Equipment maintenance schedules, maintenance procedures, and records — 820.70(g) preventive maintenance discipline carries forward.
Infrastructure scope expands beyond production equipment to facilities, IT, and software; equipment qualification records required for quality-affecting systems.
IT and software infrastructure maintenance records and equipment qualification evidence — legacy PM programs covering only production equipment miss the expanded scope.
Maps to
QMSR / ISO 13485: §820.70(g) Equipment.
ISO 13485: §6.3 Infrastructure
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.
Why this clause exists
Equipment and infrastructure failures that affect production or quality operations can introduce defects at rates and in patterns that inspection cannot reliably detect after the fact. A preventive maintenance program creates a scheduled, documented basis for equipment upkeep before failure — not reactive repair after unexpected downtime or measurement error. The requirement to identify and document required infrastructure establishes the scope baseline: the organization must know which equipment and supporting services are necessary for product conformity before it can systematically maintain them. Out-of-service equipment identification and control prevents the failure mode where equipment that has been taken offline for maintenance or found defective is inadvertently returned to use without completing the required maintenance or repair; physical segregation or lockout labeling are the typical implementation controls. Maintenance records provide the historical evidence base that an auditor or investigator can use to determine whether a batch of product was produced on equipment maintained to specification, and whether a recurring defect pattern correlates with a maintenance lapse. Equipment qualification requirements — where the output of an equipment operation is used to verify conformance of a product — create a formal basis for confirming that the equipment is capable of performing the measurement or production operation to the required accuracy before it is relied upon for quality decisions.
What changed
§820.70(g) — Part 820 (legacy)
"Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use. (1) Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented. (2) Inspection. Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall be documented. (3) Adjustment. Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments."
§6.3 — ISO 13485:2016 (current)
"The organization shall document the requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of product. Infrastructure includes, as appropriate: a) buildings, workspace and associated utilities; b) process equipment (both hardware and software); c) supporting services (such as transport, communication, or information systems). The organization shall document requirements for the maintenance activities, including the interval of performing the maintenance activities, when such maintenance activities, or lack thereof, can affect product quality. As appropriate, the requirements shall apply to equipment used in production, the control of the work environment and monitoring and measurement. Records of such maintenance shall be maintained (see 4.2.5)."
Δ Infrastructure scope explicitly includes software, information systems, and supporting services beyond physical equipment; maintenance documentation is required wherever lack of maintenance could affect product quality.
Common gaps (what we see in audits)
- IT and Software Infrastructure Not in Maintenance Program — The 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 — Production 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 — Equipment 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 — HVAC 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 — Equipment is only repaired when it breaks (reactive) with no documented 'PM Schedule.' ISO 13485 §6.3 requires defined maintenance intervals.