ISO 13485 · Expert · 14 min lesson
Auditing clean rooms and environmental monitoring
ISO 13485:2016 clauses 6.4.1, 6.4.2, 7.5.2 and 7.6; ISO 14644-1 and -2 (2015); ISO 14644-3 and -5; ISO 19011:2018 clause 6
What you will learn
- Audit clean room classification and monitoring records against ISO 14644-1 and -2 and clauses 6.4.1 and 6.4.2.
- Audit gowning, cleaning and microbial monitoring evidence, including the effectiveness of disinfectants.
- Audit excursions and trending, and write a finding that is graded by the effect on product.
Key takeaways
- Clause 6.4.2 requires documented contamination control for sterile devices; ISO 14644 gives the classification and monitoring method.
- A classification certificate must state the occupancy state, and the interval for reclassification must be met.
- Gowning, cleaning and disinfectant effectiveness need qualification records matched to who entered and what was used.
- Every action level result needs investigation, isolate identification where relevant, and an assessment of product before release.
- Trend reports must be signed, dated and acted on; a plan and instruments must be calibrated (clause 7.6).
Free practice question
Sorrel's class seven clean room certificate states the counts were taken at rest. The room is used for assembly of sterile implant packs, and no operational counts exist.
What is the best audit conclusion?
Compliant, because at rest counts prove the room at all times.
Not quite. ISO 14644-1 separates occupancy states, and clause 6.4.2 needs cleanliness during assembly, not only at rest.
The claim for production is not supported, because the operational state was not tested.
Correct. Clause 6.4.2 requires cleanliness to be maintained during assembly, which ISO 14644-1 operational data would show.
Nonconforming because classification is not required.
Not quite. Clause 6.4.1 requires documented environmental requirements, and ISO 14644-1 classification supports them.
Compliant if the report is signed by the manager.
Not quite. A signature does not provide evidence for the occupancy state required by clause 6.4.2.
Key terms
- occupancy state: The condition of the clean room when tested: as built, at rest or operational (ISO 14644-1).
- alert level: A set value that gives early warning of drift and triggers review before the action level is reached.
- action level: A set value which, when exceeded, requires investigation, corrective action and assessment of product.
- HEPA filter: High efficiency particulate air filter whose integrity is leak tested under ISO 14644-3 methods.
- settle plate: An open culture plate exposed for a set time to catch viable particles settling from the air.
- gowning qualification: Training plus practical demonstration that an operator can enter and work without contaminating the room.
Official sources
- ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 14644-2:2015 preview, monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
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.