Maintenance Activities

[ISO 13485 Cl 6.3]

ISO 13485:2016 Clause 6.3 emphasizes that an organization must determine, provide, and maintain the infrastructure required to ensure product conformity. “Infrastructure” here includes buildings, workspace, associated utilities, process equipment (both hardware and software), and supporting services such as transport, communication, and IT systems. The goal is to create a controlled and stable environment where medical devices can be manufactured consistently and safely.

Maintenance and Control: The organization is responsible for establishing and implementing a maintenance program that ensures all equipment and facilities remain in good working condition. Preventive maintenance schedules should be defined based on equipment criticality, usage frequency, and manufacturer recommendations. Additionally, corrective maintenance should be performed promptly when issues occur. After maintenance, equipment must be verified or validated before being used again for production to prevent nonconforming output.

Clause 6.3 ensures that organizations maintain a reliable, controlled, and compliant infrastructure that supports consistent product realization. A strong maintenance culture supported by planning, records, verification, and risk-based prioritization is fundamental to achieving ISO 13485 certification and ensuring ongoing regulatory compliance.

Frequently Asked Questions

What records are required for maintenance activities?

Organizations must maintain documented records for all maintenance performed — including schedules, work performed, responsible personnel, date, and post-maintenance verification results. These records demonstrate control and traceability and are vital evidence during regulatory and ISO audits.

How does maintenance link to product quality and risk management?

Poorly maintained equipment can lead to process deviations, contamination, or measurement errors. ISO 13485 expects organizations to integrate maintenance planning with risk management — ensuring that critical equipment is prioritized and that failures are assessed for their potential impact on product quality and patient safety.

What types of infrastructure are covered under this clause?

Clause 6.3 covers all resources necessary for product realization, including production equipment, measuring instruments, utilities (such as compressed air, water, HVAC), buildings, and supporting services like IT systems or sterilization facilities. Each must be maintained to meet operational and regulatory requirements.