ISO 13485 · Medium · 12 min lesson
IQ and OQ in depth - installation checks, worst case challenge, process window and protocol structure
ISO 13485:2016 clauses 6.3, 7.5.6 and 7.6, GHTF SG3 N99-10 (2004, 2nd edition) sections 5.2 to 5.4 and Annexes A and B
What you will learn
- Write an IQ protocol with checkable criteria for identification, documents, calibration, utilities, software, environment, safety and spares.
- Design an OQ that challenges the operating range at worst case and sets control parameters, action levels and a process window.
- Structure protocols, handle deviations, write reports and spot gaps in a draft validation document.
Key takeaways
- IQ asks whether the equipment is installed correctly; each criterion is a pass or fail check that points to evidence.
- Calibration under clause 7.6 comes first: data from an out-of-date instrument cannot support acceptance.
- OQ challenges the process under all anticipated conditions, that is worst case, and establishes control limits and action levels (GHTF 5.4).
- Designed experiments such as screening studies help choose factors and ranges when there are many inputs (GHTF Annex A).
- Acceptance criteria are objective and measurable, protocols are approved before execution, and every deviation is evaluated and concluded.
Free practice question
Lumora receives an Orion sealer with a supplier factory test report showing that it sealed 200 pouches successfully. The project lead proposes to skip the IQ and OQ on site and rely on the report.
What does GHTF section 5.3 say about this?
Use the report as a guide, but Lumora remains responsible for evaluating, challenging and testing the equipment itself.
Correct. GHTF section 5.3 says relying only on the supplier's validation is usually insufficient; the manufacturer decides suitability, as clause 7.5.6 b) implies.
The signed supplier report replaces the IQ.
Not quite. GHTF section 5.3 says supplier studies supplement the IQ but do not replace it, since the manufacturer is ultimately responsible.
The supplier report replaces the OQ but not the IQ.
Not quite. The supplier tested its own conditions, not the Lumora range; GHTF section 5.4 requires the manufacturer to challenge the process.
Any supplier report is acceptable if it is less than a year old.
Not quite. GHTF section 5.3 sets no age rule; the issue is responsibility for evaluating and testing the equipment for the specific device.
Key terms
- installation qualification (IQ): Objective evidence that equipment and ancillary systems are installed to the approved specification (GHTF 2.1).
- operational qualification (OQ): Objective evidence of process control limits and action levels that give product meeting all predetermined requirements (GHTF 2.2).
- worst case: The edges and combinations of the operating range where product is most likely to fail.
- action level: A control point inside the specification where the process is adjusted before it nears worst case.
- process window: The region of parameter settings that the OQ has proven to give conforming product.
- designed experiment: Purposely changing inputs and measuring the effect on outputs; screening finds key inputs (GHTF Annex A).
- deviation: A departure from the approved protocol that must be addressed, evaluated and concluded (GHTF 5.2).
- acceptance criteria: Objective, measurable limits set in the protocol before execution that define a successful result.
Official sources
- GHTF SG3 N99-10:2004 (Edition 2), Quality management systems - Process validation guidance
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.