ISO13485 internal auditing should be conducted at least once annually for each quality management system process, but in practice, the timing of audits depends on process criticality, risk level, and organizational changes. Medical technology auditing requires a risk-based approach where critical processes are audited more frequently.
The significance of ISO13485 internal auditing for medical technology companies
Internal audits form the backbone of the quality management system in medical technology companies. They are systematic and objective evaluations of organizational operations, aimed at ensuring compliance and identifying improvement needs.
Regular audits are critical for medical technology companies for several reasons. They support compliance with regulatory requirements, such as obligations under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Audits also help prepare for external audits and certification processes.
Internal audits serve as a proactive tool that reveals potential deficiencies before they become serious problems. This is particularly important in the medical technology field, where patient safety is paramount.
How often should ISO13485 internal auditing be performed?
The ISO13485 standard requires that all quality management system processes be audited according to a planned schedule at least once annually. In practice, audit frequency is determined by a risk-based approach.
When planning the annual audit program, the criticality of processes from a patient safety perspective must be considered. For example, risk management, production processes, and corrective actions may require more frequent auditing than support functions.
Process criticality assessment takes into account:
- Impact on product safety and patient risks
- Complexity of regulatory requirements
- Previous deviations and number of findings
- Process maturity and stability
A risk-based approach enables efficient allocation of resources to areas where auditing provides the most benefit for organizational development and compliance assurance.
What situations require additional ISO13485 auditing?
Audits outside the planned audit cycle are needed in connection with significant changes or when deviations are detected that may affect quality management system functionality.
Organizational changes, such as hiring new personnel for critical roles, organizational structure changes, or management transitions, may trigger additional audit needs. Changes or expansions of facilities also require auditing.
Process changes require special attention in medical technology auditing:
- Introduction of new products
- Manufacturing process changes
- Supplier network changes
- Software updates and technology changes
Deviations and findings from external audits often serve as triggers for additional audits. If customer complaints or product returns occur more than expected, internal auditing helps clarify root causes and ensure the effectiveness of corrective actions.
Regulatory changes, such as implementation of new standards or updates to regulatory requirements, also require systematic assessment of how changes affect organizational operations and compliance.
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