance with Illuminadetermined specifications and safety
regulations• After initial installation• After relocation and reinstallation• Before first-time use• After general changes to lab
environment (e.g., remodeling,construction, electrical disruptions)Operation Qualification (OQ)

Confirms correct functionality ofequipment. Specifications are
examined and quantified based on
manufacturing guidelines• After a reactive service, software
upgrade, or preventive maintenance• Periodically, according to lab
standard operating procedure• With an IQ to test for baseline level of
instrument performance• Before starting a major study orexperiments

Performance Qualification (PQ)

Ensures accuracy and precisionof instrument after a major service
event or replacement. parameters
are measured and compared against
predetermined criteria• After any qualified major repair• After maintenance, replacement, or
upgrade of selected modules

Illumina • 1.800.809.4566 toll-free (US) • +1.858.202.4566 tel • techsupport@illumina.com • www.illumina.com
For Research Use Only. Not for use in diagnostic procedures.
© 2015 Illumina, Inc. All rights reserved. Illumina, and the pumpkin orange color are trademarks of Illumina, Inc. and/or its affiliate(s) in the
U.S. and/or other countries. Pub. No. 070-2013-007 Current as of 22 April 2015