Maps to
FDA QMSR (Part 820): §820.70(c)(d)
ISO 13485: ISO 13485 §6.4
Requirement text
Work environment conditions needed to achieve product conformity must be determined and managed. For sterile and implantable devices, environmental conditions must be documented and controlled. Contamination control measures must be established and maintained.
Atomic constraints
- •Work environment requirements needed for product conformity must be documented.
- •Environmental monitoring procedures must be established where environmental conditions affect product quality.
- •Contamination control procedures must be established for products sensitive to contamination.
- •Personnel health and cleanliness requirements must be documented where applicable.
- •Environmental condition records must be maintained.
Evidence signals
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FILE_EXISTS
(Environmental.*Control|Clean.*Room|Contamination.*Control|Gowning|Environmental.*Monitor)
- •
CONTENT_MATCH
Does this document describe environmental conditions, contamination control procedures, clean room requirements, or gowning requirements?
Audit defense
Work environment controls for [your product] manufacturing are documented in [your document ID]. Environmental requirements, monitoring procedures, alert/action limits, and contamination control measures are defined and maintained per ISO 13485 6.4 and QMSR 820.70(c)(d).