Maps to
FDA QMSR (Part 820): §820.70(g)
ISO 13485: ISO 13485 §6.3
Requirement text
Infrastructure required for product conformity — including buildings, workspace, process equipment, and supporting services — must be determined, provided, and maintained. A preventive maintenance program must be documented and records of maintenance activities must be kept.
Atomic constraints
- •Required infrastructure including equipment must be identified and documented.
- •A preventive maintenance program must be documented for production and quality equipment.
- •Maintenance activities must be performed per defined schedules and recorded.
- •Out-of-service equipment must be identified and controlled to prevent use.
- •Equipment qualification must be documented where required for product quality.
Evidence signals
- •
FILE_EXISTS
(Preventive.*Maintenance|Equipment.*Maintenance|PM.*Schedule|Equipment.*Log|Maintenance.*Record)
- •
CONTENT_MATCH
Does this document describe equipment maintenance procedures, preventive maintenance schedules, or equipment qualification requirements?
Audit defense
Equipment infrastructure for [your product] manufacturing is maintained per [your document ID]. Our preventive maintenance program defines maintenance activities, frequencies, and acceptance criteria for all quality-affecting equipment, with records demonstrating timely completion per ISO 13485 6.3 and QMSR 820.70(g).