Maps to
QMSR / ISO 13485: §820.70(g)
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.
What changed
Part 820 section 820.70(g) required that each manufacturer establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met, and that these maintenance activities are documented. This was a focused, prescriptive requirement specifically about production equipment maintenance schedules.
ISO 13485 section 6.3 takes a broader view. It requires the organization to determine, provide, and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure is defined to include: (a) buildings, workspace, and associated utilities, (b) process equipment (both hardware and software), and (c) supporting services such as transport, communication, or information systems. The maintenance requirement extends beyond production equipment to encompass all infrastructure that affects product conformity.
For software-as-a-medical-device (SaMD) companies and companies with significant software components, this broader scope is significant. Infrastructure now explicitly includes IT systems, servers, development environments, cloud infrastructure, and communication systems. The requirement to 'maintain' these systems means documented maintenance activities — patching schedules, backup procedures, infrastructure monitoring, and disaster recovery testing are within scope.
The preventive maintenance aspect remains central but is framed differently. Under ISO 13485, the emphasis is on documenting maintenance requirements and demonstrating that maintenance is performed. Under Part 820.70(g), the emphasis was on schedules and specifications. Practically, the requirements are similar for traditional manufacturing equipment, but the ISO 13485 framing extends maintenance responsibilities to supporting infrastructure that Part 820 did not explicitly cover.
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.
Common gaps
IT and Software Infrastructure Not in Maintenance Program
moderateThe preventive maintenance program covers production equipment (mixers, molding machines, sterilizers) but does not include IT infrastructure (servers, network equipment, cloud services) or software systems (ERP, eQMS, LIMS) that directly affect product quality or QMS operation.
Equipment Qualification Records Missing
moderateProduction equipment is maintained per schedule but was never formally qualified (IQ/OQ/PQ) when installed. Maintenance records exist but there is no baseline qualification demonstrating the equipment meets required specifications before being placed into production use.
Out-of-Service Equipment Not Controlled
moderateEquipment removed from service for maintenance, repair, or calibration failure is not physically or systemically segregated to prevent inadvertent use. There is no labeling system or status tracking for equipment that is temporarily unavailable.
Missing 'Facility' maintenance records
moderateHVAC filters or water systems are serviced, but no 'Quality Record' is maintained within the QMS. ISO 13485 §6.3 requires maintenance records for infrastructure.
No 'Preventive' maintenance schedule
moderateEquipment is only repaired when it breaks (reactive) with no documented 'PM Schedule.' ISO 13485 §6.3 requires defined maintenance intervals.
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).