Ticking-off as a necessary evil or to build a strong foundation?
Do you think Installation Qualification (IQ) is the least important part of process validation? Do you think this is just a monotonous ticking-off boxes exercise with no value?
In fact, the Installation Qualification builds a strong foundation for the manufacturer of medical devices to prevent future issues [1].
Why You Should Perform an Installation Qualification (IQ)
The ISO 13485:2016, 7.5.6 b) requires that the organization shall document procedures for equipment qualification.
There we have it: IQ is a requirement per ISO 13485.
Also, the U.S. FDA has a similar requirement under 21 CFR 820.70(g) and other regulatory bodies too.
Even though performing an IQ is required by regulation, it should not be the only reason we perform it, but more on that later.
“establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered.”
Some manufacturers divide the Installation Qualification into two separate entities: a factory acceptance test (FAT) and a site acceptance test (SAT).
FAT activities are conducted at the equipment supplier's site before shipment. These documents can then be used to supplement the Installation Qualification at the final place of operation.
However, it is most likely insufficient to only the equipment supplier's documents. Whether a piece of equipment is suitable for the manufacture of a medical device is ultimately the responsibility of the manufacturer of the medical device.
What Information to Put in an Installation Qualification (IQ)?
GHTF mentions typical IQ considerations:
- Equipment design features (i.e., materials of construction cleanability, etc.)
- Installation conditions (wiring, utilities, functionality, etc.)
- Calibration, preventative maintenance, cleaning schedules
- Safety features
- Supplier documentation, prints, drawings, and manuals
- Software documentation
- Spare parts list
- Environmental conditions (such as clean room requirements, temperature, humidity)
The ISO 11607-2:2019 adds in 5.2.1 the following IQ considerations:
- Equipment operating within the stated design parameters
- Software and/or Firmware validation
- Environmental conditions such as cleanliness, lighting
- Documented operator training
- Operating manual or procedure
Other considerations may be:
- Health
- Ergonomics
- Interfaces
- Functional Testing
Along with technical considerations, many quality management requirements can be observed.
Calibration and preventive maintenance are examples of measures that should be triggered by the quality management system.
Therefore, it must be verified that the equipment has been integrated into the appropriate systems to ensure regular tasks.
"The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented."
Not to forget that these records shall at least be readily available and traceable to national or international standards.
Why Your Visual Inspection Fails the Audit
The 6 steps that turn visual inspection into evidence that holds up – learn what auditors expect to see, the gaps they keep finding, and the framework that closes them.
Supplier Documentation
Stop Relying on Certificates – Learn the 5 Non-Negotiables Every Auditor Actually Probes
In this webinar, you'll learn the 5 Non-Negotiables that decide every ISO 13485 audit – and how to satisfy them without dragging your team onto the audit-prep treadmill.
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Risk-Based Samples Sizes
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Gain a practical framework you can confidently defend in audits across TMV, design verification, packaging, and process validation.
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Further helpful links and resources:
- SIFo Medical YouTube: Short, valuable videos on Quality Management
- Free Resources: Get free access to checklists & templates
- TMV Guides: Your practical guide to perform test method validation (incl. templates & videos)
- TMV Online Course: Become an expert in Test Method Validation
- SIFo Medical Newsletter: Subscribe to our newsletter and receive information and updates straight into your inbox.
Are you unsure how to perform an Installation Qualification yourself?
Contact us today at office@sifo-medical.com, and we'll gladly support you with Installation Qualification.
References
[1] Quality-on-site.com, “ISO 14971 Risk Management Presentation,” [Online]. Available: http://www.quality-on-site.com/get.php?fileid=139. [Accessed: Aug. 7, 2025].
[2] Global Harmonization Task Force (GHTF), “Quality Management System – Process Validation Guidance,” GHTF/SG3/N99-10:2004, 2004. [Online]. Available: http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf.[Accessed: Aug. 7, 2025].
[3] International Organization for Standardization, ISO 11607-2:2019 — Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes, Geneva, Switzerland: ISO, 2019.
[4] International Organization for Standardization, ISO 13485:2016 — Medical devices – Quality management systems – Requirements for regulatory purposes, Geneva, Switzerland: ISO, 2016.
[5] U.S. Food and Drug Administration, “Quality System Regulation – 21 CFR Part 820,” [Online]. Available: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1. [Accessed: Aug. 7, 2025].